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Showing 4611–4620 of 53857 articles for “Art. R 213-2”
The provisions of the French pharmacopoeia and the European pharmacopoeia are made mandatory by decision of the Director General of the Agence nationale de sécurité du médicament et des produits de sa…
The detailed rules for the application of sections 1 to 12 of this chapter are determined as necessary, after obtaining the opinion of the Director General of the Agence nationale de sécurité du médic…
The application for authorisation is deemed to be complete if, within one month of receipt, the Director General of the Agence nationale de sécurité du médicament et des produits de santé has not info…
For the application of the provisions of this chapter, army hospitals and the army blood transfusion centre shall be regarded as health establishments and a blood transfusion establishment respectivel…
For the purposes of this section, advanced therapy medicinal products prepared on an ad hoc basis mean the advanced therapy medicinal products mentioned in 17° of Article L. 5121-1.For the purposes of…
Blood establishments and organisations or companies manufacturing or exploiting blood-derived medicinal products which are aware of information likely to cast doubt on the quality of blood or plasma i…
The company marketing a medicinal product shall set up an advertising department within the meaning of article L. 5122-1, under the supervision of the pharmacist responsible, which shall ensure compli…
A request for authorisation must be submitted for any changes which have an impact on the quality, safety and efficacy of the medicinal product. This application must be accompanied by a technical dos…
For the purposes of this sub-section, army hospitals and the army blood transfusion centre are regarded as public health establishments and blood transfusion establishments respectively.
Decisions to prohibit or make advertising or propaganda subject to the obligation to mention the warnings and precautions for use necessary to inform consumers, as provided for in article L. 5122-15,…
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