Health Canada Mutual Recognition Agreements

On January 1, 2004, new Natural Health Products (NKW) regulations came into force in Canada. As a result, some products previously regulated as drugs are now regulated as natural health products (e.g. B vitamins, minerals, herbal remedies, homeopathic medicines and probiotics). As a result of the new NHP regulations, drug licences previously held by companies for natural health products are considered to have expired and have not been renewed since January 2006. In order to bring these products back within the scope of the ARM, Health Canada is preparing a regulatory amendment that would allow, on a voluntary basis, Canadian natural product companies to hold, in addition to the location licence required by the NHP regulations, an establishment licence issued on the basis of compliance with Good Pharmaceutical Manufacturing Practices (GMP). For more information, visit the Natural Health Products website. Health Canada will inform the Commission of any progress in this matter. These agreements benefit regulators by reducing double inspections in any other area, allowing for a greater focus on higher-risk sites, and expanding inspection coverage of the global supply chain. Recognizing that Canadian regulations have their own GMP requirements for natural health products and do not require these products to be manufactured in a plant at a level of PMP equivalent to that of drugs, many companies ensure this level of production. 6.1 During the transition period, the Joint Committee shall develop mechanisms and procedures acceptable to both Parties for the labelling of products intended for export to Canada to demonstrate compliance with Canadian requirements. These labels must be checked by CABs, which are recognised by the competent authorities/designations, ensure traceability, provide consumers with sufficient information and do not lead to confusion with other conformity markings.

Access to the Community market is subject to CE marking. 4. The transition from the transition phase to the conditions of full mutual recognition shall be carried out unless there is documented evidence of a lack of technical competence in the conformity assessment of a Party. Having regard to the improvement of trading conditions between the Contracting Parties, which will lead to the mutual recognition of tests, certificates and marks of conformity, 5. This Agreement shall not be interpreted in such a way as to imply mutual recognition of the standards or technical regulations of the Contracting Parties and, except as otherwise provided in a Sectoral Annex, shall not imply mutual recognition of the equivalence of standards or technical regulations. The European Union (EU) has signed mutual recognition agreements (MRAs) with third country authorities on conformity assessment of regulated products. These agreements contain a sectoral annex on the mutual recognition of GMP (Good Manufacturing Practice) inspections and the certification of batches of medicinal products for human and veterinary use. 3.2. Each Party reserves the right to publish the results of conformity assessment reports in situations that may affect public health. .

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