Regulatory Notes

HEADS UP - July 26, 2010

 

Notices of Compliance - July 19 - 23, 2010

• Dexilant (dexlansoprazole) was approved as a proton pump inhibitor on 2010-07-22.

News from Health Canada

Health Canada

Foreign Product Alerts: Health Canada has issued the following Foreign Product Alerts.

http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2010/2010-132-eng.php
(Huo Luo Jing Dan)

http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2010/2010-133-eng.php
(Kam Chik San)

http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2010/2010-134-eng.php
(Magic Power Coffee)

http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2010/2010-135-eng.php
(Que She)

http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2010/2010-136-eng.php
(Sheng Yuan Fang)

Counterfeit Product: Health Canada is informing Canadians that Marché Euromix, a retail store in Pierrefonds (Montréal), was found to be selling a health product that was not authorized for sale by Health Canada and that closely resembled in appearance an authorized drug, Viagra.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2010/2010_130-eng.php

Biologics and Genetic Therapies Directorate (BGTD)

Summary Basis of Decision: A Summary Basis of Decision (SBD) is available for Ixiaro.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/phase1-decision/drug-med/sbd_smd_2010_ixiaro_120330-eng.php

Natural Health Products Directorate (NHPD)

Report: The Natural Health Products Directorate's Status of Applications Quarterly Report for the period of April 1, 2010 to June 30, 2010 (Quarter 1 of the 2010-2011 fiscal year) is available. 
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/report-rapport/qar_tri_1-10-eng.php

Therapeutic Products Directorate (TPD)

Consumer Health Advisory

Relistor: Wyeth Canada (a Pfizer Company), in collaboration with Health Canada, is advising consumers of important updates to the prescribing information for Relistor.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/public/_2010/relistor_pc-cp-eng.php

Health Care Professional Advisory

Relistor: Wyeth Canada (a Pfizer Company), in collaboration with Health Canada, would like to inform you of important new safety information added to the Product Monograph for Relistor® (methylnaltrexone bromide) Subcutaneous Injection.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2010/relistor_hpc-cps-eng.php

Rotarix: GlaxoSmithKline Inc. (GSK), in consultation with Health Canada, would like to inform health care professionals of new information on the composition of its Human Rotavirus vaccine, Rotarix™ (live, attenuated, oral vaccine).
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2010/rotarix_hpc-cps-eng.php

RotaTeq: Merck Frosst Canada Ltd., in consultation with Health Canada, would like to inform you of important new information regarding the presence of DNA from porcine circovirus types 1 and 2 (PCV1 and PCV2) in RotaTeq® (rotavirus vaccine, live, oral, pentavalent).
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2010/rotateq_hpc-cps-eng.php

Form: The Canada Vigilance Adverse Reaction Reporting Form is available.
http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/ar-ei_form-eng.php

National Interest

Federal Government

Chemical Substances Challenge: The Minister of the Environment and the Minister of Health published 11 Notices in the Canada Gazette, Part I, concerning the final screening assessment reports for 13 substances in the eighth batch of substances identified under the Challenge component of the Chemicals Management Plan.
http://www.chemicalsubstanceschimiques.gc.ca/challenge-defi/batch-lot-8/index-eng.php

Chemical Substances Challenge: The Minister of the Environment and the Minister of Health published a Notice in the Canada Gazette, Part I, concerning the draft assessment report on quinoline. The risk management scope document was also released for a 60-day public comment period.
http://www.chemicalsubstanceschimiques.gc.ca/challenge-defi/quinoline-quinoleine-eng.php

GAZETTE I

Canadian Environmental Protection Act, 1999: The Ministers of the Environment and of Health propose to recommend to Her Excellency the Governor in Council that quinoline be added to Schedule 1 to the Act. A risk management scope document for this substance has been published to initiate discussions with stakeholders on the development of a risk management approach.
http://www.gazette.gc.ca/rp-pr/p1/2010/2010-07-31/html/index-eng.html

Canadian Environmental Protection Act, 1999: The Final Decision after Screening Assessment of Substances in Batch 8 of the Chemical Substances Challenges is available.
http://www.gazette.gc.ca/rp-pr/p1/2010/2010-07-31/html/sup2-eng.html

Canadian Agency for Drugs and Technologies in Health (CADTH)

Newsletter: The August 4, 2010 COMPUS Communiqué - Vol. 5, No. 10 is available.
http://www.cadth.ca/index.php/en/compus/compus-communique/compus-communique-5-10

Reports: The following reports are available.

http://www.cadth.ca/media/pdf/m0018_egfr_economic_framework_htis-3.pdf
(Epidermal Growth Factor Receptor Mutation Analysis in Advanced Non-Small Cell Lung Cancer: Review of Economic Evaluations and Framework for Economic Analyses)

http://www.cadth.ca/media/pdf/k0225_biologics_dose_creep_htis-1-5.pdf
(Increased Dose or Decreased Dosing Interval of Biologics: Clinical Effectiveness)

http://www.cadth.ca/media/pdf/l0199_hemoglobin_screening_htis-2.pdf
(Methods to Screen for Hemoglobin S in Blood Donors Selected for Exchange Transfusions: A Review of the Clinical Effectiveness and Guidelines)

http://www.cadth.ca/media/pdf/k0228_pregabalin_treatment_fibromyalgia_htis-1-5.pdf
(Pregabalin Treatment for Patients with Fibromyalgia: Clinical Effectiveness)

http://www.cadth.ca/media/pdf/M0017_EGFR_Testing_for_NSCLC_e.pdf
(Epidermal Growth Factor Receptor Mutation Analysis in Advanced Non-Small Cell Lung Cancer: A Review of the Clinical Effectiveness and Guidelines)

http://www.cadth.ca/media/pdf/M0015_PET_for_Cardiology_e.pdf
(Positron Emission Tomography for Cardiovascular Disease: A Review of the Clinical Effectiveness)

The Patented Medicine Prices Review Board (PMPRB)

Voluntary Compliance Undertaking: The Vice-Chairperson of the Board accepted a Voluntary Compliance Undertaking (VCU) for Vancocin.
http://www.pmprb-cepmb.gc.ca/english/view.asp?x=271&id=189

Voluntary Compliance Undertaking: The Vice-Chairperson of the Board accepted an amendment to the Voluntary Compliance Undertaking (VCU) for Andriol.
http://www.pmprb-cepmb.gc.ca/english/view.asp?x=271&id=190

Newsletter: The July 2010 issue of the PMPRB NEWSletter is available.
http://www.pmprb-cepmb.gc.ca/cmfiles/newsletter/News-Jul2010-v14n3-e.pdf

National Association of Pharmacy Regulatory Authorities (NAPRA)

Meeting: The next meeting of the National Drug Scheduling Advisory Committee (NDSAC) is scheduled for September 12, 2010. The primary purpose of the meeting is to consider the following matter:

• Request for a change in scheduling of naproxen sodium 220 mg per tablet to Unscheduled.

http://napra.ca/pages/home/default.aspx?id=2746

 

~~~~~

 

HEADS UP - July 12, 2010

 

Notices of Compliance - July 5 – 9, 2010

• Renvela (sevelamer carbonate) was approved as a phosphate binder on 2010-07-07.

News from Health Canada

Biologics and Genetic Therapies Directorate (BGTD)

Announcement: Health Canada has announced the upcoming launch of the updated version of the Notice of Compliance (NOC) Online Database and the addition of Weekly Data Extracts which will replace the current NOC Listings.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/announce-annonce/nocd_notice_acd_avis-eng.php

Natural Health Products Directorate (NHPD)

Announcement: The new Natural Health Products Directorate Electronic Subscriber Service allows stakeholders to subscribe to receive NHPD messages, commonly known as “BEEPs”.
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/activit/list/index-eng.php

Therapeutic Products Directorate (TPD)

Register of Innovative Drugs: The Register of Innovative Drugs has been updated.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/regist/reg_innov_dr-eng.php

Record of Proceedings: A Record of Proceedings is available for the June 11, 2010 meeting of the Scientific Advisory Panel on Bioequivalence Requirements for Modified-Release Dosage Forms (SAP-MRDF).
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/sci-consult/mrdf-fplm/sapmrdf_rop_gscfplm_crd_2010-06-11-eng.php

National Interest

Pharmaceutical Advertising Advisory Board (PAAB)

Announcement: As part of the PAAB continuous quality improvement program, the reviewers will not be available for questions or doing reviews on August 11 and August 26, 2010.
http://www.paab.ca/en/what_is_new/

Canadian Agency for Drugs and Technologies in Health (CADTH)

Nominations: The Canadian Agency for Drugs and Technologies in Health (CADTH) has issued a call for nominations for the Drug Policy Advisory Committee.
http://www.cadth.ca/index.php/en/media-centre/2010/07/21/225

Reports: The following reports are available.

http://www.cadth.ca/media/pdf/l0198_optimal_ordering_di_tests_htis-2.pdf
(Optimizing the Implementation of Diagnostic Imaging Decision Support Tools: A Review of the Evidence and Guidelines)

http://www.cadth.ca/media/pdf/k0217_noscomial_infections_mixed_medical-surgical_htis-1-5.pdf
(Risk of Nosocomial Infections in Surgical Patients Residing on the Same Unit as Non-surgical Patients: Clinical and Cost-Effectiveness and Guidelines)

http://www.cadth.ca/media/pdf/j0454_poc_pre-hospital_testing_htis-1.pdf
(Point of Care Troponin I and Myoglobin Testing in a Pre-hospital Setting: Clinical Effectiveness and Guidelines)

http://www.cadth.ca/media/pdf/l0194_negative_pressure_therapy_htis-2.pdf
(Negative Pressure Therapy for Patients Infected Wounds: A Review of the Clinical and Cost-Effectiveness Evidence and Recommendations for Use)

http://www.cadth.ca/media/pdf/j0455_thermal_stability_guidelines_htis-1.pdf
(Thermal Stability of Urgent-Care Medications: Guidelines)

http://www.cadth.ca/media/pdf/k0219_pre-hospital_orthopedic_pain_management_htis-1-5.pdf
(Pre-Hospital Orthopedic Pain Management: Clinical Effectiveness and Guidelines)

http://www.cadth.ca/media/pdf/l0195_phosphodiesterase_5_inhibitors_htis-2.pdf
(Phosphodiesterase 5 Inhibitors: A Review of the Clinical Effectiveness and Cost-Effectiveness)

Canadian Institutes of Health Research (CIHR)

Announcement: Genome Canada and the Canadian Institutes of Health Research (CIHR) are pleased to announce a partnered program called “Advancing Technology Innovation through Discovery”. 
http://www.genomecanada.ca/en/medias/news.aspx?i=359

 

~~~~~

 

HEADS UP - July 5, 2010

 

Notices of Compliance - June 28 – July 2, 2010

• Invega Sustenna (paliperidone (supplied as paliperidone palmitate)) was approved as an antipsychotic agent on 2010-06-30.

News from Health Canada

Health Canada

Foreign Product Alerts: Health Canada is advising consumers not to use the following products due to concerns about possible side-effects.

http://hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2010/2010-122-eng.php
(Vitalex for men and Vitalex for women)

http://hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2010/2010-121-eng.php
(Stallion, SZM Formula for Men, Tomcat Ali and Volcanic)

http://hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2010/2010-120-eng.php
(Update: Atlas Operations Inc. expands its U.S. recall of over 30 sexual enhancement supplements)

http://hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2010/2010-119-eng.php
(USA Yaku Cell Slimming Capsules, Dong Gua Pai You Su, Qing Gua Pai You Su, and Mu Gua Pai You Su)

http://hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2010/2010-118-eng.php
(1 Body Beautiful)

Rosiglitazone Drugs: Information is available on the status of Rosiglitazone Drugs (Avandia®, Avandamet®, and Avandaryl™) in Canada.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2010/2010_116-eng.php

Unapproved Health Product: The unapproved health product, UP Ultimate Performance for Men, may pose serious health risks.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2010/2010_117-eng.php

Biologics and Genetic Therapies Directorate (BGTD)

Notice of Decision: A Notice of Decision was issued for Berinert.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/phase1-decision/drug-med/nd_ad_2010_berinert_121221-eng.php

Natural Health Products Directorate (NHPD)

Video: Health Canada has released the video: Read the Label - Natural Health Products.
http://www.hc-sc.gc.ca/ahc-asc/media/video/info_label-etique_video-eng.php

Therapeutic Products Directorate (TPD)

Scientific Advisory Panel: The Membership List and Biographies are available for the Scientific Advisory Panel on Bioequivalence Requirements for Modified-Release Dosage Forms (SAP-MRDF).
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/sci-consult/mrdf-fplm/index-eng.php

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/sci-consult/mrdf-fplm/sapmrdf_gcsfplm_ai-eng.php
(Summary of Expertise, Experience and Affiliations and Interests for the Scientific Advisory Panel on Bioequivalence Requirements for Modified Release Dosage Forms (SAP-MRDF))

Notice of Decision: A Notice of Decision has been issued for the Pipeline Embolization Device.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/phase1-decision/md-im/nd_ad_2010_pipeline_embolization_148227-eng.php

Newsletter: The July 2010 issue of the Canadian Adverse Reaction Newsletter, Volume 20 - Issue 3 is available.
http://www.hc-sc.gc.ca/dhp-mps/medeff/bulletin/carn-bcei_v20n3-eng.php

Record of Decision: A Record of Decision is available for the November 25, 2009 meeting between Health Canada and the Groupement provincial de l'industrie du médicament (GPIM).
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/assoc/2009-11-25-eng.php

Templates: The following templates have been updated.

