Action required: Union Product Database implementation guide is available for consultation until 21/March/2021.
Today, I shall look at three of the many changes proposed.
The first important update.
Under the New Veterinary Regulations (NVR) EU 2019/6, the European Medicines Agency (EMA) shall establish and maintain a Union Product Database (UPD). In previous blogs we looked at some of the new requirements such as UPD access policies and what it might mean for Marketing Authorisation Holders (MAHs) to deliver additional information on veterinary medicinal products. Now on 21/January/2021 the EMA released a draft implementation guide on the UPD for public consultation and one of the main areas for MAHs to consider is the implementation timelines.
Source: EMA Veterinary Regulation Highlights, Issue 3, January 2021
These timelines define when MAHs and competent authorities have to manage veterinary medicinal product information in the UPD. And these timelines are tight.
The Veterinary EU Implementation Guide for the Union Product Database
The second important update.
The EMA provided the UPD implementation guide (EMA/536780/2020, 21/January/2021) to support MAHs as well as competent authorities who are submitting veterinary medicinal product data into the UPD. The main emphasis of the implementation guide is to standardise the definition of the data elements and to assist competent authorities during the implementation. In particular, the implementation guide provides the following:
- Chapter 1: Registration and data access requirements for the User Interface and Application Programming Interface (API)
- Chapter 2: Format for the electronic submission of veterinary medicinal products information
- Chapter 3: Process for the initial submission and maintenance of veterinary medicinal products information
- Chapter 4: Processes for the submission of legacy data on veterinary medicinal products
- Chapter 5: API Technical specifications
- Chapter 6: Practical examples
One of the major aspects the implementation guide confirms is that “The UPD is building on the existing PMS database structure with connection to the three other services of SPOR”.
As a reminder, then, SPOR is based on the four pillars of
- Substance Management Services (SMS)
- Product Management Services (PMS)
- Organisation Management Services (OMS)
- Referentials Management Services (RMS)
With the SPOR portal providing the following data management services:
- view, search, export SPOR data
- request new and updated SPOR data
- translate SPOR data
- browse relevant SPOR documentation
The UPD message format
The third important update.
A further important aspect of the UPD implementation guide is the definition of the message format for the delivery of data and documents to the UPD , which will be based on the Fast Healthcare Interoperable Resource (FHIR) message format (“The information and documents related to a veterinary medicinal product shall be submitted to the UPD via a Health Level 7 (HL7) Fast Healthcare Interoperable Resource (FHIR) message based on the terminology and reference standards available in the SPOR system.”). Using the FHIR format, from 28/January/2022 MAHs shall submit the following:
(a) the dates when their authorised veterinary medicinal products are placed on the market, information on the availability of each veterinary medicinal product in each relevant Member State, and the dates of any suspension or revocation of the marketing authorisations concerned.
(b) the annual volume of sales for each of their veterinary medicinal products.
Products placed on the market before 28/January/2022 have a slightly longer deadline and should be recorded by 28/January/2023.
The EMA is inviting interested parties to comment on the UPD implementation guide until 21/March/2021. The UPD implementation guide provides timelines, details on data exchange message formats (FHIR) and further details about the use of SPOR. Stakeholders are advised to act in a timely fashion to address any issues that this implementation guide might present.
With the above, we only touched on three of the important aspects of the UPD implementation guide. More details will follow in future blogs.