Subsection 2: Administrative authorisation.

The procedures for submitting and examining applications for authorisation to open, for modification of initial authorisations and for transfer of authorisations to open, as provided for in articles R. 5142-5 to R. 5142-7, R. 5142-9, R. 5142-10, R. 5142-13 and R. 5142-14, as well as the content of the file attached to the application, are laid down, on a proposal from the Director General of the Agence nationale de sécurité…

Authorisation to open a veterinary pharmaceutical establishment is granted to the company to which it belongs by the Director General of the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail, after investigation by the competent inspectorate and after obtaining the opinion, as appropriate, of the competent central council or councils of the Ordre national des pharmaciens or the competent regional council or councils of the Ordre…

The Director General of the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail shall inform the Director General of the Agence nationale de sécurité du médicament et des produits de santé of his decision within fifteen days when the authorisation concerns an establishment comprising all or part of the premises and equipment making up an establishment authorised by the latter mentioned in 1° or 2° of…

The Director General of the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail shall inform the Prefect of the département in which the establishment is located of his decision within fifteen days when the authorisation concerns an establishment mentioned in 11° or 12° of article R. 5142-1 comprising all or part of the premises and equipment making up an establishment approved or registered in application of…

The Director General of the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail will notify the applicant of his decision within ninety days from the date of receipt of the complete application. For establishments engaged in the manufacture or import of veterinary medicinal products, the manufacture or import of medicinal products undergoing clinical trials and the manufacture or import of medicated feedingstuffs, silence on the part…

The prior authorisation referred to in the second paragraph of article L. 5142-2 is required for the following substantial changes: -carrying out a new pharmaceutical activity within the meaning of article R. 5142-1; -the manufacture or import of a new category of veterinary medicinal product; the manufacture or import of a new pharmaceutical form; – the implementation of a new product; the manufacture or import of a new category of…

Where the initial authorisation was granted after the Director General of the Agence nationale de sécurité du médicament et des produits de santé or the Prefect had been informed in accordance with the procedure laid down in Articles R. 5142-6 or R. 5142-7, they will be informed of the amendment within fifteen days.

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°…