-Dear Health Care Professional Letter Templates:

http://www.hc-sc.gc.ca/dhp-mps/pubs/medeff/_guide/2010-guid-dir_indust_hppc-cpsp/2010-temp-mod_dhcpl-aps_hp-ps-eng.php
(Health Products - Dear Health Care Professional Letter Template)

http://www.hc-sc.gc.ca/dhp-mps/pubs/medeff/_guide/2010-guid-dir_indust_hppc-cpsp/2010-temp-mod_dhcpl-aps_md-im-eng.php
(Medical Devices - Dear Health Care Professional Letter Template)

http://www.hc-sc.gc.ca/dhp-mps/pubs/medeff/_guide/2010-guid-dir_indust_hppc-cpsp/2010-temp-mod_dhcpl-aps_vacc-eng.php
(Vaccines - Dear Health Care Professional Letter Template)

-Notice to Hospitals Templates:

http://www.hc-sc.gc.ca/dhp-mps/pubs/medeff/_guide/2010-guid-dir_indust_hppc-cpsp/2010-temp-mod_nh-ah_hp-ps-eng.php
(Health Products - Notice to Hospitals Template)

http://www.hc-sc.gc.ca/dhp-mps/pubs/medeff/_guide/2010-guid-dir_indust_hppc-cpsp/2010-temp-mod_ntoh-ah_md-im-eng.php
(Medical Devices - Notice to Hospitals Template)

http://www.hc-sc.gc.ca/dhp-mps/pubs/medeff/_guide/2010-guid-dir_indust_hppc-cpsp/2010-temp-mod_nh-ah_vacc-eng.php
(Vaccines - Notice to Hospitals Template)

-Public Communication Templates:

http://www.hc-sc.gc.ca/dhp-mps/pubs/medeff/_guide/2010-guid-dir_indust_hppc-cpsp/2010-temp-mod_pc-cp_hp-ps-eng.php
(Health Products - Public Communication Template)

http://www.hc-sc.gc.ca/dhp-mps/pubs/medeff/_guide/2010-guid-dir_indust_hppc-cpsp/2010-temp-mod_pc-cp_md-im-eng.php
(Medical Devices - Public Communication Template)

http://www.hc-sc.gc.ca/dhp-mps/pubs/medeff/_guide/2010-guid-dir_indust_hppc-cpsp/2010-temp-mod_pc-cp_vacc-eng.php
(Vaccines - Public Communication Template)

National Interest

Pharmaceutical Advertising Advisory Board (PAAB)

Newsletter: The July 2010 issue of the PAAB Review is available.
http://www.paab.ca/local/files/PAAB%20Review%20Newsletter%20E.pdf

Canadian Agency for Drugs and Technologies in Health (CADTH)

Reports: The following reports are available.

http://www.cadth.ca/media/pdf/l0193_silver_dressings_htis-2.pdf
(Silver Dressings for the Treatment of Patients with Infected Wounds: A Review of Clinical and Cost-Effectiveness)

http://www.cadth.ca/media/pdf/k0222_quetiapine_the_inmate_population_htis-1-5.pdf
(Quetiapine Use in Correctional Facilities: Clinical Evidence, Abuse Potential, and Guidelines)

http://www.cadth.ca/media/pdf/k0218_non_dehp_and_totm_intravenous_tubing_htis-1-5.pdf
(Intravenous Tubing for Paclitaxel, Docetaxel, and Etoposide for Adult Patients in an Ambulatory Care Oncology Setting: Clinical Evidence and Guidelines)

http://www.cadth.ca/media/pdf/l0200_telepathology_htis-2.pdf
(Telepathology: A Review of the Clinical Effectiveness, Cost-Effectiveness, and Guidelines)

http://www.cadth.ca/media/pdf/j0457_range_motion_patients_with_ms_htis-2.pdf
(Range of Motion Therapy for Patients with Multiple Sclerosis: Clinical Effectiveness and Guidelines)

http://www.cadth.ca/media/pdf/j0453_pre_and_probiotics_celiac_htis-1.pdf
(Prebiotic and Probiotic Supplements for Patients with Celiac Disease: Clinical Effectiveness)

http://www.cadth.ca/media/pdf/l0197_cannabinoids_neuropathic_pain_htis-2.pdf
(Cannabinoids for the Management of Neuropathic Pain: Review of Clinical Effectiveness)
 

 

~~~~~

 

HEADS UP - June 28, 2010

 

Notices of Compliance - June 21 - 25, 2010

• FluMist (Influenza Virus Type A (H1N1), Influenza Virus Type A (H3N2), Influenza Virus Type B) was approved as an influenza vaccine on 2010-06-22.

News from Health Canada

Health Canada

Foreign Product Alerts: The following Foreign Product Alerts have been issued.

http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2010/2010-113-eng.php
(LiPO-4 Cap, LiPO-8 Cap and Glucomi 600 Cap)

http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2010/2010-114-eng.php
(Po Chai Pills (capsule form))

http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2010/2010-115-eng.php
(Stud Capsule for Men)

Marketed Health Products Directorate (MHPD)

Mutual Recognition Agreements: Health Canada has issued updates on Mutual Recognition Agreements.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/int/mra-arm/update-miseajour/index-eng.php

Natural Health Products Directorate (NHPD)

Agenda: The agenda is available for the June 14 and 15, 2010 meeting of the Natural Health Products Program Advisory Committee: Meeting #5.
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/activit/com/program-14-06-2010-eng.php

Therapeutic Products Directorate (TPD)

Meeting: A Record of Decision is available for the February 10, 2010 meeting between Health Canada and Canada's Medical Device Technology Companies (MEDEC).
http://www.hc-sc.gc.ca/dhp-mps/md-im/activit/meet-reunion/2010-02-10-eng.php

Draft Guidance: The draft Guidance: Labelling of Pharmaceutical Drugs for Human Use is available.
http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/consult-draft_ebauche_label_guide-eng.php

Guidance: The Guidance Document for Industry: Issuance of Health Professional Communications and Public Communications by Market Authorization Holders is available.
http://www.hc-sc.gc.ca/dhp-mps/pubs/medeff/_guide/2010-guid-dir_indust_hppc-cpsp/index-eng.php

Summary Basis of Decision: A Summary Basis of Decision (SBD) is available for Afinitor.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/phase1-decision/drug-med/sbd_smd_2010_afinitor_125809-eng.php

Summary Basis of Decision: A Summary Basis of Decision (SBD) is available for Onglyza.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/phase1-decision/drug-med/sbd_smd_2010_onglyza_123854-eng.php

Summary Basis of Decision: A Summary Basis of Decision (SBD) is available for Vidaza.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/phase1-decision/drug-med/sbd_smd_2010_vidaza_127108-eng.php

Summary Basis of Decision: A Summary Basis of Decision (SBD) is available for Vyvanse.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/phase1-decision/drug-med/sbd_smd_2010_vyvanse_120534-eng.php

National Interest

Federal Government

Chemical Substances Challenge: A new Risk Management Action Milestones table for Batch 1 substances has been published.
http://www.chemicalsubstanceschimiques.gc.ca/challenge-defi/summary-sommaire/batch-lot-1/action-tab-eng.php

Chemical Substances Challenge: The Summary Report for the February 19, 2010 meeting of the Challenge Advisory Panel and the Government response to recommendations from the Challenge Advisory Panel pertaining to Batch 9 substances are now available.
http://www.chemicalsubstanceschimiques.gc.ca/challenge-defi/panel-groupe/meet-reunion-eng.php

Canadian Intellectual Property Office (CIPO)

Pre-Consultation Notice: CIPO is now embarking on a new fee review with implementation by 2012-2013.
http://www.cipo.ic.gc.ca/eic/site/cipointernet-internetopic.nsf/eng/wr02572.html

Canadian Agency for Drugs and Technologies in Health (CADTH)

Reports: The following reports are available.

http://www.cadth.ca/media/pdf/L0192_patient_lifts_htis-2.pdf
(Patient Lifts and Transfer Equipment: A Review of Clinical and Cost-Effectiveness and Guidelines)

http://www.cadth.ca/media/pdf/j0452_opiate_related_dental_decay_htis-1.pdf
(Opiate-Related Dental Decay: Clinical Evidence)

http://www.cadth.ca/media/pdf/k0216_choking_swallowing_assessments_ltc_this-1-5.pdf
(Choking and Swallowing Assessments in Long Term Care: Clinical Indications and Guidelines)

http://www.cadth.ca/media/pdf/j0451_laser_therapy_stretch_marks_htis-1.pdf
(Laser Therapy for Stretch Marks: Clinical Effectiveness and Guidelines)

The Patented Medicine Prices Review Board (PMPRB)

Notice of Vacancy: A Notice of Vacancy is being issued to assist the Governor in Council in identifying qualified candidates for the position of Chairperson and Member of the Board.
http://www.pmprb-cepmb.gc.ca/english/view.asp?x=271&id=184

 

~~~~~

 

HEADS UP - June 21 , 2010

 

Notices of Compliance - June 14 - 18, 2010

• There were no relevant updates to the NOCs this week.

News from Health Canada

Health Canada

Announcement: On June 26, the Honourable Leona Aglukkaq, Minister of Health, and the Honourable Jim Prentice, Minister of the Environment, celebrated the achievement of another critical milestone in Canada's world-leading Chemicals Management Plan (CMP).
http://www.hc-sc.gc.ca/ahc-asc/media/nr-cp/_2010/2010_110-eng.php

Therapeutic Products Directorate (TPD)

Annual Report: The TPD Annual Report 2007-2008 is available.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/docs/tpd_rep_dpt_rap_2007-2008-eng.php

Register of Innovative Drugs: The Register of Innovative Drugs has been updated.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/regist/reg_innov_dr-eng.php

Notice: A Notice has been issued regarding revisions to the Clinical Trial Application Guidance Documents for Clinical Trial Sponsors.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/clini/notice_cta_dec_avis2-eng.php

Notice of Decision: A Notice of Decision is available for Menveo.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/phase1-decision/drug-med/nd_ad_2010_menveo_127046-eng.php

Notice of Decision: A Notice of Decision has been issued for Victoza.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/phase1-decision/drug-med/nd_ad_2010_victoza_119928-eng.php

Record of Discussions: A Record of Discussions is available for the April 20, 2010 meeting between the Canadian Advertising Preclearance Agencies and Health Canada.
http://www.hc-sc.gc.ca/dhp-mps/advert-publicit/meet-reunion/rod-rdd_2010_04_20-eng.php

National Interest

Federal Government

Chemical Substances Challenge: The Minister of the Environment and the Minister of Health published seven Notices in the Canada Gazette, Part I, concerning the draft screening assessment reports for the 12 substances in Batch 10 of the Challenge together with the additional cobalt sulfate. The proposed risk management scope document was also released for 60-day public comment period.
http://www.chemicalsubstanceschimiques.gc.ca/challenge-defi/batch-lot-10/index-eng.php

GAZETTE I

Canadian Environmental Protection Act, 1999: Publication after screening assessment of substances in Batch 10 of the Chemical Substances Challenge and publication of results of investigations and recommendations for a substance are available in the Canada Gazette I.
http://canadagazette.gc.ca/rp-pr/p1/2010/2010-06-26/html/index-eng.html

Canadian Agency for Drugs and Technologies in Health (CADTH)

Reports: The following reports are available.

http://www.cadth.ca/media/pdf/j0449_venous_ligation_stripping_procedures_htis-1.pdf
(Anesthesia for Venous Stripping and Ligation Procedures: Clinical Effectiveness, Safety, Cost-Effectiveness, and Guidelines)

http://www.cadth.ca/media/pdf/M0016_HBOT_L3_e.pdf
(Hyperbaric Oxygen Therapy for Difficult Wound Healing: Systematic Review of Clinical Effectiveness and Cost-Effectiveness)

http://www.cadth.ca/media/pdf/j0445_cannabinoids_co-analgesics_htis-1.pdf
(Cannabinoids as Co-Analgesics: Clinical Effectiveness)

http://www.cadth.ca/media/pdf/k0207_prioritization_speech_language_pathology_htis-1-5.pdf
(Prioritization Tools for Speech Language Pathology: Clinical Effectiveness and Guidelines)

http://www.cadth.ca/media/pdf/l0191_chair_alarms_htis-2.pdf
(Chair Alarms in Residential Care and Acute Care: A Review of the Clinical Effectiveness and Safety)

http://www.cadth.ca/media/pdf/l0189_bupropion_adhd_htis-2.pdf
(Bupropion for Adults with Attention Deficit Hyperactivity Disorder: A Review of the Clinical Effectiveness and Harms of Misuse)

http://www.cadth.ca/media/pdf/l0190_deep_brain_stimulation_htis-2.pdf
(Deep Brain Stimulation for Parkinson’s Disease and Neurological Movement Disorders: A Review of the Clinical and Cost-Effectiveness and Guidelines)

http://www.cadth.ca/index.php/en/hta/reports-publications/search/publication/1794
(Issue 8: Reprocessing Single-Use Medical Devices: An Update of the Clinical Evidence and an Environmental Scan of Policies in Canada)

http://www.cadth.ca/index.php/en/hta/reports-publications/search/publication/1800
(Issue 9: Endovascular Repair for Abdominal Aortic Aneurysm)

http://www.cadth.ca/media/pdf/j0448_physiotherapy_low_back_pain_htis_1.pdf
(Physiotherapy Versus Other Treatment Modalities for Chronic Low Back Pain: Comparative Clinical Effectiveness)

http://www.cadth.ca/media/pdf/k0209_managing_agitation_older_patients_htis_1-5.pdf
(Short-acting Benzodiazepines versus other Strategies for the Management of Agitation in Older Patients: Clinical Effectiveness and Guidelines)

http://www.cadth.ca/media/pdf/k0211_green_light_laser_htis_1-5.pdf
(Photoselective Vaporization of the Prostate with Green Light Laser for the Treatment of Benign Prostatic Hypertrophy: Clinical Effectiveness, Cost-Effectiveness, and Safety)

http://www.cadth.ca/media/pdf/k0212_hemoglobinometer_iron_deficiency_anemia_htis_1-5.pdf
(Hemoglobinometer for Monitoring of Iron Status, Iron Deficiency and Iron Deficiency Anemia: Clinical Effectiveness)

http://www.cadth.ca/media/pdf/k0213_iron_supplements_iron_deficiency_anemia_final.pdf
(Prescribed Iron Supplements, Natural Products, and Intravenous Iron for the Treatment of Iron Deficiency Anemia: Comparative Clinical Effectiveness and Guidelines)
 

