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 10031–10040 of 36632 articles for “Art. al. 5”
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 provisions of article R. 5132-79, with the exception of those set out in 5° and 6° of the said article, apply to containers or packaging containing psychotropic substances or their preparations. T…
The authorisation referred to in article R. 5132-88 may only be granted to a natural person. In the companies mentioned in articles L. 5124-2 and L. 5142-1, authorisation may be requested for the phar…
Faeces are collected on the premises of the establishment or body referred to in Article L. 513-11-1. By way of derogation from the first paragraph, the collection of faeces may, in the context of res…
Tattoo products are subject to vigilance designed to monitor undesirable effects occurring under normal conditions of use of the product or resulting from misuse. This vigilance is applied to all thes…
…g micro-organisms or toxins are prescribed in accordance with the conditions set out in articles R. 5132-3 and R. 5132-4. A prescription may not be made for a treatment period exceeding twelve months.…
…le de sécurité du médicament et des produits de santé under the conditions mentioned in Articles R. 5139-3 to R. 5139-7 . Failure to submit a new application for authorisation will result in the immed…
…type of toxin and for one or more of the operations mentioned in the first paragraph of Article R. 5139-1 carried out within a specific establishment. Authorisation may not be issued to a legal entit…
The decision to refuse, suspend or withdraw an authorisation must be substantiated and notified to the authorisation holder by registered letter with acknowledgement of receipt. In the event of an imp…
I. - The application for authorisation provided for in Article L. 5138-1 shall be sent to the Agence nationale de sécurité du médicament et des produits de santé by the legal representatives of the es…
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