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Showing 5271–5280 of 19551 articles for “Art. CE 28-5-2010 n° 330567”
…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.
…to 3° of article L. 5121-1, the name and address of the pharmacist who dispensed the preparation, except for ampoules and other small primary packaging mentioned in article R. 5121-146-3, for which on…
…is its name within the meaning of article R. 5121-1. He shall enter on the prescription the pharmaceutical form of the medicinal product dispensed if this differs from that of the medicinal product…
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