 

~~~~~

 

HEADS UP - June 14, 2010

Notices of Compliance - June 7 - 11, 2010

• There were no new Notices of Compliance posted for this week.

On the Move

  • Several organizational changes and staff appointments have been made to reflect CADTH’s “Next Chapter” initiatives.
  • Barb Shea (former Acting Senior Vice-President, Science Directorates) was appointed Vice-President, Products and Services, with oversight of CADTH’s drug formulary recommendation service, the rapid review service, health technology assessment program, and the optimal use program.
  • Denis Bélanger (former Acting Senior Director, Canadian Optimal Medication Prescribing and Utilization Service [COMPUS]) has assumed responsibility as Director, Formulary Recommendations (CDR) and Rapid Response Services (HTIS).
  • Trinh Luong (former Director, Submissions and Operations, CDR), has assumed responsibility as Director, Health Technology Assessment and Optimal Use (HTA and COMPUS).
  • Sandy Pagotto (former Acting Senior Director, CDR) has assumed responsibility as Director, Environmental Scanning and Program Development.
  • Jane Farquharson has been appointed Acting Vice-President, Programs, leading the areas of environmental scanning, program development, partnerships, outreach, and impact.
  • As a result of the above changes, all CDR submission-related inquiries should be directed to Elizabeth Kozyra, Submissions Officer, CDR.

http://www.cadth.ca/index.php/en/cdr/cdr-update/cdr-update-issue-71

News from Health Canada

Health Canada

Announcement: Health Canada has launched a new Consumer Side Effect Reporting Form to make it even easier for consumers to report side effects to drugs and other health products to the Canada Vigilance Program.
http://www.hc-sc.gc.ca/ahc-asc/media/nr-cp/_2010/2010_106-eng.php

Natural Health Products Directorate (NHPD)

Guidance: The Guidance document: Classification of Products at the Food-Natural Health Product Interface: Products in Food Formats is available.
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/legislation/docs/food-nhp-aliments-psn-guide-eng.php

Therapeutic Products Directorate (TPD)

Consumer Health Advisory

Update: Health Canada has issued an update on the proper dosing of Liquid Vitamin D Supplements in Infants.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2010/2010_107-eng.php

Mirena: There has been an association of Mirena (Levonorgestrel-releasing Intrauterine System) with the potential risk of uterine perforation.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/public/_2010/mirena_pc-cp-eng.php

Health Care Professional Advisory

Mirena: Bayer Inc., in collaboration with Health Canada, would like to remind you of important safety information regarding reports of uterine perforation in women treated with Mirena. There has been an association of Mirena (Levonorgestrel-releasing Intrauterine System) with the potential risk of uterine perforation.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2010/mirena_hpc-cps-eng.php

Notice: A Notice has been issued on the policy on the Importations of Drugs for Human Use Including Natural Health Products into Canada (POL-0019) / Guidance Document on the Commercial Importation and Exportation of Drugs in Dosage Form under the Food and Drugs Act (GUI-0057).
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/update-miseajour/announce-annonce-eng.php

Notice: A Notice has been issued regarding Health Canada’s intention to adopt the use of the Summary Technical Documentation (STED) for non-in vitro diagnostic Class III and IV Premarket Medical Device Licence Applications.
http://www.hc-sc.gc.ca/dhp-mps/md-im/activit/announce-annonce/md_notice_im_avis_sted_2010-eng.php

Summary Basis of Decision: A Summary Basis of Decision (SBD) has been issued for Primovist.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/phase1-decision/drug-med/sbd_smd_2010_primovist_127609-eng.php

Document: The document, Adverse Reaction Reporting, has been updated. The Consumer Side Effect Reporting Form has been added.
http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/index-eng.php

Document: The document, Your Child's Prescription: Important Questions to Ask, is available.
http://www.hc-sc.gc.ca/dhp-mps/pubs/medeff/_fs-if/2010-child-enfant-med/index-eng.php

National Interest

Canadian Agency for Drugs and Technologies in Health (CADTH)

News Update: The CDR Update — Issue 71 is available. Clarifications and changes related to extensions to the embargo period are effective immediately and will be reflected in the revised Procedure for Common Drug Review, which will be posted in the next few weeks.
http://www.cadth.ca/index.php/en/cdr/cdr-update/cdr-update-issue-71

Reports: The following reports are available.

http://www.cadth.ca/media/pdf/k0210_repeat_elective_blood_transfusion_htis-1-5.pdf
(Standing Physician Orders for Repeat Blood Transfusion: Safety and Guidelines)

http://www.cadth.ca/media/pdf/j0444_developmental_reminders_htis-1.pdf
(Developmental Reminders for Parents of Young Children: Clinical Effectiveness and Cost-Effectiveness)

http://www.cadth.ca/index.php/en/hta/reports-publications/search/publication/1790
(Issue 7: Next-generation fecal DNA tests - an evolving technology)

The Patented Medicine Prices Review Board (PMPRB)

Speech: Greg McComb, Senior Economic Analyst, NPDUIS, gave a presentation, Public Drug Plan Professional Fees: A Cost-Driver Analysis, at the 2010 Annual Conference of The Canadian Association for Health Services and Policy Research (CAHSPR).
http://www.pmprb-cepmb.gc.ca/cmfiles/Professional_Fees_Analysis-CAHSPR-May_2010.pdf

Voluntary Compliance Undertaking: The Board is proposing to approve a Voluntary Compliance Undertaking in respect of the price of the patented medicine, Faslodex.
http://www.pmprb-cepmb.gc.ca/english/view.asp?x=271&id=183

Report: The Minister of Health tabled the PMPRB´s Annual Report 2009 before Parliament on June 16, 2010.
http://www.pmprb-cepmb.gc.ca/english/view.asp?x=271&id=182

National Association of Pharmacy Regulatory Authorities (NAPRA)

Meeting: A meeting of the National Drug Scheduling Advisory Committee (NDSAC) was held on June 7, 2010 followed by a teleconference meeting on June 17, 2010 with the following Initial Recommendation made:

• Polyethlene glycol 3350 as a single ingredient oral product indicated as a laxative to treat occasional constipation be granted Unscheduled status

http://napra.ca/pages/home/default.aspx?id=2736

Health Council of Canada (HCC)

Report: The report: Generic Drug Pricing and Access in Canada: What are the Implications? is available.
http://healthcouncilcanada.ca/en/index.php?page=shop.product_details&flypage=shop.flypage&product_id=115&category_id=19&manufacturer_id=0&option=com_virtuemart&Itemid=170

 

 

~~~~~

 

HEADS UP - June 7, 2010

Notices of Compliance - May 31 – June 4, 2010

• Berinert (human C1 esterase inhibitor) was approved as a serine protease inhibitor on 2010-05-31.

On the Move

• The Vice-Chairperson of the Patented Medicine Prices Review Board (PMPRB) is pleased to announce the appointment of Michelle Boudreau as Executive Director, effective August 30, 2010. The Board wishes to take this opportunity to thank Barbara Ouellet for her important contribution to the PMPRB over the last five years.  We wish Barbara all the best in her future endeavours as she retires from the Public Service.
http://www.pmprb-cepmb.gc.ca/english/view.asp?x=271&id=181

News from Health Canada

Health Canada

Foreign Product Alerts: Health Canada is advising consumers not to use the products specified below due to concerns about possible side-effects.

http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2010/2010-102-eng.php
(COMECOO, ZHONGCAOYAO-JIANKANGJIANFEI)

http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2010/2010-103-eng.php
(Qingzhi Santian Shou)

http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2010/2010-104-eng.php
(Vita Breath)

Unauthorized Health Products: Unauthorized Health Products labelled in Russian, Ukrainian or Kazakh were removed from the Montréal market.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2010/2010_101-eng.php

Biologics and Genetic Therapies Directorate (BGTD)

Notice: A Notice has been issued regarding the revision of the Procedure on the Issuance of Drug Identification Numbers (DINs) for Unit Dose Pre-filled Syringes.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/announce-annonce/prefilled_din_preremplies-eng.php

Therapeutic Products Directorate (TPD)

Notice to Hospitals

Cancidas: Health Canada has endorsed important safety information on Cancidas (caspofungin acetate for injection) 50 mg/vial.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2010/cancidas_nth-aah-eng.php

Baxter Colleague Volumetric Infusion Pumps: Health Canada has issued important safety information on Baxter Colleague Volumetric Infusion Pumps.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2010/infusion-perfusion_pump-pompe_8_nth-aah-eng.php

Notice: Health Canada is pleased to announce the release of the revised Health Canada 3011: Drug Submission Application Form for Human, Veterinary, Disinfectant Drugs and Clinical Trial Application/Attestation.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/form/hc3011_notice_sc3011_avis-eng.php

Guidance: The Guidance: Annual Drug Notification 2010 is available.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/announce-annonce/annual_guide_annuelle-eng.php

Document: The document: Authority to Sell Drug Fees, Fee Reductions and Adjustment Requests is available.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/fees-frais/ann_fees_frais-eng.php

Guidance: A draft revision to the Guidance Document: Notice of Compliance with Conditions has been released.
http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/consult-noccg_draft_accd_ebauche-eng.php

Notice of Decision: A Notice of Decision has been issued for Swish Silver Supreme.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/phase1-decision/drug-med/nd_ad_2010_swish_silver_supreme_121017-eng.php

Qualifying Notice: A Qualifying Notice has been issued for MED-Letrozole.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/notices-avis/conditions/med-letrozole_qn_aa_122975-eng.php

Medical Devices Inspection Program: A summary of the results of the Medical Devices Inspection Program from 2004-2009 is available.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/info-prod/md-im/sum_result_md-im_doc_2004-2009-eng.php

National Interest

GAZETTE I

Canadian Environmental Protection Act, 1999: A notice of intent has been issued to recommend that mercury compounds be added to Schedule 1 of the Canadian Environmental Protection Act, 1999 under subsection 90(1) of the Act.
http://www.gazette.gc.ca/rp-pr/p1/2010/2010-06-12/html/index-eng.html

Canadian Agency for Drugs and Technologies in Health (CADTH)

Reports: The following reports are available.

http://www.cadth.ca/media/pdf/l0188_periodontal_treatment_diabetes_htis-2.pdf
(Treatment of Periodontal Disease in Patients with Diabetes: A Review of Clinical and Cost-Effectiveness)

http://www.cadth.ca/media/pdf/l0186_treatments_for_lice_scabies_htis-2.pdf
(Lindane and Other Treatments for Lice and Scabies: A Review of Clinical Effectiveness and Safety)

http://www.cadth.ca/media/pdf/l0182_pain_scales_htis-2.pdf
(Pain Scales in Acute Care Settings: A Review of the Accuracy and Reliability)

http://www.cadth.ca/media/pdf/l0187_influenza_prophylaxis_post-exposure_htis-2.pdf
(Drug Therapy for Prophylactic and Post-Exposure Treatment of H1N1: A Review of the Comparative Clinical and Cost-Effectiveness)

http://www.cadth.ca/media/pdf/k0204_speech_language_pathology_htis-1-5.pdf
(Assessment Tools and Tests for the Diagnosis of Language Disorders in Bilingual Children: Clinical Effectiveness and Guidelines)

http://www.cadth.ca/media/pdf/l0185_pet_epilepsy_htis-2.pdf
(Positron Emission Tomography for Epilepsy: Clinical Effectiveness and Guidelines)

http://www.cadth.ca/media/pdf/l0184_bluetooth-enabled_hearing_aids_htis-2.pdf
(Bluetooth®-Enabled Hearing Technologies: A Review of the Clinical and Cost-Effectiveness)

http://www.cadth.ca/media/pdf/k0208_prioritization_audiology_htis-1-5.pdf
(Prioritization Tools for Audiology Services: Clinical Effectiveness and Guidelines)

http://www.cadth.ca/media/pdf/k0206_prioritization_occupational_therapy_htis-1-5.pdf
(Prioritization Tools for Occupational Therapy: Clinical Effectiveness and Guidelines)

http://www.cadth.ca/media/pdf/k0205_prioritization_physiotherapy_htis-1-5.pdf
(Prioritization Tools for Physiotherapy: Clinical Effectiveness and Guidelines)

http://www.cadth.ca/media/pdf/k0202_pre-op_chest_x-ray_htis-1-5.pdf
(Routine Pre-Operative Chest X-Ray: Guidelines)

http://www.cadth.ca/media/pdf/k_0199_assess_tobacco_dependence_htis-1-5.pdf
(Tools for Assessing Tobacco Dependence: Clinical Effectiveness and Guidelines)

http://www.cadth.ca/media/pdf/l0183_varenicline_safety_htis-2.pdf
(Varenicline for Smoking Cessation in Patients with Psychiatric Illness: A Review of the Risks)

http://www.cadth.ca/media/pdf/k0203_calibration_infusion_pumps_htis-1-5.pdf
(Calibration of Intravenous Infusion Pumps: Effectiveness and Guidelines)

http://www.cadth.ca/media/pdf/j0447_change_disease_status_post-bariatric_surgery_htis-1.pdf
(What is the clinical evidence that bariatric surgery can improve the disease status of patients with endocrinological diseases?)

http://www.cadth.ca/media/pdf/j0443_ergotamine_vs_dihydroergotamine_htis-1.pdf
(Ergotamine versus Dihydroergotamine for the Treatment of Migraine Headaches: Comparative Clinical Effectiveness)

http://www.cadth.ca/media/pdf/k0200_rapid_suicide_screening_htis-1-5.pdf
(Rapid Assessment of Suicide Risk for Incarcerated Patients: Clinical Evidence and Guidelines for Use)

Presentation: The Presentation: Using Evidence in the Real World is available on the CADTH website.
http://www.cadth.ca/index.php/en/media-centre/2010/06/15/224

National Association of Pharmacy Regulatory Authorities (NAPRA)

Meeting: The proposed scheduling status of polyethylene glycol 3350 indicated for occasional constipation was discussed at the June 7, 2010 meeting of the National Drug Scheduling Advisory Committee.
http://www.napra.org/pages/home/default.aspx

 

Canadian Institute for Health Information (CIHI)

Survey: Results of the National Survey on Medical Isotopes Supply Disruption are available.
http://secure.cihi.ca/cihiweb/dispPage.jsp?cw_page=PG_3031_E&cw_topic=3031&cw_rel=AR_3510_E

