Article R5121-93
Classification as a medicinal product requiring special monitoring during treatment can only be made if the restrictions on prescribing the medicinal product are justified by the seriousness of the un…
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Showing 13821–13830 of 39711 articles for “Art. al. 3”
Classification as a medicinal product requiring special monitoring during treatment can only be made if the restrictions on prescribing the medicinal product are justified by the seriousness of the un…
All medicinal products are fitted with the tamper-evident device referred to in Article R. 5121-138-2. However, this device is not compulsory for medicinal products on the list set out in Annex I to C…
…ganisation responsible for the operation of the proprietary medicinal product within the meaning of 3° of Article R. 5124-2. It invites the person responsible for the notification to report this adver…
…ng authorisation in France of any serious adverse reaction, within the meaning of Article R. 5121-153, concerning the imported medicinal product, as soon as he is aware of it. It will also inform the…
At the time of each parallel distribution operation, the company responsible for the parallel distribution of the medicinal product notifies the Director General of the Agence nationale de sécurité du…
…ubject to the specific provisions relating to them respectively, which are set out in articles R. 5132-27 and R. 5132-86.
…de, in a red box and in red lettering, the words: "Do not administer" and the instructions for use; 3° The name and postcode of the in-house pharmacy or pharmacy dispensing the preparation.
…ompulsory prescription shall be provided with the unique identifier referred to in Article R. 5121-138-2, unless they are exempt from this requirement due to their presence on the list established in…
…he name, strength and pharmaceutical form of the medicinal product; 2° Its therapeutic indications; 3° Its presentation; 4° Any pharmacological, toxicological and clinical information enabling the ris…
For pharmaceutical products with a parallel import authorisation, Customs officers check the import authorisation number on the packaging. If this number does not appear on the packaging at the time o…
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