Article R5121-4
For any medicinal product authorised on the French market, each of its presentations and, where applicable, each common dispensing unit, is allocated a national identification number. This number is a…
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Showing 5971–5980 of 24448 articles for “Art. 4 Dec 2018”
For any medicinal product authorised on the French market, each of its presentations and, where applicable, each common dispensing unit, is allocated a national identification number. This number is a…
The specific obligations which may be imposed pursuant to the third paragraph of Article L. 5121-9 and which must be mentioned in the risk management system are, in particular, the following: 1° The a…
…rticle L. 5121-9, as assessed by the Director General of the Agency, is no longer favourable. If no decision is notified or if no request for additional justification is sent to the applicant by the d…
…opean Community when the competent authority of that Member State has already checked the batch and declared it to comply with the approved specifications. The Minister for Health may, on a proposal f…
…tary medicinal product and withdraw it from the market on the grounds mentioned in Article L. 5121-14-2. The decision must state the reasons on which it is based and, except in an emergency, may only…
…on may only be rejected after the applicant has been invited to present his observations. Rejection decisions must state the reasons on which they are based and indicate the appeal procedures and time…
…nts to the summary of product characteristics. If the Director General of the Agency has not made a decision within ninety days of the date of submission of the application, the applicant may proceed…
The committee responsible for proposing the list of approved products for public authorities, in accordance with the provisions of articles L. 5123-2 and L. 5123-3, is the Transparency Committee, the…
…produits de santé a report on their establishment, the form and content of which are determined by decision of the Director General of the Agency.
Manufacturers, importers, operators, stockists, wholesaler-distributors, wholesale distributors of pharmaceutical products other than medicinal products, wholesale distributors of medicinal plants, di…
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