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Showing 10621–10630 of 36632 articles for “Art. al. 5”
The marketing authorisation, the early access authorisation pursuant to 1° of II of article L. 5121-12 or the compassionate access authorisation pursuant to II of article L. 5121-12-1 or the compassio…
…ité du médicament et des produits de santé makes use of the derogation mentioned in V of article L. 5121-12-1, the compassionate prescription framework is accompanied by a protocol for therapeutic use…
…renew the compassionate access authorisation if the conditions set out in I, II and V of Article L. 5121-12-1 are no longer met, if the obligations set out in this Article are not complied with or for…
…consult a doctor or pharmacist for any clarification or advice relating to the use of the product; 5° A description of the adverse reactions that may be observed during normal use of the medicinal pr…
…ve days from the date of receipt of the complete application and dossier referred to in Articles R. 5121-120 and R. 5121-121, authorisation of the parallel import will be refused. This time limit is e…
…t in that they include : 1° The addition, in addition to the information provided for in Article R. 5121-138, of the name and address of the establishment responsible for modifying the packaging ; 2°…
…composition, pharmaceutical form, strength and route of administration; 4° The quantities imported; 5° The purpose of the import.
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 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…
…duct characteristics, as well as the latest updated periodic safety report or equivalent documents; 5° Where applicable, a copy of decisions to refuse or withdraw marketing authorisation for the medic…
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