Reimbursement of costs for advice provision
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.
How to process when applying for an advice
Applicant for advice provision (hereinafter applicant) contacts the expert – consultant, or assistant (or section) of relevant department by email or by phone.
Department contacts:
- Borderline products
- Marketing authorisation of pharmaceuticals
- Clinical trials
- Specific therapeutic programmes and non-authorised MP
- Pharmaceuticals supply, sale and preparation
- Pharmacovigilance
- Distribution of pharmaceuticals
- Surveillance over the manufacture of pharmaceuticals
- Human tissues and cells
- Surveillance in the area of advertising
- Laboratory activities and pharmacopeia
- Medical devices
- Medical device containing active substance
1/ When first contacting, the applicant sends preliminary application for advice provision containing specific questions or topics of the advise, expected time scope, proposed date/dates of the consultation, contact person with telephone number and email.
2/ The applicant is contacted by the consultant or department assistant.
3/ The applicant sends official application for advice provision to the email of the assistant of the relevant department or section. The application must contain:
- Specific questions (possibly required documentation)
- Approved time scope of the meeting
- Approved date of the advise
- Number and names of attendees
- Contact person, telephone and email
- Business name of the company
- Address of the company
- Identification number
- Variable symbol (in case of reimbursed advice)
4/ Further, the applicant proceeds according to the instructions of the consultant or of the assistant.
Information concerning the payment of reimbursed costs and variable symbol will be provided to the applicant by department assistant.
It is possible to make the payment before or after the advice provision.
- In case of payment before the advice provision the applicant is given a receipt for reimbursement of costs for scientific advice.
- In case of payment after the advice provision the receipt is sent to the applicant by post after the payment is effected.
Course of the advice
The Institute provides either oral or written scientific advice.
In case of oral consultation the applicant is bound to take minutes. These minutes are sent within 5 days to the consultant. The consultant reviews the minutes and sends the final version to the applicant within 5 days as of delivery of payment receipt.
The minutes are understood as a discussed planning conception. The deadlines for minutes elaboration might be agreed otherwise.
In case the consultant does not receive the minutes draft within the set deadline, he/she briefly summarizes the information provided to the applicant and the case is concluded as an advice without SUKL opinion.
July 2nd, 2010
cz