Variation of marketing authorisation, registration, exemption
Legal basis
REGULATION (EU) 2019/6 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC shall apply from 28 January 2022.
Handling of Changes
Changes to the terms of the marketing authorisations or registration or changes to the information accompanying the application for exemption shall be notified to the BVL in accordance with the relevant legal basis.
Changes to the terms of the marketing authorisations are also referred to as variations.
Regulation (EU) 2019/6 rules
Variations to the terms of a marketing authorisation that do not require an assessment - commonly also referred to as variations not requiring assessment (VNRA) and
Variations to marketing authorisation conditions that require an assessment - commonly referred to as Variations requiring assessment (VRA).
§ 4 (4) TAMG applies to changes to the informaton accompanying the application for exemption.
Further guidance on variations is available on the following websites:
- for MRP/DCP veterinary medicinal products on the website of the coordination group (CMDv)
- for centrally authorised veterinary medicinal products, the website of the European Medicines Agency (EMA)
The website of the coordination group (CMDv) includes information on not already listed variations.
Further information on the procedures can be found here.
Notes on administrative practice
Contact email for national variations:
tam-aenderungsanzeigen@bvl.bund.de
Contact email for variations in MR/DC procedures:
Contact email for enquiries towards exempted TAMs:
Requests for supplementary information will be sent to the email address of the contact person stated in the electronic application form. The corresponding email triggers the deadline for the amendment of deficiencies.
Fees
The BVL reserves the right to charge fees and expenses for the processing of variations for purely national marketing authorisations.
Find out more
- European marketing authorisation procedures
- National authorisation
- Veterinary medicinal products for food-producing animals
- Assessment of applications for marketing authorisation
- Validity of marketing authorisations and re-examination of marketing authorisations for limited markets and in exceptional circumstances
- Marketability and legal status of supply
- Variation of marketing authorisation, registration, exemption
- SPC harmonisation
- Parallel trade
- Registration
- Co-distribution of veterinary medicinal products
- Examination of registration documents