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Showing 1461–1470 of 37960 articles for “Art. L 227-16”
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…
Any company or organisation exploiting a medicinal product or a product mentioned in Article R. 5121-150 is required to: 1° Record all adverse reactions suspected of being due to a medicinal product o…
I.-Any company or organisation exploiting a medicinal product or a product mentioned in article R. 5121-150 is required to transmit electronically to the European Medicines Agency a periodic safety up…
The marketing authorisation holder may, by written reasoned request, refer the matter to the Committee for Medicinal Products for Human Use referred to in Article 56 of Regulation (EC) No 726/2004 of…
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…
For reasons relating to the protection of public health, the measures provided for in article R. 5122-15 may be taken in the event of misuse, as defined in article R. 5121-153, or drug dependence or a…
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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