 

~~~~~

 

HEADS UP - May 31, 2010

Notices of Compliance - May 24 - 28, 2010

• Votrient (pazopanib (supplied as pazopanib hydrochloride)) was approved as an antineoplastic agent on 2010-05-27.

News from Health Canada

Health Canada

Information Sheet: Health Canada has released information for consumers on Insulin Products.
http://www.hc-sc.gc.ca/hl-vs/iyh-vsv/med/insul-eng.php

Unauthorized Products: Health Canada is warning Canadians that the unauthorized health products ”Vigofit“ and ”Once More,” which are promoted to enhance male sexual performance, have been seized by Health Canada inspectors from retail stores in Abbotsford and Surrey, British Columbia.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2010/2010_96-eng.php

Unauthorized Products: Following a February 2010 Advisory concerning unauthorized products sold under the OM Fusion Distributors LLC label, additional unauthorized products with the OM Fusion label have been removed from the Canadian market by Health Canada.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2010/2010_92-eng.php

Natural Health Products Directorate (NHPD)

Meeting: The Natural Health Products Program Advisory Committee Agenda: Meeting #4, March 22 and 23, 2010 is available.
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/activit/com/program-22-03-2010-eng.php

Report: Report #1 on Standards of Evidence for Non-Traditional Natural Health Products is available from the Natural Health Products Program Advisory Committee to the Natural Health Products Program.
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/activit/com/soe-rep-npr-rap-eng.php

http://www.hc-sc.gc.ca/dhp-mps/prodnatur/activit/com/soe-rep-npr-rap-pre-eng.php
(Preliminary Response: Report 1 - Standards of Evidence for Non-Traditional Natural Health Products)

Report: Report #2 - Product Testing Requirements Connected to Good Manufacturing Practices for Natural Health Products is available from the Natural Health Products Program Advisory Committee to the Natural Health Products Program.
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/activit/com/gmp-rep-bpf-rap-eng.php

http://www.hc-sc.gc.ca/dhp-mps/prodnatur/activit/com/gmp-rep-bpf-rap-pre-eng.php
(Preliminary Response to Report #2 - Product Testing Requirements Connected to Good Manufacturing Practices for Natural Health Products)

Therapeutic Products Directorate (TPD)

Notice to Hospitals

Ciprofloxacin Injection: There is a voluntary recall of Ciprofloxacin Injection 2 mg/mL (Intravenous Infusion) 100 mL bag (UPC 00891339001048) and/or 200 mL bag (UPC 00891339001055) DIN 02301296.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2010/ciprofloxacin_nth-aah-eng.php

Qualifying Notice: A Qualifying Notice has been issued for Mylan-Letrozole.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/notices-avis/conditions/mylan-letrozole_qn_aa_123133-eng.php

Qualifying Notice: A Qualifying Notice has been issued for Letrozole Tablets USP.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/notices-avis/conditions/accord-letrozole_qn_aa-127212-eng.php

Qualifying Notice: A Qualifying Notice has been issued for Novo-Letrozole.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/notices-avis/conditions/novo-letrozole_qn_aa_124459-eng.php

Register of Innovative Drugs: The Register of Innovative Drugs has been updated.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/regist/reg_innov_dr-eng.php

Notice: Health Canada is pleased to announce the launch of the Post-Notice of Compliance (NOC) Changes: Notices of Change (Level III) Form in fillable, Portable Document Format.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/postnoc_change_apresac/noc_pn_leviii_notice_form_ac_sa_niviii_avis-eng.php

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/form/noc_pn_leviii_form_ac_sa_niviii-eng.php
(Post-Notice of Compliance (NOC) Changes: Notices of Change (Level III) Form)

Notice of Decision: A Notice of Decision has been issued for Kuvan.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/phase1-decision/drug-med/nd_ad_2010_kuvan_128151-eng.php

Meeting: A draft agenda is available for the June 11, 2010 meeting of the Scientific Advisory Panel on Bioequivalence Requirements for Modified-Release Dosage Forms (SAP-MRDF).
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/sci-consult/mrdf-fplm/sapmrdf_a_gcsfplm_o-eng.php

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/sci-consult/mrdf-fplm/sapmrdf_m_gscfplm_m-eng.php
(Membership List)

National Interest

Federal Government

Notice of Intent: On June 5, 2010, a Notice of Intent to indicate how Health Canada and Environment Canada will address azo- and benzidine-based substances to assess and reduce related health and ecological risks potentially posed by these substances was published in the Canada Gazette.
http://www.chemicalsubstanceschimiques.gc.ca/plan/approach-approche/azo_benzidine-eng.php

GAZETTE I

Canadian Environmental Protection Act, 1999: A Notice of  Intent has been issued to assess and manage the risks to the health of Canadians and their environment posed by aromatic azo substances which may break down to certain aromatic amines, substances which may break down to certain benzidines, and the corresponding aromatic amines or benzidines.
http://www.gazette.gc.ca/rp-pr/p1/2010/2010-06-05/html/index-eng.html

GAZETTE II

Food and Drug Regulations: Regulations amending the Food and Drug Regulations (1595 — Schedule F) are available.
http://www.gazette.gc.ca/rp-pr/p2/2010/2010-06-09/html/sor-dors114-eng.html

Canadian Agency for Drugs and Technologies in Health (CADTH)

Announcement: With a newly created governing structure in place, Canada’s provincial, territorial and federal Deputy Ministers of Health now invite applications and nominations for the roles of Chair and six non-jurisdictional Directors to serve on CADTH’s new Board which will also include six jurisdictional members.
http://www.cadth.ca/index.php/en/media-centre/2010/06/8/223

Articles: The Canadian Agency for Drugs and Technologies in Health (CADTH) is pleased to announce the publication of new articles exploring the utilization, expenditure, and efficacy of self-monitoring of blood glucose (SMBG) in patients with type 2 diabetes not using insulin.
http://www.cadth.ca/index.php/en/media-centre/2010/06/7/222

Guidance: A Policy Guidance on Hip Protectors in Long-Term Care is available.
http://www.cadth.ca/index.php/en/hta/reports-publications/recommendations/policy-guid-hip-protect

Reports: The following reports are available.

http://www.cadth.ca/media/pdf/k0195_integrated_imaging_surgery_htis-1-5.pdf
(Integrated Imaging and Surgical Technologies for Cardiology and Neurology: Clinical and Cost-Effectiveness)

http://www.cadth.ca/media/pdf/l0160_pre-hospital_blood_work_htis-2.pdf
(Pre-Hospital Phlebotomy for Patients with Urgent Conditions: A Review of the Clinical Effectiveness and Guidelines)

http://www.cadth.ca/media/pdf/k0197_pain_management_immunization_htis-1-5.pdf
(Methods for Managing Patient Discomfort During Immunization: Clinical Effectiveness, Safety, and Guidelines)

http://www.cadth.ca/media/pdf/l0176_sepsis_indicators_htis-2.pdf
(Early Identification of Sepsis: A Review of the Evidence for Clinical Indicators and Guidelines for Management)

http://www.cadth.ca/media/pdf/j0441_hydrotherapy_labour_htis-1.pdf
(Hydrotherapy for Women in Active Labour: Clinical Effectiveness, Cost- Effectiveness, and Guidelines)

http://www.cadth.ca/media/pdf/j0442_surgical_management_microtia_htis-1.pdf
(Surgical Management of Microtia: Clinical and Cost-Effectiveness, and Guidelines)

National Association of Pharmacy Regulatory Authorities (NAPRA)

In Memoriam: We regret to announce that Barb Wells, founding Executive Director for the National Association of Pharmacy Regulatory Authorities (NAPRA) passed away on Monday, June 7, 2010 following a courageous battle with cancer.
http://napra.ca/pages/home/default.aspx

 

~~~~~

 

HEADS UP - May 24, 2010

Notices of Compliance - May 17 - 21, 2010

• Adacel-Polio (Pertussis Toxoid, Filamentous Haemagglutinin, Fimbriae Type 2 and 3 (FIM), Pertactin, Tetanus Toxoid, Diphtheria Toxoid, Inactivated Poliomyelitis Vaccine (V.C.O.) Type 1 Mahoney, Inactivated Poliomyelitis Vaccine (D.C.O.) Type 2 M.E.F. 1, Inactivated Poliomyelitis Vaccine (V.C.O.) Type 3 Saukett) was approved as an active immunizing agent on 2010-05-21.

• Victoza (liraglutide) was approved as a human glucagon like peptide-1 (GLP-1) on 2010-05-21.

News from Health Canada

HPFB Inspectorate

Guidance: A Guidance Document is available on the Import Requirements for Health Products under the Food and Drugs Act and its Regulations (GUI-0084).
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/import-export/gui-0084_biu-uif-eng.php

Policy: An Import and Export Policy is available for Health Products under the Food and Drugs Act and its Regulations (POL-0060).
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/import-export/pol-0060_biu-uif-eng.php

Document: The document: Border Integrity Approach (POL-0059) is available.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/import-export/pol-0059_biu-uif-eng.php

Meetings: Notes are available from Compliance & Enforcement Activities - Compressed Gas Association (CGA) Meetings.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/activit/meet-reunion/index-eng.php

Biologics and Genetic Therapies Directorate (BGTD)

Notice of Decision: A Notice of Decision has been issued for Actemra.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/phase1-decision/drug-med/nd_ad_2010_actemra_121089-eng.php

Subsequent Entry Biologics (SEBs): Questions and Answers are available to accompany the Final Guidance for Sponsors: Information and Submission Requirements for Subsequent Entry Biologics (SEBs).
http://www.hc-sc.gc.ca/dhp-mps/brgtherap/applic-demande/guides/seb-pbu/01-2010-seb-pbu-qa-qr-eng.php

Therapeutic Products Directorate (TPD)

Consumer Health Advisory

Champix: Health Canada has endorsed important safety information on Champix (varenicline tartrate).
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/public/_2010/champix_2_pc-cp-eng.php

Health Care Professional Advisory

Champix: Pfizer Canada, in collaboration with Health Canada, would like to inform you of important changes to the Product Monograph for Champix®, including changes to the Consumer Information section.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2010/champix_2_hpc-cps-eng.php

Register of Innovative Drugs: The Register of Innovative Drugs has been updated.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/regist/reg_innov_dr-eng.php

Guidance: The Global Harmonization Task Force (GHTF) Guidance: Quality Management System - Medical Devices - Guidance on the Control of Products and Services Obtained from Suppliers has been adopted.
http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/guide-ld/md_gd_suppliers_im_ld_fournisseurs-ghtf-eng.php

National Interest

Federal Government

Bill C-32: An Act to amend the Copyright Act (Copyright Modernization Act) was introduced in the House of Commons on June 2, 2010.
http://www2.parl.gc.ca/HousePublications/Publication.aspx?Docid=4580265&file=4

Canadian Intellectual Property Office (CIPO)

Annual Report: CIPO’s 2008-09 Annual Report was tabled in the House of Commons on May 6, 2010.
http://www.cipo.ic.gc.ca/eic/site/cipointernet-internetopic.nsf/eng/h_wr00030.html

Canadian Agency for Drugs and Technologies in Health (CADTH)

Reports: The following reports are available.

http://www.cadth.ca/media/pdf/k0201_chelation_therapy_htis-1-5.pdf
(Chelation Therapy for Heavy Metal Poisoning: Clinical Effectiveness and Guidelines)

http://www.cadth.ca/media/pdf/k0195_integrated_imaging_surgery_htis-1-5.pdf
(Integrated Imaging and Surgical Technologies for Cardiology and Neurology: Clinical and Cost-Effectiveness)

http://www.cadth.ca/media/pdf/l0176_sepsis_indicators_htis-2.pdf
(Early Identification of Sepsis: A Review of the Evidence for Clinical Indicators and Guidelines for Management)

http://www.cadth.ca/media/pdf/l0178_plasma_protein_products_htis-2.pdf
(Albumin versus Synthetic Plasma Volume Expanders: A Review of the Clinical and Cost-Effectiveness and Guidelines for Use)

http://www.cadth.ca/media/pdf/k_0198_cytoprotection_and_ppis_htis-1-5.pdf
(Cytoprotective Properties of Proton Pump Inhibitors: Comparative Clinical Effectiveness)

http://www.cadth.ca/media/pdf/l0181_foot_orthotics_htis-2.pdf
(Prefabricated and Custom Made Foot Orthotics: A Review of the Clinical and Cost-Effectiveness)

http://www.cadth.ca/media/pdf/k0196_monitoring_bath_water_temperature_htis-1-5.pdf
(Devices and Methods for Monitoring Bath Water Temperature: Accuracy and Guidelines)

Canadian Institute for Health Information (CIHI)

Report: The report: Health Indicators 2010 is available.
http://secure.cihi.ca/cihiweb/dispPage.jsp?cw_page=PG_2951_E&cw_topic=2951&cw_rel=AR_152_E

