Registering the continued use of antimycotics or antiprotozoal veterinary medicinal products exclusively intended for specific companion animals
Prior to the introduction of the Veterinary Medicinal Products Regulation, antimycotics (antifungal agents) and antiprotozoal veterinary medicinal products exclusively intended for specific companion animal were exempt from the marketing authorisation requirement for veterinary medicinal products. This changed earlier this year, when the Veterinary Medicinal Products Regulation came into force, in which these products are categorised as antimicrobial veterinary medicinal products, which are always subject to prescription. As such, these products no longer meet the conditions for exemption set out in Article 5(6) of the Veterinary Medicinal Products Regulation.
For a list of these specific companion animals and more information about these requirements, see the following page: Marketing authorisation exemption.
Update 18 July 2023
Publication of list of products
Attached is a list of registered antimycotics (antifungals) and antiprotozoal agents intended exclusively for specific companion animals.
Registration
If you are responsible for the marketing in the Netherlands of antimycotics or antiprotozoal veterinary medicinal products intended for specific companion animals, but you did not register these yet? The transitional period is still valid if you register these veterinary medicines before 1.8.2023. This can be done by completing the form Registration of antimycotics or antiprotozoal veterinary medicinal products.
In line with national agreements, the following applies to products that have not been notified before 1.8.2023: the manufacturer is no longer allowed to manufacture the veterinary medicinal product; existing stock of batches that have already been released can be delivered to the wholesale and/or retail trade for a maximum period of 6 months ; retailers and animal keepers are allowed to sell these products and use them until (nearly) the end of their shelf life.
Transitional period for the use of antimycotics or antiprotozoal veterinary medicinal products exclusively intended for specific companion animals
An extended transitional period has been agreed for the use of these veterinary medicinal products intended for the Dutch market, whereby:
- manufacturers may continue to produce batches until 28 July 2024;
- wholesalers may continue to supply retailers with batches that have already been released until 31 December 2024; and
- retailers and companion animal owners may continue to supply/use these veterinary medicinal products until their expiry date;
- provided that the party responsible for placing the veterinary medicinal product(s) on the market in the Netherlands issues an overview to the Veterinary Medicinal Products Unit before 1 March 2023. This overview must include a list of the product names and active substances.
Publication of list of active substances
Based on the registrations we receive, a list of the active substances that continue to be used as part of antimycotics or antiprotozoal veterinary medicinal products for specific companion animals will be published in mid-March 2023.
If you are a wholesaler or retailer of these veterinary medicinal products and you discover that the published list does not yet include all active substances, please inform the person responsible for placing the relevant product(s) on the market in the Netherlands and ask that they register the continued use of the active substance(s) as soon as possible.
Reason for extension of transitional period
This extended transitional period has been agreed because of the expectation that there would otherwise have been problems with the continued availability of these veterinary medicinal products. How these veterinary medicinal products are to be dealt with after 28 July 2024 is yet to be determined at the national level and possibly at the European level.
Registering the continued use of products
If you are responsible for the marketing in the Netherlands of any veterinary medicinal products intended for specific companion animals, and you wish to continue to use such products during the transitional period, you must register these with us before 1 March 2023. To this end, you must complete the form for the Registration of antimycotics or antiprotozoal veterinary medicinal products
A list of the active substances that have been registered with us will be published on the website of the Veterinary Medicinal Products Unit in mid-March 2023.
Note: These veterinary medicinal products are intended exclusively for specific companion animals. The packaging size you register with us must be in accordance with this intended use.
More information
For more information, see our newsletter for manufacturers and wholesalers that place veterinary medicinal products on the market in the Netherlands that are not subject to prescription and are intended for specific companion animals. This newsletter gives more background information on the conditions for the exemption set out in Article 5(6) of the Veterinary Medicinal Products Regulation. We will at a later date provide further information on how to apply for a ‘Registration’ for each veterinary medicinal product that meets the requirements set out in Article 5(6) of the Regulation.
If you have any further questions, please submit them to the Veterinary Medicinal Products Unit by using our contact form. Please select ‘Other’ in the list of topics and specify that your question relates to the exemption for specific companion animals.
