Article R5141-9
Any substantial amendment to the trial must be the subject of a prior additional declaration by the sponsor sent by registered post with acknowledgement of receipt to the Director General of the Agenc…
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Showing 8681–8690 of 25519 articles for “Art. IV bis”
Any substantial amendment to the trial must be the subject of a prior additional declaration by the sponsor sent by registered post with acknowledgement of receipt to the Director General of the Agenc…
The experimenters, investigators, experts and persons called upon to collaborate in the trials are bound by professional secrecy under the conditions and penalties laid down inarticle 226-13 of the Fr…
Medicinal products subject to clinical trials, on the one hand, and any reference medicinal products and placebos, on the other, are prepared in accordance with good manufacturing practice, defined in…
As stated in article R. 234-5 of the French Rural and Maritime Fishing Code, which reads as follows: "When a person who keeps animals belonging to one of the species whose flesh or products are intend…
As long as the information concerning each medicinal product reproduces in full the summary of product characteristics mentioned in article R. 5141-15, publications intended to reference veterinary me…
…quest for prior authorisation for advertising relating to a medicinal product and comprising up to five advertising supports and €400 for any additional support; b) €2,000 per request for prior author…
In the case of small immediate packaging other than ampoules containing only one dose of use and on which it is impossible to include all the information provided for in Article R. 5141-74, the inform…
The companies referred to in article R. 5142-1 are prohibited from directly or indirectly providing users and persons authorised to prescribe or dispense medicinal products with premiums, objects or p…
…lowing information: 1° The name of the medicated feed ; 2° The net weight or volume; 3° The qualitative composition and quantity of the medicated premix incorporated into the medicated feed; 4° The ba…
When permitted under article R. 5141-84, advertising of veterinary medicinal products to the public: 1° Is designed in such a way that the advertising nature of the message is obvious and the product…
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