Remuneration For Professional Acts Of Power. In The State. Institute For Drug Control

Original Language Title: úhrady za odborné úkony vykon. ve Stát. ústavu pro kontrolu léčiv

Read the untranslated law here: https://portal.gov.cz/app/zakony/download?idBiblio=67573&nr=427~2F2008~20Sb.&ft=txt

427/2008 Sb.



DECREE



of 10 June 1999. December 2008



to determine the amount of reimbursement for professional activities pursued within the scope of

The State Institute for drug control, and the Institute for State control

Veterinary Biologicals and medicaments



Change: 160/2009 Sb.



Change: 327/Sb.



The Ministry of health and Ministry of agriculture lays down pursuant to §

paragraph 114. 2 and for the implementation of § 112 para. 2, paragraph 1. 4 (b). (c)) and paragraph 2. 7

Act No. 378/2007 Coll., on pharmaceuticals and on amendments to some related

laws (law on medicinal products):



§ 1



Definition of the technical operations that are performed by the State Institute for

drug control (hereinafter referred to as "the Institute"), pursuant to section 112 of the law on pharmaceuticals, and above

reimbursement for their implementation are set out in annex 1 to this

the Decree. The definition of professional acts that are carried out by the Institute for

State control of veterinary Biologicals and medicaments (hereinafter referred to as

"The animal health Institute") under section 112 of the law on pharmaceuticals, and the amount of refunds

expenses for their implementation are set out in annex 2 of this order.



Reduction or waiver of reimbursement of expenditure in the field of medicinal products for human use

products



§ 2



(1) in the case of professional acts, for which you can waive the reimbursement of expenses

or part thereof pursuant to § 112 para. 3 (b). (b)) of the law on pharmaceuticals, and that the

Professional acts done in relation to the assessment of the application for

the registration of the medicinal product, change requests, renewal or transfer

registration, applications for the authorisation of the parallel imports of the medicinal product

or to amend or extend the validity of the parallel import authorisation

requests for permission or changing the hospital exemption, an application for authorisation,

modification or extension of the authorization to manufacture or distribution, application for

enable and change activity control laboratories, the application for authorisation and

change production in the facilities services, transfusion application for registration

provider of medicinal products, the data change request

held in the register of providers of medicinal products and applications for

issue of the certificate or opinion, technical operations in

the context of the assessment of applications for authorisation or the Declaration of the clinical

reviews and subsequent changes, support acts of

consultation and issue an opinion on requests relating to medicinal

orphan medicinal products or medicinal products intended to

used exclusively for persons under 18 years of age, and the applicant requests a waiver

reimbursement of expenses or part thereof shall be submitted together with the application the following

documentation:



and proof of the determination of) a medicinal product as medicinal

of orphan ^ 1)



(b)) a declaration that the professional Act applies to the medicinal product intended for

used exclusively for persons under 18 years of age, or



(c)) document proving the cost reduction from the resources of the public

health insurance with the fact that this document shall be accompanied by, in particular, for

Generics ^ 2).



(2) in the case of professional acts



and in the context of) conducted assessments of the application for authorisation or

the announcement of the clinical trial of the medicinal product and notification of the contracting authority

about additions to the Protocol, in cases where the sponsor of the clinical

the evaluation is high school or State through its organizational

folders, and on which the participating manufacturers of medicinal products or

them commercially linked, and reviews used to compile data for the

the registration procedure,



(b)) to be carried out in the context of the assessment of the request for an opinion to the

conditions of use of the medicinal product, its manner of distribution, supply and

monitoring and evaluation of its quality, safety and efficiency in the

under the specific treatment program, when the submitter is high

the school or the State through its organizational folder



(c)) consisting in consultations and opinions on the cases referred to in

(a)), or (b)) and an applicant requests a waiver of the refund of expenditure or

parts thereof shall be submitted together with the application documentation that proves the

compliance with the conditions referred to in subparagraph (a)), or (b)).



(3) in the case of professional acts, for which you can waive the reimbursement of expenses

or part thereof pursuant to § 112 para. 3 (b). (b)) of the law on pharmaceuticals, on

whose implementation is in the public interest, or may have a particularly significant

implications for a wider range of people and are not listed in paragraph 1 or 2,

in particular, in the case of professional acts carried out in connection with extraordinary

measures when the epidemic intelligence or at the risk of their creation ^ 3) or

humanitarian aid or in the context of the unavailability of the medicinal

preparation for treatment, prophylaxis and prevention or the health diagnosis

seriously threatening the health of humans, and an applicant requests a waiver of the refund

the expenditure shall be presented together with the application, the grounds for the request, from which the

be evident, based on what the facts claimed for remission of refund

expenses or part thereof.



