Amendment to the reimbursement decree – payments for marketing authorisation variations

On 15 October 2013, the 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 (the “reimbursement decree”),  has come into effect.  

Payment of reimbursement of costs associated with applications submitted until 14 October 2013

Applications filed until 14 October 2013 (inclusive) are subject to the rules governing the payment and amount of reimbursement of costs set forth in the reimbursement decree effective before the amendment.

The rules for payment of reimbursement of costs associated with applications to vary marketing authorisations filed in accordance with Commission Regulation (EC) No. 1234/2008 as amended by Commission Regulation (EU) No. 712/2012 until 14 October 2013 are provided on our website – http://www.sukl.eu/medicines/payments-for-variations-submitted-before-the-effective-date.

 

Payment of reimbursement of costs associated with applications submitted as of 15 October 2013

Applications submitted as of 15 October 2013 (inclusive) are subject to the new rules governing the payment and amount of costs reimbursement; the online form for these applications is available here –  http://www.sukl.eu/modules/payment2/?id_oblasti=2&token=.

 

Payment of reimbursement of costs associated with RMS, CMS and national variations to marketing authorisations applied for as of 15 October 2013

For applications for marketing authorisation variation filed according to the Commission Regulation (EC) No. 1234/2008 as amended by Commission Regulation (EU) No. 712/2012 as of 15 October 2013, the amounts of costs to be reimbursed shall be amended as follows:

 

 Type of variation  

Original rates

New rates

RMS

IA

12 800

12 000

IB

13 900

25 000

II

100 000

100 000

CMS

IA

4 700

4 000

IB

4 700

10 000

II

50 000

50 000

National

IA

4 700

6 000

IB

6 700

15 000

II

70 000

70 000

 

In addition to the above rates, a new method has been introduced to calculate the total amount of costs to be reimbursed for RMS, CMS and national marketing authorisation variations containing several marketing authorisation numbers and/or several variations, i.e. mainly for grouping and worksharing:

 

Individual amounts of costs to be reimbursed for each marketing authorisation variation applied for in an application shall be summed in the full amount for the first marketing authorisation number, while every other marketing authorisation number included in the given application is subject to a 50% discount on the total amount of costs reimbursement calculated for the first marketing authorisation number submitted in the given application. The calculation formula is the following:

 

Amount of costs to be reimbursed (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 associated with the respective type IA, IB or II marketing authorisation variation

mIA, mIB, mII= number of marketing authorisation variations of the given type (IA, IB or  II) for the first marketing authorisation number in the application

(n-1) = number of additional marketing authorisation numbers within one application.

 

In the online form for the payment of costs to be reimbursed for applications for marketing authorisation variations filed as of 15 October 2013, the user must always enter all variations for the first marketing authorisation number and then the number of additional marketing authorisation numbers in the given application. Then the total amount of costs to be reimbursed is calculated according to the submitted data for the entire application. Therefore, there is always only one form generated for the total amount of costs to be reimbursed.

 

Example:  An application for type IB grouped variation 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 this case, the following data will be entered in the online costs reimbursement form:

For type IA variations - code R-008 (CZK 6 000) – number of variations: 1

For type IB variations - code R-040 (CZK 15 000) – number of variations: 2

Number of additional medicinal products included in the application: 1

 

Amount of costs to be reimbursed (in CZK) = (6 000*1) + (15 000*2) + 1*0,5*((6 000*1) + (15 000*2))

 

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:

 

Reimbursement of costs – CZK 54 000

Administrative fee – CZK 2 000

 

Worksharing procedures, where the European Medicines Agency (EMA) or a competent authority of another Member State is the reference authority, i.e. where the Czech Republic is not the reference authority, are subject to the same amounts of costs to be reimbursed as CMS marketing authorisation variations applying the above formula for calculation of the total amount of costs to be reimbursed for the entire application.

 

Worksharing procedures, where the Czech Republic is the reference authority, are subject to the same amounts of costs to be reimbursed as RMS marketing authorisation variations applying the above formula for calculation of the total amount of costs to be reimbursed for the entire application.

 

Applications for variation to the package information or package information leaflet unrelated to the summary of product characteristics

Applications for variation to the package information or package information leaflet unrelated to the summary of product characteristics (national, RMS and CMS) submitted as of 15.10.2013 are not subject to the Commission Regulation (EU) No 712/2012 and have been transferred to the same category as IA type variations, i.e. R-008, R-025 and R-034.