 

~~~~~

 

HEADS UP - May 17, 2010

Notices of Compliance - May 10 - 14, 2010

• Yondelis (trabectedin) was approved as an antineoplastic agent on 2010-05-13.

News from Health Canada

Health Canada

Unauthorized Health Product: Unauthorized health products that may pose a serious health risk were seized by Health Canada at YVS (Your Vitamin Store) in Metrotown, Burnaby, British Columbia.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2010/2010_84-eng.php

Biologics and Genetic Therapies Directorate (BGTD)

Summary Basis of Decision: A Summary Basis of Decision (SBD) has been issued for Arepanrix H1N1.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/phase1-decision/drug-med/sbd_smd_2010_arepanrix_h1n1_132070-eng.php

Natural Health Products Directorate (NHPD)

Updated International Trade Certificate Forms: The following International Trade Certificate Forms have been updated.
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/applications/int-certificat/form/index-eng.php

http://www.hc-sc.gc.ca/dhp-mps/prodnatur/applications/int-certificat/form/gmp_form-eng.php
(Good Manufacturing Practices Certificate of Compliance)

http://www.hc-sc.gc.ca/dhp-mps/prodnatur/applications/int-certificat/form/itc-eng.php
(International Trade Certificate)

http://www.hc-sc.gc.ca/dhp-mps/prodnatur/applications/int-certificat/form/stamping_form-eng.php
(Request for Stamping Form)

Form: A Foreign Site Reference Number Authorization form is available.
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/applications/licen-site-exploit/form/form_fsrn-nrse-eng.php

Form: A Foreign Site Reference Number Application form is available.
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/applications/licen-site-exploit/form/form_fsrna-anrse-eng.php

Report: The NHPD has released its Status of Applications Quarterly Report, Quarter 4 (January 1, 2010 to March 31, 2010).
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/report-rapport/qar_tri_4-10-eng.php

Program Advisory Committee: Health Canada's Natural Health Products (NHP) Program Directorates (the Natural Health Products Directorate, the Marketed Health Products Directorate and the Health Products and Food Branch Inspectorate) are seeking nominations for Active Members to participate in the Natural Health Products Program Advisory Committee (NHP PAC).
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/activit/com/index-eng.php

http://www.hc-sc.gc.ca/dhp-mps/prodnatur/activit/com/nom-invit-let-eng.php
(Call for Nominations)

Therapeutic Products Directorate (TPD)

Health Care Professional Advisory

RISPERDAL® CONSTA® (risperidone): Janssen-Ortho, in cooperation with Health Canada, would like to provide you with important information concerning the needle assembly used for the gluteal injection for RISPERDAL® CONSTA® (risperidone).
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2010/risperdal_consta_hpc-cps-eng.php

Notice: A Notice is available regarding Classification of Medical Devices Class I or Class II Patient Management Software.
http://www.hc-sc.gc.ca/dhp-mps/md-im/activit/announce-annonce/md_notice_software_im_avis_logicels-eng.php

Guidance: The Guidance Document for Source Establishments - Reporting Adverse Reactions to Human Cells, Tissues and Organs is available.
http://www.hc-sc.gc.ca/dhp-mps/pubs/medeff/_guide/2010-guid-dir_indust_cto/index-eng.php

Form: A Mandatory Adverse Reaction Reporting Form for Industry is available.
http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/ar-ei_indus_form-eng.php

Notice of Decision: A Notice of Decision has been issued for Effient.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/phase1-decision/drug-med/nd_ad_2010_effient_121143-eng.php

Notice of Compliance with Conditions: A Notice of Compliance with Conditions has been issued for Novo-Letrozole.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/notices-avis/conditions/novo-letrozole_nocc_124459-eng.php

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/notices-avis/conditions/novo-letrozole_fs_fd_124459-eng.php
(Fact Sheet)

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/notices-avis/conditions/novo-letrozole_dhcpl_lapds_124459-eng.php
(Dear Health Care Professional Letter)

Notice of Compliance with Conditions: A Notice of Compliance with Conditions has been issued for Letrozole Tablets USP.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/notices-avis/conditions/accord-letrozole_127212-eng.php

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/notices-avis/conditions/accord-letrozole_fs_fd_127212-eng.php
(Fact Sheet)

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/notices-avis/conditions/accord-letrozole_dhcpl_lapds_127212-eng.php
(Dear Health Care Professional Letter)

National Interest

GAZETTE II

Food and Drug Regulations: Regulations amending the Food and Drug Regulations (743 — Non-Medicinal Ingredients) are available.
http://www.gazette.gc.ca/rp-pr/p2/2010/2010-05-26/html/sor-dors105-eng.html

Canadian Agency for Drugs and Technologies in Health (CADTH)

Guidance: CADTH has issued a Policy Guidance on Hip Protectors in Long-Term Care.
http://www.cadth.ca/index.php/en/hta/reports-publications/recommendations/policy-guid-hip-protect

Reports: The following reports are available.

http://www.cadth.ca/media/pdf/k0168_tmj_treatment_htis-1-5.pdf
(Treatment for Temporomandibular Joint Dysfunction: Guidelines)

http://www.cadth.ca/media/pdf/k0193_diabetes_first_nations_htis-1-5.pdf
(Diabetes in First Nations People: Guidelines for Screening and Treatment)

http://www.cadth.ca/media/pdf/l0180_infliximab_crohn's_disease_htis-2.pdf
(Infliximab for Maintenance Therapy for Treatment of Crohn's Disease: A Review of the Clinical Effectiveness and Guidelines)

The Patented Medicine Prices Review Board (PMPRB)

Presentation: Barbara Ouellet delivered a presentation on May 6, 2010: A Modern Regulator for a Changing Industry, at the Drug Patents in Canada conference, in Toronto.
http://www.pmprb-cepmb.gc.ca/cmfiles/2010-PEA-05001%20-%20Drug%20Patents%20in%20Canada%20-%20Final%20(2010-05-06).pdf

CPI Adjustment Factors for 2011: Changes were made to the CPI Adjustment Factors for 2011.
http://www.pmprb-cepmb.gc.ca/english/view.asp?x=271&id=180

 

~~~~~

 

HEADS UP - May 10, 2010

Notices of Compliance - May 3 - 7, 2010

• Latisse (bimatoprost) was approved as an eyelash growth enhancer on 2010-05-05.

On the Move

• Organizational changes and staff appointments have been made to reflect CADTH – The Next Chapter initiatives. 
 http://www.cadth.ca/index.php/en/cadth/corporate-profile/executive-news

News from Health Canada

Health Canada

Foreign Product Alerts: The following foreign product alerts have been issued.

http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2010/2010-77-eng.php
(Botanical Slimming 100% Natural Soft Gel, also sold as Meizitang)

http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2010/2010-78-eng.php
(Marsha Slim Plus)

http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2010/2010-79-eng.php
(S&S Super Slender)

HPFB Inspectorate

International Regulatory Forum: Health Canada’s Health Products and Food Branch (HPFB) will be holding its International Regulatory Forum 2010.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/int/forum/notice_avis_hpfb_dgpsa_forum_2010-eng.php

Natural Health Products Directorate (NHPD)

Natural Health Products Regulations: Information is available on the proposed regulations on Natural Health Products (Unprocessed Product Licence Applications) Regulations, which were published in the Gazette I on Saturday, May 8, 2010, in Vol. 144, No. 19.
http://www.gazette.gc.ca/rp-pr/p1/2010/2010-05-08/html/reg16-eng.html

http://www.hc-sc.gc.ca/dhp-mps/prodnatur/legislation/acts-lois/gazette1/regul-regle_cba-aca-eng.php
(Cost and Benefit Analysis)

http://www.hc-sc.gc.ca/dhp-mps/prodnatur/legislation/acts-lois/gazette1/fiche_info_sheet-eng.php
(Fact Sheet for Consumers)

http://www.hc-sc.gc.ca/dhp-mps/prodnatur/legislation/acts-lois/gazette1/regul-regle_questions-eng.php
(Frequently Asked Questions for manufacturers and distributors of natural health products)

Gluten Consultation: A Proposed Policy Intent for revising Canada's Gluten-free labelling requirements is available.
http://www.hc-sc.gc.ca/fn-an/consultation/init/gluten2010/draft-ebauche-eng.php

Therapeutic Products Directorate (TPD)

Consumer Health Advisory

Tysabri: New Information is available on the risk of Progressive Multifocal Leukoencephalopathy (PML) with Tysabri® (natalizumab).
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/public/_2010/tysabri_3_pc-cp-eng.php

Maalox Multi Action Liquid: Novartis Consumer Health Canada Inc., in consultation with Health Canada, would like to bring to your attention important safety information about the differences between our product Maalox Multi Action and other Maalox liquid products.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/public/_2010/maalox_pc-cp-eng.php

Health Care Professional Advisory

Tysabri: Updated safety information is available regarding Progressive Multifocal Leukoencephalopathy (PML) associated with Tysabri® (natalizumab).
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2010/tysabri_3_hpc-cps-eng.php

Maalox Multi Action Liquid: Novartis Consumer Health Canada Inc., in consultation with Health Canada, would like to bring to your attention important safety information concerning the differences between our product Maalox Multi Action liquid and other Maalox liquid products.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2010/maalox_hpc-cps-eng.php

Notice to Hospitals

Certain Cuffed Shiley Tracheostomy Products: There has been an urgent medical device recall on Certain Cuffed Shiley™ Tracheostomy Products.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2010/trach_tubes_nth-aah-eng.php

Counterfeit Health Products: The document entitled, “Policy on Counterfeit Health Products (POL-0048)”, is available.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/activit/pol_0048_counterfeit-contrefacon-eng.php

Qualifying Notice: A Qualifying Notice has been issued for Co-Memantine.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/notices-avis/conditions/co-memantine_qn_aa_122439-eng.php

Notice of Compliance with Conditions: A Notice of Compliance with Conditions has been issued for Mylan-Letrozole.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/notices-avis/conditions/mylan-letrozole_nocc_123133-eng.php

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/notices-avis/conditions/mylan-letrozole_fs_fd_123133-eng.php
(Mylan-Letrozole Fact Sheet)

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/notices-avis/conditions/mylan-letrozole_dhcpl_lapds_123133-eng.php
(Mylan-Letrozole Dear Health Care Professional Letter)

Notice of Compliance with Conditions: A Notice of Compliance with Conditions has been issued for Sandoz Memantine.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/notices-avis/conditions/sandoz-memantine_nocc_134283-eng.php

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/notices-avis/conditions/sandoz-memantine_fs_fd_134283-eng.php
(Sandoz Memantine Fact Sheet)

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/notices-avis/conditions/sandoz-memantine_dhcpl_lapds_134283-eng.php
(Sandoz Memantine Dear Health Care Professional Letter)

Notice of Compliance with Conditions: A Notice of Compliance with Conditions has been issued for MED-Letrozole.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/notices-avis/conditions/med-letrozole_nocc_122975-eng.php

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/notices-avis/conditions/med-letrozole_fs_fd_122975-eng.php
(MED-Letrozole Fact Sheet)

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/notices-avis/conditions/med-letrozole_dhcpl_lapds_122975-eng.php
(MED-Letrozole Dear Health Care Professional Letter)

Notice of Compliance with Conditions: A Notice of Compliance with Conditions has been issued for Letrozole (Cobalt Pharmaceuticals Inc.).
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/notices-avis/conditions/cobalt-letrozole_1365640-eng.php

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/notices-avis/conditions/cobalt-letrozole_fs_fd_1365640-eng.php
(Letrozole Fact Sheet - Cobalt Pharmaceuticals Inc.)

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/notices-avis/conditions/cobalt-letrozole_dhcpl_lapds_136540-eng.php
(Letrozole Dear Health Care Professional Letter - Cobalt Pharmaceuticals Inc.)

Notice of Compliance with Conditions: A Notice of Compliance with Conditions has been issued for Letrozole (Teva Canada Limited).
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/notices-avis/conditions/teva-letrozole_137039-eng.php

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/notices-avis/conditions/teva-letrozole_fs_fd_137039-eng.php
(Letrozole Fact Sheet - Teva Canada Limited)

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/notices-avis/conditions/teva-letrozole_dhcpl_lapds_137039-eng.php
(Letrozole Dear Health Care Professional Letter - Teva Canada Limited)

National Interest

Canadian Agency for Drugs and Technologies in Health (CADTH)

CDR Update: The May 14, 2010 CDR Update — Issue 70 is available. The Canadian Agency for Drugs and Technologies in Health (CADTH) is announcing a number of changes and updates to the Common Drug Review (CDR) program and its key documents, the Procedure for CDR and the CDR Submission Guidelines for Manufacturers.
http://www.cadth.ca/index.php/en/cdr/cdr-update/cdr-update-issue-70

http://www.cadth.ca/media/cdr/process/CDR_Procedure_e.pdf
(Procedure for Common Drug Review – May 2010)

http://www.cadth.ca/media/cdr/process/CDR_Submission_Guidelines.pdf
(Common Drug Review Submission Guidelines for Manufacturers – May 2010)

CDR Update: The May 13, 2010 CDR Update — Issue 69 is available. The Canadian Agency for Drugs and Technologies in Health (CADTH) is pleased to announce that, as of May 13, 2010, patient groups may formally provide input into CADTH’s Common Drug Review (CDR) process.
http://www.cadth.ca/index.php/en/cdr/cdr-update/cdr-update-issue-69

Reports: The following reports are available.

http://www.cadth.ca/media/pdf/k0191_folic_acid_smokers_htis1-5.pdf
(Folic Acid for Smokers in a Primary Care Setting: Clinical Effectiveness and Guidelines)

http://www.cadth.ca/media/pdf/L0174_remote_ischemic_conditioning_htis2.pdf
(Remote Ischemic Conditioning: A Review of the Clinical Effectiveness)

http://www.cadth.ca/media/pdf/k0181_heparin_dosing_with_epidurals_htis1-5.pdf
(Twice a Day versus Three Times a Day Unfractionated Heparin in Post-Operative Patients with Epidurals: Clinical Benefits and Harms)

http://www.cadth.ca/media/pdf/k0192_premixed_heparin_htis1-5.pdf
(Pre-Mixed Heparin Solutions for Infusion: Comparative Safety and Guidelines)

http://www.cadth.ca/media/pdf/k0190_management_post-partum_women_gestational_diabetes_htis1-5.pdf
(In-Hospital Management of Post-Partum Women with Gestational Diabetes: Guidelines)

http://www.cadth.ca/media/pdf/k0182_warming_iv_fluids_htis1-5.pdf
(Alternate Methods of Warming Intravenous Fluids: Clinical Effectiveness)

http://www.cadth.ca/media/pdf/k0185_statins_post-mi_treatment_htis1-5.pdf
(Statin Administration Following Acute Myocardial Infarction: Guidelines)

http://www.cadth.ca/media/pdf/k0167_treatment_periodontal_disease_htis1-5.pdf
(Treatment of Periodontal Disease: Guidelines and Impact)

http://www.cadth.ca/media/pdf/k0186_aspirin_post-mi_treatment_htis1-5.pdf
(Acetylsalicyclic Acid Administration Following Acute Myocardial Infarction: Guidelines)

http://www.cadth.ca/media/pdf/k0187_ace_inhibitors_post-mi_management_htis1-5.pdf
(Administration of Angiotensin Converting Enzyme Inhibitors Following Acute Myocardial Infarction: Guidelines)

http://www.cadth.ca/media/pdf/L0175_cbt_for_insomnia_htis-2.pdf
(Cognitive Behavioural Therapy for Insomnia in Adults: A Review of the Clinical Effectiveness)

 

