Article R5134-4-1
In order to allow contraceptive treatment to continue when all the contraceptives prescribed have been dispensed, the pharmacist may dispense, for a period not exceeding six months, the oral contracep…
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Showing 7911–7920 of 26171 articles for “Art. 4 B”
In order to allow contraceptive treatment to continue when all the contraceptives prescribed have been dispensed, the pharmacist may dispense, for a period not exceeding six months, the oral contracep…
The pharmacist must inform the woman concerned that this method of dispensing is non-renewable beyond 6 months and that she should consult a doctor or midwife if she intends to continue taking medicat…
The following are laid down by order of the Minister for Health, on a proposal from the Director General of the Agence nationale de sécurité du médicament et des produits de santé: 1° The list of subs…
In order to obtain a marketing authorisation for a medicinal product which is not covered by the marketing authorisation procedure issued by the European Commission pursuant to Regulation (EC) No 726/…
…t, he shall immediately inform the European Medicines Agency for the application of the Community arbitration procedure. In exceptional cases, where the Director General of the Agence nationale de séc…
…refer the matter to the European Medicines Agency with a view to the application of the Community arbitration procedure provided for in Articles 36 to 38 of Directive 2001/82/EC of the European Parlia…
In order to obtain recognition in France of a marketing authorisation issued by another Member State of the European Union, known as the reference State, the holder of this authorisation must submit a…
In order to obtain recognition, by at least one other Member State of the European Union, of a marketing authorisation issued by the Director General of the Agence nationale de sécurité sanitaire de l…
…pplicant shall refer the matter to the European Medicines Agency for application of the Community arbitration procedure before a decision is taken on the granting, variation, suspension or withdrawal…
At the end of the Community arbitration procedure implemented in accordance with the provisions of Articles R. 5141-47-9 to R. 5141-47-11, the Director General of the Agence nationale de sécurité sani…
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