Mandatory payment of annual maintenance fees

SÚKL informs marketing authorisation holders about their obligation to reimburse compensation of costs for SÚKL activities associated with the maintenance of medicinal product marketing authorisations by means of annual maintenance fees.   

The provisions of Section 112, paragraph 2 of Act No 378/2007 Coll., on Pharmaceuticals and on Amendment to Some Related Acts (Act on Pharmaceuticals), as amended (hereinafter referred to as the “Act on Pharmaceuticals”) stipulate the obligation of marketing authorisation (MA) holders to reimburse compensation of costs for the activities performed by the State Institute for Drug Control (hereinafter referred to as “SÚKL”) in association with the maintenance of medicinal product marketing authorisations in the form of annual maintenance fees as follows: by the end of the year the MA holder is obliged to pay the annual maintenance fee for the following calendar year. Should the MA holder fail to comply with the obligation to make such payment by the end of the calendar year, SÚKL will invite the MA holder to make an additional payment within the timeline of 15 days of delivery of the invitation.

The maintenance fee shall not be paid for the calendar year in which the marketing authorisation is granted. Where the MA holder fails to pay the annual maintenance fee within the 15-day additional payment timeline, they shall be obliged to make a payment increased by 50%.

The amount of compensation of costs of expert activities associated with the maintenance of marketing authorisations of medicinal products is set forth by Decree No. 427/2008 Coll., stipulating the amounts of reimbursement of costs of expert  activities conducted within the scope of powers of the State Institute for Drug Control and the Institute for the State Control of Veterinary Biologicals and Medicaments, as amended:

Amount of compensation of costs of expert activities associated with the maintenance of marketing authorisation

Code

Category

Sub-category or specification

Amount of cost reimbursement

U-001

Annual maintenance fee

Performance of expert activities associated with the maintenance of a medicinal product marketing authorisation, except for cases listed under codes U-002, U-003, U-004, and U-005

19,500 CZK

U-002

Annual maintenance fee

Performance of expert activities associated with the maintenance of a medicinal product marketing authorisation where theCzechRepublicis theReferenceMemberState

39,100 CZK

U-003

Annual maintenance fee

Performance of expert activities associated with the maintenance of a marketing authorisation of a homeopathic product

3,000 CZK

U-004

Annual maintenance fee

Performance of expert activities associated with the maintenance of a medicinal product marketing authorisation where the MA holder is a micro-enterprise

5,000 CZK

U-005

Annual maintenance fee

Performance of expert activities associated with the maintenance of a medicinal product marketing authorisation where the MA holder is a small company and it does not involve homeopathic products

9,500 CZK

The annual maintenance fee for the respective year is payable on 1 January of the calendar year.

SÚKL does not collect maintenance fees for centralised marketing authorisations and for the year in which the marketing authorisation has been granted.

The annual maintenance fee is to be paid individually for every single medicinal product which is identified by a marketing authorisation number. For every calendar year, it is necessary to generate a new variable symbol for the respective marketing authorisation number in a web form, on the basis of which the payment will be identified.

The web form for the generation of the variable symbol for the payment of annual maintenance fee is available here.

When completing the form, it is necessary to fill in a correct marketing authorisation number.  The marketing authorisation number allocated by SÚKL has the following structure: AA/BBBB/XX-C or S/C, or, if applicable, A/C and other alphabetical characters. It is very important to enter the marketing authorisation number with a dash and exact sequence of the letters and slash after the dash.

SÚKL bank details for payment transfers of reimbursement of costs of expert activities:

Bank name

Česká národní banka

Bank address

Na Příkopě 28/3181

Praha 1

115 03

CzechRepublic

Account number

35-623101

Bank sort code

0710

IBAN

CZ94 0710 0000 3500 0062 3101

BIC (originally SWIFT)

CNBACZPP

Constant symbol

0308

Variable symbol

generated as described above

 

Should the MA holder fail to pay the annual maintenance fee by the end of the calendar year, the MA holder will be invited by SÚKL to make an additional payment within the timeline of 15 days of the delivery of the invitation. Where the annual maintenance fee is not paid within the 15-day timeline established for the additional payment, the marketing authorisation holder shall be obliged to make the payment increased by 50%.  For the purposes of identification of an overdue payment, the web form contains a tick box “Payment after date”. Once this box is ticked, an amount increased by 50% will be automatically generated.

Where the MA holder fails to pay the annual maintenance fee increased by 50% without unnecessary delay, workout in compliance with relevant legal regulations shall be employed in respect of this amount.

The annual maintenance fee is to be executed without submission of an application, only via the web form. The “Proof of payment covering expenditures for expert activities conducted upon request” form is not to be sent to SÚKL.  Following verification of correctness of the payment, SÚKL shall send the “Confirmation of payment of the annual maintenance fee” to the specified address of the payer.

Marketing Authorisation Branch

2 October 2015