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Showing 3701–3710 of 8936 articles for “Art. 9 Mar 2004”
Where the application for registration concerns a product which has been the subject of a Community herbal monograph established by the Committee for Herbal Medicinal Products of the European Medicine…
…ase basis, specific measures to limit it are envisaged; 8° Description of the manufacturing method; 9° Therapeutic indications, contra-indications and adverse reactions; 10° Explanation of the precaut…
…or which has been brought to their attention or any other information mentioned in article R. 5141-90 which has been brought to their attention. The same applies to any member of a healthcare profess…
A company operating a veterinary medicinal product must: 1° Keep detailed records of all suspected adverse reactions which have occurred inside or outside the European Union; 2° To record any suspecte…
…l'alimentation, de l'environnement et du travail, annually and immediately on request, a report summarising the information relating to all the adverse reactions that it has declared or that have bee…
The company exploiting a veterinary medicinal product may not communicate to the public information on this veterinary medicinal product relating to pharmacovigilance without transmitting it, beforeha…
The procedures and standard form for the declarations and the periodic pharmacovigilance update report mentioned in articles R. 5141-103 to R. 5141-105-1 are laid down by decision of the Director Gene…
Without prejudice to the conditions laid down when the marketing authorisation is granted pursuant to the provisions of the fourth paragraph of Article L. 5141-5, the company operating the veterinary…
In accordance with the last paragraph of Article 20 of Regulation (EU) No 596/2014 of the European Parliament and of the Council of 16 April 2014 on market abuse (Market Abuse Regulation) and repealin…
…cumulative amount of guarantee fund interventions made pursuant to the provisions of article L. 421-9 from the start of the 2004 financial year may not exceed 700 million euros.
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