Marketability and legal status of supply
Marketability
It is the prerequisite for sale and use of a veterinary medicinal product that it is marketable. A veterinary medicinal product becomes marketable upon granting of a marketing authorisation. An authorised veterinary medicinal product is no longer marketable if the shelf life has expired or if there have been changes in the pharmaceutical quality that may entail a risk in the use of a veterinary medicinal product or if the marketing authorisation is suspended. A veterinary medicinal product is no longer marketable in case the marketing authorisation is revoked. You can find further information on marketability here.
Withdrawal of marketing authorisation
A marketing authorisation holder can revoke a marketing authorisation by means of withdrawal. You can find further information on the withdrawal of a marketing authorisation here.
Legal status of supply
The legal status of supply regulates the way a (veterinary) medicinal product can be acquired by the patient or, in the case of animals, by the patient's owner. A distinction is made between prescription-only, pharmacy-only and veterinary medicinal products available on general sale. Narcotic drugs face additional restrictions in accordance with the German Narcotic Drugs Act ("Betäubungsmittelgesetz", BtMG). The legal status of a veterinary medicinal product is determined with its marketing authorisation and decided individually for each product. You can find more information on the legal status of supply here.
Find out more
- European marketing authorisation procedures
- National authorisation
- Veterinary medicinal products for food-producing animals
- Assessment of applications for marketing authorisation
- Validity of marketing authorisations and re-examination of marketing authorisations for limited markets and in exceptional circumstances
- Marketability and legal status of supply
- Variation of marketing authorisation, registration, exemption
- SPC harmonisation
- Parallel trade
- Registration
- Co-distribution of veterinary medicinal products
- Examination of registration documents