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Showing 11621–11630 of 38939 articles for “Art. al. 4”
The experts referred to in Article L. 5141-16 shall have the following qualifications and experience, set out in a summary of the curriculum vitae attached to the marketing authorisation application d…
When an application for authorisation concerns a generic veterinary medicinal product of a reference veterinary medicinal product which has not been authorised in France but which has been authorised…
Where a veterinary medicinal product, which has already been authorised or is the subject of an application for marketing authorisation under examination in another Member State of the European Union,…
Experiments on veterinary medicinal products within the meaning of article L. 5141-16 are any tests, research or experiments, hereinafter referred to as trials, which are carried out with a view to ob…
…du travail shall register the homeopathic veterinary medicinal products referred to in Article L. 5141-9, on the basis of an application accompanied by a dossier submitted and examined in accordance w…
…the reference State, the application is examined under the conditions provided for in Article R. 5141-27. The Director General of the Agency sends the States concerned and the applicant a draft asses…
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…
…ect to the national procedure are taken in accordance with the procedures laid down in Article R. 5141-27 relating to the examination of these applications.They may only be the subject of a contentiou…
For the purposes of Article L. 5141-5, type II variations and extensions as defined in 3° and 4° of Article 2 of Commission Regulation (EC) No 1234/2008 of 28 November 2008 concerning the examination…
…he manufacturing methods and control techniques set out in the dossier provided for in Article R. 5141-64 are modified in line with scientific and technical progress.
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