Article R5121-9-4
Decisions to include a medicinal product on the reference list of similar biological groups, to amend these decisions and to remove it from this list are published on the website of the Agence nationa…
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Showing 3201–3210 of 8170 articles for “Art. 494-9”
Decisions to include a medicinal product on the reference list of similar biological groups, to amend these decisions and to remove it from this list are published on the website of the Agence nationa…
The request for an opinion from the Agence nationale de sécurité du médicament et des produits de santé by the ministers responsible for health and social security, on the order mentioned in the last…
With a view to their inclusion in the register of hybrid groups mentioned in the last paragraph of Article L. 5121-10, hybrid medicinal products are identified by a decision of the Director General of…
The reference list of similar biological groups provided for in article L. 5121-10-2 is presented for each reference biological medicinal product for which the name, strength, pharmaceutical form and…
In specific cases of interest to the European Union, the Director General of the National Agency for the Safety of Medicines and Health Products or the applicant shall refer the matter to the European…
I. - If required for public health reasons, in the event of a breach of the obligation to monitor patients and collect information, or if the conditions set out in Article L. 5121-12-1 are no longer m…
I.-When a medicinal product, which is the subject of a compassionate access authorisation, obtains a marketing authorisation, the Director General of the Agence nationale de sécurité du médicament et…
Each société de participations financières de profession libérale de pharmaciens d'officine may be subject to occasional checks on the scope of its activities, as prescribed by the Conseil national de…
I.-Pharmacists and nurses practising within an in-house pharmacy may prescribe and administer the vaccines mentioned in the decrees provided for respectively in 6° and 7° of article L. 5126-1 to perso…
The Executive Committee shall prepare the meetings of the Regional Committee. It guides and monitors the work of the planned commissions mentioned in article R. 6123-3-13.It is responsible for consult…
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