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Showing 10641–10650 of 36632 articles for “Art. al. 5”
The marketing authorisation, the early access authorisation under 1° of II of article L. 5121-12 or the compassionate access authorisation under II of article L. 5121-12-1 or the compassionate prescri…
The Director General of the Agence nationale de sécurité du médicament et des produits de santé may, with a view to the application of the provisions of this section and after inviting the marketing a…
…te access authorisations have been issued in application of the first paragraph of II of Article L. 5121-12-1, the Director of the Agency will request, without delay and by any means giving a date cer…
…may not be required. II.-The prescribing doctors and pharmacists or persons mentioned in article L. 5126-10 concerned and, in the case of a compassionate access authorisation granted in application of…
All medicinal products are fitted with the tamper-evident device referred to in Article R. 5121-138-2. However, this device is not compulsory for medicinal products on the list set out in Annex I to C…
…onths of the withdrawal from the list by the Commission, the information and documents mentioned in 5°, 6° and 16° of Article R. 5121-107-4.
Classification as a hospital prescription-only medicinal product may only take place if the restrictions placed on the prescription of the medicinal product are justified by the need to carry out the…
…n holder or the company organises the collection of data by the prescribers mentioned in Article L. 5121-12-1. When the compassionate prescription framework concerns several medicinal products, the co…
I. - On the basis of the information referred to in article R. 5121-76-3 and the scientific knowledge available, as well as, where applicable, the information transmitted in application of article R.…
…ts and for products which must be covered by the marketing authorisation provided for in article L. 5121-8, after this authorisation has been issued;2° For the medicinal products mentioned in article…
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