Format and structure of the dossier
The European “Guideline on the specifications for provision of an electronic submission for a veterinary medicinal product" must be followed.
If the structure proposed in this guideline is not suitable for the application to be submitted (abridged dossier, variation, etc.), the general principles such as the presence of an indexed table of contents, file sizes, and folder names, must still be applied.
Any dossier submitted in electronic format that proves impossible to review for material or technical reasons, including specifically non-compliance with the European Directive, could be rejected or refused for assessment.
The electronic version must be accompanied by a cover letter (Cover letter template for new MA applications)
Technical validation of the electronic dossier
A technical validation tool for electronic dossiers called "VNeeS Checker" has been developed jointly by the Belgian and French Agencies and must be used by applicants before submission of the dossier to ANSES-ANMV, to check technical compliance of the dossier.
Dossiers in electronic format should preferably be submitted via the Common European Submission Platform (CESP). This is a tool enabling secure electronic transfer of dossiers to the regulatory authorities of the Member States of the European Union.
It was developed by the Irish Medicines Board and its implementation is placed under the responsibility of the Heads of Medicines Agencies (HMAs). It enables submission of dossiers in a secure environment, without size restrictions, to several recipients simultaneously (several Medicines Agencies). It is a one-way system solely for dossier submission to the Agencies.
As part of the policy to promote routine online communication, fostered by the ANMV, applicants can submit their dossiers using the CESP: for new MA applications, MA modification applications, renewals, transfers, and so on.
Applicants are strongly encouraged to submit their dossier using this procedure.
If applicants submit their dossiers to the ANMV via the CESP, they must not forward in parallel all or part of the modules in paper or CD/DVD format.
If this instruction is not followed, handling of the submitted dossier may be delayed. Furthermore, applicants are not obliged to inform the ANMV in advance that they intend to submit a dossier via the CESP.
- indicates the Agencies that accept dossier submission via the CESP;
- provides details for applicants on registering to use the CESP;
- describes the dossier submission process;
- provides tutorials on use and a series of questions and answers.
However, if the platform cannot be used, applicants may submit their dossiers in electronic format by CD/DVD, along with a cover letter.
The CDs or DVDs must be labelled with the following information: Name of the veterinary medicinal product(s), procedure number and ANMV case number, type of application, applicant, date and version number, calendar date of the procedure to which the submission belongs (D0, D106, etc.).
To facilitate management and handling of applications, and as indicated in the guidelines, submitted material must not be protected by a password.
In terms of the number of copies to submit, a single CD/DVD of the full dossier should be forwarded to the ANMV. If the dossier is submitted via the CESP, it is not necessary to send a CD or DVD.
Submissions by email/Eudralink are only accepted for modification and transfer applications, and for responses to the list of questions. For this type of data transfer, two addresses have been set up: email@example.com (for immunological medicinal products) and firstname.lastname@example.org (chemically defined and homeopathic medicinal products).
Only these addresses should be used. It cannot be guaranteed that applications/supplemental data submitted to another address will be processed. For European procedures, submission of documentation to these addresses does not exempt applicants from email contact with the Rapporteur in charge of the procedure.
Like CDs and DVDs, emails and Eudralink contacts must be identified with the following information: Name of the veterinary medicinal product(s), procedure number and ANMV case number, type of application, applicant, date and version number, calendar date of the procedure to which the submission belongs (D0, D106, etc.). Eudralink transfers must have a reasonable duration of validity enabling processing of the dossier.
Using this method of submission does not exempt applicants from following the guidelines. In particular, files must be presented in a folder structure (zipped files in the same archive) enabling extraction in a single action. If the structure proposed in the guidelines is not suitable for the application to be submitted, the general principles such as the presence of an indexed table of contents, file sizes, and folder names, must still be applied.
Contact: Administrative Decisions Department - Licensing Unit (email@example.com)