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Showing 7291–7300 of 41745 articles for “Art. 4 mai 1994”
The decision to suspend approval must be justified by the urgency of the situation and can only be based on facts that immediately and seriously jeopardise the health or morals of the child. Reasons m…
The specific arrangements for packaging, labelling and information for the insured party, as well as traceability for medicinal products dispensed individually in dispensing pharmacies, are set out in…
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…
…ing authorisation procedure issued by the European Commission pursuant to Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004, in more than one Member State of t…
When the Director General of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail considers that the variation, suspension or withdrawal of a marketing author…
…at the veterinary medicinal product in question falls within the categories defined in Article L. 5142-5-1, he will inform the reference State and the other States concerned that he is no longer takin…
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…
In specific cases of Community interest, the Director General of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail or the applicant shall refer the matter…
…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 sanitaire de l'al…
For each batch of medicinal products referred to in articles R. 5142-45 and R. 5142-46, the pharmacist or veterinarian responsible shall release the batches and certify that each manufacturing batch c…
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