Article R5121-16
Investigational medicinal products are prepared in accordance with the good practices mentioned in article L. 5121-5. The information appearing on the labelling must be written at least in French. The…
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Showing 1371–1380 of 19937 articles for “Art. Cass. com. – 16 Nov. 2004 – no. 01-10666”
Investigational medicinal products are prepared in accordance with the good practices mentioned in article L. 5121-5. The information appearing on the labelling must be written at least in French. The…
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…
The doctor, dental surgeon, midwife, pharmacist or nurse shall immediately report any adverse reaction suspected of being due to a medicinal product or to a product mentioned in article R. 5121-150 of…
Any company or organisation exploiting a medicinal product or a product mentioned in Article R. 5121-150 shall implement a pharmacovigilance system in order to fulfil its pharmacovigilance obligations…
…rganisation;2° Setting up and managing the pharmacovigilance system provided for in Article R. 5121-162 and the risk management system provided for in Article R. 5121-163 ; 3° Prepare and submit the d…
Any company or organisation exploiting a medicinal product or a product mentioned in Article R. 5121-150 implements procedures to obtain accurate and verifiable information for the scientific evaluati…
A private practice company may not operate more than one pharmacy.
The internal-use pharmacy may only operate at each of its sites in the presence of the pharmacist in charge or his replacement or an assistant pharmacist mentioned in article R. 5125-34 practising in…
The hourly amount of the flat-rate assistance for training costs mentioned in article R. 5522-14 is set at 7.62 euros.
When applying for registration, the ministries and certifying bodies inform the Director General of France Compétences of the authorisations they have issued to bodies to prepare for the acquisition,…
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