Guidance and application form to apply for a Marketing Authorisation (MA) to place a veterinary medicine on the market.
Details on the following can be found on the Marketing authorisations for veterinary medicines page.
- Authorisation Routes
- Legal Bases
- Post-Authorisations Steps
- Distribution Categories
How to apply
For additional information about the Mutual Recognition and Decentralised procedures, go to the Heads of Medicines Agencies website.
For guidance and information about the centralised procedures, go to the Commission Website.
Prior to submission
You are welcome to meet with VMD assessors to discuss your proposed application; we strongly encourage you to do this particularly in the case of Exceptional MAs. To arrange a meeting, please email: firstname.lastname@example.org and include ‘Request to arrange a company meeting’ in the subject line.
You may submit your application electronically, or in hard-copy. See the Submission of an application for an animal medicine licence page for more details.
Application forms are available on the European Commission Website except the following:
Exceptional MA (Limited and Provisional) application form (MS Word Document, 76KB)
Parellel import (MAPI) application form (MS Word Document, 49.6KB)
Guidance for the covering letter (PDF, 21.4KB, 3 pages)
You should provide the information set out in Volumes 6a and 6b of the European Notice to Applicants and in Annex 1 of Directive 2001 / 82 / EC, as amended.
The VMD will take in to account any other data or knowledge that it has when assessing applications for abridged MAs.
The data requirements for Exceptional MAs and MAPIs are annexed to their application forms. For Exceptional MAs, you should explain in a covering letter accompanying your application how your product will fill a therapeutic gap in the market.
All applications are checked (validated) upon receipt.
It is up to you to identify and submit all the necessary information in support of your application. If the application is incomplete, it is likely to fail validation.
Once the application has passed validation, it will proceed into the assessment phase.
The timescales may be suspended if we need further information from you, or in accordance with the timetables set for applications dealt with on a European level.
If the outcome is to approve an application, you will be sent authorisation documentation at the end of the application procedure.
SPCs and product literature
See the SPC and Product Literature guidance page for more details.
The following provides information on the timescales used for applications dealt with on a national basis. The timescales for variations dealt with on a mutual recognition basis are outlined in the relevant Best Practice Guides.
|Validation||Validated within 10 days of receipt. NB. 21 days for Limited MAs|
|Initial Assessment||Approved, refused, or questions asked within 90* days of validation passed|
|Company Response||If questions asked, you should provide a full company response within the deadline set|
|Sign-off||Approved or refused by 180** days from receipt. The timescales may be suspended during this time if further information is required from you|
|Mock-ups||Mock-ups approved within 20 days from receipt of correct versions|
|Issue||Following approval, authorisation documentation will be issued within 10 days|
*75 days for copycats and MAPIs (where the parent product is mutually recognised)
**130 days for copycats and MAPIs (where the parent product is mutually recognised)
Once an application has passed validation, you will be sent an invoice for the fee
For further information about fees see the Application fees for animal medicines page.
You can use the fees calculator to help you work out what the fee will be.
The VMD now issues all invoices electronically, so please provide a valid email address of where to send the invoice; failure to do so will result in your application being rejected.
Expiry of a Marketing Authorisation
To expire a Marketing Authorisation, Animal Test Certificate, or Homeopathic Registration, you will need to send an email to: email@example.com.
Expiry of an MA or Homeopathic Registration means that no more product may be released by the qualified person (QP) on or after the date of expiry. Any product already QP released may still be placed on the market for sale and supply after this date unless the MA or Registration has been expired due to safety reasons. In this case, this will be noted in the expiry letter sent to you.
For queries relating to on-going applications, please contact the relevant person stated on the email sent to you following validation of your application.
Published: 27 November 2014
Updated: 31 March 2016
- Revised link to SPC and product literature guidance
- Inclusion of expiry procedure guidance
- New combined QRD template for national applications
- First published.