Marketing authorisation exemption

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 intended solely for aquarium/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. This is stated in Article 5, paragraph 6 of the Veterinary Medicinal Products Regulation. In the Netherlands, this exemption is incorporated into Article 2(1) of the Veterinary Medicines Regulations (Regeling diergeneesmiddelen 2022).

Please note: these veterinary medicines 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 medicines (in compliance with the GMP);
  • They must comply with the rules governing the collection and disposal of waste stemming from veterinary medicines; 
  • They must comply with the rules governing the advertising of veterinary medicines
  • Inspections and monitoring must be possible; 
  • It is prohibited to supply a veterinary medicine if Article 134 applies; 
  • They must comply with the rules and legislation governing monitoring of veterinary medicines

In addition, there is only a very limited number of categories of over-the-counter veterinary medicines. For example, antimicrobial medicines (antibiotics) are always prescription-only and are not covered by Article 5 paragraph 6. 

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 medicines – with the exception of antimicrobial medicines – can provisionally remain on the market until greater understanding is gained into which categories of veterinary medicines will not require a prescription from a veterinarian on the grounds of Article 34 of Regulation (EU) 2019/6.

As a first follow-up step, you must notify the authorities when bringing any product to market that is exempted from registration. 

Are you a wholesaler that will be bringing a veterinary medicine to the Dutch market intended for specific pets? If so, then you will have received a letter at the end of May containing further information. Have you not received it? If this is the case, then click here to read the letter.

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.

More information

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.