Regulation of veterinary medicines also safeguards human health
The increase of antimicrobial resistance shifts attention to the medication of animals. The Veterinary Medicinal Products Regulation became applicable in 2022, along with many changes that keep experts in the regulation of veterinary medicines busy.
Ban on the use of certain antimicrobials on animals began in February 2023
The criteria for selecting which antimicrobials are exclusively for use on humans, and the list of antimicrobials are lower-level statutes of the EU Veterinary Medicinal Products Regulation. They are legislation that is directly applicable in the Member States.
The primary purpose of listing antimicrobials is to protect newer and broad-spectrum antimicrobials and to maintain their effectiveness for the protection of human health. The list of antimicrobials includes 18 antibiotics, 18 antivirals, and one antiprotozoal drug whose use on animals will be banned in the EU from 9 February 2023. According to information from Fimea and the Finnish Food Safety Authority, amantadine is the only medicinal substance on the list that was used on animals in Finland in the autumn of 2022. Amantadine has other properties besides antimicrobial properties, and it has been used on individual animals in the combination treatment of severe chronic pain.
Finland has had national restrictions on the use of antimicrobials on animals since the 1990s. Since then, Sweden has followed the same model, and from February 2023 the principle will be applied to the entire EU area. This policy has also served as a vanguard in the fight against antimicrobial resistance for the rest of the world.
Finland has participated in the European Surveillance of Veterinary Antimicrobial Consumption (ESVAC) project of the European Medicines Agency (EMA), and EMA published the 12th ESVAC report in November 2022. In the same month, the Finnish Food Authority, University of Helsinki and Fimea published the FINRES-Vet 2021 report based on information obtained from pharmaceutical wholesalers. The monitoring figures show that the total sale of veterinary antimicrobials clearly decreased in the 2010s but increased by five per cent in 2021.
The World Organisation for Animal Health (WOAH, formerly known as OIE) also gathers information on the consumption of veterinary antimicrobials. The information for 2020 and 2021 was submitted for the organisation in October 2022. WOAH’s report ‘Annual Report on Antimicrobial Agents Intended for Use in Animals, 6th edition’ was published in September 2022.
Marketing authorisations for veterinary medicines – some expected for sale
In 2022, a total of 53 marketing authorisations were granted for veterinary medicines, 5 of which were immunological products. The total number of marketing authorisations granted for veterinary medicines is 1,192, 179 or which are immunological products. Most of the new marketing authorisations pass through the decentralised or the centralised authorisation procedure. In terms of the availability of veterinary medicines, it would be essential to have the authorised veterinary medicines for sale in Finland.
The number of received applications and the number of processed applications fell by 13.2% and 23.7% from the previous year, respectively. The Veterinary Medicinal Products Regulation 2019/6, which became applicable on 28 January 2022, contributed to the decrease in the number of applications. Based on the Regulation, variation applications are classified into variations requiring assessment and variations not requiring assessment. The legislative change gives all parties much to learn, and practices must be agreed on at EU level. The Regulation also changed the practices concerning some applications for a marketing authorisation and extensions of existing marketing authorisations. The application balance for 2022 shows that the queue did not grow. Old types of variation applications have not arrived since 28 January 2022. However, new types of variation applications have arrived after 28 January 2022, and many are still pending. The assessment of Nordic labelling continued, and Finland is still a reference Member State (RMS).
During the performance year, Fimea received one new rapporteur task and one co-rapporteur task. We received a request for a new subsequent recognition procedure (SRP), which corresponds to the former repeat use procedure, concerning one product whose reference Member State Finland is. It will be initiated in 2023 after update of the application documentation Fimea welcomes more tasks as a RMS. No national marketing authorisation applications were received.
Special permits and exemptions for veterinary medicinal products safeguard availability
Before the transition to a fully electronic procedure, special permits for veterinary medicinal products were applied for and approved electronically. In 2022, 825 special permits were granted for veterinary products. One aim of Regulation (EU) 2019/6 on veterinary medicinal products is to increase the availability of veterinary medicinal products. To achieve this goal, the focus is shifted from individual special permits to fixed-term special permits. A total of 71 decisions were made on fixed-term special permits. The number of granted special permits decreased slightly, and the number of fixed-term special permits increased.
