NHPD Monthly Communiqué

Transcription

1 NHPD Monthly Communiqué Vol. 3, Issue 5 February 2008 The NHPD Monthly Communiqué is a publication of Health Canada s Natural Health Products Directorate (NHPD), the federal department responsible for the regulation of natural health products sold in Canada. The communiqué is released to the Canadian public each month via the NHPD's electronic bulletin. Subscribe to the NHPD e-bulletin at: Questions or comments regarding the content of the NHPD Monthly Communiqué may be addressed to NHPD_DPSN@hc-sc.gc.ca. TABLE OF CONTENT PRODUCT LICENSING INFORMATION:...2 New and Revised Natural Health Product Monographs...2 Advertising Claims on Label Texts for Natural Health Products...4 REVISIONS Important Tips and Recommendations for Assembling a Product Licence Application Package...4 New Guidance Document Post Licensing Guidance Document...5 Revised Guidance Document Application for International Trade Certificate for Natural Health Products...6 SITE LICENSING INFORMATION:...6 COMPLIANCE CORNER:...6 Compliance Date for Priority 5 Natural Health Products...6 CLINICAL TRIAL INFORMATION:...7 POLICY AND REGULATORY AFFAIRS:...7 RESEARCH INFORMATION:...7 OTHER INFORMATION:...7 Expert Advisory Committee (EAC) - Update...7 1

2 PRODUCT LICENSING INFORMATION: New and Revised Natural Health Product Monographs Recognizing the important role monographs can play both in facilitating the review and processing of product licence applications and as reliable sources of product information for consumers, the NHPD is committed to developing new monographs as well as revising and updating existing monographs to reflect new research and evidence. New Single Ingredient Monographs 5-HTP Monograph: Coenzyme Q 10 Monograph: Thiamine Monograph: Applicants that have already submitted a non-compendial product licence application for one of the substances listed above are encouraged to reclassify their application as a compendial product licence application, citing the corresponding monograph. Instructions on how to reclassify an application are available in the July 2007 issue of the NHPD Monthly Communiqué ( Revised Single Ingredient Monographs Angelica Monograph: Astragalus Monograph: Avens Monograph: Bilberry Monograph: Boldo Monograph: Burdock Monograph: Caffeine Monograph: 2

3 Cranberry Monograph: Cayenne Monograph: Dandelion Monograph: Evening Primrose Monograph: Figwort Monograph: Fish Oil Monograph: Flax Monograph: Ginger Monograph: Lysine Monograph: Mugwort Monograph: Pantothenic Acid Monograph: Seal Oil Monograph: Skullcap Monograph: Product licence holders of natural health products previously licensed under the old versions of the single ingredient listed above are encouraged to commission new labels that comply with the revised monographs as soon as possible. As per section 11 of the Natural Health Products Regulations, an amendment with the revised information must 3

4 be filed with and approved by the NHPD before proceeding with the new label run. Applicants should note that any submissions in queue are required to attest to the revised monographs. Advertising Claims on Label Texts for Natural Health Products The purpose of this article is to clarify the review of advertising claims in proposed label texts by the Natural Health Products Directorate (NHPD). The NHPD reviews proposed label texts as per the labelling requirements set out in Part 5 of the Natural Health Products Regulations. Part 5 does not outline any requirements with respect to advertising claims and as such, the NHPD will no longer review advertising claims indicated on the label texts. Applicants are responsible for ensuring that advertising claims on the labels of their products do not contravene Section 9 of the Food and Drugs Act. Section 9(1) of the Food and Drugs Act states that No person shall label, package, treat, process, sell or advertise any drug in a manner that is false, misleading or deceptive or is likely to create an erroneous impression regarding its character, value, quantity, composition, merit or safety. Advertising claims will not be reviewed during assessment with the exception of comparative claims and clinically proven/tested claims. The NHPD may request additional evidence to support comparative and clinically proven/tested claims. Furthermore, compendial applications with comparative claims that require additional evidence may see their applications transferred to the non-traditional assessment stream. If the claim is removed, the application can remain in the compendial assessment stream. Information specific to acceptable advertising claims, including comparative claims and clinically proven/tested claims, can be obtained from the guidance document Consumer Advertising Guidelines for Marketed Health Products for Nonprescription Drugs including Natural Health Products, which is available at: This document provides guidance to industry and stakeholders so that they can meet the provisions of the Food and Drugs Act and its Regulations. REVISIONS Important Tips and Recommendations for Assembling a Product Licence Application Package The Natural Health Products Directorate (NHPD) has modified its tips and recommendations for assembling a Product Licence Application (PLA) package. These revised recommendations replace those previously published in the Vol. 2, Issue 5 - February 2007 of the NHPD Monthly Communiqué and currently found in Chapter 3.1 of the Product Licensing Guidance Document. Tips and Recommendations 4

