Article R5132-16
…by a 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 medic…
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Showing 1691–1700 of 9666 articles for “Art. CE 16-11-1988 n° 47685-47741”
…by a 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 medic…
…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 medicinal products i…
…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 objectives: 1° To…
…r 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 or user…
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…
The purpose of the vigilance exercised over the software mentioned in 18° of Article L. 5311-1 and the devices mentioned in 19° of the same article, used in medical biology laboratories, is to monitor…
Any healthcare professional who, in the course of his duties within a health care establishment, observes one or more cases of nosocomial infections, informs, on the one hand, the practitioner respons…
The agenda for meetings of the National Committee is set by the minister(s) responsible for social action, health and social security.
The interventions of the SMUR and those of the SMUR branches mentioned in article R. 6123-5 are triggered and coordinated by the SAMU. The mobile emergency and resuscitation structure team informs the…
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