Article R5132-99
The Agence nationale de sécurité du médicament et des produits de santé is responsible for implementing addictovigilance. It defines the guidelines, leads and coordinates the actions of the various pa…
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Showing 5021–5030 of 13064 articles for “Art. CE 9-12-2022 n° 459206”
The Agence nationale de sécurité du médicament et des produits de santé is responsible for implementing addictovigilance. It defines the guidelines, leads and coordinates the actions of the various pa…
The following definitions apply1° Drug dependence: a set of behavioural, cognitive and physiological phenomena of varying intensity, in which the use of one or more psychoactive substances becomes a h…
…cine from pupils who are minors and adults, as well as the number of pupils to whom emergency contraception has been administered and the number of pupils who are minors and adults referred to other s…
Exceptionally and where necessary, in order to ensure the availability of medicinal products, where a manufacturing establishment of an active substance intended for export and located in a third coun…
…drugs without a special authorisation issued for each operation by the Director General of the Agence nationale de sécurité du médicament et des produits de santé. This authorisation is issued under…
…l trade are required to draw up an annual summary statement indicating for each psychotropic substance or medicinal product containing it: 1° The quantities acquired on the national market ; 2° Quanti…
…1 carrying out operations relating to medicinal products containing one or more psychotropic substances are subject to the provisions of articles R. 5132-91 to R. 5132-94.
…of a prior additional declaration by the sponsor sent by registered post with acknowledgement of receipt to the Director General of the Agence nationale de sécurité sanitaire de l'alimentation, de l'…
…ph of article L. 5142-2 is required for the following substantial changes:-carrying out a new pharmaceutical activity within the meaning of article R. 5142-1;-the manufacture or import of a new catego…
For the purposes of this Title, accessories to medical devices are treated as devices in their own right. Accessories are classified as such, independently of the devices with which they are used, wit…
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