Article R5121-29-1
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…
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Showing 5171–5180 of 6073 articles for “Art. 28 March 2012”
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…
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…
For the implementation of the monitoring and alert system mentioned in article L. 5312-4, the Agence nationale de sécurité du médicament et des produits de santé is responsible for receiving and proce…
…table: Applicable articles In the wording resulting from the decree R. 561-1 to R. 561-3-0 No 2018-284 of 18 April 2018 R. 561-4 and R. 561-5 No. 2020-118 of 12 February 2020 R. 561-5-1 n° 2021-387 o…
…32-23n° 2017-1253 of 9 August 2017R. 214-32-24 to R. 214-32-27n° 2013-687 of 25 July 2013R. 214-32-28n° 2022-82 of 28 January 2022R. 214-32-29n° 2021-898 of 6 July 2021R. 214-32-30, R. 214-32-32 to R…
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