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,- |
|
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
To evaluate the claim for part of the costs to be waived, the applicant shall submit the documentation stipulated in parts a)-g) related to the last accounting period pursuant to Decree No 427/2008 Coll. together with the application to carry out expert activity.
The Documents in points a) b) and c) are not required, when those have been already submitted by the applicant in the same year as part of a different application for expert activity.
a) data on average headcount
b) data on annual turnover of the applicant
c) applicant's balance should the applicant be part of the consolidated body also consolidated balance; the balance possibly consolidated balance have to be verified by an auditor should it be stipulated by any other legal regulation.
d) Applicant's declaration stating that the applicant is not in any business or other relation with any entity, that would not meet the stipulated criteria for inclusion in the category of micro, small and medium enterprise whereas business relation is considered a company where a different company or a group of companies own 25% and over of equity or voting rights, that do not meet the criteria of micro, small or medium enterprise,
e) Applicant's declaration stating that the applicant does not perform any activity related to the required activity based on a contractual or other similar relation for the entity that does not meet the stipulated criteria for inclusion in the category micro, small and medium enterprise,
f) Trade licence, trade permit certificate, a copy of an entry in the Commercial Register, possibly articles of incorporation or status issued by a competent authority of the Czech Republic or other Member State, which cannot date back more than three months at the time of submission, or any other document or licence authorising to carry out a business activity,
g) Applicant's declaration stating that all provided data and documents are up to date, complete and true.
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.