Only days to go – The New Veterinary Regulation is coming into force on 28th January 2022.
Time is running out for Marketing Authorisation Holders (MAHs), regulators and solution providers. The New Veterinary Regulation (NVR) is coming into force on 28/January/2022. Part of the NVR is the requirement for MAHs to provide information about the “Volume of Sales”.
Why provide “Volume of Sales” data?
Chapter IV of the NVR, Section 1 Union Product Database states that alongside information such as name of veterinary medicinal product, active substance and strength, package leaflets or marketing dates, the Union Product Database (UPD) should contain “…the annual volume of sales…”. Member states shall collect the data on the volume of sales and on the use of antimicrobial medicinal products. The data will be used to enable the analysis of any incidents that might occur during product life cycle.
What shall be submitted?
MAHs have to provide the following:
i. Package Identifier (generated by the UPD)
iii. Country identifier
iv. Month/Year (time period of submitted volume of sales)
v. Volume of sales (per package, species, country and month)
vi. Species Identifier
vii. Species % (estimated split of use per species)
viii. Dose Factor (average number of animals that can be treated using one package)
ix. Comment (optional field)
What format is required?
MAHs can download a csv file with prefilled information for product identifier, product name, packaging and more. This csv file needs to be updated with the information as stated above.
It is also possible to access the UPD via an API using a Regulatory Information Management (RIM) solution to manage the relevant data.
What are the problems?
Using the csv file format has its disadvantages considering regional requirements or different versions of Windows® etc. Chapter 7 of the EU Implementation Guide of veterinary medicinal product data in the Union Product Database dated 13/December/2021 highlights some of the challenges and how best to overcome them.
But there is – at least for now – another catch: although great progress has been made with the UPD implementation with new releases coming out every few weeks, there are still a few issues that need to be addressed. As of 21/December/2021, two examples from the results of User Acceptance Testing for “Submit volume of sales” UC07 are
- UPD-7985: zero/negative dose factor does not throw a validation error
- UPD-7994: the system validates creation date of product from the downloaded file while submitting even if the field is not mandatory
With the deadline of the NVR coming into force on 28/January/2022, the resolution of these and other challenges is becoming time critical.
Time is running out for the UPD to be ready for MAHs, NCAs and solution providers. Rapid progress has been made to meet deadlines, but a few issues still need to be addressed. However, MAHs should be fully prepared ahead of time to allow provision of all required information for the UPD when released.
Please get in touch if we can be of assistance.