A marketing authorisation is not always needed in order to bring veterinary medicines to market.
Exemption for specific pets
Exemptions to the requirement for a marketing authorisation can be granted for veterinary medicinal products that are exclusively intended for aquarium or pond animals, ornamental fish, ornamental birds, homing pigeons, terrarium animals, small rodents, and ferrets and rabbits kept exclusively as pets. These exemptions can be granted provided that the products do not contain substances that are available on prescription only.
Please note: these veterinary medicinal products must comply with Article 2, paragraph 4 of the Veterinary Medicinal Products Regulation. This means that:
- They must be registered in the UPD;
- They must comply with the rules governing the manufacturing of veterinary medicinal products (in compliance with the GMP);
- They must comply with the rules governing the collection and disposal of waste stemming from veterinary medicinal products;
- They must comply with the rules governing the advertising of veterinary medicinal products;
- Inspections and monitoring must be possible;
- It is prohibited to supply a veterinary medicinal product if Article 134 applies;
- They must comply with the rules and legislation governing monitoring of veterinary medicinal products.
Transitional provision for over-the-counter veterinary medicines for particular animal species that were exempted from requiring a marketing authorisation before 28 January 2022
These veterinary medicinal can provisionally remain on the market until there is more clarity regarding the categories of veterinary products that do not require prescription by a veterinarian under Article 34 of Regulation (EU) No. 2019/6. Antimicrobial products are an exception to this, details of which are given below.
From the start of 2023 onwards, wholesale traders in veterinary medicinal products with an exemption for specific pets will be required to notify the authorities and assessments of relevant veterinary medicinal products will take place.
If you are a wholesaler who brings a veterinary medicine to the Dutch market that is intended for specific pets, you have received news items in May and December 2022 containing further information. If you have not received these news items, these can be found here (in Dutch).
Antimicrobials are prescription-only and are not covered by this exemption. Antimycotics (antifungal agents) and antiprotozoal agents have also been classified under antimicrobial agents since the entry into force of the Veterinary Medicinal Products Regulation. This means that they will also be subject to prescription.
Transitional period antimycotics and antiprotozoal agents
A transitional period has been set for antifungals and antiprotozoal agents intended exclusively for specific companion animals due to a possible lack of availability. You can read more about this in this news item.
Important note: The above antimicrobial medicines should not be confused with the old “5-gram rule”. This term concerns 5-gram authorisations for tetracyclines and sulphonamides, which were permitted until 28 January 2022 under a national stipulation. Tetracyclines and sulphonamides are prescription-only and can only be provided to keepers of companion animals (typically pigeons) by a veterinarian. These medicines may contain a maximum of 5 grams of tetracyclines and sulphonamides, and are also subject to a transitional period. They are permitted on the market until their expiry date or 29 January 2027, whichever is the earliest. The relevant medicines are listed here. They will require a regular marketing authorisation.
The legal basis for the exemption for specific pets is set out in Article 5(6) of the Veterinary Medicinal Products Regulation. In the Netherlands, this exemption has been incorporated in Article 2.1 of the Veterinary Medicines Regulations 2022.
Exemption for animal experiments
Article 2.1 paragraph 2 of the Veterinary Medicines Decree 2022 contains information about exemptions from the ban on importing, transporting, receiving, possessing or using veterinary medicines in the Netherlands for the purposes of animal experiments. This exemption applies to experiments performed in compliance with the Experiments on Animals Act (Wet op de dierproeven) by the licence holders specified in the act.
Diagnostic testing of non-living material from an animal
All products intended for use on animals for the purposes of making a medical diagnosis are included in the definition of the term 'veterinary medicine' (Article 4(1)(c) of the Veterinary Medicinal Products Regulation). These products are also known as in-vivo diagnostic medical devices.
In-vitro diagnostics are tests performed on non-living material from an animal.
Examples include blood, urine, saliva or hair samples. The purpose of such diagnostic tests is to make a medical diagnosis. These tests are not classified as animal experiments. As a result, the requirements governing the introduction to market do not apply to these in-vitro tests.
The non-living animal material on which the diagnostic tests are performed does not subsequently enter the food chain. From the perspective of animal welfare or public health, it is therefore not necessary to require a full dossier of documentation or to issue a marketing authorisation for the purposes of such diagnostic medical devices.
In-vitro diagnostic medical devices intended for use on humans may be governed by Regulation (EU) 2017/746 on in-vitro diagnostic medical devices. As a result, the CE marking is required for in-vitro diagnostic medical devices for use on humans.
However, in the Netherlands, no EU or national requirements apply to in-vitro diagnostic medical devices for use on animals.
If you would like to know if an exemption applies to a specific veterinary medicine and whether this medicine complies with the applicable requirements, then you can ask the Veterinary Medicinal Products Unit via their contact form.