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Fiche 1,  Justifications,  Anglais

Record number: 1, Textual support number: 1 DEF

An official document issued by the competent drug regulatory authority for the purpose of marketing or free distribution of a product after evaluation for safety, efficacy and quality.  1, fiche 1, Anglais, - marketing%20authorization

Record number: 1, Textual support number: 1 CONT

The marketing authorization must set out, inter alia, the name of the product, the pharmaceutical dosage form, the quantitative formula (including excipients) per unit dose (using INNs [international nonproprietary names] or national generic names where they exist), the shelf-life and storage conditions, and packaging characteristics. It specifies the information on which authorization is based (e.g. "The product(s) must conform with all the details provided in the application and as modified in subsequent correspondence"). It also contains the product information approved for health professionals and the public, the sales category, the name and address of the holder of the authorization, and the period of validity of the authorization. Once a product has been given marketing authorization, it is included on a list of authorized products - the register - and is often said to be "registered" or to "have registration". Market authorization may occasionally also be referred to as a licence or product licence.  1, fiche 1, Anglais, - marketing%20authorization

Record number: 1, Textual support number: 2 CONT

Health Canada suspends the market authorization of Adderall XR.  2, fiche 1, Anglais, - marketing%20authorization

Fiche 1,  Justifications,  Français

Record number: 1, Textual support number: 1 DEF

Acte de naissance de la spécialité pharmaceutique issue d'une décision administrative, basé sur des contraintes réglementaires garantissant sa qualité, son efficacité et son innocuité.  2, fiche 1, Français, - autorisation%20de%20mise%20sur%20le%20march%C3%A9

Fiche 1,  Justifications,  Espagnol