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Showing 5661–5670 of 17844 articles for “Art. 815-5”
I.-The granting of a compassionate access authorisation is subject to the establishment by the Agence nationale de sécurité du médicament et des produits de santé of a therapeutic use and patient moni…
The compassionate prescribing framework drawn up by the Director General of the Agence nationale de sécurité du médicament et des produits de santé states in particular, for each medicinal product: 1°…
I.-For the medicinal products of major therapeutic interest referred to in article L. 5111-4, marketing authorisation holders and pharmaceutical companies exploiting medicinal products shall, under th…
Where batches of investigational medicinal products come from another Member State of the European Community or party to the Agreement on the European Economic Area and are manufactured or imported in…
Before removing or partially or totally covering the safety features provided for in article R. 5121-138-2, the pharmaceutical establishment which manufactures medicinal products shall check that the…
By way of derogation from the provisions of the first sub-section, the provisions of this sub-section apply to the manufacture and importation of investigational medicinal products.
For investigational medicinal products, the documents relating to each batch are kept by the pharmaceutical establishment which manufactures it, for at least five years after the end of the trial or t…
I.-In application of 7° of article L. 5125-1-1 A, the patient may designate a pharmacist who holds a dispensary or who manages a mutualist or miner's aid pharmacy, participating in the same coordinate…
The manufacturer or importer of investigational medicinal products shall ensure that all manufacturing operations are carried out in accordance with the information provided by the sponsor in the appl…
Registration of the company in the Trade and Companies Register is governed by articles R. 123-31 et seq. of the Commercial Code, subject to the following provisions. The joint representative appointe…
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