Article R5121-37-1
…ng authorisation holder must immediately forward to the National Agency for the Safety of Medicines and Health Products, indicating the scope of the information, any new data which it has or becomes a…
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Showing 2341–2350 of 62446 articles for “Art. 215 al. 3 and 220”
…ng authorisation holder must immediately forward to the National Agency for the Safety of Medicines and Health Products, indicating the scope of the information, any new data which it has or becomes a…
…eral of the Agence nationale de sécurité du médicament et des produits de santé may require samples and mock-ups to be submitted when the medicinal product is marketed.
…procedure or a decentralised procedure for which France is designated as the reference Member State and at least one different strength or pharmaceutical form of this medicinal product is marketed in…
…e use of the medicinal product or product; 2° The performance of post-authorisation safety studies; 3° Compliance with specific obligations regarding the recording or reporting of suspected adverse re…
…ement system as conditions of the marketing authorisation, in accordance with 1° of Article R. 5121-36-1.
When one or more of the obligations and prohibitions mentioned in Article D. 32-29 have been imposed, the victim may, if he or she expressly consents and for a specified period, be allocated a remote…
The application for registration of a company shall be accompanied by the documents mentioned in
Before taking a decision, the committee requests the opinion of the National Council by registered letter with a request for a reasoned opinion of receipt. The Council has one month in which to give t…
…dicial administrators provided for by the first sentence of the first paragraph of Article L. 811-7 and the multi-professional practice partnerships provided for by article L. 811-7-1-A as well as eac…
The committee may only rule on registration in the presence of the chairman and at least five of its members. Where one of the members or the chairman of the committee has authority over the applicant…
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