Article R5122-5
A schedule of periods for submitting the visa applications referred to in Article L. 5122-8 is set for each year, by decision of the Director General of the National Agency for the Safety of Medicines…
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Showing 8601–8610 of 24607 articles for “Art. CA Douai 12-5-2016 n° 15/03664”
A schedule of periods for submitting the visa applications referred to in Article L. 5122-8 is set for each year, by decision of the Director General of the National Agency for the Safety of Medicines…
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…
…ognise the control reports corresponding to these batches held by the manufacturing establishment located in the Member State or party concerned, which holds a manufacturing or import authorisation fo…
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…
…health, he shall immediately notify the Director General of the Agence nationale de sécurité du médicament et des produits de santé.
The provisions of articles R. 5124-49 to R. 5124-55 are applicable to manufacturers and importers of dressing articles or articles presented as complying with the pharmacopoeia mentioned in 2° of arti…
The initial application may be confirmed until the expiry of a period of two months from notification of the rejection decision or from the formation of this decision when it is implicit. In the meant…
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.
…ame and dose of each of the active substances contained in the prepared product. These last two indications defined in articles R. 5125-58 and R. 5125-59 may be replaced as follows: a) If it appears i…
…duct or product other than that prescribed pursuant to article L. 5125-23, the pharmacist shall indicate on the prescription the name of the medicinal product or product dispensed, which, in the case…
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