Amendment to the Reimbursement Decree effective as of 1 June 2019
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 and the web form for these applications will be available under the heading “Marketing authorisations” from here.
1) Reimbursement of costs associated with applications for new marketing authorisations submitted from 1 June 2019:
|
Marketing authorisation type |
Marketing authorisation as per article of Directive 2001/83/EC |
Payment code |
Original rate |
New rate |
|
RMS-DCP
|
8(3), 10a, 10b, 16a, 10(4)) |
R-041 |
390 000 |
430 000 |
|
10(1), 10(3), 10c, 14 |
R-042 |
310 000 |
340 000 |
|
|
another strength/pharmaceutical form, line extension |
R-044 |
170 000 |
190 000 |
|
|
Duplicate |
R-045 |
120 000 |
140 000 |
|
|
RMS-MRP |
8(3), 10a, 10b, 16a, 10(4)) |
R-017 |
250 000 |
280 000 |
|
10(1), 10(3), 10c, 14 |
R-018 |
200 000 |
220 000 |
|
|
another strength/pharmaceutical form, line extension |
R-020 |
100 000 |
110 000 |
|
|
Duplicate |
R-021 |
80 000 |
90 000 |
|
|
Repeat-use MRP-RMS |
R-022 |
100 000 |
115 000 |
|
|
CMS (DCP and MRP) |
8(3), 10a, 10b, 16a, 10(4)) |
R-027 |
110 000 |
125 000 |
|
10(1), 10(3), 10c, 14 |
R-028 |
90 000 |
105 000 |
|
|
another strength/pharmaceutical form, line extension |
R-030 |
40 000 |
45 000 |
|
|
Duplicate |
R-031 |
30 000 |
35 000 |
|
|
National |
8(3), 10a, 10b, 16(1), 16a, 10(4)) |
R-001 |
250 000 |
280 000 |
|
10(1), 10(3), 10c, 14 |
R-002 |
200 000 |
230 000 |
|
|
another strength/pharmaceutical form, line extension |
R-004 |
100 000 |
110 000 |
|
|
Duplicate |
R-003 |
70 000 |
80 000 |
2) Reimbursement of costs associated with applications for type II variations to marketing authorisation submitted pursuant to Commission Regulation (EC) No 1234/2008, as amended by Commission Regulation (EU) No 712/2012 as of 1 June 2019:
|
Variation type |
Payment code |
Original rate |
New rate |
|
|
RMS |
II |
R-023 |
100 000 |
115 000 |
|
II; containing a bioequivalence/comparability study |
R-051 |
120 000 |
140 000 |
|
|
CMS |
II |
R-032 |
50 000 |
55 000 |
|
II; containing a bioequivalence/comparability study |
R-052 |
70 000 |
80 000 |
|
|
National |
II |
R-007 |
70 000 |
80 000 |
|
II; containing a bioequivalence/comparability study |
R-049 |
90 000 |
100 000 |
|
Methodology of calculation of the reimbursement of costs associated with applications for variation to marketing authorisation
Together with the specified amounts of reimbursement of costs, the same methodology of calculation of the total amount of reimbursement of costs associated with applications for variation to marketing authorisation containing several marketing authorisation numbers and/or several variations, particularly for grouping and work-sharing variations, shall apply to the RMS, CMS as well as national variations to marketing authorisations:
Individual amounts of reimbursement of costs associated with each variation to marketing authorisation submitted as part of a single application shall be added up in the full amount for the first marketing authorisation number, while for any other marketing authorisation numbers within the scope of the concerned application, a 50% discount of the total amount of reimbursement of costs calculated for the submitted variations to marketing authorisation for the first marketing authorisation number shall apply. The calculation formula is as follows:
Amount of reimbursement of costs (in CZK) = (IA*mIA) + (IB*mIB) + (II*mII) + (n-1)*0.5*((IA*mIA) + (IB*mIB) + (II*mII))
where:
IA, IB, II = amount of reimbursement of costs of the respective type IA, IB or II variation to marketing authorisation
mIA, mIB, mII= number of variations to marketing authorisation of individual types (IA, IB or II) for the first marketing authorisation number within the application
(n-1) = number of other marketing authorisation numbers within a single application.
The web form for the payment of reimbursement of costs associated with variations to marketing authorisation has been modified and it is necessary to always enter all of the variations for the first marketing authorisation number for each application and, below, the number of other marketing authorisation numbers within a single application. Thereafter, the total amount of reimbursement of costs will be automatically calculated for the entire application on the basis of the entered data. For this reason, for each application for variations to marketing authorisation, only one form for the total amount of reimbursement of costs will be always generated.
For example, in case of a type IB grouping for two national marketing authorisation numbers, the following variations will be specified:
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 (ASMF)
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 this case, the following entries are to be made in the web form for payment of reimbursement of costs:
For type IA variations – code R-008 (6 000 CZK) – number of variations: 1
For type IB variations – code R-040 (15 000 CZK) – number of variations: 2
Number of other medicinal products included in the application: 1
Amount of reimbursement of costs (in CZK) = (6 000*1) + (15 000*2) + 1*0.5*((6 000*1) + (15 000*2))
For each submitted application, one administrative fee shall be paid.
In total, the following must be paid for the aforementioned type IB grouping:
Reimbursement of costs – 54 000 CZK
Administrative fee – 2 000 CZK
In case of work-sharing procedures, where the reference authority is the European Medicines Agency (EMA) or the concerned authority of another Member State, i.e. the Czech Republic is not the reference authority, the amounts of reimbursement of costs as those for CMS variations to marketing authorisations shall be applied together with the aforementioned methodology for calculating the total amount of reimbursement of costs for the entire application.
In case of work-sharing procedures, where the reference authority is the Czech Republic, amounts of reimbursement of costs as those for RMS variations to marketing authorisation shall apply together with the aforementioned methodology for calculating the total amount of reimbursement of costs for the entire application.
Applications for variation to labelling or patient information leaflet unrelated to the summary of the product characteristics
An application for variation to labelling or patient information leaflet unrelated to the summary of the product characteristics (national, RMS as well as CMS), to which the change procedure does not apply (medicinal products cannot be grouped within a single application), shall be considered the same category as type IA variations, i.e. R-008, R-025, and R-034.
3) Reimbursement of costs of applications for taking over the role of RMS, foreign-language batches, and applications for sunset clause exception submitted from 1 June 2019:
In respect of applications for taking over the role of RMS (change from CMS to RMS), a reimbursement of costs in the amount of 100 000 CZK shall be paid, under code R-048, for the entire procedure, rather than for each strength/pharmaceutical form of the medicinal product.
In respect of applications for permission to place foreign-language batch of a medicinal product onto the market (in compliance with Section 3, paragraph 6(b) of the Marketing Authorisation Decree), newly, a reimbursement of costs in the amount of 4 500 CZK, under code R-012, shall be paid (for each individual medicinal product) instead of the original 3 900 CZK.
In respect of applications for sunset clause exception, newly, a reimbursement of costs in the amount of 5 400 CZK, under code R-053, shall be paid for each individual medicinal product.
Marketing Authorisation Branch
22. 5. 2019