11/02/2022

Export certification

Anses-ANMV may issue certificates at the request of pharmaceutical establishments exporting veterinary medicinal products to third countries (Public Health Code, Article R.5141-127) or medicated feed to other Member States of the European Union or to third countries (Public Health Code Article R.5141-128).

These certificates shall be issued on receipt of an application which complies exclusively with the following conditions and in accordance with the procedures described below. 

Requests are submitted preferably by secure electronic means via CESP or by post. For reasons of ease of management and handling of applications, it is requested not to send a paper file in parallel with a submission via CESP.

  • the pharmaceutical authority of the veterinary pharmaceutical establishment manufacturer or operator upon authorisation of the marketing authorisation holder; 
  • the marketing authorisation holder (MA) of the veterinary medicinal product.
     

  • having a marketing authorisation valid in France on the day of application;
  • with the exception of veterinary medicinal products which have obtained a marketing authorisation by the centralised procedure (apply to the European Agency in this case); 
  • not having a marketing authorisation in France but manufactured in France (batch liberator).

  • the particulars notified in the MA issued in France to the exclusion of any other and in identical terms;
  • particulars relating to the administrative situation of the manufacturing establishment, to the exclusion of any other and in identical terms, if it is located in France.

  • certificate of Origin – veterinary medicinal product without an MA  (CO Template in French (PDF)
  • certificate of Origin and Free Sale (FSC Template in French (PDF)
  • veterinary medicinal product certificate according to the WHO template (WHO Template in French (PDF))
  • specific certificate for Taiwan (to be provided pre-completed, according to the template in force)
  • the following may be provided in the annex, for medicinal products with an MA, on request
    • The complete SPC
    • The complete composition
    • The MA number 
 Manufacturer responsible for batch release located in FranceManufacturer responsible for batch release located outside France
 
MA in France
 
Certificate of Origin and Free Sale
or
Veterinary medicinal product certificate (WHO Template)
 
Veterinary medicinal product certificate according to the WHO Template
 
No MA in France
 

Certificate of Originor
or
Veterinary medicinal product certificate (WHO Template)

No certificate
 

 

  • packaging and leaflet, if supplied;
  • translation into English and/or Spanish of the complete SPC provided on company letterhead and in accordance with the French MA.

No annex is issued for a veterinary medicinal product without an MA

  • bilingual French/English version by default;
  • trilingual version (French/English/Spanish) on request.

  • only one by default unless otherwise stated;
  • state the number of certificates requested;
  • each certificate issued is identified with a unique number.

  • a certified true copy of any administrative decisions relating to the applicant, the originals of which are held by ANSES-ANMV, in particular for information that is not included in the SPC (decision on MA or variation of MA, decision of authorisation of the manufacturing site responsible for batch release);
  • certified true copies of the establishments' GMP certificates are not issued, as the original has been given to the parties concerned.