Article R5132-103
Any company or organisation exploiting a medicinal product or product mentioned in article R. 5132-98 must immediately report any serious case of pharmacodependence, abuse or misuse of this medicinal…
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Showing 10061–10070 of 36632 articles for “Art. al. 5”
Any company or organisation exploiting a medicinal product or product mentioned in article R. 5132-98 must immediately report any serious case of pharmacodependence, abuse or misuse of this medicinal…
Establishments or organisations authorised under article L. 513-11-1 shall appoint a referral doctor responsible for selecting stool donors.
In the event of a serious adverse reaction likely to be due to a tattooing product, the persons responsible for placing a tattooing product on the market, the health professionals who have observed it…
…or General of the Agency when it has been withdrawn in accordance with the provisions of article R. 5139-8 and article R. 5139-11.On expiry of the authorisation or in the event of withdrawal of the au…
…re de l'alimentation, de l'environnement et du travail, under the conditions laid down inarticle R. 533-8 of the Environment Code, or of the Comité d'expertise des utilisations confinées d'organismes…
…The contraceptive in question is not on the list referred to in the second paragraph of article L. 5125-23-1; 2° The prescription is less than one year old. The additional dispensing period carried o…
…s imported; 4° The quantities used for the manufacture of the preparations mentioned in articles R. 5132-44 and R. 5132-2, or the manufacture of non-psychotropic substances; 5° The quantities used for…
…arried out, included in the adverse reaction report in accordance with the provisions of article L. 513-10-8.
…ucts includes : 1° The immediate reporting of the serious adverse reactions mentioned in article L. 513-10-8, including those resulting from misuse, and the collection of information concerning them,…
The application for authorisation shall be sent to the Director General of the Agence nationale de sécurité du médicament et des produits de santé by registered letter with acknowledgement of receipt…
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