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Showing 1651–1660 of 38032 articles for “Art. L 227-14”
A copy of the report or record of sampling shall be sent by its author(s), as appropriate, to the Director General of the Agence nationale de sécurité du médicament et des produits de santé or to the…
The holder of an authorisation must send the Director General of the Agence nationale de sécurité du médicament et des produits de santé, by 15 February each year at the latest, an annual statement of…
Advertising aimed at healthcare professionals, for a product or object defined in article R. 5134-11, is adapted to its target audience. It specifies the date on which it was drawn up or last revised…
The application for marketing authorisation for a veterinary medicinal product contains the following information: 1° The name or corporate name and address of the future holder of the marketing autho…
I.-The companies mentioned in 1°, 3°, 4°, 5°, 8° and 9° of article R. 5142-1 declare, for transfers of veterinary medicinal products containing one or more antibiotic substances, the following data: 1…
The change of ownership or management lease of part of a veterinary pharmaceutical establishment is subject : 1° A modification of the initial opening authorisation under the conditions set out in art…
Monitoring self-vaccines for veterinary use consists of the authorisation holder recording the following information in chronological order: 1° The name and address of the owner of the animal or farm…
I.-The National Council of the Order of Veterinary Surgeons has two months from the date of receipt of the application to give its opinion. If the National Council of the Order of Veterinary Surgeons…
The CE marking may be affixed to a medical device only if it complies with the essential health and safety requirements referred to in Section 5 of this Chapter and has undergone the certification pro…
Manufacturers or their agents, importers and distributors shall declare without delay to the Director General of the Agence nationale de sécurité du médicament et des produits de santé any incidents o…
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