 

~~~~~

 

HEADS UP - May 3, 2010

Notices of Compliance - April 26 - 30, 2010

• Actemra (tocilizumab) was approved as an interleukin receptor inhibitor on 2010-04-30.

News from Health Canada

Health Canada

Unauthorized Drug Product: Health Canada is warning Canadians of the risks to health associated with use of the unauthorized drug product, Miracle Mineral Solution (MMS), which was distributed on the Internet by MMSsupplier.com to treat drinking water.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2010/2010_74-eng.php

Rotavirus Vaccines: Health Canada is advising Canadians and Canadian healthcare practitioners that we are currently reviewing new information regarding the presence of porcine circovirus (PCV-1 and PCV-2) DNA in rotavirus vaccines.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2010/2010_69-eng.php

Therapeutic Products Directorate (TPD)

Register of Innovative Drugs: The Register of Innovative Drugs has been updated.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/regist/reg_innov_dr-eng.php

Scientific Advisory Panel: Draft Terms of Reference, an announcement of a meeting and an invitation to participate in an associated workshop have been issued by the Scientific Advisory Panel (SAP) on Bioequivalence Requirements for Modified-Release Dosage Forms (SAP-MRDF).
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/sci-consult/mrdf-fplm/index-eng.php

National Interest

Government of Canada

Chemical Substances Challenge: On May 12, 2010, an Order adding toxic substances to Schedule 1 to the Canadian Environmental Protection Act, 1999 (CEPA, 1999) was published in the Canada Gazette Part II, Vol. 144 No. 10, for five substances and one group of three substances in Batch 1 of the Challenge.
http://www.chemicalsubstanceschimiques.gc.ca/challenge-defi/batch-lot-1/index-eng.php

GAZETTE I

Canadian Environmental Protection Act, 1999: A science assessment document entitled Human Health Risk Assessment for Inhaled Manganese is available.
http://www.gazette.gc.ca/rp-pr/p1/2010/2010-05-08/html/index-eng.html

Food and Drugs Act: Proposed Natural Health Products (Unprocessed Product Licence Applications) Regulations are available that would provide a temporary instrument to permit NHPs, for which a product licence application has been filed with Health Canada but a decision to issue or refuse a licence has not been made, to be sold on the market, with an exemption to the prohibition on sale in the NHPR.
http://www.gazette.gc.ca/rp-pr/p1/2010/2010-05-08/html/reg16-eng.html

GAZETTE II

Food and Drug Regulations: Regulations amending the Food and Drug Regulations (1353 — Corrective Amendments, Miscellaneous Program) are available.
http://www.gazette.gc.ca/rp-pr/p2/2010/2010-05-12/html/sor-dors94-eng.html

Food and Drug Regulations: Regulations amending the Food and Drug Regulations (1447 — Good Manufacturing Practices) are available.
http://www.gazette.gc.ca/rp-pr/p2/2010/2010-05-12/html/sor-dors95-eng.html

Canadian Environmental Protection Act, 1999: An Order has been issued adding toxic substances to Schedule 1 to the Canadian Environmental Protection Act, 1999.
http://www.gazette.gc.ca/rp-pr/p2/2010/2010-05-12/html/sor-dors98-eng.html

Advertising Standards Canada (ASC)

Newsletter: The ASC Spring 2010 Newsletter is available.
http://www.adstandards.com/en/ASCLibrary/newsletters/spring2010_newsletter.html

Canadian Agency for Drugs and Technologies in Health (CADTH)

Webcast Presentations: The following webcast presentations are available.

http://www.cadth.ca/index.php/en/media-centre/2010/05/10/217
(Grey Matters)

http://www.cadth.ca/index.php/en/media-centre/2010/05/10/216
(Health Information)

Reports: The following reports are available:

http://www.cadth.ca/media/pdf/l0179_percutaneous_heart_valves_update_htis-2.pdf
(Percutaneous Heart Valves for Valvular Heart Disease: An Updated Review of the Clinical and Cost-Effectiveness and Guidelines)

http://www.cadth.ca/media/pdf/20100430-143350_k0165_dental_implants_vs._bridges_final.pdf
(Dental Implants, Bridges, and Dentures: Guidelines)

http://www.cadth.ca/media/pdf/20100503-141823_k0184_viscosupplementation_for_oa_final.pdf
(Viscosupplementation for Osteoarthritis of the Hip, Ankle, or Shoulder: Clinical Effectiveness)

http://www.cadth.ca/media/pdf/20100503-090753_l0173_screening_asymptomatic_aneurysms_final.pdf
(Screening Programs for Asymptomatic Unruptured Intracranial Aneurysms: Review of Clinical Effectiveness, Cost-Effectiveness, and Evidence-Based Guidelines)

http://www.cadth.ca/media/pdf/20100504-111032_k0189_mri_indications_final.pdf
(Magnetic Resonance Imaging: Indications for Use)

http://www.cadth.ca/media/pdf/20100505-084210_k0166_mucocutaneous_disease_treatment_final.pdf
(Treatment for Mucocutaneous Disease: Guidelines)
 

 

~~~~~

 

HEADS UP - April 26, 2010

Notices of Compliance - April 19 - 23, 2010

• There were no new Notices of Compliance posted this week.

On the Move

• Staff changes at the Patented Medicine Prices Review Board (PMPRB): Executive Director of the PMPRB, Barbara Ouellet, will be retiring from the Public Service in June 2010. Dr. Anthony Boardman’s term as a member of the Board ended on March 11, 2010. The term of Brien G. Benoit, MD, Chairman and CEO of the PMPRB, ends on May 18, 2010.
http://www.pmprb-cepmb.gc.ca/english/view.asp?x=271&id=179

News from Health Canada

Health Canada

Children and Infant's Motrin and Tylenol Products: Following the recent recall of Children and Infant's Motrin and Tylenol products by McNeil Consumer Healthcare, Health Canada is updating Canadians on our completed risk assessment of the products.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2010/2010_67-eng.php

Foreign Product Alert: Foreign Product Alerts have been issued for the following products.

http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2010/2010-61-eng.php
(Ba Bao Xiao Ke Dan)

http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2010/2010-62-eng.php
(Bao Shu Tang Wu Zi Yan Zong Wan)

http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2010/2010-63-eng.php
(Lin Yan Yin Chiao)

http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2010/2010-64-eng.php
(Man Power)

http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2010/2010-65-eng.php
(17 products sold through MuscleMaster.com)

http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2010/2010-66-eng.php
(Seven Slim 7 Seshou (Qingchun Shaonüxing), Seven Slim 7 Seshou (Jieshixing), Seven Slim 7 Seshou (Guifurenxing), Seven Slim 7 Seshou (Songchixing), Shoushen Jiaoguan-Tinei Yundong Wan (Jian Xiabanshen), and Shoushen Jiaoguan-Tinei Yundong Wan (Jian Quanshen Feipang))

Biologics and Genetic Therapies Directorate (BGTD)

Report: The Biologics and Genetic Therapies Directorate Drug Submission Performance Quarterly Report January – March 2010 is available.
(See attached)

Natural Health Products Directorate (NHPD)

Form: The NHPD has released the form entitled, “Quality Assurance Report (QAR) Form”.
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/applications/licen-site-exploit/form/form_qar-raq-eng.php

Form: The NHPD has released the form entitled, “Supplementary Quality Assurance Report Form Homeopathic Medicines (HM)”.
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/applications/licen-site-exploit/form/forms_sqar-sraq-eng.php

Therapeutic Products Directorate (TPD)

Consumer Health Advisory

Exelon Patch: Novartis Pharmaceuticals Canada Inc. ("Novartis"), in consultation with Health Canada, would like to remind you of the importance of the proper use of Exelon Patch (rivastigmine transdermal patch) and the symptoms associated with its overdose.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/public/_2010/exelon_pc-cp-eng.php

Health Care Professional Advisory

Exelon Patch: Novartis Pharmaceuticals Canada Inc. ("Novartis"), in consultation with Health Canada, would like to inform you that serious adverse events including death, have occurred following rivastigmine overdose due to medication errors /misuse of Exelon Patch.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2010/exelon_hpc-cps-eng.php

Guidance: The finalized Guidance Document: Non-Clinical Laboratory Study Data Supporting Drug Product Applications and Submissions: Adherence to Good Laboratory Practice has been released.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/glp_bpl-eng.php

Questions and Answers: A Questions and Answers document is available for the Guidance Document: Non-Clinical Laboratory Study Data Supporting Drug Product Applications and Submissions: Adherence to Good Laboratory Practice.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/glp_qa_bpl_qr-eng.php

Report: The Therapeutic Products Directorate Drug Submission Performance Quarterly Report January – March 2010 is available.
(See attached)

Document: The final version of the document entitled, “Risk classification of Observations made during Inspections of Blood Establishments (GUI-0061)”, is available.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/info-prod/don/gui-0061_risk_class_observ_insp_blood_esta_doc-eng.php

Updated List: The List of Registered Cells, Tissues and Organs (CTO) Establishments has been updated.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/info-prod/cell/cto-estab-etab-eng.php

National Interest

Government of Canada

Chemical Substances Challenge: The Governor in Council has announced, in the Canada Gazette, Part I, the proposed Order Adding Toxic Substances to Schedule 1 to the Canadian Environmental Protection Act, 1999 for three substances in Batch 7 of the Challenge.
http://www.chemicalsubstanceschimiques.gc.ca/challenge-defi/batch-lot-7/index-eng.php

GAZETTE I

Canadian Environmental Protection Act, 1999: A proposed Order has been issued adding toxic substances to Schedule 1 to the Canadian Environmental Protection Act, 1999.
http://www.gazette.gc.ca/rp-pr/p1/2010/2010-05-01/html/reg2-eng.html

Canadian Agency for Drugs and Technologies in Health (CADTH)

Reports: The following Health Technology reports are available.

http://www.cadth.ca/media/pdf/k0164_dental_filling_materials_htis-1-5.pdf
(Dental Filling Materials: Clinical Effectiveness and Guidelines)

http://www.cadth.ca/media/pdf/k0188_bone_density_scanning_htis-1-5.pdf
(Bone Density Scanning: Clinical Effectiveness)

http://www.cadth.ca/media/pdf/k0178_poc_inr_htis-1-5.pdf
(Point-of-Care International Normalized Ratio Testing Versus Plasma-Based Testing: Comparative Accuracy and Reliability)

http://www.cadth.ca/media/pdf/l0172_positive_negative_needleless_connectors_htis-2.pdf
(Positive versus Negative Needleless Connectors for Central Venous Lines and Peripheral Lines: A Review of the Clinical Effectiveness and Guidelines)

http://www.cadth.ca/index.php/en/hta/reports-publications/search/publication/1690
(Triple Therapy for Moderate-to-Severe Chronic Obstructive Pulmonary Disease)

The Patented Medicine Prices Review Board (PMPRB)

Newsletter: The PMPRB has released the April 2010 issue of its NEWSletter.
http://www.pmprb-cepmb.gc.ca/english/view.asp?x=271&id=179

 

~~~~~

 

HEADS UP -April 19, 2010

Notices of Compliance - April 12 - 16, 2010

• Intanza (haemagglutinin-strain A (H1N1) / haemagglutinin-strain A (H3N2) / haemagglutinin-strain B) was approved as an active immunizing agent on 2010-04-15.

• Effient (prasugrel (supplied as prasugrel hydrochloride)) was approved as a platelet aggregation inhibitor on 2010-04-16.

On the Move

• Advertising Standards Canada has announced its 2010/2011 Board of Directors.
http://www.adstandards.com/en/MediaAndEvents/2010BoardOfDirectorsPressRelease.aspx

News from Health Canada

Health Canada

Unauthorized Health Product: Health Canada is warning Canadians that an unauthorized health product, “Slim-30” distributed in Ontario and Quebec by Dux Enterprises Inc., contains an undeclared pharmaceutical ingredient similar to the prescription drug, sibutramine.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2010/2010_59-eng.php

Financial Statements: Information is available on future-oriented Financial Statements.
http://www.hc-sc.gc.ca/ahc-asc/performance/estim-previs/plans-prior/2010-2011-smr-drd-eng.php

Health Advisory: Health Canada is informing health care professionals and Canadians, including parents and caregivers, of recent changes to the prescribing information for the injectable form of the prescription drug promethazine.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2010/2010_58-eng.php

Therapeutic Products Directorate (TPD)

FAQ: Frequently Asked Questions related to Health Canada's Guidance Document: Disinfectant Drugs have been released.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/disinfect-desinfect/notice_faq_disinfec_avis_faq-eng.php

Register of Innovative Drugs: The Register of Innovative Drugs has been updated.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/regist/reg_innov_dr-eng.php

Summary Basis of Decision: A Summary Basis of Decision (SBD) is available for Besivance.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/phase1-decision/drug-med/sbd_smd_2010_besivance_123400-eng.php

National Interest

Advertising Standards Canada (ASC)

Annual Report: Advertising Standards Canada has released its 2009/2010 annual report.
http://www.adstandards.com/en/AboutASC/2010AnnualReport.pdf

Canadian Agency for Drugs and Technologies in Health (CADTH)

Program: The Canadian Agency for Drugs and Technologies in Health (CADTH) is pleased to offer a free educational program for pharmacists and other health care professionals on applying the principles of evidence-based medicine to clinical practice.
http://www.cadth.ca/index.php/en/events/evidence-real-world

Award: Dr. Brian Ordure, President and CEO of the Canadian Agency for Drugs and Technologies in Health (CADTH), is pleased to announce that Dr. Andrea’s Laupacis, MD, M.Sc, FRCPC, is the inaugural recipient of the Jill M. Sanders Award of Excellence in Health Technology Assessment (HTA).
http://www.cadth.ca/index.php/en/media-centre/2010/04/21/215

Reports: The following reports are available.

http://www.cadth.ca/media/pdf/k0175_disulfiram_alcohol_dependence_htis-1-5.pdf
(Disulfiram for Alcohol Dependence: Clinical Effectiveness and Safety)

http://www.cadth.ca/media/pdf/l0177_transcatheter_aortic_valves_htis-2.pdf
(Transcatheter Aortic Valve Implantation: A Critical Appraisal of a Health Technology Assessment and Comparison with a Rapid Review

http://www.cadth.ca/media/pdf/k0180_implanted_vascular_access_devices_htis-1-5.pdf
(Intraoperative Use of Implanted Vascular Access Devices in Adults: Safety)

http://www.cadth.ca/media/pdf/k0179_interpreting_12-lead_ecgs_htis-1-5.pdf
(Timeframe for Interpretation of 12-Lead Electrocardiogram Reports: Guidelines)

http://www.cadth.ca/media/pdf/k0176_corneal_crosslinkingriboflavin_htis-1-5.pdf
(Corneal Cross Linking with Riboflavin for Keratoconus: Clinical and Cost-Effectiveness)

http://www.cadth.ca/media/pdf/k0163_xylitol_products_tooth_decay_htis-1-5.pdf
(Xylitol Products for Tooth Decay: Clinical Effectiveness and Compliance)

http://www.cadth.ca/media/pdf/k0174_patient_discharge_instructions_htis-1-5.pdf
(Discharge of Patients Following Interventional Angiogram Procedures: Risk of Complications and Guidelines for Self-Care Instructions)

http://www.cadth.ca/media/pdf/k0177_screening_depression_htis-1-5.pdf
(Prenatal and Postnatal Screening for Depression in First Nations Women: Diagnostic Accuracy and Evidence-Based Guidelines)

National Association of Pharmacy Regulatory Authorities (NAPRA)

Membership Vacancy: The National Drug Scheduling Advisory Committee (NDSAC) is soliciting nominations to fill a membership vacancy.
http://napra.ca/pages/home/default.aspx?id=2704

Canadian Institute for Health Information (CIHI)

Report: The report, Drug Expenditure in Canada, 1985 to 2009, is available.
http://secure.cihi.ca/cihiweb/dispPage.jsp?cw_page=media_20100422_e

 

~~~~~

 

HEADS UP - April 12, 2010

 

Notices of Compliance - April 5 - 9, 2010

• Verdeso (desonide) was approved as a topical corticosteroid therapy on 2010-04-07.

