Veterinary Medicinal Products Regulation: QRD template, GMP certificates, OMS registration and EMA activities
The entry into force of the Veterinary Medicinal Products Regulation ( Regulation (EU) 2019/6) on 28 January 2022 will result in many changes in the field of veterinary medicinal products. An overview of the latest updates follows below, including a new QRD template and the automatic extension of GMP certificates.
New QRD template for veterinary medicinal products available in Dutch
The Dutch version of QRD template v.9.0 is now available. It sets out the new rules for SPCs, labels and package leaflets.
QRD template v. 9.0 is obligatory for all applications submitted on or after 28 January 2022. Existing SPCs, labels and package leaflets must be updated in line with the new version of the QRD template before 29 January 2027. Existing SPCs, labels and packaging leaflets must be updated in line with QRD v. 9.0 via a one-off change and assessment. Please note: the SPC, label and packaging leaflet for existing procedures cannot be updated in line with QRD v. 9.0. For more information, see the CMDv QA document on transitional arrangements.
GMP certificates automatically extended until the end of December 2022
The certificates issued to manufacturers (holders of a manufacturing authorisation for veterinary medicinal product) will be automatically extended for a second time. On this occasion, they will be extended until the end of December 2022. In line with the policy of the European Medicines Agency (EMA), the Health and Youth Care Inspectorate (Inspectie Gezondheidszorg en Jeugd (IGJ)) is carrying out Good Manufacturing Practice inspections (GMP inspections) in the premises of manufacturers of veterinary medicinal products on behalf of the Minister of Agriculture, Nature and Food Quality. Exceptions to the above apply if GMP certificates have been issued for a specific period of time and in situations where there are changes to the scope of the GMP certificate. For example, new buildings or new veterinary medicinal products.
For more information about automatic extensions and other changes prompted by the COVID-19 pandemic, see the website of the EMA.
Check registration in OMS database before submitting new applications
From 28 January 2022, companies such as yours must be registered in the Organisation Management Service (OMS) database of the EMA. While this is currently already the case for marketing authorisation holders, this requirement will also start to apply to manufacturing authorisation (MIA) holders, wholesale distribution authorisation holders (WDA) and owners of veterinary ingredients (VET API REG) from 28 January 2022.
The data in the Organisation Management Service database (OMS database) is used to grant manufacturing authorisations, wholesale distribution authorisations, certificates and API registrations. This will be the standard effective 28 January 2022. As such, it will be important for you to check the data held about your organisation in the OMS database. If the data is correct, you will be able to apply for a new or amended manufacturing authorisation, wholesale distribution authorisation, GMP certificate or veterinary API registration. These applications must be submitted to the Veterinary Medicinal Products Unit.
The above applies to all manufacturers, importers and distributors of veterinary medicines (or active ingredients thereof) intended for the European market.
EMA activities: webinar and second veterinary medicines info day
- EMA/FVE webinar about data collection about sale and use of antimicrobial agents - 24 November 2021, 14.00-15.30 hours
- Second veterinary medicines info day - 30 November 2021, 10.00-17.00 hours
About the new Veterinary Medicinal Products Regulation
The new Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6) and Regulation (EU) 2019/4 on medicated feed are both coming into effect on 28 January 2022. A great deal will change as from next year due to the implementation of the Veterinary Medicinal Products Regulation (VMR). The development and further detailing of the Veterinary Medicinal Products Regulation have been in progress since its publication in January 2019.