TERMIUM Plus®
The Government of Canada’s terminology and linguistic data bank.
marketing authorization [1 record]
Record 1 - internal organization data 2005-06-02
Record 1, English
Record 1, Subject field(s)
- Pharmacology
- Restrictive Practices (Law)
Record 1, Main entry term, English
- marketing authorization
1, record 1, English, marketing%20authorization
correct
Record 1, Abbreviations, English
Record 1, Synonyms, English
- market authorization 2, record 1, English, market%20authorization
correct
Record 1, Textual support, English
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, record 1, English, - 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, record 1, English, - marketing%20authorization
Record number: 1, Textual support number: 2 CONT
Health Canada suspends the market authorization of Adderall XR. 2, record 1, English, - marketing%20authorization
Record 1, French
Record 1, Domaine(s)
- Pharmacologie
- Pratiques restrictives (Droit)
Record 1, Main entry term, French
- autorisation de mise sur le marché
1, record 1, French, autorisation%20de%20mise%20sur%20le%20march%C3%A9
correct, feminine noun
Record 1, Abbreviations, French
- AMM 2, record 1, French, AMM
correct, feminine noun
Record 1, Synonyms, French
Record 1, Textual support, French
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, record 1, French, - autorisation%20de%20mise%20sur%20le%20march%C3%A9
Record 1, Spanish
Record 1, Textual support, Spanish
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