Marketing Authorization

The official document or license issued by a national or trans-national drug licensing and approval authority, which renders a drug legal for sale in that authority’s jurisdiction. It will specify the sales name of the product (if different from any generic name), the pharmaceutical dosage form(s), the quantitative formula per unit dose, the shelf-life, storage conditions, and packaging characteristics. It will also specify the information on which authorization is based (e.g., “[t]he product(s) must conform with all the details provided in your application, as modified by subsequent correspondence.”) It will also contain a list of the product information that can be provided to health-care professionals and to the public and will state the name and address of the holder of the authorization, and the term of the authorization. Marketing authorization is reviewed periodically, usually every five years. Drugs that have marketing authority are described as registered and the list of such drugs as the register.

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