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Showing 2001–2010 of 25255 articles for “Art. Cass. com. – 15 March 2017 – no. 14-17873”
The declarations provided for in Article L. 5131-5 shall be made in accordance with the procedures and standard form laid down by order of the Minister for Health on a proposal from the Director Gener…
The outer packaging of medicinal products covered by this section shall include : 1° If the medicinal product is intended for humans, a white space, surrounded by a coloured line, in which the dispens…
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.
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…
The provisions of article R. 5211-21 are applicable to in vitro diagnostic medical devices.
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…
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