In 2022, exemptions were applied for 60 veterinary medicinal products. Similarly to previous years, exemptions were mostly granted to critical veterinary medicinal products with low consumption and packages that are in a foreign language and for veterinary medicinal products when the expiry date indicated on the package did not meet the requirements. With regard to the latter, the majority concerned renewal of permits granted in the previous year. The most exemptions were applied and granted for immunological veterinary medicinal products. The calculation method for exemption applications received in 2022 is different and since 2022, the figures are not fully comparable with the previous years. An exemption was granted for 53 products, and the application was rejected for seven products because they did not meet the criticality criterion. The number of permits increased slightly from the previous year.
Clinical trials for veterinary medicinal products and scientific advice support drug development
In accordance with Regulation (EU) 2019/6 on veterinary medicinal products, an application must be submitted instead of a prior notice when the purpose of the trial is obtaining a marketing authorisation or a change thereof. In 2022, no applications for clinical trials for veterinary medicinal products were received.
In 2022, we received one request for national scientific advice. No medicines guidance meetings were arranged.
Legislative changes require a lot of work
Following the transition period, the EU Veterinary Medicinal Products Regulation (VMPR) became applicable on 28 January 2022. Several related implementation and delegated acts have been completed, and the rest are under preparation. The Ministry of Social Affairs and Health is preparing national implementation of the VMPR. Its implementation was not completed during the performance year, and it will be carried over to the next government term, after the election in the spring of 2023. Fimea will update its provisions once the national implementation has been completed.
In connection with the entry into force of the VMPR on 28 January 2022, a Union Product Database (UPD) was launched. It contains information on all veterinary medicinal products authorised in the EU. Saga, Fimea’s marketing authorisation and medicinal product register, will be developed to meet the requirements of the UPD. In the future, data can be automatically transferred from Saga to UPD, and vice versa. UPD will be further developed to ensure that it functions as planned.
Fimea’s experts contribute actively to the EU pharmacovigilance network. The workload of the Committee for Medicinal Products for Veterinary Use (CVMP) is large due to preparation of new guidelines and updating of policies, advice and guidelines related to the VMPR. As a new issue, the Regulation creates a legal basis for the approval of products intended for limited markets with the aim of improving the availability of veterinary medicinal products. In 2022, CVMP assessed several applications to decide if the planned products could be classified as veterinary medicinal products intended for limited markets.
Scientific advice prepared for the European Commission on antimicrobials only authorised for human use and the cascade use of antimicrobials was very significant work in terms of public health. The advice on antimicrobials only authorised for human use was approved in February 2022. The advice on the cascade use of antimicrobials will be completed in 2023.
For the last three years, the Coordination group for Mutual recognition and Decentralised procedures, veterinary (CMDv) has actively contributed to the implementation of the VMPR. CMDv has updated its guidelines and prepared new guidelines for the processes established by the Regulation in cooperation with EMA and CVMP. One of the goals of CMDv is to reduce the administrative burden, and a significant share of the national special requirements related to the marketing authorisation processes has been reduced.
Safety of veterinary medicinal products and drug information
In 2022, Fimea received 215 reports of adverse reactions to veterinary medicinal products. The reason for this is that after the VMPR entered into force on 28 January 2022, marketing authorisation holders no longer sent incident reports to an authority but recorded them directly in the EudraVigilance database, and their processing was congested at Fimea. However, the magnitude of the number of received field reports remained the same, as a total of 266 reports were received in 2021. As before, the majority of these reports (193) came from veterinarians. Animal owners and pharmacies submitted 22 reports.
A total of 206 of the field reports concerned adverse reactions in animals and nine a suspected lack of efficacy. Two reports included a product with a special permit. As before, most reports were made of adverse reactions in dogs (183 field reports). Reports of adverse reactions in production animals are significantly more rare. 58% of the received adverse reaction records were classified as severe. Similarly to previous years, the reported harmful effects were generally related to vaccinations and antiparasitic drugs.
The veterinary medicines unit produces information about veterinary medicinal products in Fimea’s Sic! journal. Journal 1/2022 published a summary of the adverse reactions of veterinary medicinal products in 2021. The theme of journal 3/2022 was topical information about veterinary medicinal products, and several articles related to the Veterinary Medicinal Products Regulation were published. Drug information was also provided through the media and newsletters.
- FINRES-Vet 2021 report
- European Surveillance of Veterinary Antimicrobial Consumption, ESVAC: Sales of veterinary antimicrobial agents in 31 EU/EEA countries in 2021
- World Organisation for Animal Health, WOAH: Annual Report on Antimicrobial Agents Intended for Use in Animals, 6th edition