A prerequisite for sale and use of a veterinary medicinal product is its marketability. A veterinary medicinal product is marketable if:

• it is authorised or registered,

  or

• it is exempt from marketing authorisation.

Responsibility for supervision of marketability lies with the respective German federal state (Laender) authorities.

The legal basis for granting a marketing authorisation is defined in Art. 5 of Regulation (EU) 2019/6), the legal basis for the registration of homeopathic veterinary medicinal products is defined in Arts. 86 and 87 thereof.

Under certain conditions, veterinary medicinal products for certain pets may be exempt from the obligation to obtain a marketing authorization upon application in accordance with Section 4 of the Veterinary Medicinal Products Act (TAMG).

According to Art. 23 of Regulation (EU) 2019/6, it is possible to obtain a marketing authorisation for a veterinary medicinal product for limited markets and, according to Art. 25 of the respective regulation, also in exceptional circumstances. The respective validity of these types of marketing authorisations is repeatedly re-examined in accordance with Arts. 24 and 27 of Regulation (EU) 2019/6.

The marketing authorisation or registration of a veterinary medicinal product may, in accordance with Art. 130 of Regulation (EU) 2019/6, be:

• revoked

  or

• suspended.

In case of a revocation marketability of the veterinary medicinal product shall cease irrevocably on the date of the decision, whereas in case of a suspension, marketability shall cease temporarily until the decision suspending the marketing authorisation is lifted.

The marketability of a veterinary medicinal product also ends after notification of withdrawal of the marketing authorisation by the marketing authorisation holder pursuant to Section 9(5) of the Veterinary Medicinal Products Act (TAMG), in conjunction with Art. 58 (6) and (13) of Regulation (EU) 2019/6.

The exemption of veterinary medicinal products can also be revoked in accordance with Section 6 of the Veterinary Medicinal Products Act (TAMG), in this case the marketability automatically ends, too.

Irrespective of the provisions on marketability with regard to with marketing authorisation or registration, according to Section 38 of the Veterinary Medicinal Products Act an individual veterinary medicinal product ceases to be marketable if

• the shelf life has expired
• it is not insignificantly reduced in quality (deviation from recognized pharmaceutical rules

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