EMA update
The EMA published their June newsletter on the implementation of EU IT requirements for veterinary medicines. The EMA has now formally closed the IT development programme, which has now moved to a care, maintenance, and quality improvement phase.
On 24 April 2023 the EMA hosted a webinar on the requirements for veterinary companies to submit annual volume of sales data for each of their products to the Union Product Database (UPD) before 30 June 2023. This requirement is set out in Article 58(12) of Regulation 2019/6. A recording of that webinar, which is intended for industry users, is available on the EMA website.
The EMA is hosting a Veterinary Awareness Day on 12-13 September 2023. The event will provide an overview of the agency’s work, one year on from implementation of the new legislative requirements. More information is available on the EMA Veterinary Awareness Day event webpage. The EMA has updated the EudraVigilance User Manual for companies reporting adverse reactions to the database.
CMDv update
The Coordination Group for Mutual Recognition and Decentralised Procedures for Veterinary Medicinal Products (CMDv) has established a new clinical trials subgroup. This group is currently developing an application form to be used when applying for an EU multicentre clinical trial.
The CMDV has revised their Best Practice Guide for Variations not Requiring Assessment (VNRAs) which is available on the CMDv pages of the HMA website. Annex II of the guide lists VNRAs which now require submission to the affected CMS(s) only. Although technical grouping is still restricted to VNRA codes C1 (QPPV), C5 and C6 (PSMF code and location), the guide has been revised to advise applicants that where a VRA is submitted in a worksharing procedure, the consequential VNRAs may be super grouped. This means that all products involved in the worksharing application can be included in a single submission in the UPD even if different decision-making authorities are involved.
The CMDv submitted a query to the European Commission on the “generic extension” of a complete dossier. The answer was published in the CMDv’s report for April and May.
In its answer, the Commission concludes that Regulation 2019/6 does not exclude an MAH that has been granted a marketing authorisation (MA) following the submission of comprehensive technical documentation from requesting a variation to expand the terms of the originally granted MA following a generic approach This can be done by demonstrating bioequivalence with another veterinary medicinal product.
European Commission update
The European Commission has recently provided the following updates for veterinary industry stakeholders.
- It intends to monitor progress regarding changing of product labelling in accordance with the requirements of Regulation 2019/6. There is a concern that progress to implement the QRD template requirements is slow. Accordingly, the Commission has requested regular feedback from Member States.
- The scientific advice of the EMA in respect of the list of antimicrobials which shall not be used under the cascade provisions has been delayed. This list is expected to be available later this year.
- It has initiated a targeted consultation of users and stakeholders on pictograms that will be used in place of text on veterinary product labelling. The deadline for response to the survey is 30 September 2023. Following that, an Implementing Act will be developed.
- In accordance with Commission Delegated Regulation 2021/578, data on the volume of sales and use of antimicrobials for cattle, pigs, chickens and turkeys for the year 2023 will need to be submitted to the EMA for the first time during 2024.
- A draft delegated regulation on veterinary medicinal products for oral administration to food-producing animals via routes other than medicated feed is in development. The goal of the legislation is to minimise any risks of inappropriate administration and the development of antimicrobial resistance with consequences for public and animal health and environmental safety. The Commission expects to allocate a period of 3 years from the date of entry into force of the legislation to update all relevant marketing authorisations.
HPRA update
On 6 July 2023 the national parliament passed the Veterinary Medicinal Product, Medicated Feed and Fertilisers Regulation Act, 2023 . This wide ranging national legislative framework is expected to be signed into law by the President over the coming weeks.
The Act repeals the Animal Remedies Act, 1993. Once the Act has been commenced, the Minister for Agriculture, Food and the Marine will have authority to make various regulations under the Act. This is expected to include legislation on the supply of veterinary medicinal products that are not subject to veterinary prescription.
The HPRA continues its efforts to upload any remaining national product legacy data to the UPD. We are also working to deploy an IT tool to allow automatic updating of information from our national database to the UPD. The HPRA continues to experience challenges in processing VNRAs and G.I. 18 variations, particularly due to technical issues with the functionality of the UPD. This has led to an increase in the number of applications under review by us as ‘work-in-progress’ due to the time needed to clarify issues and close the procedures concerned. It is especially frustrating for applicants as well as the HPRA to process applications where the UK (Northern Ireland) is a concerned Member State, but where the product concerned is not available in the UPD. Despite raising this matter with the EMA, a solution has not been found. As a result, we have contacted the European Commission on the matter.
To facilitate the timely issuing of new product authorisations, the HPRA has separated the approval of label mock-ups from the issuing of the marketing authorisations. The HPRA will now issue the marketing authorisation once the procedure has concluded. Mock-up review will then be conducted in a separate G.I.15z application. Applicants may submit the G.I.15z variation for mock-up approval as soon as they are available for review. These changes are expected to result in a timelier and more predictable time for MAHs and will facilitate mock-up reviews being synchronised with product launch.
For a very few products where we reached out to applicants to encourage them to provide essential information on their national products to the UPD, but they have not done so, we have had to initiate a process to revoke the marketing authorisations concerned. If the mandatory requirements for data upload to the UPD are not respected, the HPRA has little choice but to report them as a non-compliance with the legal requirements. However, the process of revocation represents a high and avoidable administrative burden which increases costs to the HPRA.
The HPRA is planning to host a webinar on the implementation of Regulation 2019/6 during quarter four of this year. We are working on the agenda of the virtual meeting currently, but any ideas for hot topics should be emailed to veterinarywebinar@hpra.ie. More details will be provided elsewhere on the HPRA website in due course.