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Showing 11641–11650 of 38939 articles for “Art. al. 4”
…echnical and scientific progress under the conditions laid down in Commission Regulation (EC) No 1234/2008 of 28 November 2008 concerning the examination of variations to the terms of a marketing auth…
…tural or legal person who initiates a veterinary medicinal product trial as defined in article R. 5141-2 is called the sponsor. The persons who direct and supervise the performance of pharmaceutical t…
The name of a veterinary medicinal product may be either an invented name or a common or scientific name accompanied by a trade mark or the name of the holder of the marketing authorisation or of the…
The amount of the fee provided for in 7° of 1 of I of article L. 5141-8 is set at €100 for an application for export certification.
In the absence of agreement within the coordination group, the Community arbitration procedure provided for in Articles 36 to 38 of Directive 2001/82/EC of the European Parliament and of the Council a…
The applicant for marketing authorisation is responsible for the accuracy and sincerity of the information and data provided to the Agence nationale de sécurité sanitaire de l'alimentation, de l'envir…
…of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail; 4° Therapeutic indications, contraindications and adverse reactions; 5° The dosage for the different…
…rial was conducted; 3° For the medicinal product undergoing the trial, the information mentioned in 4° of Article R. 5141-8 ; 4° For a reference medicinal product, the information mentioned in 5° of A…
Post-authorisation studies may be carried out, on behalf of this licence holder and under its responsibility, by another company or organisation. Any study must be the subject of a protocol validated…
The Director General of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail or the applicant for marketing authorisation may refer the matter to the European…
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