Article R5124-63
The approval of a not-for-profit humanitarian organisation as provided for in article L. 5124-7 is granted by the Minister for Health, after obtaining the opinion of the Minister for Humanitarian Acti…
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Showing 6301–6310 of 60433 articles for “Art. Loi 86-18 du 6-1-1986”
The approval of a not-for-profit humanitarian organisation as provided for in article L. 5124-7 is granted by the Minister for Health, after obtaining the opinion of the Minister for Humanitarian Acti…
I.-The Ministers responsible for health and social security, in the case of a medicinal product mentioned in 2° of Article R. 5126-61, or the Director General of the Agency, in the case of a medicinal…
Cosmetic products are subject to vigilance designed to monitor all undesirable effects and misuse resulting from their use. This vigilance is applied to all these products once they have been placed o…
The emergency contraception determined in article D. 5134-5 may be administered by nurses attached to an establishment with premises where confidentiality can be respected.
After registration has been granted, the manufacturing methods and control techniques set out in the dossier provided for in Article R. 5141-64 are modified in line with scientific and technical progr…
…s' instructions, it is considered to be a device in its own right subject to the certification procedures.
The systems and kits are accompanied by the information mentioned in Article R. 5211-22, including, where applicable, the information supplied by the manufacturers of the devices that have been assemb…
The approved body may require the manufacturer to provide any information and to carry out any test or assessment necessary for it to carry out the verifications for which it is responsible.
Where an authorized body finds that the requirements of this Title applicable to this device have not been met or are no longer being met by the manufacturer, or where a certificate should not have be…
…ce is any medical device manufactured specifically in accordance with the written prescription of a duly qualified practitioner, or any other person who is authorised to do so by virtue of his profess…
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