Medicated feed for animals and fish
Medicated feed is a mixture of large quantities of animal feed and a veterinary premix (medicinal product containing one or more active substances).
The Danish Medicines Agency authorises activities with medicated feed according to section 39 of the Danish Medicines Act.
Any company importing, exporting, manufacturing, storing, selling or dispensing medicated feed must obtain authorisation from the Danish Medicines Agency according to section 39(1) of the Danish Medicines Act. The Danish Medicines Agency only grants authorisation to manufacturers of medicated feed (feed mills) when they have the required authorisation from the Danish Veterinary and Food Administration.
Whenever medicated feed travels across borders in the EU/EEA, an accompanying certificate must exist for each consignment. It is the regulatory authority of the exporting country that issues the accompanying certificate.
The marketing authorisation referred to in section 7 of the Danish Medicines Act is not required for medicated feed, see section 11 of the Danish Medicines Act.
Rules and legislation
The rules governing activities with medicated feed for animals and fish stem from Council Directive of 26 March 1990 laying down the conditions governing the preparation, placing on the market and use of medicated feedingstuffs in the Community (90/167/EEC).
In Denmark, the rules governing medicated feed for animal and fish are implemented by the Danish Medicines Act and established in the below Danish executive orders, all of which are in Danish only:
The manufacture of medicated feed should follow the rules on good manufacturing practice. Detailed guidelines on good manufacturing practice for medicinal products are published by the European Commission in ”The rules governing medicinal products in the European Union”, Volume 4.
The distribution of medicated feed should follow the GDP rules, see the Danish executive order on distribution of medicinal products.
Application form for authorisation to manufacture medicated feed (feed mills) Application is done on the same form which is used to apply for authorisation to manufacture and import medicines and intermediates (GMP). A manufacturer of medicated feed needs no other special authorisation to distribute its own manufactured medicated feed.
Application form for authorisation to wholesale distribute medicated feed, including storing, dispensing, importing from another EU/EEA country and exporting to another EU/EEA. Application is done on the same form which is used for to apply for authorisation of wholesale distribution of medicinal products within the EU/EEA (GDP).
Companies authorised to manufacture and wholesale distribute medicated feed
See the list of companies holding an authorisation pursuant to section 39 of the Danish Medicines Act to manufacture and/or wholesale distribute medicated feed. The list is updated daily.