Article R5138-8
The written confirmation referred to in article R. 5138-7 is not required when the active substances imported come from a country on the list provided for in article 111b of Directive 2001/83/EC of th…
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Showing 10071–10080 of 36632 articles for “Art. al. 5”
The written confirmation referred to in article R. 5138-7 is not required when the active substances imported come from a country on the list provided for in article 111b of Directive 2001/83/EC of th…
…material for pharmaceutical use does not comply with the good practices provided for in Article L. 5138-3, the inspected establishment shall immediately inform the manufacturers of the medicinal prod…
…nsible for social security of the number of boxes of the medicinal products mentioned in article D. 5134-1 dispensed to minors and invoiced to the health insurance funds between 1 September of the pre…
Where it appears that a reagent presents risks to public health, including as a result of non-compliance with the rules laid down in this chapter, the Director General of the Agence nationale de sécur…
The provisions of this section apply only to medicinal products appearing on the list established by order of the Minister for Health made on a proposal from the Director General of the Agence nationa…
…rganisms contaminated by micro-organisms and toxins included on the list provided for in article L. 5139-1. In the event of permanent closure of the establishment or cessation of activity, this regist…
…s required for use of the reagent; 4° Relevant information on its diagnostic and therapeutic value; 5° The principle of measurement and a description of the reaction(s) involved; 6° Details of : a) Th…
The production, manufacture, transport, import, export, possession, offer, transfer, acquisition and use of micro-organisms and toxins or products containing them in a form or under a name liable to c…
…ucation establishments, in application of the provisions of the second paragraph of I of article L. 5134-1, are set out in this section. In order to comply with these provisions, it is up to these est…
An order of the Minister for Health, issued on a proposal from the Director General of the Agence nationale de sécurité du médicament et des produits de santé and after consultation with the Commissio…
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