Amendment to the Reimbursement Decree effective as of 1 June 2019

On 1 June 2019, amendment to Decree No 427/2008 Coll., on determination of the amount of costs to be reimbursed for specialised tasks performed by the State Institute for Drug Control and the Institute for State Control of Veterinary Biologicals and Medicines, amending reimbursements of costs in the sphere of clinical trials.    

Payment of reimbursement of costs associated with applications submitted until 31 May 2019

For applications submitted until 31 May 2019 (incl.), the amounts of reimbursement of costs set forth by Decree No 427/2008 Coll., on determination of the amount of costs to be reimbursed for specialised tasks performed by the State Institute for Drug Control and the Institute for State Control of Veterinary Biologicals and Medicines (hereinafter referred to as the Reimbursement Decree”) before the aforementioned amendment shall be applicable.

 

Payment of reimbursement of costs associated with applications submitted from 1 June 2019

For applications submitted from 1 June 2019 (incl.), the new amounts of reimbursement of costs set forth by the amendment to the Reimbursement Decree shall apply.

 

Reimbursement of costs associated with applications for clinical trials submitted from 1 June 2019:


CLINICAL TRIALS, THERAPEUTIC PROGRAMMES, DISTINCTIONS BETWEEN PHARMACEUTICALS AND OTHER PRODUCTS

Code

Category

Subcategory or specification

Original rate

New rate

K-001

Approval of a clinical trial on a medicinal product

• application for an approval of a clinical trial on a medicinal product

 

 

Notices: The same amount of cost reimbursement applies also if an earlier approved/notified trial has not commenced within 12 months and major changes have been made to the original documentation.

67 300 CZK

98 100 CZK

K-002

Approval of a clinical trial on a medicinal product

• notification of a clinical trial on an authorised medicinal product (30 days)

15 800 CZK

20 700 CZK

Notices: The same amount of cost reimbursement applies also if an earlier approved/notified trial has not commenced within 12 months and major changes have been made to the original documentation.

K-003

Approval of a clinical trial on a medicinal product

other notifications of clinical trials on medicinal products (60 days)

33 900 CZK

45 000 CZK

Notices: The same amount of cost reimbursement applies also if an earlier approved/notified trial has not commenced within 12 months and major changes have been made to the original documentation.

K-004

Sponsor's notification of a Substantial Amendment to the protocol, Investigator´s Brochure, IMPD (Investigational Medicinal Product Dossier). Notices: Substantial Amendment to the Protocol requiring assessment due to a major change to the Protocol, new safety information to the Investigator´s Brochure or changes to the IMPD (Investigational Medicinal Product Dossier), which is likely to affect the safety of trial subjects or to alter the scientific hypothesis of the concerned clinical trial or if the change is significant for another reason.

The costs shall be reimbursed in this amount also if the previously authorised/notified study has not commenced within 12 months and minor changes to the originally submitted documentation are made.

15 800 CZK

20 500 CZK

K-007

Approval of a hospital exemption

 

90 000 CZK

90 000 CZK

K-008

Variation to a hospital exemption – changes to the manufacturing process, quality of the starting material

 

20 000 CZK

20 000 CZK

K-009

Variation to a hospital exemption – adding of a new facility that would administer the medicinal product subject to the hospital exemption, or increase of the maximum number of patients

 

2 500 CZK

2 500 CZK

K-010

Issuing of a Good Clinical Practice Certificate to an individual (eg. Investigator, monitor)

 

-

21 600 CZK

K-011

Issuing asubsequent  certificate of Good Clinical Practice to an individual

 

-

10 800 CZK


Clinical Trials of Medicinal Products Department    

27th May 2019