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The marketing of veterinary drugs

The marketing of veterinary medicinal products is subject to the release of the relevant authorisation by the competent authority. In Italy the application should be submitted to the Ministry of Health that takes care of the release of authorisations of veterinary drugs to be used for the therapeutic treatment of animals, both for pets and for those intended for food production for human consumption.

In the latter case, the assessment of the benefit/risk profile is particularly important. In fact, the essential goal is to ensure that the marketed medicines have quality, proven clinical efficacy and safety for both animals, operators and the environment. The marketing authorisation can be released via different procedures.

This can be either a national procedures, if the MA holder is interested to the sale of the medicinal product in one single European country; or a mutual recognition and decentralised procedure to market the veterinary drug in more European countries.

If, on the other hand, the business interests include the all European Union, then a centralised authorisation procedure can be followed. In any case, a preliminary registration is required to be able to market veterinary drugs.

To this purpose, the concerned company (that will be the future MA holder of the medicine) shall submit a request of authorisation to the competent authority, enclosing the application form, payment of the due fees, and the dossier of the veterinary product.

The dossier of a veterinary medicinal

The dossier of a veterinary medicinal product is quite substantial, and is made of 4 parts. Part 1 includes all administrative information, the product information, and the expert reports; part 2 refers to quality and is constituted by the pharmaceutical technical documentation referring to the drug quality features.

Part 3 is divided into 2 parts, part 3A and 3B, and regards the assessment of safety and residues. The last part, part 4 includes the documentation on non clinical and clinical characteristics of the veterinary drugs suitable to demonstrate its efficacy.

There are, however, special cases when it is possible to proceed to the application without submitting the full dossier as described above. For instance, a generic or bibliographic dossier can be submitted, or even a dossier of duplicate product.

Wholesale and retail trade activities of veterinary drugs shall also be carried out according to the regulations, and for this an explanatory memorandum on veterinary drugs trade can also be published, including indications for the concerned companies.

Registering a veterinary medicinal product appears to be no easy task, and requires deep competence; therefore, the assistance of qualified technicians that can assist the company in the preparation of the dossier as well as in the contacts with the Ministry of Health until the release of the marketing authorisation is therefore necessary.

Written by: Federica Montozzi

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