Article R5127-16
The results of the analyses and the conclusions of the analysis report are communicated to the officials who drew up the report or the sampling record and, as appropriate, to the Agence nationale de s…
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Showing 2131–2140 of 7791 articles for “Art. CA Paris – 26 June 2019 – no. 16/23435”
The results of the analyses and the conclusions of the analysis report are communicated to the officials who drew up the report or the sampling record and, as appropriate, to the Agence nationale de s…
…coloured line, are shown on the outer packaging, directly under the special name of the pharmaceutical speciality or product. The provisions of 2° of article R. 5132-15 do not apply to the medicinal…
…he authorisation, the holder must send the Director General of the Agency within one month a certificate stating that he does not hold any micro-organisms or toxins covered by the authorisation. In th…
The application for marketing authorisation is accompanied by a dossier containing : 1° The administrative information required to examine the application ; 2° Scientific documentation demonstrating t…
…an in charge and the delegated pharmacist(s) or veterinarian(s) must have at least two years' practical experience in one or more establishments authorised to manufacture or import veterinary medicina…
…f the Minister for Health. The CE marking must be affixed visibly, legibly and indelibly to the medical device or to the packaging ensuring sterility, as well as to the commercial packaging and to the…
…n order to comply with the requirements relating to design and manufacture, in vitro diagnostic medical devices are designed, manufactured and packaged in such a way as to meet the following objective…
…users or third parties who observe or are aware of incidents or risks of incidents involving a medical device. Third parties are considered to be persons who are neither manufacturers or their agents…
At the request of the Director General of the Agence nationale de sécurité du médicament et des produits de santé, the manufacturer or its authorised representative shall provide any information relat…
The list of decisions of the Director General referred to in Article L. 5322-2 which are communicated to the Ministers for the Economy, Health and Social Security for information fifteen days before t…
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