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Showing 5411–5420 of 19750 articles for “Art. CE 25-5-1988 n° 81512”
…a and the national formulary mentioned in Article R. 5112-4 are published on the website of the Agence nationale de sécurité du médicament et des produits de santé.
Articles R. 4234-18 to R. 4234-22 are applicable in New Caledonia and French Polynesia in the version published in Decree no. 2022-381 of 16 March 2022.
…wo months, during which applications must be submitted. Visa applications are deemed to have been accepted in the absence of a decision by the Director General of the Agency within two months of the d…
The procedures for submitting and examining applications for authorisation to open, for modification of initial authorisations and for transfer of authorisations to open, as provided for in Articles R…
…ng to these batches held by the manufacturing establishment located in the Member State or party concerned, which holds a manufacturing or import authorisation for such medicinal products or products…
The pharmaceutical establishment manufacturing medicinal products mentioned in 1° of article L. 4211-1, generators, kits or precursors mentioned in 3° of this article has a documentation system compri…
…may result in a risk to public health, he shall immediately notify the Director General of the Agence nationale de sécurité du médicament et des produits de santé.
…ioned in 4° of article L. 5121-1. The obligations laid down by these articles are applied by reference to the pharmacopoeia monographs which describe them.
…quired. The Director General of the Regional Health Agency registers the application and issues a receipt. It is examined under the conditions set out in articles R. 5125-2 to R. 5125-4.
The medicinal products, products or articles mentioned in article L. 4211-1 are transported by the pharmacist dispensing them at home under conditions which guarantee their perfect preservation.
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