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Showing 3991–4000 of 32301 articles for “Art. 9 May 2017”
…of Medicines and Health Products under the conditions laid down in Articles R. 5121-21 and R. 5121-97 respectively.
When a herbal substance, a herbal preparation or a combination of substances is withdrawn from the list drawn up by the Commission of the European Communities, any registration of traditional herbal m…
…y-year period. By way of derogation from the previous paragraph, the Director General of the Agency may, where appropriate, register a product that has been in use in the European Community or the Eur…
…ng the application. Where no Community monograph has been established for the product concerned, he may refer to other appropriate monographs, publications or data.
…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…
…rian who has observed, or to whom has been reported, a serious or unexpected adverse reaction which may be attributed to the use of a veterinary medicinal product, whether or not he has prescribed it,…
…rious adverse reactions, adverse reactions in humans or the transmission of infectious agents which may be due to this medicinal product which have occurred in this other State or these other States.
…ny suspected serious adverse reaction in animals and any suspected adverse reaction in humans which may be due to an auto-vaccine for veterinary use. It sends the Director General of the Agence nation…
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 declaration and reporting obligations laid down in this section apply without prejudice to those laid down for veterinary medicinal products authorised by the European Medicines Agency in Regulati…
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