The Director General of the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail may request from the applicant any additional information necessary for the examination of the application. In this case, the deadlines set out in articles R. 5142-8 to R. 5142-9 are suspended until the additional data required has been provided.
If, within a period of two years following notification of the authorisations provided for in articles R. 5142-8 to R. 5142-10, the establishment is not operating, these authorisations lapse. However, if justification is provided before the expiry of this period, it may be extended by the Director General of the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail.
When a company mentioned in article R. 5142-1 plans to close one of its establishments authorised in application of the provisions of article R. 5142-5, it informs the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail. This information is provided: 1° No later than six months before the definitive closure of this establishment for the establishments mentioned in 1° to 3° of article R. 5142-1; 2°…
In the event of a change of ownership of a veterinary pharmaceutical establishment, the authorisation to open is transferred to the new owner on application made jointly by the two responsible pharmacists or veterinarians concerned to the Director General of the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail. If the establishment is leased, the authorisation to open is transferred under the same conditions to the…
The change of ownership or management lease of part of a veterinary pharmaceutical establishment is subject : 1° A modification of the initial opening authorisation under the conditions set out in articles R. 5142-9 and R. 5142-10 ; 2° The issue of an authorisation to open the establishment granted to the purchaser or the lessee-manager under the conditions defined in articles R. 5142-5 to R. 5142-8.
The suspension, which may not exceed one year, and the withdrawal of the authorisation to open, provided for in article L. 5142-2, are decided by the Director General of the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail. Except in urgent cases, these decisions may only be taken after the interested party has been given the opportunity to present his observations. When the decision concerns an…
In the companies and their establishments mentioned in 1° and 2° of article R. 5142-1, the pharmacist or veterinarian 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 medicinal products in a Member State of the European Community or a party to the Agreement on the European Economic Area. However, all or…
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 months : a) For those whose higher education was provided as part of a programme lasting at least six years ; b) For those whose higher education studies were completed within the framework of a…
In the companies and their establishments mentioned in 3° of article R. 5142-1, the pharmacist or veterinarian in charge and the delegated pharmacist(s) or veterinarian(s) must provide proof of at least six months’ practical experience acquired under the conditions mentioned in article R. 5142-16. This experience may have been acquired in whole or in part in an establishment operating medicinal products for human use or veterinary medicinal products, provided that…
The pharmacist or veterinary surgeon in charge of the companies mentioned in 4°, 5°, 6°, 7°, 8°, 9° and 10° of article R. 5142-1 and the pharmacist(s) or veterinary surgeon(s) in charge of their establishments must provide proof of at least six months’ practical experience in a pharmaceutical establishment, a veterinary pharmaceutical establishment, a pharmacy or a pharmacy for internal use mentioned in article L. 5126-1. The experience referred to…
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is a Registered Trademark of
PETROFF LAW FIRM (SELARL LEGASTRAT)
182, rue de Rivoli
75001, Paris France
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