Article R5121-76-12
On receipt of the opinion of the Agence nationale de sécurité du médicament et des produits de santé or on expiry of the period provided for in II of Article R. 5121-76-11, the Minister for Defence ma…
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Showing 2951–2960 of 56635 articles for “Art. Decree 2023-1409 of 29-12-2023”
On receipt of the opinion of the Agence nationale de sécurité du médicament et des produits de santé or on expiry of the period provided for in II of Article R. 5121-76-11, the Minister for Defence ma…
…re a Community herbal monograph has been established or where the herbal medicinal product consists of herbal substances, preparations or combinations thereof included in the list drawn up by the Comm…
When the Director General of the Agence nationale de sécurité du médicament et des produits de santé makes a reasoned request, the person responsible for placing the product on the market shall send h…
…ng intended for slaughter for human consumption, medicinal products for human use classified in one of the categories subject to restricted prescription by Article R. 5121-77, benefiting from a market…
…inal product in parallel is accompanied by a dossier comprising :1° For each presentation, a sample of the proprietary medicinal product which has obtained marketing authorisation in France and a samp…
By way of derogation from article R. 5141-123, the importation of veterinary medicinal products intended exclusively for animals whose flesh or products are not intended for human consumption is not s…
…ferences have no therapeutic impact and do not entail any risk to public health.II. - The labelling of the proprietary veterinary medicinal product benefiting from a parallel import authorisation may…
…re met:1° The veterinary medicinal product is obtained from a company authorised within the meaning of Articles 44 or 65 of Directive 2001/82/EC of the European Parliament and of the Council of 6 Nove…
Silence on the part of the Director General of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail shall constitute refusal of authorisation on expiry of a p…
…authorisation to import a veterinary medicinal product in parallel is sent to the Director General of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail. I…
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