On the Move

• Kathy Vesterfelt joined NAPRA as Manager, Professional and Regulatory Affairs. Kathy’s responsibilities include the oversight of the National Drug Schedules/NDSAC and the management of special projects.
http://napra.ca/Content_Files/Files/NAPRA_Notes_April2010_Final.pdf

News from Health Canada

Therapeutic Products Directorate (TPD)

Health Care Professional Advisory

Invirase: Hoffmann-La Roche Limited, in consultation with Health Canada, would like to inform healthcare professionals of important new safety information regarding the use of Invirase® (saquinavir mesylate) and significant dose-dependent prolongations of QT and PR intervals in healthy volunteers.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2010/invirase_hpc-cps-eng.php

Consumer Health Care Advisory

Invirase: Health Canada has endorsed important safety information on Invirase (saquinavir mesylate).
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/public/_2010/invirase_pc-cp-eng.php

Summary Basis of Decision: A Summary Basis of Decision (SBD) is available for Toctino.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/phase1-decision/drug-med/sbd_smd_2010_toctino_119010-eng.php

Update: The Medical Devices Establishment Licence Listing (MDEL) has been updated.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/licences/mdel-lepim-eng.php

Update: The Drug Establishment Licence Listing (DEL) has been updated.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/licences/del-leppp-eng.php

Newsletter: The Canadian Adverse Reaction Newsletter, Volume 20 - Issue 2 - April 2010 is available.
http://www.hc-sc.gc.ca/dhp-mps/medeff/bulletin/carn-bcei_v20n2-eng.php

Consultation: Health Canada is pleased to announce proposed changes to the Therapeutic Products Directorate's (TPD) List of Recognized Standards for medical devices.
http://www.hc-sc.gc.ca/dhp-mps/consultation/md-im/consult_md_stand_im_norm_prop_lst-eng.php

Notice of Decision: A Notice of Decision is available for Ilaris.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/phase1-decision/drug-med/nd_ad_2010_ilaris_131009-eng.php

National Interest

Pharmaceutical Advertising Advisory Board (PAAB)

Newsletter: The April 2010 issue of the PAAB Review is available.
http://www.paab.ca/local/files/en/newsletter//PAAB%20Review%20Newsletter%20April%202010%20E.pdf

PAAB Opinions Policy: Clarification of the PAAB Opinions Policy is available.
http://www.paab.ca/local/files/opinionsand%20cross%20reference%20april%2019.pdf

Canadian Agency for Drugs and Technologies in Health (CADTH)

Reports: The following reports are available.

http://www.cadth.ca/media/pdf/k0170_iv_labetalol_obstetric_patients_htis-L1-5.pdf
(Monitoring Obstetrical Patients Receiving Intravenous Labetalol: Guidelines)

http://www.cadth.ca/media/pdf/k0171_six_minute_walk_test_htis-L1-5.pdf
(The Six Minute Walk Test: Clinical Effectiveness and Guidelines)

http://www.cadth.ca/media/pdf/k0169_walking_blood_donor_programs_htis-L1-5.pdf
(Walking Blood Donor Programs: Clinical Effectiveness and Guidelines)

http://www.cadth.ca/media/pdf/k0172_monitoring_hemoglobin_a1c_levels_L1-5.pdf
(Frequency of Monitoring Hemoglobin A1C Levels in Adults with Type 2 Diabetes: Evidence-Based Guidelines and Clinical Effectiveness)

http://www.cadth.ca/media/pdf/k0173_lymphedema_htis-L1-5.pdf
(Manual Lymph Drainage or Intermittent Pneumatic Compression for Adult Patients with Secondary Lymphedema: Clinical Effectiveness)

http://www.cadth.ca/media/pdf/k0160_oxygen-powered_resuscitators_htis-L1-5.pdf
(Oxygen-Powered Automatic Respiratory Resuscitators: Clinical Effectiveness)

http://www.cadth.ca/media/pdf/k0161_dental_crowns_inlays_overlays_htis-L1-5.pdf
(Dental Crowns, Inlays, and Overlays: Guidelines)

http://www.cadth.ca/media/pdf/k0162_crown_lengthening_surgery_htis-L1-5.pdf
(Crown Lengthening Surgery: Clinical Effectiveness and Guidelines)

http://www.cadth.ca/media/pdf/L0171_bupropion_risk_seizure_htis-L2.pdf
(Use of Bupropion in Patients with Depression and the Associated Risk of Seizures: Safety)

The Patented Medicine Prices Review Board (PMPRB)

Hearing: The Hearing Panel issued its decision on the merits in the matter of Hoechst Marion Roussel Canada Inc. (sanofi-aventis Canada Inc.) and the medicine Nicoderm, concluding the proceedings.
http://www.pmprb-cepmb.gc.ca/english/view.asp?x=271&id=178

National Association of Pharmacy Regulatory Authorities (NAPRA)

NDSAC: The Initial Recommendation made by the National Drug Scheduling Advisory Committee (NDSAC) on March 7, 2010 for the scheduling of:

-Diclofenac diethylamine in preparations for topical use on the skin in concentrations of not more than the equivalent of 1% diclofenac – Unscheduled (from Schedule III) was finalized effective April 15, 2010. Final approval of the initial recommendation was made by NAPRA’s Executive Committee, in consideration of comments received during the 30-day review period. The National Drug Schedules will be revised accordingly.
http://napra.ca/pages/home/default.aspx?id=2700

Newsletter: The NAPRA Notes, April 2010 Volume 5, Number 1 are available.
http://napra.ca/Content_Files/Files/NAPRA_Notes_April2010_Final.pdf
 

 

~~~~~

 

HEADS UP - March 22, 2010

Notices of Compliance - March 15 - 19, 2010

•  Agriflu (haemagglutinin-strain A (H1N1), haemagglutinin-strain A (H3N2), haemagglutinin-strain B) was approved as an active immunizing agent for the prevention of influenza on 2010-03-17.

News from Health Canada

Health Canada

Report: The Health Canada report, Health Canada 2010-2011 Estimates
Part III – Report on Plans and Priorities, is available.
http://www.tbs-sct.gc.ca/rpp/2010-2011/index-eng.asp?acr=1578

http://www.hc-sc.gc.ca/ahc-asc/performance/estim-previs/plans-prior/2010-2011-tpp-ppt-eng.php
(Summary of Three-Year Plan for Transfer Payment Programs (2010-2013))

Unauthorized Health Product: Health Canada is warning Canadians that an unauthorized health product, "West Pharm Therma Lean Fat Burner Energizer", was found on the Canadian market.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2010/2010_53-eng.php

Unauthorized Health Product: Health Canada is warning Canadians that an unauthorized health product, "Herbal Diet Natural", has been found on the Canadian market and contains an undeclared pharmaceutical ingredient similar to the prescription drug sibutramine.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2010/2010_48-eng.php

Biologics and Genetic Therapies Directorate (BGTD)

Meeting: Meeting Notes are available for the November 18, 2009 Association Bilateral Meeting between BIOTECanada and the Biologics and Genetic Therapies Directorate (BGTD).
http://www.hc-sc.gc.ca/dhp-mps/brgtherap/activit/meet-reunion/biotecanada-mm-crr-2009-11-18-eng.php

Therapeutic Products Directorate (TPD)

Consumer Health Advisory

Rotarix: On March 19, 2010, Health Canada was notified by GlaxoSmithKline (GSK) of the presence of DNA from a virus identified as porcine circovirus-1 (PCV-1) in batches of its oral rotavirus vaccine, Rotarix.
http://www.hc-sc.gc.ca/dhp-mps/brgtherap/activit/announce-annonce/rotarix-eng.php

Guide: The final revisions have been released to Health Canada's Guide for the Analysis and Review of QT/QTc Interval Data.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/qtqtc/qt_review_examen-eng.php

Guidance: The revised version of Health Canada's QT/QTc Interval Prolongation: Guidance for Product Monograph Content has been released.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/qtqtc/qt_pm_mp-eng.php

Interim Guidance: An Interim Guidance entitled, “Fair Balance in Direct-to-Consumer Advertising of Vaccines”, is available.
http://www.hc-sc.gc.ca/dhp-mps/advert-publicit/pol/guide-ldir_dtca-pdac_vaccine-vaccins-eng.php

National Interest

Federal Government

Chemical Substances Challenge Report: The Summary Report for the December 2009 meeting of the Challenge Advisory Panel and the Government response to recommendations from the Challenge Advisory Panel pertaining to Batch 8 substances are now available.
http://www.chemicalsubstanceschimiques.gc.ca/challenge-defi/panel-groupe/meet-reunion-eng.php

GAZETTE II

Controlled Drugs and Substances Act: Regulations amending the Marihuana Medical Access Regulations are available.
http://www.gazette.gc.ca/rp-pr/p2/2010/2010-03-31/html/sor-dors63-eng.html

Canadian Agency for Drugs and Technologies in Health (CADTH)

Newsletter: The March 31, 2010 issue of the COMPUS Communiqué — Vol. 5, No. 9 is available and includes information on the latest tools from CADTH’s suite of products on the topic of self-monitoring of blood glucose (SMBG).
http://www.cadth.ca/index.php/en/compus/compus-communique/compus-communique-5-9

Report: The Issues in Emerging Health Technologies Report entitled, “New Anticoagulants for Stroke Prevention in Patients with Atrial Fibrillation”, is available.
http://www.cadth.ca/media/pdf/R0004_Anticoagulants_Atrial_Fibrillation_cetap_e.pdf

Report: The Health Technology Assessment Rapid Review Report entitled, “Self-Directed Cognitive Behavioural Therapy for Adults with Diagnosis of Depression: Systematic Review of Clinical Effectiveness, Cost-Effectiveness, and Guidelines”, is available.
http://www.cadth.ca/media/pdf/M0014_CBT_for_Depression_L3_e.pdf

Report: The Technology Report entitled, “Pulmonary Rehabilitation for Chronic Obstructive Pulmonary Disease: Clinical, Economic, and Budget Impact Analysis”, is available.
http://www.cadth.ca/index.php/en/hta/reports-publications/search/publication/962

The Patented Medicine Prices Review Board (PMPRB)

Speech: Dr. Benoit delivered a presentation, Canada´s Patented Medicines Prices Review Board, at the Pharma Pricing & Market Access Outlook conference, in London, UK.
http://www.pmprb-cepmb.gc.ca/cmfiles/PMPRB-Chair-LondonDeck(2010-03-24)Conference.pdf

National Association of Pharmacy Regulatory Authorities (NAPRA)

Announcement: NAPRA has secured funds from the Government of Canada to develop the International Pharmacy Graduates’ Gateway to Canada Project.
http://napra.ca/Content_Files/Files/NR_NAPRA_IPGProject_Funding_Announcement_March252010_Bilingual_Final.pdf

Canadian Institutes of Health Research

Financial Conflicts of Interest Checklist: A CIHR-funded team led by Dr. Paula Rochon of the Women's College Research Institute has developed the Financial Conflicts of Interest Checklist that aims to minimize financial conflicts in clinical research.
http://www.openmedicine.ca/fcoichecklist/

 

~~~~~

 

HEADS UP - March 15, 2010

 

Notices of Compliance - March 8 - 12, 2010

• Clinoleic 20% (olive oil / soybean oil) was approved as a lipid emulsion for intravenous nutrition on 2010-03-08.

On the Move

• The Board of Directors of the Canadian Agency for Drugs and Technologies in Health (CADTH) confirmed that Dr. Brian O’Rourke will continue his duties with the organization as the interim President and CEO. This appointment is for a period of one year. http://www.cadth.ca/index.php/en/cadth/corporate-profile/executive-news

News from Health Canada

Health Canada

Avelox: Health Canada is informing health care professionals and Canadians of changes to the labelling information for the prescription antibiotic Avelox (moxifloxacin). The updated labelling incorporates important safety information related to the rare risk of severe liver injury.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2010/2010_42-eng.php

Announcement: On March 20th, the Honourable Leona Aglukkaq, Minister of Health, and the Honourable Jim Prentice, Minister of the Environment, released the draft screening assessment reports for 17 substances assessed in Batch 9 of the Chemicals Management Plan.
http://www.hc-sc.gc.ca/ahc-asc/media/nr-cp/_2010/2010_45-eng.php

Biologics and Genetic Therapies Directorate (BGTD)

Summary Basis of Decision: A Summary Basis of Decision (SBD) has been issued for Cimzia.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/phase1-decision/drug-med/sbd_smd_2010_cimzia_120296-eng.php

Arepanrix™ H1N1 Pandemic Influenza Vaccine: On November 18th, 2009, the Public Health Agency of Canada communicated to GlaxoSmithKline Biologicals and GlaxoSmithKline Inc. (collectively "GlaxoSmithKline"), and to Health Canada, concerns that a higher frequency of anaphylaxis than is usually seen following immunization was reported for one lot of Arepanrix™ H1N1 pandemic influenza vaccine (Combo Lot A80CA007A).
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/legislation/interimorders-arretesurgence/qual-vaccin-eng.php

Natural Health Products Directorate (NHPD)

Checklist for Labelling: A checklist has been made available to be used for label generation by applicants intending to submit a Product Licence Application (PLA) for a natural health product (NHP).
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/legislation/docs/label-list-etiquet-eng.php

Therapeutic Products Directorate (TPD)

Consumer Health Advisory

WinRho SDF (Rho(D) Immune Globulin (Human)): Cangene Corporation, in consultation with Health Canada, is informing Canadian patients and healthcare professionals of important new safety information concerning the use of WinRho® SDF (Rho(D) Immune Globulin (Human)) for the treatment of immune thrombocytopenic purpura, also called immune thrombocytopenia, or ITP.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/public/_2010/winrho_2_pc-cp-eng.php

Ratio-Prednisolone Ophthalmic Solution: Health Canada is advising consumers that Ratiopharm Inc., of Mirabel, Quebec, has voluntarily recalled all units from Lot HF26 and Lot HF27 of the prescription drug Ratio-Prednisolone Ophthalmic Solution (DIN 00700401) in 1.0% strength because some bottles may contain particles that could lead to increased eye irritation.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2010/2010_46-eng.php

