Article R3512-13
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…
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Showing 6241–6250 of 21547 articles for “Art. Cass. com. 25 March 2014”
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…
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…
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…
The bonuses, allowances and reimbursements of expenses mentioned in 2° of Article R. 6153-1-7 are: 1° Where applicable, the allowance provided for in 1° of Article D. 6153-10-1; 2° Where applicable, t…
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…the wording resulting from L. 314-1 Order no. 2017-1433 of 4 October 2017 L. 314-2 Order no. 2017-1252 of 9 August 2017 L. 314-3 and L. 314-4 Order no. 2009-866 of 15 July 2009 L. 314-5 law no. 2018-…
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