What is the UPD?
According to the New Veterinary Regulations (NVR) EU 2019/6, the European Medicines Agency (EMA) shall establish and maintain a Union Product Database (UPD). With that in mind, implementation acts are required laying out electronic exchange mechanism and data format, database functionality and interface/API as well as detailed specifications of the data to be managed.
The EMA recommends building a system utilising existing functionalities as far as possible. This, for example, includes the current development of SPOR (Substance, Products, Organisation, Referentials) which is applicable to both human and veterinary products. However, because of the tight time frame, the initial development will focus on a minimum viable product fulfilling only legislative requirements.
Part of SPOR is the Product Management Service (PMS) that has been modelled based on ISO IDMP (Identification of Medicinal Products), managing medicinal products for humans and veterinary use. However, PMS is slightly smaller than the full ISO IDMP. The UPD now mandates fields and entities that largely fall within the scope of PMS. However, there are a few exceptions required in the UPD that are not covered under PMS such as volume of sales or variations not requiring assessment.
So, what is the suggested content of the UPD?
The UPD has been designed to simplify data sharing from Marketing Authorisation Holder (MAH) via regulators to patients. With that in mind, for veterinary medicinal products the following data fields are considered:
- name of the veterinary medicinal product;
- active substance(s) and strength;
- summary of product characteristics;
- package leaflet;
- the assessment report;
- manufacturing sites;
- the dates of the placing of the veterinary medicinal product on the market.
For homeopathic veterinary medicinal products, the data fields are as follows:
- name of the registered homeopathic veterinary medicinal product;
- package leaflet; and
- manufacturing sites.
Furthermore, veterinary medicinal products allowed to be used in a Member State in accordance with Article 5(6) are also managed in the UPD.
Last but certainly not least, the annual volume of sales and information on the availability for each veterinary medicinal product is also managed in the UPD. This point is one that needs urgent attention from MAHs as this data has to be collected in the relevant Regulatory Information Management (RIM) systems. Further details on the format of the data to be collected can be found in EMA/CVMP/586518/2019.
What about other UPD stakeholders?
The Federation of Veterinarians of Europe (FVE) for example describes the UPD as the most important tool to increase availability of veterinary medicines for practitioners, mainly because it allows searching for veterinary products EU wide in case no suitable treatment can be found nationally (FVE/20/doc/055, August 2020). The FVE also made some interesting suggestions including the point that all veterinary products should be entered into the UPD no later than January 2022 to avoid the current status of the EudraPharm Veterinary Database, which is still seen as incomplete.
One other interesting suggestion from the FVE is to state strongly that “The Union product database must avoid duplicate input of data in different Union systems.” Moving away from ‘The Union product database should be developed…” clearly demonstrates the desire to reduce data duplication. Now why should this remind me of the “Single Place of Truth”® for Regulatory Information Management?
The Union Product Database has been welcomed by many and will certainly improve the safety, availability and maintenance of veterinary medicinal products in the EU. Furthermore, with the implementation of the NVR, of which the UPD is a pivotal part, administrative burden on MAH and regulators will be reduced although some additional information such as sales data will be required. I am looking forward to seeing more detailed UPD implementation guide in due course.
Please feel free to contact us if you require further information.