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Showing 10461–10470 of 36632 articles for “Art. al. 5”
…ications to the authorisation to open a pharmaceutical establishment, as provided for in article L. 5124-3, which relate to one of the following, are subject to authorisation because of their substant…
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…
…rs of medicinal products or products covered by a marketing authorisation referred to in article L. 5121-8, an advanced therapy medicinal product authorisation referred to in 17° of article L. 5121-1,…
When the companies and organisations mentioned in article R. 5124-2 become aware of the falsification or suspected falsification of medicinal products which they manufacture, operate or distribute, wh…
Where the company is owned by a pharmacist, the pharmacist may be replaced by : 1° A delegated or assistant pharmacist from the same company ; 2° A pharmacist who has no other professional activity du…
…s occupied by third parties. Pharmaceutical establishments authorised under 1° and 4° of article R. 5124-2 may include, without separate authorisation, a storage room located close to the establishmen…
…nefiting from the authorisations or registration provided for in the second paragraph of Article R. 5124-49 is subject, in France, to control of the finished product when it is imported : 1° From a St…
Any change in the holder of an authorisation to open a pharmaceutical establishment is subject to prior authorisation. However, the Director General of the Agence nationale de sécurité du médicament e…
…n of advanced therapy medicinal products prepared on an ad hoc basis mentioned in 17° of article L. 5121-1 which are not used in the context of research mentioned in the first paragraph of article L.…
By way of derogation from the provisions of Article R. 5124-3, manufacturers and importers of medicinal products may only distribute investigational medicinal products and, where applicable, ancillary…
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