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)

 

Marketing authorisation

Code Category Subcategory or specification Reimbursement (CZK)  
R-001 National application for a marketing authorisation of a medicinal product • stand alone application as referred to under Art. 8(3) of Directive 2001/83/EC
• well-established use application as referred to under Art. 10a of Directive 2001/83/EC
• fixed combination application as referred to under Art. 10b of Directive 2001/83/EC
• homeopathic product as referred to under Art. 16(1) of Directive 2001/83/EC
• traditional-use registration for herbal product as referred to under Art. 16a of Directive 2001/83/EC
• similar biological application as referred to by Art. 10(4) of Directive 2001/83/EC
280000,-
R-002 National application for a marketing authorisation of a medicinal product • generic application as referred to under Art. 10(1) of Directive 2001/83/EC
• hybrid application as referred to under Art. 10(3) of Directive 2001/83/EC
• informed consent application as referred to under Art. 10c of Directive 2001/83/EC
• homeopathic product registered via simplified procedure as referred to under Art. 14 of Directive 2001/83/EC
230000,-
R-003 National application for a marketing authorisation of a medicinal product • marketing authorisation of an identical product under another name (duplicate) 80000,-
R-004 National application for a marketing authorisation of a medicinal product • another strength or pharmaceutical form
• line extension
110000,-
R-007 National type II variation to a marketing authorisation 80000,-
Number of variations:
R-008 National type IA variation to a marketing authorisation, national change to the labelling or package leaflet unrelated to the summary of product characteristics and variation of a parallely imported medicinal product 6000,-
Number of variations:
R-009 National application for renewal of a marketing authorisation of a medicinal product • for each medicinal product except for homeopathic products registered via simplified procedure 150000,-
R-010 National application for renewal of a marketing authorisation of a medicinal product • for a homeopathic product registered via simplified procedure 35000,-
R-011 Application for transfer of a marketing authorisation of a medicinal product • for a medicinal product authorised via national procedure, MRP, DCP (with the Czech Republic as the RMS or CMS) 20000,-
R-012 Application for permission to place foreign-language batch of a medicinal product onto the market 4500,-
R-013 Application of a notified body for the issuance of an opinion regarding a pharmaceutical which forms an integral part of a medical device 70000,-
R-015 Application for withdrawal of a marketing authorisation • for a medicinal product authorised via national procedure, MRP, DCP (with the Czech Republic as the RMS or CMS) with required gradual recall 6100,-
R-017 MRP-RMS: Application for initiation of the mutual recognition procedure with the Czech Republic acting as the RMS
Notices: This type of application shall be submitted after the national marketing authorisation of the medicinal product concerned is completed (see R-001 to R-004)
• stand alone application as referred to under Art. 8(3) of Directive 2001/83/EC
• well-established use application as referred to under Art. 10a of Directive 2001/83/EC
• fixed combination application as referred to under Art. 10b of Directive 2001/83/EC
• traditional-use registration for herbal product as referred to under Art. 16a of Directive 2001/83/EC
• similar biological application as referred to under Art. 10(4) of Directive 2001/83/EC
280000,-
R-017a MRP-RMS: Application for initiation of the mutual recognition procedure with the Czech Republic acting as the RMS in case the application for marketing authorisation of a medicinal product, in respect of which the initiation of the MRP-RMS procedure has been applied for, was submitted to SÚKL prior to June 5 2003 • stand alone application as referred to under Art. 8(3) of Directive 2001/83/EC
• well-established use application as referred to under Art. 10a of Directive 2001/83/EC
• fixed combination application as referred to under Art. 10b of Directive 2001/83/EC
• traditional-use registration for herbal product as referred to under Art. 16a of Directive 2001/83/EC
• similar biological application as referred to under Art. 10(4) of Directive 2001/83/EC
380000,-
R-018 MRP-RMS: Application for initiation of the mutual recognition procedure with the Czech Republic acting as the RMS
Notices: This type of application shall be submitted after the national marketing authorisation of the medicinal product concerned is completed (see R-001 to R-004)
• generic application as referred to under Art. 10(1) of Directive 2001/83/EC
• hybrid application as referred to under Art. 10(3) of Directive 2001/83/EC
• informed consent application as referred to under Art. 10c of Directive 2001/83/EC
• homeopathic product registered via simplified procedure as referred to under Art. 14 of Directive 2001/83/EC
220000,-
R-018a MRP-RMS: Application for initiation of the mutual recognition procedure with the Czech Republic acting as the RMS in case the application for marketing authorisation of a medicinal product, in respect of which the initiation of the MRP-RMS procedure has been applied for, was submitted to SÚKL prior to June 5 2003 • generic application as referred to under Art. 10(1) of Directive 2001/83/EC
• hybrid application as referred to under Art. 10(3) of Directive 2001/83/EC
• informed consent application as referred to under Art. 10c of Directive 2001/83/EC
• homeopathic product registered via simplified procedure as referred to under Art. 14 of Directive 2001/83/EC
320000,-
R-020 MRP-RMS: Application for initiation of the mutual recognition procedure with the Czech Republic acting as the RMS
Notices: This type of application shall be submitted after the national marketing authorisation of the medicinal product concerned is completed (see R-001 to R-004)
• another strength or pharmaceutical form
• line extension
110000,-
R-021 MRP-RMS: Application for initiation of the mutual recognition procedure with the Czech Republic acting as the RMS
Notices: This type of application shall be submitted after the national marketing authorisation of the medicinal product concerned is completed (see R-001 to R-004)
