Veterinary medicinal products regulation
- Published: December 17, 2021
- Last updated: January 26, 2022
On January 28, 2022, the new Veterinary Medicinal Products Regulation (EU) 2019/6 will enter into force.
Important message for MAH from EMA
Implementation of the new QRD template
According to new information from the European Commission it is confirmed that Marketing Authorisation Holders will have until 29 January 2027 to update product information of approved veterinary medicinal products according to the new regulation. However, companies are urged not to wait until the last minute, but instead to "spread out" the adaptation of the medicines over time in order to reduce the risk of difficulties in keeping timelines towards the end of the period.
Launch av Union Product Database (UPD)
IMPORTANT: Please note that EU/EEA national competent authorities are currently completing and enriching product data submission. This includes the identification and addition of product owners (MAHs) to the national datasets, which is not complete at this point in time. If your organisation has not been assigned yet as a product owner to a specific product in the database, the product will not appear when you log into the restricted area. Please rest assured that the NCAs are in progress of finalising this work as soon as possible and the completeness of your list of products should progressively improve.
Therefore, in case you notice that some products seem to be missing for the marketing authorisation holder you represent, please allow at least two working weeks (until 14 February 2022) before escalating requests for any missing products and, if needed, liaising with the respective NCA so they can add any missing products in case you need these urgently.
Please share this communication also with any additional users you will approve.
Technical support
Should you require technical support, please contact EMA’s VMP-Regulation User Support Service and select the ‘Union Product Database’ tab on the left of the page.
The regulation
The current veterinary medicines directive (2001/82/EC) will be repealed and replaced by the new veterinary regulation (EU) 2019/6.
The regulation will be directly applicable in the member states when it enters into force on 28 January 2022.
The new regulation covers many aspects of veterinary medicines:
- manufacturing
- application procedures
- pharmacovigilance
- distribution
- supervision
- use of EU common IT systems
The regulation will apply as Swedish law and contains 160 articles. More detailed rules are set out in 30 implementing and delegated acts.
Work on most of the acts will continue until the first implementation date and some will be further elaborated during a transition period.
The Ministry of Enterprise and Innovation has finalized the directive to adapt Swedish legislation to regulation (EU) 2019/6.
Why new rules?
The intention of the new regulation is to stimulate innovation, reduce administrative burden and increase availability to veterinary medicines in the EU. Other reasons for the new legislation are to define rules that can reduce and prevent the rise of antimicrobial resistance and take environmental issues into greater consideration.
Regulation (EU) 2019/6
Delegated acts and implementing acts
Report – SoU 2021:45
Contact us
Department of Efficacy and Safety
Email: registrator@lakemedelsverket.se
Telephone: +46 (0)18-17 46 00