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anses

French Agency for Food, Environmental and Occupational Health & Safety

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Updated on 22/04/2020

Export certification

ANSES-ANMV can issue certificates at the request of pharmaceutical establishments exporting veterinary medicines to third countries (Public Health Code, Article R.5141-127) or medicated feeding stuffs to other European Union Member States or to third countries (Public Health Code, Article R.5141-128).

These certificates are issued on receipt of an application meeting exclusively the following conditions and in accordance with the procedures described below.

Applications should preferably be submitted by secure electronic means via the CESP (see www.cesp.hma.eu) or by post. To facilitate the management and processing of applications, please do not send paper applications in parallel with dossiers submitted via the CESP.

1/ for veterinary medicinal products

 Who can apply?

  • The qualified person of the veterinary pharmaceutical manufacturing or operating site on the authorisation of the MA holder  
  • The holder of the marketing authorisation (MA) for the veterinary medicinal product

 For which type of veterinary medicinal product?

  • One with an MA that is valid in France on the day of application
  • This excludes medicinal products for which the MA was obtained by the centralised procedure (in this case, please contact the European Agency)
  • One with no MA in France but manufactured in France (entity responsible for batch release)

What information can be certified?

  • The statements notified in the MA issued in France, to the exclusion of all others and in identical terms
  • Statements concerning the administrative situation of the manufacturing site, to the exclusion of all others and in identical terms, if it is located in France  

What type of certificate and in which case?

  • Certificate of Origin – drugs without an MA (CO template)
  • Certificate of Origin and Free Sale (FSC template)
  • Veterinary medicinal product certificate according to the WHO template (WHO template)
  • 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 France

Manufacturer 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 Origin
or
Veterinary medicinal product certificate (WHO template)

No certificate

What documents can be stamped in the Annex for drugs with an MA?

  • 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 drug without an MA

In which language are the certificates issued?

  • Bilingual French/English version by default
  • Trilingual version (French/English/Spanish) on request

 How many copies?

  • Only one by default unless otherwise stated
  • State the number of certificates requested
  • Each certificate issued is identified with a unique number

 What other types of document can be issued?

  • 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

The process normally takes one month.

1A/ WHAT DOCUMENTS CONSTITUTE THE DOSSIER?

  • Application on applicant's letterhead paper, signed by the qualified person (template application letter)
  • Attach the completed accompanying form (VMP template form)
  • One application per veterinary medicinal product (MA) and per type of certificate
  • A copy of the ANSM's prior authorisation for narcotics and psychotropic drugs
  • The leaflet, for medicines without an MA
  • The full composition if requested, and its translation into English and Spanish if necessary
  • For the WHO certificate, the completed template (WHO template to be completed)
  • Labels, leaflets and packaging to be stamped depending on the application
  • A stamped addressed envelope for the return of the issued certificates, enclosed with the application if it is sent by post. If the application is submitted electronically, this envelope must have been sent to ANSES-ANMV beforehand. A single, grouped mailing of envelopes and stamps may be sent at the beginning of each year, based on the applications submitted the previous year. The name and email address of the contact person should also be provided in case there are requests for additional information. 

The destination country must be stated on the application.

Only complete applications that comply with the aforementioned administrative authorisations, notified and valid on the day of application, will result in a certificate being issued. Statements that cannot be verified by ANSES-ANMV will not be certified.

Otherwise, the applicant will receive a refusal decision.

1B / HOW TO APPLY?

To submit an electronic application for an export certificate via the CESP:

1. Create a user account via the Register menu on the home page of the website www.cesp.hma.eu. When creating your account, request access to the following "Areas":  "Scientific Establishments" and "Veterinary Medicines".  

2. Create a "Delivery File" from the New Delivery File menu by selecting "Veterinary Medicines" in the Area section, "Certificate (Free Sale, WHO)" in the Regulatory Activity section and "Not applicable" in the Sub Activity section. Save the file on your computer (DO NOT rename this file).