• marketing authorisation for an identical medicinal product with a different name (duplicate) 90000,-
R-022 RUP-RMS: Application for initiation of a repeat-use mutual recognition procedure with the Czech Republic acting as the RMS • for a medicinal product of any legal basis 115000,-
R-023 MRP-RMS type II variation to a marketing authorisation 115000,-
Number of variations:
R-024 MRP-RMS type IB variation to a marketing authorisation 25000,-
Number of variations:
R-025 MRP-RMS type IA variation to a marketing authorisation and MRP-RMS change to the labelling or package leaflet unrelated to the summary of product characteristics 12000,-
Number of variations:
R-026 MRP-RMS application for renewal of a marketing authorisation of a medicinal product 200000,-
R-027 DCP/MRP-CMS application for a marketing authorisation of a medicinal product • stand alone application as referred to under Art. 8(3) of Directive 2001/83/EC
• well-established use application as referred to under Art. 10a of Directive 2001/83/EC
• fixed combination application as referred to under Art. 10b of Directive 2001/83/EC
• traditional-use registration for herbal product as referred to under Art. 16a of Directive 2001/83/EC
• similar biological application as referred to under Art. 10(4) of Directive 2001/83/EC
125000,-
R-028 DCP/MRP-CMS application for a marketing authorisation of a medicinal product • generic application as referred to under Art. 10(1) of Directive 2001/83/EC
• hybrid application as referred to under Art. 10(3) of Directive 2001/83/EC
• informed consent application as referred to under Art. 10c of Directive 2001/83/EC
• homeopathic product registered via simplified procedure as referred to under Art. 14 of Directive 2001/83/EC
105000,-
R-030 DCP/MRP-CMS application for a marketing authorisation of a medicinal product • another strength or pharmaceutical form
• line extension
45000,-
R-031 DCP/MRP-CMS application for a marketing authorisation of a medicinal product • marketing authorisation for an identical medicinal product with a different name (duplicate) 35000,-
R-032 MRP-CMS type II variation to a marketing authorisation 55000,-
Number of variations:
R-033 MRP-CMS type IB variation to a marketing authorisation 10000,-
Number of variations:
R-034 MRP-CMS type IA variation to a marketing authorisation and MRP-CMS change to the labelling or package leaflet unrelated to the summary of product characteristics 4000,-
Number of variations:
R-035 MRP-CMS application for renewal of a marketing authorisation of a medicinal product 80000,-
R-036 Application for authorisation of parallel import of a medicinal product • authorisation valid for one state of origin from which the product is to be imported 60000,-
R-037 Application for authorisation of parallel import of a medicinal product • authorisation for any other strength of the same medicinal product from the same state of origin 25000,-
R-038 Application for authorisation of parallel import of a medicinal product • authorisation valid for one state of origin from which the product is to be imported involving more complicated assessment of therapeutic comparability (e.g. a bio-equivalence study or independent stability study) 80000,-
R-039 Application for renewal of the authorisation of parallel import of a medicinal product 30000,-
R-040 National type IB variation to a marketing authorisation 15000,-
Number of variations:
R-041 DCP-RMS application for a marketing authorisation of a medicinal product • stand alone application as referred to under Art. 8(3) of Directive 2001/83/EC
• well-established use application as referred to under Art. 10a of Directive 2001/83/EC
• fixed combination application as referred to under Art. 10b of Directive 2001/83/EC
• traditional-use registration for herbal product as referred to under Art. 16a of Directive 2001/83/EC
• similar biological application as referred to under Art. 10(4) of Directive 2001/83/EC.
430000,-
R-042 DCP-RMS application for a marketing authorisation of a medicinal product • generic application as referred to under Art. 10(1) of Directive 2001/83/EC
• hybrid application as referred to under Art. 10(3) of Directive 2001/83/EC
• informed consent application as referred to under Art. 10c of Directive 2001/83/EC
• homeopathic product registered via simplified procedure as referred to under Art. 14 of Directive 2001/83/EC
340000,-
R-044 DCP-RMS application for a marketing authorisation of a medicinal product • another strength or pharmaceutical form
• line extension
190000,-
R-045 DCP-RMS application for a marketing authorisation of a medicinal product • marketing authorisation for an identical medicinal product with a different name (duplicate) 140000,-
R-048 Application for RMS (change from CMS to RMS) per procedure 100000,-
R-049 National type II variation to a marketing authorisation in module 3 including a new a bio-equivalence study or comparability study for biological products 100000,-
Number of variations:
R-050 Subsequent application of a notified body for the issuance of an opinion regarding a pharmaceutical which forms an integral part of a medical device, for which an opinion has already been issued previously (variation) • change that could affect the quality, safety or beneficial effect of an active substance in a medical device, such as the change of the active substance manufacturer, change to the manufacturing of the active substance, change to the sterilization method, extension of the shelf life 15000,-
R-051 MRP-RMS type II variation to a marketing authorisation in module 3 including a new a bio-equivalence study or comparability study for biological products 140000,-
Number of variations:
R-052 MRP-CMS type II variation to a marketing authorisation in module 3 including a new a bio-equivalence study or comparability study for biological products 80000,-
Number of variations:
R-053 Application for sunset clause exemption • for a medicinal product authorised via national procedure, MRP, DCP (with the Czech Republic as the RMS or CMS) 5400,-

Fields marked by (R) are required

 

(R)

Medicinal product

(R)

(R)

(R)

(R)

(R)

(R)

(R) (please, fill in a date like dd.mm.rrrr fe.: 20.05.2010)

Dossier in electronic format: (R)
Yes     No

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.