Health Care Professional Advisory

WinRho SDF (Rho(D) Immune Globulin (Human)): Cangene Corporation, in consultation with Health Canada, wishes to inform healthcare professionals of changes to the prescribing information, including new contraindications and conditions for use, for the treatment of ITP with WinRho® SDF.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2010/winrho_2_nth-aah-eng.php

Summary Basis of Decision: A Summary Basis of Decision (SBD) has been issued for Emend IV.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/phase1-decision/drug-med/sbd_smd_2010_emendiv_120374-eng.php

Information Sessions on Finalized Guidance: Health Canada has finalized the guidance document entitled, "Good Manufacturing Practices (GMP) Guidelines - 2009 Edition (GUI-0001)". Implementation of the guidelines came into effect on November 8, 2009. Health Canada will be delivering information sessions regarding this guideline in six Canadian cities.
http://www.hc-sc.gc.ca/dhp-mps/consultation/compli-conform/2010gmp-bpf-rs-tp-index-eng.php

National Interest

Federal Government

Chemicals Management Plan: The Minister of the Environment and the Minister of Health published 13 notices in the Canada Gazette, Part I, concerning the draft screening assessment reports for the 17 substances in the ninth batch of substances identified under the Challenge component of the Chemicals Management Plan.
http://www.chemicalsubstanceschimiques.gc.ca/challenge-defi/batch-lot-9/index-eng.php

GAZETTE I

Department of Health Act: A Notice has been issued amending Health Canada’s National Dosimetry Services Products, Services and Fee Schedule –monitoring radiation exposure in the workplace.
http://www.gazette.gc.ca/rp-pr/p1/2010/2010-03-13/html/index-eng.html

Patent Act: The Patented Medicine Prices Review Board will hold a hearing into the matter of Sandoz Canada Inc. at the Board’s offices in the Standard Life Centre, 18th Floor, 333 Laurier Avenue W, Ottawa, Ontario, on a date to be set by the Board.
http://www.gazette.gc.ca/rp-pr/p1/2010/2010-03-20/html/index-eng.html

Canadian Environmental Protection Act, 1999: Notice has been given of publication after screening assessment of substances — Batch 9 and publication of results of investigations and recommendations for substances.
http://www.gazette.gc.ca/rp-pr/p1/2010/2010-03-20/html/sup-eng.html

Advertising Standards Canada (ASC)

Annual General Meeting: The ASC will hold its annual General Meeting and Breakfast Program on Tuesday, April 27, 2010 in Toronto.
http://www.adstandards.com/en/Events/201004AGM.asp

Canadian Agency for Drugs and Technologies in Health (CADTH)

Report: The Health Technology Assessment Report entitled, “Polymerase Chain Reaction Tests for Methicillin-Resistant Staphylococcus aureus in Hospitalized Patients: Clinical and Cost-Effectiveness Analyses”, is available.
http://www.cadth.ca/index.php/en/hta/reports-publications/search/publication/952

Webcast: CADTH will host a Seminar entitled, “Web Cast- Health Information — Is it a Public Good?”.
http://www.cadth.ca/index.php/en/events/webcast-public-good

The Patented Medicine Prices Review Board (PMPRB)

Hearing: The Hearing Panel issued a Board Order in the matter of sanofi pasteur Limited and the medicines Quadracel and Pentacel, concluding the proceedings initiated on March 27, 2007.
http://www.pmprb-cepmb.gc.ca/english/view.asp?x=271&id=175

Canadian Institute of Health Information (CIHI)

Report: The report entitled, “Drug Use among Seniors on Public Drug Programs in Canada, 2002 to 2008”, is available.
http://secure.cihi.ca/cihiweb/dispPage.jsp?cw_page=PG_2791_E&cw_topic=2791&cw_rel=AR_3410_E

 

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HEADS UP - March 8, 2010

 

 Notices of Compliance - March 1 - 5, 2010

• Butrans (buprenorphine) was approved as an opioid analgesic on 2010-03-05.

News from Health Canada

Health Canada

Daylight Savings Time: Health Canada would like to remind the thousands of Canadians who rely on medical devices or systems with internal clocks to check these devices to ensure they switch from Standard Time to Daylight Savings Time on Sunday, March 14, 2010 at 2:00 a.m.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2010/2010_37-eng.php

Biologics and Genetic Therapies Directorate (BGTD)

Announcement: Health Canada has authorized Covidien of Hazelwood, Missouri, to use Molybdenum 99 (Moly-99) produced by the Maria Reactor in Poland to make Tc-99m for diagnostic imaging in Canadian health care facilities.
http://www.hc-sc.gc.ca/dhp-mps/brgtherap/activit/announce-annonce/med_isotopes-eng.php

Expert Advisory Panel on Insulin: Information is available on the Expert Advisory Panel on Insulin.
http://www.hc-sc.gc.ca/dhp-mps/brgtherap/activit/sci-consult/insulin/index-eng.php

Therapeutic Products Directorate (TPD)

Consumer Health Advisory

OneTouch SureStep Test Strips: OneTouch® SureStep® test strips may provide low test results when your blood glucose is greater than 22.2 mmol/L.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/public/_2010/onetouch_pc-cp-eng.php

Report: The report entitled, “Therapeutic Products Directorate Statistical Report 2008: Patented Medicines (Notice of Compliance) Regulations and Data Protection (C.08.004.1 of the Food and Drug Regulations)”, is available.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/docs/patmedbrev/patmrep_mbrevrap_2008-eng.php

Summary Basis of Decision (SBD): A Summary Basis of Decision has been issued for cobas TaqScreen MPX Test.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/phase1-decision/md-im/sbd_smd_2010_cobas_taqscreen_124928-eng.php

National Interest

Advertising Standards Canada (ASC)

Report: The ASC released the Ad Complaints Report - 2009 Year in Review.
http://www.adstandards.com/en/ConsumerComplaints/2009AdComplaintsReport.pdf

Canadian Agency for Drugs and Technologies in Health (CADTH)

Newsletter: The March 10, 2010 issue of the Health Technology Update- Issue 13 is available.
http://www.cadth.ca/index.php/en/hta/reports-publications/search/publication/963

Newsletter: The March 12, 2010 COMPUS Communiqué — Vol. 5, No. 8 is available.
http://www.cadth.ca/index.php/en/compus/compus-communique/compus-communique-5-8

National Association of Pharmacy Regulatory Authorities (NAPRA)

Statistics: 2010 national statistics for pharmacists and pharmacies are available.
http://napra.ca/pages/Practice_Resources/National_Statistics.aspx

Meeting: A meeting of the National Drug Scheduling Advisory Committee (NDSAC) was held on March 7 and 8, 2010 with the following Initial Recommendation made:

•  Diclofenac diethylamine in preparations for topical use on the skin in concentrations of not more than the equivalent of 1% diclofenac - Unscheduled (from Schedule III)

http://napra.ca/pages/home/default.aspx?id=2678

 

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HEADS UP - March 1, 2010

Notices of Compliance - February 22 - 26, 2010

• Ilaris (canakinumab) was approved as an immunomodulatory agent – a selective interleukin-1 beta (IL-1beta) inhibitor on 2010-02-26.

News from Health Canada

Health Canada

Unapproved Health Product: Health Canada is warning consumers about an unapproved health product, "POWER-MAX", which may pose serious health risks.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2010/2010_34-eng.php

Biologics and Genetic Therapies Directorate (BGTD)

Final Guidance: Health Canada has released the finalized Guidance for Sponsors: Information and Submission Requirements for Subsequent Entry Biologics (SEBs), as well as, updates to the Guidance Document: Data Protection under C.08.004.1 of the Food and Drug Regulations and updates to the Guidance Document: Patented Medicines (Notice of Compliance) Regulations.
http://www.hc-sc.gc.ca/dhp-mps/brgtherap/applic-demande/guides/seb-pbu/notice-avis_seb-pbu_2010-eng.php

http://www.hc-sc.gc.ca/dhp-mps/brgtherap/applic-demande/guides/seb-pbu/seb-pbu_2010-eng.php
(Guidance for Sponsors: Information and Submission Requirements for Subsequent Entry Biologics (SEBs))

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/data_donnees_protection-eng.php
(Updates to the Guidance Document: Data Protection under C.08.004.1 of the Food and Drug Regulations)

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/patmedbrev/pmreg3_mbreg3-eng.php
(Updates to the Guidance Document: Patented Medicines (Notice of Compliance) Regulations)

Natural Health Products Directorate (NHPD)

Monograph: A new single ingredient monograph is available for Conjugated Linoleic Acid.
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/applications/licen-prod/monograph/mono_cla-alc-eng.php

Information: Information is available on: What is the Licensed Natural Health Product Database (LNHPD) Data Extract?
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/applications/licen-prod/lnhpd-bdpsnh_data_extract-eng.php

Phase 1 Action Plan: The NHPD document, “Phase I Action Plan: Natural Health Products Regulatory Review”, is available.
http://www.hc-sc.gc.ca/dhp-mps/pubs/natur/act-plan-act-phase1-eng.php

Therapeutic Products Directorate (TPD)

Consumer Health Advisory

Fentanyl Transdermal Systems: The manufacturers of Fentanyl Transdermal Systems, in collaboration with Health Canada, would like to inform Canadians of important new changes made to the Dose Conversion Guidelines in the Product Monograph.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/public/_2010/fentanyl_2_pc-cp-eng.php

Health Care Professional Advisory

Fentanyl Transdermal Systems: The manufacturers of Fentanyl Transdermal Systems (FTS) in collaboration with Health Canada wish to provide you with important new information regarding changes to the Dose Conversion Guidelines in the Dosage and Administration section of the Canadian Product Monographs for FTS.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2010/fentanyl_2_hpc-cps-eng.php

http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2010/fentanyl_2_nth-aah-eng.php
(Notice to Hospitals)

Notice: Product Monograph Template Revisions are available: a) New Boxed Message Insert for Overdose Management Information; b) New Address for Canada Vigilance Program.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/monograph/pmappe_mpanne_notice_avis_rev-eng.php

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/monograph/pmappe_mpanne-eng.php
(Appendix E Template - Standard Product Monograph Template)

Notice: Health Canada has decided to license blood glucose meters and associated software that display results solely in millimoles per litre (mmol/L) for sale in Canada.
http://www.hc-sc.gc.ca/dhp-mps/md-im/activit/announce-annonce/md_notice_glucosemeters_im_avis_glycometres-eng.php

Register of Innovative Drugs: The Register of Innovative Drugs has been updated.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/regist/reg_innov_dr-eng.php

National Interest

Federal Government

Chemical Management Plan: The Minister of the Environment and the Minister of Health published 9 Notices in the Canada Gazette, Part I, concerning the final screening assessment reports for 14 substances in the seventh batch of substances identified under the Challenge component of the Chemicals Management Plan. The proposed risk management approach documents were also released for a 60-day public comment period.
http://www.chemicalsubstanceschimiques.gc.ca/challenge-defi/batch-lot-7/index-eng.php

Canadian Environmental Protection Act, 1999: The Minister of the Environment published in the Canada Gazette, Part I, a notice of intent to amend the Domestic Substances List to apply the Significant New Activity provisions of the Canadian Environmental Protection Act, 1999 to eight additional substances in Batch 6 of the Challenge.
http://www.chemicalsubstanceschimiques.gc.ca/challenge-defi/batch-lot-6/index-eng.php

GAZETTE I

Canadian Environmental Protection Act, 1999: A notice of intent has been issued to amend the Domestic Substances List to apply the Significant New Activity provisions of the Canadian Environmental Protection Act, 1999 to eight additional substances in Batch 6 of the Challenge.
http://www.gazette.gc.ca/rp-pr/p1/2010/2010-03-06/html/index-eng.html

Advertising Standards Canada (ASC)

Guide: ASC Clearance Services launched a new, definitive guide to Children's Broadcast Advertising in March 2010.
http://www.adstandards.com/en/Clearance/Childrens/childrensBroadcastAdvertisingClearanceGuide.aspx

http://www.adstandards.com/en/Clearance/Childrens/kidsGuide.pdf
(Guide to Children's Broadcast Advertising)
 

 

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HEADS UP - February 22, 2010

Notices of Compliance - February 15 - 19, 2010

• There were no relevant NOCs published this week.

News from Health Canada

Health Canada

Announcement: The Honourable Leona Aglukkaq, Minister of Health, announced the launch of a campaign to help make Canadian families more aware of the environmental health risks around them.
http://www.hc-sc.gc.ca/ahc-asc/media/nr-cp/_2010/2010_26-eng.php

Announcement: The Honourable Leona Aglukkaq, Minister of Health, announced federal funding of over $1.5 million to the Association of Faculties of Medicine of Canada (AFMC) to strengthen the postgraduate medical education system.
http://www.hc-sc.gc.ca/ahc-asc/media/nr-cp/_2010/2010_32-eng.php

Foreign Product Alerts: Health Canada is advising consumers not to use the products specified below due to concerns about possible side-effects.

http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2010/2010-28-eng.php
(Certain lots (Lot Numbers 494, 520, 520A, 520B, 520C, 521, 705, 706, 779 and 807) of sexual enhancement dietary supplements sold by Atlas Operations Inc.)

http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2010/2010-27-eng.php
(2H & 2D)

http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2010/2010-29-eng.php
(65 products sold through Bodybuilding.com)

http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2010/2010-30-eng.php
(STRO Emperor Capsules)

http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2010/2010-31-eng.php
(Tian Yang Xu Huo Oral Ulcer Capsule Batch number 0812003, expiry date 11.2011)

Therapeutic Products Directorate (TPD)

Interim Policy Statement: Health Canada is announcing the adoption of an Interim Policy Statement on Health Canada's Working Definition for Nanomaterials.
http://www.hc-sc.gc.ca/sr-sr/consult/_2010/nanomater/index-eng.php

http://www.hc-sc.gc.ca/sr-sr/consult/_2010/nanomater/draft-ebauche-eng.php
(Consultation Document)

Record of Decisions: A Record of Decisions is available for the November 19, 2009 meeting between Health Canada and Canada's Medical Device Technology Companies (MEDEC).
http://www.hc-sc.gc.ca/dhp-mps/md-im/activit/meet-reunion/2009-11-19-eng.php

National Interest

GAZETTE I

Canadian Environmental Protection Act, 1999: An Order has been issued adding a toxic substance, Benzene, to Schedule 1 to the Canadian Environmental Protection Act, 1999.
http://www.gazette.gc.ca/rp-pr/p1/2010/2010-02-27/html/reg1-eng.html

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Regulatory Notes Archive