Prior notice of clinical veterinary drug research
- Permit or other obligation
- Nationwide
- Public service
Clinical research on veterinary drugs refers to research carried out on the target species to determine the safety, efficacy, absorption, distribution, metabolism, excretion or residues of veterinary drugs. The purpose of the veterinary research shall be veterinary justifiable and include sufficient knowledge of the drug.
Under section 88a of the Medicines Act, prior notice of clinical trials wi ...
Do the following
Prior notice is made using the form available on Fimea's website.
The notice shall be accompanied by an accompanying letter listing the documents to be attached to the notice.
The information and documents required for the prior notice are specified in Fimea's regulation "clinical trials on veterinary drugs".
To whom and on what terms
For whom?
Private researchers, research groups, universities and other similar actors carrying out research.
Deadline
Prior to starting the research
Processing time
60 days without time for any additional clarifications
Period of validity
Until the end of the study of possible interruption of the study.