Article R5139-15
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.
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Showing 2521–2530 of 22567 articles for “Art. Cass. com. – 21 June 2017 – no. 15-29.127”
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…
I.-The veterinarians mentioned in article L. 5143-2 declare, for sales of veterinary medicinal products containing one or more antibiotic substances, the following data: 1° The registration number of…
I.-The pharmacists mentioned in article L. 5143-2 declare, for sales of veterinary medicinal products containing one or more antibiotic substances or medicinal products for human use containing one or…
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…
Local reactovigilance correspondents are responsible for : 1° Recording and analysing any reported incident or risk of incident likely to be due to an in vitro diagnostic medical device; 2° Declaring…
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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