Certain structures located in the national territory as well as manufacturing establishments of veterinary medicinal products intended for the EU market located in third countries may request an inspection for the manufacture of veterinary medicinal products from Anses-ANMV in order to obtain a certificate of conformity.

For the national territory, these are mainly structures which do not require authorisation to open as a pharmaceutical establishment but have accepted pharmaceutical activities by subcontracting such as:

• quality control for the exclusive realisation of:
  • microbiological, biological and physico-chemical tests on raw materials (active substances or excipients) or intermediate products;
  • stability tests other than on marketed finished products;
  • tests to produce research data where the products are not intended to be placed on the market or are used in a clinical trial.
• Ionising radiation sterilisation.

For third countries, this applies to establishments engaged in the manufacture or control of all or part of veterinary medicinal products intended for the EU market. The procedures for carrying out the Good Manufacturing Practices (GMP) inspections carried out by Anses-ANMV outside the French territory as part of its annual inspection programme or at the request of the EMA are described in a note available in the links below.

In order to make an inspection request to the Anses-ANMV, this request must be sent by post or e-mail to the Inspection Unit (see contact section below) specifying:

• name and full address of the establishment to be inspected;
• name, function, telephone, contact e-mail in the establishment to be inspected;
• names and pharmaceutical forms of the medicinal products concerned by the application accompanied by the number of the regulatory files concerned where applicable (MA);
• date of inspection desired.

Please note that it is not guaranteed that such an application will be honoured immediately by Anses-ANMV insofar as it inspects the establishments under its supervision, in particular in relation to the risk that may affect the quality or safety of the medicinal products. Thus, accepted inspection requests will be programmed on the basis of priorities. Priority will be given first to inspections of the annual programme and then to pending applications. 

These inspections expressly requested are subject to the levying of a fee, the amount of which varies depending on the country of establishment of the inspected establishment (in or outside the European Union/European Economic Area), the number of inspectors and the duration of the inspection

To access the “Inspection” page 

To access the regulatory referential

To access the Anses service catalogue 

Three regulatory authorities are responsible for verifying the conformity of the GLP studies and the facilities where they are carried out, depending on the nature of the chemical being evaluated.

• medicinal products for human use, cosmetics and tattoo products, medical devices: ANSM;
• veterinary medicinal products: Anses-ANMV; 
• other chemicals: COFRAC.

Registration in the Anses-ANMV GLP inspection program is a prerequisite for any inspection request. This is a voluntary approach of the structure concerned.

The entry concerns any testing facility located in France and declaring to apply GLP for the conduct of non-clinical and pre-clinical safety tests for veterinary medicinal products.

The list of documents to be provided for the preparation of a GLP file is available below. 

In addition, to complete the registration in the GLP inspection programme, a supplement is sent by post or e-mail to the inspection unit (see contact) specifying:

• name and full address of the test facility;
• name, function, telephone, contact mail in test facility to be inspected;
• OECD area(s) concerned by the studies carried out;
• date of completion of the first study and desired inspection date.

If the activities of the test facility are effectively within the competence of Anses-ANMV and if at least one study is completed, an inspection will be notified to the Director of the Test Facility by the Director of Anses-ANMV, by letter stating:

• the persons who will participate in the inspection (lead inspector, associate, prospective expert), the date, duration and scope of the inspection;
• the obligation to submit at least 15 days before the inspection an updated test facility status, in accordance with Decision 2010/03/131 of 24 March 2010 on the state of play of the test facilities and Annex “GLP — Situation review”; or, for mixed test facilities (also carrying out studies for the medicinal product for human use), in accordance with the state of play required for testing facilities by the ANSM (current version).

On-site inspections are intended to determine the degree of compliance of testing facilities with the principles of good laboratory practice for the veterinary medicinal product.

Depending on the nature and extent of the non-compliance with the GLP identified and/or persisting as a result of the proposed corrective measures, the test facility is assigned a compliance status according to the classification of the Order of 28/01/2005:
 

• A: in compliance with GLP.
• B: in partial compliance with GLP.
• C: not GLP compliant, (if serious deviations are not addressed by corrective measures deemed adequate).

To access the “Inspection” page 

To access the regulatory referential

List of documents to be provided for a GLP dossier (+ OECD nomenclature) and for amendments requiring an administrative declaration (PDF in French)/(WORD in French)