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French Agency for Food, Environmental and Occupational Health & Safety

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Updated on 22/04/2020

Application for official release of a batch of inactivated or live rabies vaccines for veterinary use

In accordance with the provisions of Article R. 5141-81 of the Public Health Code, ANSES-ANMV carries out official batch releases of immunological products (OCABR) for rabies vaccines. Batches of inactivated or live rabies vaccines for veterinary use placed on the market in France are subject to an official batch release by the ANMV, which is the competent national authority. This official batch release includes an analysis of the documents relating to the batch manufacture and analytical controls carried out at ANSES's Nancy Laboratory.

What are the documents to be supplied? 

  • The application letter for the official release of a batch of immunological products (Annex 1), completed and signed by a qualified person. For an inactivated vaccine, the applicant should specify the type of test desired:

- Serological test (carried out by default in the absence of justification for the other two cases)

- Appearance test alone (in which case the applicant must indicate the final batch number, the certificate date for the related batch and the number of the bulk batch from which the two batches came)

- Mouse test (in which case the applicant must provide justification for carrying out this test)

  • The test protocol corresponding to the batch to be released, completed and signed:

- for an inactivated virus vaccine (Annex 2)
- for a live virus vaccine (Annex 3)

  • The samples to be tested (Annex 4) accompanied by a copy of the protocol should be sent to ANSES-Laboratoire de la rage et de la faune sauvage de Nancy, CS 40009, 54220 MALZEVILLE CEDEX, France

 

Dossiers should be submitted by secure electronic means via the CESP (see https://cespportal.hma.eu).

All information about the CESP is available on the website: https://cespportal.hma.eu

 

To submit an electronic application for official release of immunological products via the CESP, there are six steps to be completed:

  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, "Official Batch Protocol Review of IVMP" in the Regulatory Activity section and "Not applicable" in the Sub Activity section. Save the "Delivery File" on your computer (DO NOT rename this file).

  3. Compile the dossier with the required documents (mentioned below). 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" you created in point 2.

  6. You will receive an email confirming that loading has been completed.

Compilation of the dossier described in step 3:

Reminder, this dossier must be saved in .zip format after it has been compiled.

The dossier consists of a single file in PDF format, not protected by a password, containing all the required documents.

The CESP dossier and the pdf file should be named as follows: SENDER – OCABR – DRUG NAME – FINAL BATCH NUMBER.

Within what time frame?

When the application for official release of the batch in question, the test protocol and the samples have been deemed admissible, a notice of admissibility is sent to the applicant. In the event of inadmissibility, the applicant receives a decision of inadmissibility.

A certificate of compliance or a notification of non-compliance, together with the release test results for the batch in question, are sent to the applicant within 60 days of the date of admissibility.

How much does it cost?

The rates can be consulted on the web page "Fees and services in the area of veterinary medicinal products".

 Payment must be sent on receipt of the invoice in accordance with the terms stated on this invoice.

Certificate issued by another Member State for the official release of a batch of rabies vaccines for veterinary use

What are the documents to be supplied?

  • The certificate issued by the Member State that carried out the assessment
  • The notification to market a batch of rabies vaccines (Annex 5)
  • Any document ensuring traceability between the tested batch and the products offered for sale

Dossiers should be submitted by secure electronic means via the CESP (see https://cespportal.hma.eu).

All information about the CESP is available on the website: https://cespportal.hma.eu.

To submit an electronic application for a certificate issued by another Member State via the CESP, there are six steps to be completed:

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, "Official Batch Protocol Review of IVMP" in the Regulatory Activity section and "Not applicable" in the Sub Activity section.

Save the "Delivery File" on your computer (DO NOT rename this file).

3. Compile the dossier with the required documents (mentioned below). 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" you created in point 2.

6. You will receive an email confirming that loading has been completed.

Compilation of the dossier described in step 3:

Reminder, this dossier must be saved in .zip format after it has been compiled.

The dossier consists of a single file in PDF format, not protected by a password, containing all the required documents.

The CESP dossier and the pdf file should be named as follows: SENDER – OCABR – DRUG NAME – FINAL BATCH NUMBER.

Within what time frame?

An acknowledgement of admissibility is sent to the applicant by post within seven working days.

How much does it cost?

Recognition of certificates issued by another Member State does not give rise to an invoice.

TO CONTACT US:

For all administrative information, contact:

ANSES-ANMV, FOUGERES
tel: +33 (0)2-99-94-66-65
email: etab@anses.fr

For all technical information, contact:

ANSES's Nancy Laboratory for Rabies and Wildlife
tel: +33 (0)3-83-29-89-50
email: ocabr.lerrpas@anses.fr