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Article R5141-148 of the French Public Health Code

I.-The companies mentioned in 1°, 3°, 4°, 5°, 8° and 9° of article R. 5142-1 declare, for transfers of veterinary medicinal products containing one or more antibiotic substances, the following data: 1° The number of the authorisation to open the transferring veterinary pharmaceutical establishment; 2° The name of the medicinal product, its pharmaceutical form and the content by weight, volume or units of doses; 3° The number of units for…

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Article R5141-149 of the French Public Health Code

I.-The companies mentioned in 11° and 13° of article R. 5142-1 declare the following information for the sale of medicated feedingstuffs containing one or more antibiotic substances: 1° The number of the authorisation to open the transferring veterinary pharmaceutical establishment; 2° The surname, first name or business name and delivery address of the transferee; 3° The date of the transfer; 4° The registration number of the prescribing veterinarian; 5° The…

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Article R5141-150 of the French Public Health Code

I.-The veterinarians mentioned in article L. 5143-2 declare, for sales of veterinary medicinal products containing one or more antibiotic substances, the following data: 1° The registration number of the prescribing veterinarian; 2° The identification of the farm when the veterinary medicinal products are intended for animals belonging to species whose flesh or products are intended for human consumption; 3° The date of the transfer; 4° The category and sub-category of…

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Article R5141-151 of the French Public Health Code

I.-The pharmacists mentioned in article L. 5143-2 declare, for sales of veterinary medicinal products containing one or more antibiotic substances or medicinal products for human use containing one or more antibiotic substances prescribed in application of article L. 5143-4, the following data: 1° The identifier of the national file of health and social establishments of the dispensing pharmacy; 2° The registration number of the prescribing veterinarian; 3° The identification of…

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Article R5142-1 of the French Public Health Code

The following definitions apply 1° Manufacturer: a company comprising one or more veterinary pharmaceutical establishments engaged in the manufacture of veterinary medicinal products other than medicated feedingstuffs, with a view to their wholesale sale, free transfer or use in clinical trials on animals. Manufacturing includes operations relating to the purchase of raw materials and packaging items, production operations, quality control, batch release, as well as the corresponding storage operations, as…

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Article R5142-2 of the French Public Health Code

For medicinal products other than those subject to clinical trials on animals and medicated feedingstuffs, where the manufacturer or importer does not itself operate the business, it may only wholesale or transfer free of charge the medicinal products it manufactures or imports through the intermediary of the operator who carries out these sales or transfer operations. Operators, stockists and wholesale distributors of veterinary medicinal products may only distribute the medicinal…

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Article R5142-3 of the French Public Health Code

The companies mentioned in article R. 5142-1 may export the veterinary medicinal products they sell, transfer free of charge or distribute outside national territory. Exports by these companies to other Member States of the European Union or parties to the Agreement on the European Economic Area may only be made to natural or legal persons authorised to carry out similar activities or authorised to supply these medicinal products or, in…

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Article R5142-4 of the French Public Health Code

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…

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Article R5142-5 of the French Public Health Code

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…

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Article R5142-6 of the French Public Health Code

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…

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