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Showing 1621–1630 of 44169 articles for “Art. 4 Oct 1996 — RJDA 3/97 n° 431”
…down in this Title; 3° Where the obligations imposed pursuant to articles R. 5121-36-1 and R. 5121-43 are not fulfilled; 4° When the authorisation must be brought into line with the decision taken by…
…eutical, by an authorised person; 3° The package leaflet and any medical information must draw the doctor's attention to the fact that, in certain aspects, specifically designated, there is not yet su…
The marketing authorisation is renewable on application by the holder to the National Agency for the Safety of Medicines and Health Products no later than nine months before its expiry date. The appli…
In the case of blood-derived medicinal products, the Agence nationale de sécurité du médicament et des produits de santé may, when examining the application for marketing authorisation, submit samples…
When, on the occasion of the implementation of Article 20(4) of Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004, urgent action is essential to protect human…
…tary medicinal product and withdraw it from the market on the grounds mentioned in Article L. 5121-14-2. The decision must state the reasons on which it is based and, except in an emergency, may only…
…of the marketing authorisation;3° The designation of the manufacturing, testing and packaging sites;4° An undertaking by the applicant to comply with all the conditions to which the marketing authoris…
The Director General of the Agence nationale de sécurité du médicament et des produits de santé shall refuse the marketing authorisation on the grounds mentioned in Article L. 5121-9. The application…
The marketing authorisation holder shall submit to the Director General of the Agence nationale de sécurité du médicament et des produits de santé any proposed amendment to the labelling or package le…
For the purposes of calculating the number of staff referred to in Articles R. 5124-38 and R. 5124-39, account is taken of persons engaged in the following operations: 1° Manufacturing and import oper…
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