The EMA released version 01.02 of the Union Product Database on 16th March 2021.
As part of the New Veterinary Regulations (NVR) implementation, the EMA is developing a Union Product Database (UPD) to allow the management of veterinary medicinal products in the EU. The UPD has been welcomed by many and will certainly improve the safety, availability and maintenance of veterinary medicinal products. In a previous blog we looked at the UPD, how it impacts Marketing Authorisation Holders (MAHs) and to better understand purpose and advantages.
Today though, I shall look at the latest UPD product release version 01.02 that contains additional functionality compared to its previous releases. But there are also some alarming uncertainties that require urgent attention.
The important updates
The new UPD version 01.02 provides the following additions:
- Additional functionality compared to release 01.00 (core UPD Repository and Application Programming Interface (API), including document management and validation).
- The first version of the National Competent Authority (NCA) User Interface (UI), providing search, view and create functionality.
It should be noted though, that this release is limited to centrally and nationally authorised products with functionality for DCP and MRP to be provided in the release scheduled for July 2021.
The important notes
Besides not supporting DCP and MRP, it is important to understand that this new UPD version is compliant with the EU implementation guide dated back to 2020. It is not compliant with the more recent guidance published in January 2021 for which the consultation period just closed. This however highlights at least one major challenge for all stakeholders: any new implementation guide might require changes to the underlying data structure of the UPD. This by itself brings another challenge as the data already entered into the UPD might not be retainable. The notification from the EMA is clear: “… we do not recommend to use this release of the UPD for production purposes yet.” Considering the tight timetable for implementation, this will be a further blow to outside stakeholders such as the Marketing Authorisation Holders (MAHs) and solution providers who eagerly await a stable data structure and API. According to the EMA, more functionality will be made available gradually between now and January 2022 but for a successful interaction with the UPD, stable APIs and data structure are a must.
The changes
The new UPD version 01.02 provides mainly four areas of improvements via the User Interface (UI) for National Competent Authorities (NCAs):
- Create product via UI (for centralised and national procedures)
- Search product via UI
- View product via UI
- Manage notifications via UI (for centralised and national procedures)
This should allow NCAs to test their interaction with the UPD using the UI.
The API has been enhanced too with the following:
- Get a specific Product version
- Get everything of Product version
- Get all Product versions
- Update Product
- Validate Product
- Create document
- Retrieve document (by ID)
- Search document (by ID)
- Update document (by ID)
There are further updates on existing APIs such as changes to the “create Product key” and “update Product” in line with the changes in the UI. Some examples will help defining and understanding the FHIR (Fast Healthcare Interoperability Resources) messages. However, there is also a long list of issues with the UI and API.
In summary
Release 01.02 of the UPD brings some additional functionality, allowing NCAs to test their data exchange method with the UPD. However, as this release is based on the guidance document from 2020, the data structure as well as API and UI might still change which will make life difficult for MAHs and solution providers alike. With the implementation timeline for the NVR in January 2022 looming, not much time is left for stakeholders to comply. A stable data structure and API will be a must to move forward successfully.
Pharma Whisper 