Article R4211-34
I. - The application for authorisation or renewal of authorisation of an establishment or organisation to carry out the activities referred to in Article R. 4211-32 relating to advanced therapy medici…
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Showing 8511–8520 of 50062 articles for “Art. s. R 622-8 to R 622-9”
I. - The application for authorisation or renewal of authorisation of an establishment or organisation to carry out the activities referred to in Article R. 4211-32 relating to advanced therapy medici…
The person in charge referred to in Article R. 4211-37, the interim persons in charge, the person in charge of site activities and the interim person in charge of site activities must hold the qualifi…
I. - With the exception of the establishments and organisations mentioned in II and III, any establishment or organisation benefiting from the authorisation provided for in this section shall put in p…
I. - The provisions of this section apply to the categories of establishments or organisations defined in the second paragraph of this article which meet the conditions for obtaining the authorisation…
To avoid any risk of cross-contamination, where storage, preparation and transfer activities for scientific purposes are carried out on the same premises as those dedicated to the preparation, storage…
The court shall rule before the expiry of the periods provided for in Article L. 621-3. When a draft plan is not presented in due time, the court may be asked to close the proceedings by the public pr…
A veterinarian who has observed, or to whom has been reported, a serious or unexpected adverse reaction which may be attributed to the use of a veterinary medicinal product, whether or not he has pres…
A company operating a veterinary medicinal product must: 1° Keep detailed records of all suspected adverse reactions which have occurred inside or outside the European Union; 2° To record any suspecte…
The declaration and reporting obligations laid down in this section apply without prejudice to those laid down for veterinary medicinal products authorised by the European Medicines Agency in Regulati…
The procedures and standard form for the declarations and the periodic pharmacovigilance update report mentioned in articles R. 5141-103 to R. 5141-105-1 are laid down by decision of the Director Gene…
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