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)

 

General

Code Category Subcategory or specification Reimbursement (CZK)  
O-001 One-hour oral consultation or issuance of a written opinion concerning regulation upon request in a scope corresponding to a one-hour consultation (not related to a pending application) E.g. a position on the use of pure alcohol per one product 5000,-
Hours:
O-002 One-hour oral consultation or issuance of a written opinion upon request in a scope corresponding to a one-hour consultation, addressing an issue relevant to the activities conducted by SUKL in the sphere of pharmaceuticals E.g. a distinction to determine whether a clinical trial is concerned, a hospital exemption, opinion on possible confusion of the name of a medicinal product requested outside the scope of a marketing authorisation procedure (the most 3 different names for a single product at one time), opinion on proposed advertising of a human medicinal product disseminated by channels other than radio and television broadcasting and preliminary assessment of the advertising materials. 5800,-
Hours:
O-003 One-hour oral expert consultation or issuance of a written opinion upon request in a scope corresponding to a one-hour consultation (not related to a pending application), an assessment of the structure and content of the risk management plan (RMP) E.g. an assessment of the design of the proposed clinical study, hospital exemption, preclinical testing, analytical method, statistical analysis, expert assessment of proposed texts (SmPC, PIL). 20200,-
Hours:
O-004 Preparation and delivery of an expert lecture upon request Dissemination of education (in the sphere of pharmaceuticals) at professionals' workshops and lectures. 2000,-
Kč/per hour

Hours:
O-006 Application for processing of database system outputs generated based on the notifications filed by distributors and operators authorised to dispense medicinal products Processing of specific outputs on distributed and dispensed medicinal products extracted from the respective databases applying expert viewpoints according to the required criteria and above the scope of usually and regularly published data 900,-
Kč/per hour

Hours:

Fields marked by (R) are required

 

(R)

Applicant

(R)

(R)

(R)

(R)

(R)

(R)

The applicant is pursuant to Section 5 of the Decree No 427/2008 Coll. considered as medium, small or micro enterprise: (R)
(When selecting YES, the applicant shall submit the required documentation.)
Yes      No

Is established contact/authorised person for communication with SÚKL on behalf of the applicant?: (R)
Yes      No

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

(R)

(R)

Is the address same as applicant 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.

Please print out this document and enclose it to your documentation on submission to SUKL. Where a request for opinion or consultation in a general area is concerned (O-001, O-002 or O-003), please send the proof attn. the person or department handling your request.