Veterinary pharmaceutical companies
The production, wholesale distribution, processing, and import and export of veterinary medicinal products are activities which are subject to authorisation by the Director General of ANSES.
These authorisations are issued to companies for the specific facilities where the activity in question actually takes place.
These facilities are designated as veterinary pharmaceutical companies and possess premises with appropriate equipment and qualified personnel who work under the responsibility of a head pharmacist or veterinarian.
The opening of a company is subject to prior administrative authorisation for one or several activities enumerated in the French Public Health Code. Authorisation is granted following an administrative and technical assessment based on a descriptive dossier.
These companies must be run according to the regulations set down in the Public Health Code and specified in the good practices enforceable for each type of activity in question.
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The aim of good laboratory practice is to guarantee the quality and integrity of data obtained in non-clinical trials carried out on veterinary medicinal products with a view to obtaining marketing authorisation, so that these data can be recognised internationally (in particular by OECD Member States) without the need to duplicate studies. GLP is a quality assurance system covering the way in which non-clinical safety studies relating to human and animal health and the environment are organised and the conditions under which these studies are planned, performed, monitored, recorded, reported, archived and disseminated.
Keywords : Veterinary medicinal products
Every year, veterinary pharmaceutical establishments must forward information concerning their activity to the ANMV. This includes changes that occurred in their establishment over the preceding year. The Order of 4 May 2005, in application of Article R. 5142-42 of the French Public Health Code, lays down the required data along with presentation and submission formats in the form of Status reports for veterinary pharmaceutical establishments. The report is closed on 31 December and covers the preceding calendar year. A status report is required from companies for each of their establishments. Reports must be forwarded in duplicate to the ANMV no later than 31 March of the following year.
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