Specific rules for medicines
Applying for authorisation for a medicine study
The purpose of clinical studies involving the investigation of a new medicine may be to discover or verify clinical and pharmacological effects, to identify any side-effects and/or to study its absorption, distribution, metabolism and excretion. If your planned medicine study is a therapy study, then authorisation from the Medical Products Agency is always required. If your planned study is an observation study without any experimental features, then only approval from the Etichal Review Authority is required.
For guidance whether your planned study requires authorisation, you can use the Medical Products Agency’s test .
The European database for clinical medicine studies, EudraCT, constitutes a register of all medicine studies carried out within the EU, and each study is identified by means of a unique number, an “EudraCT number”. This number is downloaded via EudraCT’s website and is the first step in an application to the Medical Products Agency. Once the EudraCT number has been downloaded, an electronic application form can be created at the Medical Products Agency. The application to the Medical Products Agency shall be supplemented with appendices, among them a study protocol, product information and a list of studies in progress with the same substance and safety evaluation. The Medical Products Agency’s website has a step by step guide to the application.
If the Ethical Review Authority has reached a decision on the study in question, the decision shall accompany the application. If not, the sponsor shall make sure the decision is sent to the Medical Products Agency as soon as possible. The decision must have been received by the Medical Products Agency no later than 15 days after the sponsor has received the decision.