Article R5132-15
…narian enters the prescribed dosage as well as the statement provided for in 12° of article R. 5141-73 in black lettering on a red background. In the case of a medicinal product classified as a narcot…
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Showing 1501–1510 of 29080 articles for “Art. Cass. crim. 7 décembre 2016 n° 15-86731”
…narian enters the prescribed dosage as well as the statement provided for in 12° of article R. 5141-73 in black lettering on a red background. In the case of a medicinal product classified as a narcot…
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.
The application for marketing authorisation is accompanied by a draft summary of product characteristics, the presentation and content of which are laid down in accordance with Article 14 of Directive…
The affixing of marks or inscriptions on a medical device, on its packaging or on the instructions for use which are likely to mislead as to the meaning or form of the CE marking is prohibited. Any ot…
The provisions of article R. 5211-21 are applicable to in vitro diagnostic medical devices.
…édicament et des produits de santé on the evaluation of the incidents mentioned in Article R. 5232-17.
The following incidents may be reported: 1° A noxious and unintended reaction occurring during the use of a medical device in accordance with its intended purpose; 2° A noxious and unintended reaction…
The Chief Executive is the authorising officer for the revenue and expenditure of the Agency's budget. He may appoint secondary authorising officers. He may delegate his signature to staff under his a…
The certification procedure established by the Haute Autorité de santé provides in particular for :1° Informing the institution, all the institutions involved or associated with the regional hospital…
In healthcare establishments, the head of the establishment appoints, after consulting the establishment's medical committee or medical conference, the healthcare professional responsible for notifyin…
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