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Showing 12551–12560 of 15302 articles for “Art. 12 al. 2”
…tablishment's blood transfusion activities comply with the good practices referred to in article L. 1222-12 and with the operating and equipment standards applicable to them. As part of these inspecti…
…rentals concerning them and involving commitments for a term in excess of that which it determines; 12° Authorisation to take legal action and, in the case of transactions above a threshold that it de…
The certificate is accompanied by a file containing the following information: 1° The results of the quality controls mentioned in articles L. 6221-9 and L. 6221-10, carried out during the previous fi…
The Director General of the Agence nationale de sécurité du médicament et des produits de santé will notify the applicant of his decision on prior authorisation within two months of the date of receip…
The certificate drawn up by the person responsible for the second-hand resale certifies that the second-hand in vitro diagnostic medical device has been serviced as part of the accreditation referred…
For the application of this section, orders issued by the Minister for Health, on a proposal from the Director General of the National Agency for the Safety of Medicines and Health Products, shall spe…
In order to comply with the requirements relating to design and manufacture, in vitro diagnostic medical devices are designed, manufactured and packaged in such a way as to meet the following objectiv…
The provisions of Section 7 of Chapter I of Title I of this Book, with the exception of Article R. 5211-54, the second paragraph of Article R. 5211-55 and Articles R. 5211-55-1, R. 5211-62 and R. 5211…
…cal devices; 5° Giving opinions and advice to the health professionals mentioned in article R. 5222-12 to help them report incidents; 6° Raising awareness of reactovigilance among all users and assist…
…athered, the Director General takes, where appropriate, the decisions provided for in Articles L. 5312-1 to L. 5312-3.
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