Section 2.22, paragraph 1 of the Veterinary Medicinal Products Decree states that marketing authorisation for a veterinary medicine shall lapse if the veterinary medicine has not been marketed within three years after the marketing authorisation has been issued, or is no longer actually being marketed. This is called the sunset clause.
'Marketed' means: “actual availability for use in the Netherlands, to be demonstrated as required by a sales transaction of at least one package to an authorised individual”.
Pursuant to Section 2.22, paragraph 2 of the same Decree, the Minister may in exceptional circumstances or for reasons of human or animal health, extend the three-year term for lapsing, as intended by the first paragraph, by a term to be determined, in the interests of animal welfare, animal health, public health or the environment.
Legal framework: implementation of Section 28, paragraph 5 of Directive 2001/82.
Implementation in the Netherlands
In principle, the marketing authorisation holder is responsible for determining whether and when a product falls under the sunset clause. In such cases, the marketing authorisation holder must submit a request for marketing authorisation withdrawal with the MEB Agency, Veterinary Medicinal Products Unit.
The marketing authorisation holder is also responsible for determining whether there is an exception to the general rule. The underlying reasoning must be documented and may be requested and evaluated as required.
Exceptions to the sunset clause
There are circumstances in which marketing authorisation for a veterinary medicine may be permitted without actual sales and use in the Netherlands. This is described in Section 2.22, paragraph 2 of the Veterinary Medicinal Products Decree.
Pursuant to Section 2.22, paragraph 2 of the Veterinary Medicinal Products Decree, in exceptional circumstances or for reasons of human or animal health, the three-year term for lapsing, as intended by the first paragraph, may be extended by a term to be determined, in the interests of animal welfare, animal health, public health or the environment.
Situations that may be covered by this exception include:
- medicinal products that may not be used due to injunction by the government, such as vaccines for foot and mouth disease and swine fever
- medicinal products for specific, unique and/or rare indications that are important to public health, animal health or animal welfare, as well as the treatment of minor species
- medicinal products that require Dutch marketing authorisation to be marketed in third countries for the local promotion of public health or animal health or welfare
- medicinal products that require a Dutch marketing authorisation because they are a reference medicine for generic medicinal products that are being marketed
- medicinal products for which the Netherlands is the Reference Member State and are marketed in a Concerned Member State
- medicinal products for which marketing authorisation must remain in the market due to reference medicinal product status for newer generations of veterinary medicinal products and references in dossiers
- presentations of medicinal products for which a different presentation is marketed based on the same marketing authorisation
- product-specific other circumstances that make continued marketing authorisation desirable, for example completion of a series of related products, situations pertaining to handling of variations prior to marketing of a product, or legal impossibilities pertaining to marketing the product or keeping it available.