5 Applicants are now only required to provide one copy of the submission package for each PLA and not two copies as previously recommended. PLAs should continue to be typed, submitted by mail/courier, and contain original signatures. In light of this revision, duplicate copies sent to the NHPD will not be associated with the submission file and will be discarded upon receipt. To ensure that PLAs can be processed quickly and efficiently, the NHPD has the following additional tips and recommendations it strongly encourages applicants to follow. Compliance with these recommendations will accelerate the issuance of acknowledgement letters: Supporting documents included with the PLA should not be stapled, coiled, or bound. Elastic bands and/or large presentation clips should be used to hold documents together. The use of dividers, binders, duo-tangs is not recommended. They will be discarded upon receipt. All documents should be double-hole punched at the top of the document and organized in the following order: 1. Cover Letter 2. Letter of Access (if applicable) 3. Completed PLA Form 4. Designated Party Authorization Form (if applicable) 5. Animal Tissue Form (if applicable) 6. NHP Label Text 7. Drug Label Text (if applicable, in the case of products previously licensed as drugs and issued DINs) 8. Quality Summary Report including finished product specifications (if applicable) 9. Evidence Summary Report (if applicable) 10. Safety Summary Report (if applicable) 11. References (if applicable)\ New Guidance Document Post Licensing Guidance Document Once a Natural Health Product (NHP) has been granted a Natural Product Number (NPN, or DIN-HM for homeopathic medicines), it is not uncommon for licensees to make changes to the product; such changes are referred to as post-licensing changes. The Post Licensing Guidance Document provides information on the different types of post licensing changes as well as recommendations for licencees on how to submit the required documentation to Health Canada. This new guidance document is available online at: 5

6 Revised Guidance Document Application for International Trade Certificate for Natural Health Products The Natural Health Products Directorate (NHPD) has made the following addition to Chapter 3.3. of the Application for International Trade Certificate for Natural Health Products guidance document: When requested to issue an International Trade Certificate, the Natural Health Products Directorate will also consider any current compliance and enforcement action being taken against the product, site or applicant in question. The revised document is available online at: SITE LICENSING INFORMATION: No new information to report this month. COMPLIANCE CORNER: Compliance Date for Priority 5 Natural Health Products On January 10, 2008, the Natural Health Products Directorate (NHPD) released an important notice reminding stakeholders that the compliance date for Priority 5 natural health products (NHPs) has passed (January 1, 2008). Priority 5 NHPs include vitamins and minerals. In accordance with the Compliance Policy for Natural Health Products, Priority 5 NHPs that present an unacceptable risk to health or that have not been issued a submission number by January 1, 2008, will be subject to compliance action, which may include the removal of all Priority 5 NHPs from the Canadian market as well as the refusal of incoming shipments of Priority 5 NHPs. Compliance and enforcement actions will be carried out by the Health Products and Food Branch Inspectorate (HPFBI) in accordance with the Compliance and Enforcement Policy (POL 0001). A copy of the January 10, 2008 notice is available online at: 6

7 CLINICAL TRIAL INFORMATION: No new information to report this month. POLICY AND REGULATORY AFFAIRS: No new information to report this month. RESEARCH INFORMATION: No new information to report this month. OTHER INFORMATION: Expert Advisory Committee (EAC) - Update Further to the Open Call for Nominations issued in June 2007 for an expert in herbalism/ nutrition, the NHPD has completed its selection process and is pleased to announce the addition of Amanda Howe to the Expert Advisory Committee (EAC) on Natural Health Products Amanda Howe will be joining current EAC members Dr. Heather Boon (co-chair of the EAC), Dr. Joseph Betz, Dr. John Thor Aranson, Dr. David Lescheid, Dr. David Brule, Dr. Leonard Piché, Ron Rosenes, Dr. Ikhlas Khan, Dr. Mary Hardy, Dr. Fereidoon Shahidi, Dr. Colin Barrow, Dr. Francis Law and Dr. Michael Chung. The EAC is an external group composed of approximately 10 to 14 non-governmental scientists and professionals with extensive knowledge and expertise in a variety of fields, including naturopathy, homeopathy, traditional Chinese medicine, Aboriginal medicine, chemistry, biology, pharmacology, nutrition, and toxicology. Its role is to provide the NHPD with advice and guidance on questions pertaining to the safety, quality, efficacy, claims use, and regulation of natural health products in Canada. The open call process in general was extremely successful, with over 20 nominations submitted for consideration. The Directorate is indeed encouraged to see such a vast interest in the science and regulation of natural health products in Canada. 7

8 In closing, the NHPD would also like to take this opportunity to thank the departing member of the EAC, Gillian Leverkus. Ms Leverkus, has been involved with Health Canada for several years, participating on a number of natural health product working groups and committees. Her contributions over the years have been invaluable to the Natural Health Products Directorate. The NHPD wishes Ms. Leverkus the best of luck in her future endeavours. 8