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Showing 981–990 of 3738 articles for “Art. n° 19-22829”
The managers of the establishments referred to in articles L. 5124-2 and L. 5142-1 and the natural or legal persons authorised to place orders with them must, at all times, provide proof of the acquis…
The transmission of information referred to in Articles R. 5139-4, R. 5139-5, R. 5139-12 and R. 5139-14 may be carried out electronically after affixing an electronic signature in accordance with the…
The dossiers provided in support of the authorisation of the veterinary medicinal products mentioned in articles R. 5141-16 and R. 5141-18 are considered to include all the data necessary and sufficie…
Pharmacists or veterinary surgeons in charge and delegates who carry out their duties in a company or in an establishment of a company mentioned in 1° to 10° of article R. 5142-1 on 22 March 2003 are…
On duly justified request, the Director General of the Agence nationale de sécurité du médicament et des produits de santé may authorise, by way of derogation, the placing on the market and putting in…
For the purposes of this chapter, army hospitals and the army blood transfusion centre are considered, respectively, as public health establishments and as a blood transfusion establishment. The local…
The conformity of in vitro diagnostic medical devices with the essential health and safety requirements is assessed by carrying out one or more of the following procedures: 1° The procedure applicable…
When the facts mentioned in Article L. 5212-2 are brought to the attention of the Director General of the Agence nationale de sécurité du médicament et des produits de santé by a user or a third party…
For the purposes of this section, foodstuffs as defined in Article 2 of Regulation (EC) No 178/2002 and substances, mixtures and articles as defined in Article 3 of Regulation (EU) No 1907/2006, with…
Sterilisation is the set of operations used to obtain the sterile state of a medical device and to maintain this state.The activity of sterilising medical devices is subject to the granting of an auth…
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