or a Repeat Use Procedure for veterinary medicinal products
Name of the veterinary medicinal product
Asp no
Is the product a duplicate?
(The product should be considered as duplicate only if all regulatory activities of the original product have been followed)
Yes No
If yes, please state the name of the original product:
Has the marketing authorisation been renewed and granted for an unlimited period?
Yes No
If no, please state the renewal date:
MRP / Repeat use MRP
Procedure number:
List of Concerned Member States
AT BE BG CY CZ DE DK EE EL ES FI FR HR HU IE
IS IT LI LT LU LV MT NL NO PL PT RO SI SK UK
Have the following articles in Directive 2001/82/EC been implemented or updated in the current dossier of the concerned product?
Article 12(3) (j)4th indent
Environmental risk assessment
Yes No
If yes, please state in which procedure this was made:
Article 12 (k)
Information relating to the Pharmacovigilance including Pharmacovigilance system
Yes No
If yes, please state in which procedure this was made:
Article 45(c)
Qualified Persons (QPs) declaration
Yes No
If yes, please state in which procedure this was made:
Only for generic applications in accordance 3ith the Article 13(1) in Directive 2001/82/EU and hybrid applications in accordance with the Article 13(3) in Directive 2001/82/EU:
Will the concept of the European Reference Veterinary Medicinal Product (ERVMP) be used in any CMS?
Yes No
If yes, please state the CMS(s) where ERVMP will be used:
Are there divergences in the indication, animal species or withdrawal period of the Reference Medicinal Product in the CMSs and the RMS?
Yes No
If yes, please detail the approved indications in the CMSs in a separate annex.
For Repeat Use procedures only
Have the package leaflet and labelling been harmonised in all current CMSs?
Yes No
Furthermore, the request should be accompanied by the following documents :
- Proposed application form to be submitted to the CMS.
- A detailed list of all variations (if any) submitted after the grant of the marketing authorisation or latest finalised MRP/Repeat UseProcedure.
- A compiled list, if applicable, of all changes referring to variations/new data which have been made to Part II since approval/last MRP/repeat use in one document, for example updated stability data.
- For the initial MRP only - proposed translations of the SPC, PL and labelling into English, using the CMDv template which can be found at (in WORD-format).
Applicant
Authorised contact person
Phone number
E-mail address
Please note that the invoice of the application fee will be issued after receipt of the request form.
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