Does Health Canada require that all documents be translated to French?
DOES HEALTH CANADA REQUIRE THAT ALL DOCUMENTS BE TRANSLATED TO FRENCH?
Not at all. Both official languages in Canada, that is English and French, are accepted. That being said, the regulatory dossiers are usually submitted to Health Canada in English. French dossiers, or the supporting documents that are in French, are also acceptable, however, the review could be a little more challenging since most of the Health Canada reviewers are Anglophone. Even if it is not required to submit French documents to Health Canada, the French translation of the informed consent form must be generated and available for francophone patients. Also, there are specific language regulations to respect on Canadian labels. That being said, Health Canada has established standard target review timelines that they respect, which is not influenced by the selected submission language.
For questions about the Canadian Drug Review & Regulatory approval process that is not covered in this section, please go ahead and contact us directly.
With a quarter of a century of consistent and successful results, SPharm has become one of the leading Drug Regulatory Advisory firms in Canada. Drug companies from around the world count on SPharm to help them navigate the drug (and other health products) review & approval process in Canada.
Avec un quart de siècle de résultats et de succès constants , SPharm est devenue une entreprise de services de référence au Canada en stratégie de développement de médicaments et affaires réglementaires. Des compagnies pharmaceutiques à travers le monde comptent sur SPharm pour faciliter le processus d’homologation de leurs médicaments (et autres produits de santé) au Canada.