Interactive form for application related to covering expenditures for expert activities conducted upon request and administrative fees

version valid from 15.10.2013

Select one from sections:

 

Covering expenditures


(payment to bank account 10030-623101/0710)

 

Covering expenditures

 

(payment to bank account 35-623101/0710)

 

Administration fees

 

(payment to bank account 3711-623101/0710)

 

Annual maintenance fee

Code Category Subcategory or specification Refund (Kč)  
U-001 Annual maintenance fee Conduct of expert activities in respect of the duration of marketing authorisation of a medicinal product with the exception of cases specified under codes U-002, U-003, U-004 and U-005 19500,-
U-002 Annual maintenance fee Conduct of expert activities in respect of the duration of marketing authorisation of a medicinal product where the Czech Republic is the Reference State 39100,-
U-003 Annual maintenance fee Conduct of expert activities in respect of the duration of marketing authorisation of a homeopathic product 3000,-
U-004 Annual maintenance fee Conduct of expert activities in respect of the duration of marketing authorisation of a medicinal product where the marketing authorisation holder is a micro-company 5000,-
U-005 Annual maintenance fee Conduct of expert activities in respect of the duration of marketing authorisation of a medicinal product where the marketing authorisation holder is a small company and homeopathic products are not involved 9500,-

Fields marked by (R) are required

Medicinal product

(R)

(R)

Yes     No   (R)

Marketing authorisation holder

(R)

(R)

(R)

(R)

(R)

(R)

Has any person responsible for the annual maintentnace fee administration been established?: (R)
Yes      No

Contact/authorised person for communication with SÚKL on behalf of the applicant

(R)

(R)

Is the mailing address for proofs of payment identical to the MAH's address?: (R)
Yes      No

(R)

(R)

(R)

(R)

(R)

(R)

(R)


Once you click "Submit" the filled-in data will be entered in the database and a new page - "Proof of payment of costs reimbursement for expert activities performed upon request" will display automatically. This page contains necessary data related to your application and shows the "Variable symbol" to be used when making your payment.

The annual maintenance fees are to be paid without any submission of an application and the payment confirmation form shall not be sent to SÚKL. Having verified the accuracy of the payment, SÚKL shall send the proof of payment of the annual maintence fee to the address designated by the payee.