The reimbursement of costs for provision of scientific advice is stipulated by regulation No. 427/2008 Coll., on stipulating the amounts of reimbursement of costs of expert activities conducted within the scope of powers of the State Institute for Drug Control and the Institute for the State Control of Veterinary Biologicals, as amended are stated in guideline UST-29 - Administrative fees, reimbursement of costs for expert activities associated with the provision of information and reimbursement of other activities.
The reimbursement of costs is done via an interactive form – Reimbursement of costs / General including advertisement of medicinal products.
Reimbursement of costs is not required:
- for oral advice provided within the scope of running expert activities of the Institute already covered according to guideline UST-29,
- for advice where costs were waived according to guideline UST-24,
- for advice associated to medical devices.
Meetings with representatives of regulated bodies called up by Institute representatives are not considered scientific advice.
Medical device with active substance – in case the advice is related to the active substance which is part of medical device, the advice is reimbursed according to guideline UST-29.