Legal status of supply

The legal status of supply of a veterinary medicinal product is determined with its marketing authorisation and decided individually for each product.

Prescription-only veterinary medicinal products

Veterinary medicinal products that may present a risk even when used as recommended, may only be supplied to consumers if prescribed by a veterinarian.

Risks may concern the animal treated or other animals, the person administering the product or the environment. They may relate to the active substance or the excipients of the veterinary medicinal product or to its route of administration. Prescription-only veterinary medicinal products may only be dispensed in pharmacies and veterinary dispensaries.

Classification of a product as prescription-only is carried out by the competent authority in accordance with Article 34 of Regulation (EU) 2019/6.

The following veterinary medicinal products shall always be classified as subject to veterinary prescription in accordance with Article 34(1) of Regulation (EU) 2019/6:

veterinary medicinal products which contain narcotic drugs, psychotropic substances or substances frequently used in the illicit manufacture of those drugs or substances;
antimicrobial veterinary medicinal products;
veterinary medicinal products used for euthanasia of animals;
veterinary medicinal products containing active substances having a hormonal or thyrostatic action or beta-agonists.

In addition, the following veterinary medicinal products are subject to veterinary prescription in accordance with Article 34(1) of Regulation (EU) 2019/6:

veterinary medicinal products for food-producing animals;
veterinary medicinal products intended for treatments of pathological processes which require a precise prior diagnosis or the use of which may have effects which impede or interfere with subsequent diagnostic or therapeutic measures;
veterinary medicinal products containing an active substance that has been authorised for less than five years in the Union;
immunological veterinary medicinal products.

However, these veterinary medicinal products may be classified as not subject to veterinary prescription if all of the following conditions of Article 34(3) of Regulation (EU) 2019/6 are fulfilled:

the administration of the veterinary medicinal product is restricted to pharmaceutical forms requiring no particular knowledge or skill in using the products;
the veterinary medicinal product does not present a direct or indirect risk to the treated animal or animals, to other animals, to the person administering it or to the environment, even if administered incorrectly;
the summary of the product characteristics of the veterinary medicinal product does not contain any warnings of potential serious adverse events deriving from its correct use;
neither the veterinary medicinal product nor any other product containing the same active substance has previously been the subject of frequent adverse event reporting;
the summary of the product characteristics does not refer to contra-indications related to the use of the product concerned in combination with other veterinary medicinal products commonly used without prescription;
there is no risk to public health as regards residues in food obtained from treated animals, even where the veterinary medicinal product is used incorrectly;
there is no risk to public or animal health as regards the development of resistance to substances, even where the veterinary medicinal product containing those substances is used incorrectly.

In addition, if the summary of product characteristics of a veterinary medicinal product contains special precautions which, in the view of the competent authority, necessitate a veterinary prescription, this may justify the classification of the veterinary medicinal product as prescription-only in accordance with Article 34(2) of Regulation (EU) 2019/6.

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Pharmacy-only and veterinary medicinal products for general sale

Veterinary medicinal products are categorised as pharmacy-only or products for general sale according to § 40 of the Veterinary Medicinal Products Act (Tierarzneimittelgesetz, TAMG).

Pharmacy-only veterinary medicinal products may only be dispensed in pharmacies and veterinary dispensaries. Further details are regulated by the Act on Pharmaceutical Services (Apothekengesetz, ApoG) and the Veterinary In-House Dispensaries Ordinance (Verordnung über tierärztliche Hausapotheken, TÄHAV). Prescription-only veterinary medicinal products are always categorised as pharmacy-only.

Veterinary medicinal products for general sale may also be sold outside a pharmacy or veterinary dispensary, for example in a drugstore or feed store. Veterinary medicinal products that do not require a marketing authorisation or registration or that are exempt from the obligation to obtain a marketing authorisation in accordance with § 4 TAMG may always be made available on general sale.