Clinical trials on veterinary medicinal products

A clinical trial of a veterinary medicinal product refers to a study of the effect of a veterinary medicinal product on a target animal species with the objective of assessing the safety, efficacy, absorption, distribution, metabolism, excretion and residues of the product in the target species. Clinical trials of veterinary medicinal products must be justifiable in terms of veterinary medicine, and sufficient pharmacological, toxicological and pharmaceutical/immunological information must be available on the product.

Notification

Pursuant to section 88a of the Medicines Act the Finnish Medicines Agency (Fimea) must be provided with advance notification of any clinical trials of veterinary medicinal products. In unclear cases, Fimea must be consulted beforehand as to whether or not an advance notification is required.

The sponsor of the trial or its representative must submit the advance notification (pdf) to Fimea at least 60 days prior to the planned commencement of the trial. The advance notification must be made electronically using the form provided for this purpose by Fimea and sent by e-mail to [email protected].  The notification must be accompanied by a covering letter listing the appended documents. Before preparing the advance notification, it is advisable to carefully study Fimea Regulation 3/2010 Clinical trials of medicinal products for veterinary use (pdf). This provides more detailed instructions on the documents to be appended to the advance notification.
Information on food-producing animals as test animals is provided in the Circular of the Ministry of Agriculture and Forestry 175/73/2001 (pdf, in Finnish).

Handling fee

The Ministry of Social Affairs and Health has confirmed the handling fee payable for notifications of clinical trials of veterinary medicinal products (Decree of the Ministry of Social Affairs and Health concerning activities of the Finnish Medicines Agency subject to fees, pdf).
Following the change in Fimea's invoicing process on 1 Oct 2015, advance payment for clinical trial applications will no longer be required. Instead, invoicing will be based on applications received. For more info, please contact [email protected].

A waiver of processing fee may be requested in respect of a notification relating to a clinical trial on a medicinal product conducted by an individual investigator, a trial team, a university institute, a university hospital clinic or the National Institute for Health and Welfare without outside financing or with financing by a non-profit corporation. In these cases, the notification concerning a trial must be accompanied by an informal statement to the effect that the investigation will not receive any outside financing. Medicinal products received free of charge for the purpose of the investigation are not deemed outside financing.