Article R5139-13
…ent et des produits de santé keeps an up-to-date list of authorisation holders and authorised persons. These lists are accessible at all times to the Ministers of Foreign Affairs, Defence and the Inte…
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Showing 4381–4390 of 52403 articles for “Art. s. 414-1”
…ent et des produits de santé keeps an up-to-date list of authorisation holders and authorised persons. These lists are accessible at all times to the Ministers of Foreign Affairs, Defence and the Inte…
The holder of an authorisation must send the Director General of the Agence nationale de sécurité du médicament et des produits de santé, by 15 February each year at the latest, an annual statement of…
…accordance with the provisions of Decree No. 2017-1416 of 28 September 2017 on electronic signatures.The decision to refuse, suspend or withdraw an authorisation may also be sent under these conditio…
…ssued to a legal entity. It is not transferable. Authorisations are valid for a maximum of five years. II - The application for renewal of the authorisation is sent by the holder to the Director Gener…
I. - Any change of establishment or use of premises intended to receive micro-organisms and toxins or products containing them, or any modification of the operations provided for in the authorisation,…
For the purposes of this chapter, "establishment" means any place or site where one or more operations involving micro-organisms and toxins or products containing them are carried out.
…13 December 2001 on the control of the export, import and transfer of dual-use goods and technologies. Authorisation is granted for the purposes of preparing, manufacturing, placing on the market or p…
The authorisation holder keeps the list provided for in 1° of Article R. 5139-3 up to date and sends it to the Agence nationale de sécurité du médicament et des produits de santé by 15 February each y…
…of all or part of micro-organisms or toxins with the aim of causing disease or death in human beings.
The application for marketing authorisation is accompanied by a dossier containing : 1° The administrative information required to examine the application ; 2° Scientific documentation demonstrating t…
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