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Showing 2031–2040 of 50062 articles for “Art. s. R 622-8 to R 622-9”
The responsible person as determined in Article 4 of Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 concerning cosmetic products and distributors of cos…
The provisions of this section apply to substances or plants having a psychoactive effect, as well as to medicines or other products containing them, with the exception of ethyl alcohol and tobacco.
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…
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…
Any substantial amendment to the trial must be the subject of a prior additional declaration by the sponsor sent by registered post with acknowledgement of receipt to the Director General of the Agenc…
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…
The financial penalties and daily fines provided for in Article L. 5145-5 are recovered by the accounting officer of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et…
The Chairman sets the agenda on a proposal from the Chief Executive. Items which the Minister for Health, the Chairman of the Board of Directors or at least one third of its members request to be incl…
A summary of the healthcare establishment's annual infection control programme is given to each patient with the welcome booklet.
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