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Showing 1641–1650 of 38251 articles for “Art. L. 145-15”
The provisions of articles R. 5122-5, R. 5122-6, R. 5122-7, R. 5122-9 and R. 5122-13 to R. 5122-16 are applicable to condom advertising. Applications for approval must be accompanied either by the cer…
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.
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…
…mation, omission or inadequacy in the instruction leaflet, instructions for use or maintenance manual.
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…
In the event that the service provider or equipment distributor is unable to provide the equipment or service adapted to the person who is ill or has an incapacity or disability, they will immediately…
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…
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