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Showing 5571–5580 of 6566 articles for “Art. 31 March 2009”
I.-The notification referred to in III of article L. 3512-17 includes the following information: 1° A detailed description of the product and instructions for its use; 2° The information on the ingred…
The sponsor shall provide the investigators of chemical, pharmaceutical, biological, pharmacological or toxicological tests with:1° The title and objective of the test requested ;2° Identification of…
When an application for authorisation concerns a generic medicinal product of a reference medicinal product which has not been authorised in France, the applicant must indicate the Member State of the…
The Director General of the Agence nationale de sécurité du médicament et des produits de santé may prohibit the prescription and supply of a proprietary medicinal product and withdraw it from the mar…
Except where there are public health reasons for not doing so, parallel import authorisation is granted if the following conditions are met: 1° The proprietary medicinal product is obtained from an au…
As part of the pharmacovigilance system, any company or organisation exploiting a medicinal product or a product mentioned in Article R. 5121-150 : 1° Implements a risk management system for each medi…
Without prejudice to the obligations laid down in Articles R. 5121-138 to R. 5121-142, the packaging of a blood-derived medicinal product includes three detachable labels, separate from the informatio…
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…
Veterinary pharmacovigilance includes : 1° The reporting of adverse reactions to veterinary medicinal products and medicinal products for human use administered under the conditions provided for in a…
For the purposes of placing on the market in vitro diagnostic medical devices other than those subject to a performance evaluation, manufacturers shall follow the following procedures: 1° For in vitro…
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