According to the New Veterinary Regulations (NVR) EU 2019/6, the European Medicines Agency (EMA) shall establish and maintain a Union Product Database (UPD). In July 2020 the EMA published the UPD access policy (EMA/198149/2020), which outlines who gets access to which data stored in the UPD. It outlines how all parties can meet their obligations as provided in the Veterinary Medicinal Product (VMP) regulations and at the same time protect personal as well as confidential data.
But who can access the UPD?
The UPD will be open to agencies, marketing authorisation holders as well as the public. Different access levels will be provided, allowing data entry and updates where required. Considering the needs and requirements from different UPD stakeholders, UPD access levels are as follows:
- Full access for authorities, EMA and Commission.
- MAH will have access to their own MA.
- Limited read only access for the public (including veterinary practitioners).
The public will be able to search the UPD for product information nationally and in the wider EU. Data fields of interest include but are not limited to the product name, active substance, country of authorisation, target species, and MAH.
How will it all work?
The status of the Union Product Database (UPD) has again been updated. The release notes from the EMA have been published (EMA/556635/2020) together with additional information on which data can already been accessed. This release of the UPD makes the first components such as the API available, thereby providing access initially for National Competent Authorities (NCA). However, the functionality is limited to reading information on centrally authorised products and automatically creating MRP/DCP/NAP product information. NCAs can link to the UPD via an API to extract Centralised Authorised Product (CAP) information. NCAs can also start testing product information upload. Further information on increased functionality is planned to be released gradually throughout the coming months.
What about other stakeholders?
The Federation of Veterinarians of Europe (FVE) has very specific expectations with regards to the UPD search capabilities (FVE/20/doc/055, August 2020). The following search criteria are especially seen as relevant for veterinary practitioners:
- Product name,
- qualitative and quantitative composition of the pharmacologically active substance(s),
- the pharmaceutical form,
- countries the veterinary medicinal product is authorised in,
- indications for use,
- target species and dosage for each species,
- method and route of administration,
- contra-indications and adverse events,
- drug-drug interactions,
- information essential for safety or health protection,
- withdrawal time,
- distribution category,
- Marketing Authorisation Holder (MAH) and
- therapeutic group.
Although only from one stakeholder’s point of view, the benefits of a single database seem obvious.
The expectations are high, the list of demands looks excessive. But it also highlights the benefits that can be achieved with the UPD if implemented correctly with all stakeholders in mind. If combined with keyword or wildcard searching and access to SPC and PIL documents, the UPD will truly be single source of information for many – as long as all product information is actually managed within it of course.
Please feel free to contact us if you require further information.