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 marketing authorisation of medicinal products, particularly for expert activities associated with applications for new marketing authorisations and type II variations to marketing authorisation, becomes effective.  

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