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Showing 6101–6110 of 35258 articles for “Art. Aut. conc. n° 16-D-24 du 8 Nov 2016”
…operation entered in the register or record is given a serial number which may apply to all the products which have been the subject of a single delivery. The entry for each transaction is made in in…
…osmetovigilance system comprises : 1° The National Agency for the Safety of Medicines and Health Products ; 2° The Directorate-General for Consumer Affairs, Competition and Fraud Control; 3° The respo…
A proprietary medicinal product covered by the regulations on poisonous substances may not be unpackaged by the dispensing pharmacist with a view to its incorporation into a magistral preparation.This…
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…
…neral of the Agency in the following cases: 1° When the use of the micro-organisms and toxins or products containing them mentioned in this authorisation no longer complies with the provisions of this…
The purpose of veterinary pharmacovigilance is to monitor the effects of veterinary medicinal products, mainly their adverse effects on animals and humans, and the scientific evaluation of information…
If a medical device is intended to be used in conjunction with another medical device, the classification rules apply separately to each device. Computer software controlling a device or influencing i…
…anied by a daily penalty payment. This penalty payment is notified in accordance with the same procedural rules as the main sanction. The amount of the daily penalty is calculated from the date of not…
Without prejudice to the provisions of Article R. 5221-9, in vitro diagnostic medical devices which comply with the standards relating to them and transposing the harmonised European standards, the re…
The authorisation is issued for a period of five years. At the request of the holder, submitted no later than two months before the normal expiry date, the initial authorisation is renewed for a perio…
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