Article L5138-4
When, as part of its inspection powers, the Agence nationale de sécurité du médicament et des produits de santé finds that the manufacture or repackaging and relabelling for distribution of raw materi…
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Showing 341–350 of 3405 articles for “Art. VIII”
When, as part of its inspection powers, the Agence nationale de sécurité du médicament et des produits de santé finds that the manufacture or repackaging and relabelling for distribution of raw materi…
The activities of manufacturing, importing and distributing active substances, including with a view to export, may only be carried out in establishments authorised by the National Agency for the Safe…
Raw materials for pharmaceutical use comply with pharmacopoeia specifications where these exist. Active substances used as starting materials in medicinal products for human use are manufactured and d…
Active substances may only be imported from third countries if they have been manufactured in accordance with standards of good practice at least equivalent to those laid down by the European Union, a…
Falsified raw material for pharmaceutical use means any active substance or any excipient, the pharmaceutical use of which is established, which is misrepresented as to its identity, including its pac…
I.-"Raw materials for pharmaceutical use" means all the constituents of medicinal products within the meaning of Article L. 5111-1, i.e. :1° The active substance or substances. An active substance is…
For the manufacture of medicinal products for veterinary use, the pharmaceutical establishments mentioned in article L. 5142-1, veterinarians, dispensing pharmacies and persons authorised to prepare s…
…decisions, including those to institute legal proceedings, taken, pursuant to the provisions of II, VIII, IX and XII of article L. 144-2 and articles R. 144-8 and R. 144-14, by the general meeting of…
…he local authority shall adopt its decision on the matter that was the subject of the consultation. VIII. - The first eleven paragraphs of Article LO 1112-6 and the articles LO 1112-8 to LO 1112-14 ar…
…g pool and of any changes that may affect the implementation of health monitoring and surveillance. VIII-The provisions of V of this article do not apply to the facilities mentioned in IV of article D…
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