Rules for activities with certain substances
Wholesale distribution of certain substances
Article 2(6)(a) of the Veterinary Regulation provides that Chapter VII of the Regulation on the wholesale distribution of medicinal products also applies to companies wishing to wholesale distribute certain substances. This means that the company must be in possession of a wholesale distribution authorisation and comply with GDP requirements.
As a result, Section 93(1) of the Danish Medicines Act inserts a requirement that the wholesale distribution of certain substances may not take place without a wholesale distribution authorisation for medicinal products. The same applies to wholesale distribution of products in which one or more of the substances are included as a constituent.
Authorised companies shall comply with Commission Implementing Regulation (EU) 2021/1248 on good distribution practice for veterinary medicinal products.
The Danish Medicines Agency allows wholesale distributors of certain substances to import certain substances from third countries for distribution, provided that they have applied for and the activity has been approved on their authorisation.
Retail distribution of certain substances
Under the regulation, it is up to the Member States to lay down rules for retail distribution, i.e. sales to the end users, and in Denmark we have decided not to require authorisation or registration for the marketing of certain substances to end users.
Please note, however, that Section 93(3) of the Danish Medicines Act requires that retail distributors of certain substances only acquire substances from authorised wholesale distributors in Denmark.
Possession and use of certain substances
It does not require a registration or authorisation to possess certain substances, but they must have been purchased by a distributor in Denmark, cf. Section 93(5) of the Danish Medicines Act. Therefore, imports of certain substances by an end user are not permitted.
It is prohibited to use certain substances or products in which certain substances are included, and which are not authorised medicinal products, on or in animals, see section 93(4). It is also prohibited to possess certain substances etc. if the purpose of possession is intended for use on or in animals.
The prohibition does not apply if the substances are administered or used on animals covered by and in accordance with the law on animal testing. That is, if there is an authorisation for the use of the substances in an approved animal experiment.
The previous registration system
The registration system for veterinary medicinal substances was repealed by amending the Medicines Act and entry into force of the Veterinary Regulation (Regulation (EU) 2019/6) on 28 January 2022. The previous executive order on certain substances (in Danish only) ceased at the same time and the handling of certain substances is instead covered by Chapter VII of the Veterinary Regulation.