Payments for variations submitted before the effective date of the reimbursement decree (effective as of 15 October 2013)

The State Institute for Drug Control hereby informs of the rules of reimbursement of costs of marketing authorisation variations applied for before the effective date of the amended 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 (the “reimbursement decree”), i.e. until 14 October 2013.      

Payments for applications to vary national marketing authorisations submitted as of 4 August 2013

For applications submitted until 14 October 2013 (inclusive), the costs to be reimbursed for variations to national marketing authorisations shall be charged in the amounts stipulated in the reimbursement decree effective before the amendment.

In the case of an application for grouped variations relevant to nationally authorised medicinal products filed as of 4 August 2013, the reimbursement of costs will be charged in full for each variation and each marketing authorisation number stated in the application.

 

Example:  An application for type IB grouping for two national marketing authorisation numbers includes the following variations:

Type IA – A.7 –Deletion of manufacturing sites for an active substance

Type IB – B.I.a.2e –Minor change to the restricted part of an Active Substance Master File

Type IB – B.III.2a1 – Change of specification(s) of a former non EU Pharmacopoeial substance to fully comply with the Ph. Eur. or with a national pharmacopoeia of a Member State

 

In the online form for payment of reimbursement of costs the user in the above example may enter the cost reimbursement codes (this applies only to national marketing authorisation variations):

For type IA variations - code R-008 – number of variations: 1, number of additional medicinal products included in the application: 1

For type IB variations - code R-040 – number of variations: 2, number of additional medicinal products included in the application: 1

 

Each application filed is subject to one administrative fee.

 

The total amount to be paid for the type IB grouping described in the example would be the following:

Costs to be reimbursed – CZK 36,200

Administrative fee – CZK 2,000

 

Payment of reimbursement of costs for variations to MRP/DCP marketing authorisations

For applications submitted before 14 October 2013, the reimbursement of costs associated with variations to DCP/MRP marketing authorisations, including grouped variations, shall be charged in the amounts and under the terms stipulated in the reimbursement decree effective before the amendment.