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Substantial changes of a technical nature relating to veterinary establishments

In accordance with Article R. 5142-9 of the Public Health Code, any substantial change of a technical nature to a veterinary pharmaceutical establishment must be the subject of a prior application to Anses (e.g.: The manufacture of a new pharmaceutical form or category of veterinary medicinal products, the extension or removal of premises in which pharmaceutical operations for manufacturing, import, distribution, storage, pursuit of a new activity are carried out, etc.).

Non-substantial changes shall be reported to the Director of Anses within one month of their implementation.