The new Veterinary Medicines Regulation will modernize the existing rules on the authorization and use of veterinary medicines in the European Union (EU) when it becomes applicable on 28 January 2022.
New measures have become active to increase the availability and safety of veterinary medicines and enhance EU actions against antimicrobial resistance.
The new Draft Implementation Guide for the Union Product Database (UPD) is available for public consultation. Comments shall be sent to vetchange.programme@ema.europa.eu by 21st March 2021. The UPD will draw on the four substance, product, organization, and referential (SPOR) data management services for the centralized management of master data in the EU.
Organizations must undergo a SPOR onboarding process, including the registration as MAH in the OMS database of EMA. The dataset to be submitted mirrors the current xEVMPD dataset only for VET products, e.g., QPPV details, Master File location, and vetATC.
Published as DRAFT for comment are:
EU Implementation Guide (IG) on veterinary medicines product data in the Union Product Database
- Chapter 1: Registration and data access requirements for the User Interface (UI) and Application Programming Interface (API)
- Chapter 2: Format for the electronic submission of veterinary medicinal product information
- Chapter 3: Process for the initial submission and maintenance of veterinary medicinal products information
- Chapter 4: Process and format for the submission of legacy data on veterinary medicinal products
- Chapter 5: Technical specification
The main objectives of the new regulation are:
- Simplify the regulatory environment and reduce the administrative burden for pharmaceutical companies developing veterinary medicines, for example, through streamlined pharmacovigilance rules
- Encourage the development of innovative veterinary medicinal products, including products for small markets (minor use and minor species)
- Improve the functioning of the internal market for veterinary medicinal products
- Reinforce EU action to combat antimicrobial resistance through specific measures to ensure prudent and responsible use of antimicrobials in animals, including the reservation of certain antimicrobials for the treatment of infections in humans
Regulation (EU) 2019/6 repeals Directive 2001/82/EC and amends the provisions of Regulation (EU) 726/2004 on the authorization and supervision of veterinary medicinal products, which currently governs the centralized authorization procedure for both human and veterinary medicinal products.
The European Parliament and the European Council adopted Regulation (EU) 2019/6 in December 2018. It will enter into force on 28 January 2022.
The main benefits of the regulation:
- Improved availability and access to safe and high-quality medicines for veterinarians, farmers, and pet owners for the treatment and prevention of animal diseases
- Reduced administrative burden and better incentives for pharmaceutical companies developing new and innovative veterinary medicines, benefiting micro, small and medium-sized enterprises (SMEs) in particular
- New and improved rules to maintain the efficacy of antimicrobials (including antibiotics) based on a "One Health" approach for the benefit of animal health and public health as well as all EU citizens
Role of the EMA in the implementation of the regulation:
The EMA contributes to the discussions on implementing and delegated acts prepared by the European Commission in the context of the implementation of the Regulation. In particular, the agency provides scientific and technical advice when requested by the European Commission.
The EMA is also responsible for:
- Revising its procedures and its regulatory and scientific guidance documents in accordance with the regulation and its implementing and delegated acts;
- Managing the implementation of the IT systems required by the regulation, including the EU product database, which will provide information on all authorized veterinary medicinal products and their availability in the EU Member States
- Implementing the results of the implementing and delegated acts.
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