Article R5126-17
Pharmacists working in the internal-use pharmacies of the establishments, services or organisations mentioned in Article R. 5126-1 shall inform the operator defined in 3° of Article R. 5124-2, in part…
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Showing 1321–1330 of 4847 articles for “Art. 17 sept. 2020”
Pharmacists working in the internal-use pharmacies of the establishments, services or organisations mentioned in Article R. 5126-1 shall inform the operator defined in 3° of Article R. 5124-2, in part…
It is prohibited to use, for the medicinal products mentioned in article R. 5132-1, containers or packaging bearing the name of a product intended for human or animal consumption or likely to create c…
If the analysis report reveals facts that could lead to criminal prosecution, it is forwarded to the public prosecutor, together with the report or record of the sample-taking and the third sample kep…
The authorisation holder shall record any acquisition, transfer, import or export of micro-organisms and toxins or products containing them in a special register or by any appropriate computer system.…
The expert reports provided for in article R. 5141-16 consist of a critical evaluation of the various trials carried out, taking into account the state of scientific knowledge at the time of submissio…
The period of practical experience provided for in article R. 5142-16 is reduced : 1° To one year for professionals whose higher education was completed as part of a five-year programme ; 2° To six mo…
No medical device may be placed on the market or put into service in France unless it complies with the essential health and safety requirements referred to in section 5 of this chapter which apply to…
Reports are made :1° To the local materiovigilance correspondent when these reports are made by users or third parties who carry out their duties in one of the establishments or associations mentioned…
The manufacturer or his authorised representative, the importer or the distributor is required to keep, for each incoming and outgoing transaction, at least the following information: 1° The date of t…
For the application of this section, orders issued by the Minister for Health, on a proposal from the Director General of the National Agency for the Safety of Medicines and Health Products, shall spe…
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