3. Compile the dossier with the required documents (mentioned above). Save this dossier in .zip format.

4. Using the Web Upload menu, select "Integrated upload" and upload your dossier in .zip format.

5. When the transfer is complete, upload the "Delivery File" created in point 2.

6. The applicant receives an email confirming that loading has been completed.

All required and signed documents must be sent in a single file in zipped PDF format: the application letter signed by the qualified person, the form and the various annexes depending on the application.

The CESP dossier and the pdf file should be named as follows:

  • SENDER-EXPORT-DRUG NAME-MA DOSSIER NUMBER-DOCUMENT TYPE REQUESTED
  • For a drug without an MA: SENDER-EXPORT-DRUG NAME-DOCUMENT TYPE REQUESTED

The type of document requested should be indicated in the title as follows: FSC (Free Sale certificate), CO (Origin), T (Taiwan), WHO, CTC (Certified true copy)

To submit an application for an export licence by post

All required and signed documents should be sent to the following address: ANSES-ANMV, 14 rue Claude Bourgelat, Parc d'Activités de la Grande Marche - Javené - CS 70611 - 35306 FOUGERES Cedex - France

2/ for medicated feeding stuffs

Who can apply?

  • The veterinarian/pharmacist contractually bound to the medicated feedingstuff manufacturer possessing an opening authorisation for the manufacture of medicated feedingstuffs that is valid on the day of application
  • The veterinarian/pharmacist contractually bound to the medicated feedingstuff distributor possessing an opening authorisation for the distribution of medicated feedingstuffs that is valid on the day of application

For which type of medicated feedingstuff?

  • Manufactured with a premix with an MA in France
  • And possessing the required authorisations in the destination country (under the responsibility of the applicant)

 When should the application be submitted?

  • Before any export: the issued certificate must accompany the product

 Certificate template and statements:

2A/ WHAT DOCUMENTS CONSTITUTE THE DOSSIER?

  • Application letter (template application letter for medicated feedingstuffs) completed and signed by the veterinarian/pharmacist contractually bound to the establishment
    • All sections must be completed
    • All statements must comply with the administrative authorisations that are valid on the day of application
  • A copy of the medicated feedingstuff label
  • A stamped addressed envelope for the return of the issued certificates, enclosed with the application if it is sent by post. If the application is submitted electronically, this envelope must have been sent to ANSES-ANMV beforehand. A single, grouped mailing of envelopes and stamps may be sent at the beginning of each year, based on the applications submitted the previous year. The name and email address of the contact person should also be provided in case there are requests for additional information. 

2B / HOW TO APPLY?

To apply for an export certificate electronically via the CESP:

1. Create a user account via the Register menu on the home page of the website www.cesp.hma.eu. When creating your account, request access to the following "Areas":  "Scientific Establishments" and "Veterinary Medicines".  

2. Create a "Delivery File" from the New Delivery File menu by selecting "Veterinary Medicines" in the Area section, "Certificate (Free Sale, WHO)" in the Regulatory Activity section and "Not applicable" in the Sub Activity section. Save the file on your computer (DO NOT rename this file).

3. Compile the dossier with the required documents (mentioned above). Save this dossier in .zip format.

4. Using the Web Upload menu, select "Integrated upload" and upload your dossier in .zip format.

5. When the transfer is complete, upload the "Delivery File" created in point 2.

6. The applicant receives an email confirming that loading has been completed.

All required and signed documents must be sent in a single file in zipped PDF format: the application letter signed by the contractually bound incumbent or substitute responsible and the copy of the medicated feedingstuff label.

The CESP dossier and the pdf file should be named as follows:

  • SENDER-EXPORT-NAME OF THE MEDICATED FEEDINGSTUFF-MA

To submit an application for an export licence by post

All required and signed documents should be sent to the following address: ANSES-ANMV, 14 rue Claude Bourgelat, Parc d'Activité de la Grande Marche - Javené - CS 70611 - 35306 FOUGERES Cedex – France