(4) a reduction or waiver of refund pursuant to paragraphs 1 to 3 shall be carried out in

accordance with the directly applicable European Union law ^ 4).



§ 3



In the case of professional acts



and) undertaken at the request, and that the assessment of applications for clinical trials

the assessment of the medicinal products, report of the clinical trial of medicinal

products and their subsequent changes, the authorization and manufacturing authorization changes

relating to the manufacture of investigational medicinal products or medicinal ^ 5)

orphan medicinal products,



(b)) to be carried out on the basis of the request, the applicant meets the requirements for

inclusion in the category of micro, small or medium-sized enterprise in accordance with § 5

paragraph. 2 and does not carry out the activities, related to the requested action, the

the basis of a contractual or other similar relationship for a body which

does not fulfil the criteria of micro, small or medium-sized businesses, and



(c) where the applicant requests a) remission of part of the reimbursement of expenses in accordance with section

paragraph 112. 3 (b). (b)) of the law on pharmaceuticals with submission of documentation referred to in §

5 (3). 3,



the applicant shall pay the reimbursement of expenses in accordance with a directly applicable regulation

The European Union ^ 6) up to 50% of the refund fixed tariff for the

the professional Act referred to in annex 1 of this order; to determine the

the specific amount of compensation within this range is based on the calculation

the formula referred to in annex 3.



§ 4



Reduction or waiver of reimbursement of expenditure in the field of veterinary medicinal

products



(1) in the case of professional acts carried out by the Veterinary Institute under section

paragraph 112. 3 (b). (b) section 3 of the Act) on pharmaceuticals, on the application for

a clinical trial authorisation of veterinary medicinal products and their

subsequent changes, the application for marketing authorisation of the medicinal product, the changes

registration, renewal, for authorisation of parallel imports and

issue of the certificate or opinion, the reimbursement of expenditure provided for in annex No. 2

This order is for a request to be reduced by 75%, if this is about

the request, which covers only minority species or use in

minor indications, as defined by the guidelines of the European Commission,

The European Medicines Agency and the Veterinary Institute.



(2) applications referred to in paragraph 1, the applicant shall submit documentation that you

shows that the requirements for the classification of animal species between

minor animal species, or for detailed rationale for the inclusion of terms and conditions

use between a minor indication in accordance with the instructions of the European Commission,

The European Medicines Agency ^ 7) and the Veterinary Institute.



(3) in the case of professional acts carried out in the context of the assessment of

the application for authorisation of a clinical trial of veterinary medicinal

products and their subsequent changes, when the sponsor of the clinical

the evaluation is high school or State through its organizational

folders, and on which the participating manufacturers of medicinal products or

them commercially linked, and reviews used to compile data for the

the registration proceedings for compensation for expenses or part thereof shall be waived. In such a

If the applicant submits documentation that demonstrates compliance with those

the conditions, which must be clear, based on what the facts are

requests for a waiver of the refund of expenses or part thereof.



(4) in the case of professional acts pursuant to § 112 para. 3 (b). (b)) of the

Pharmaceuticals, on whose implementation is in the public interest, in the case of the professional acts

carried out in connection with the measures, in particular, on the occurrence of animal diseases

or zoonoses or within the framework of measures aimed at increasing the availability of

veterinary medicinal products for minor animal species or

use in minority and sought indications, waiver of refunds

the expenditure shall be presented together with the application, the grounds for the request.



(5) the reduction or remission of refund pursuant to paragraphs 1 to 4 shall be carried out

by directly applicable regulation unieí ^ 4).



(6) in the case of professional acts carried out at the request of, and assessment

applications for clinical trials of veterinary medicinal products and their

subsequent amendments, and the applicant meets the requirements for inclusion in the category

micro, small or medium enterprise pursuant to § 5 para. 2 and does not

the activities, related to the Act, on the basis of a contractual or

other similar relationship for a body which does not fulfil the criteria of micro,


small or medium-sized enterprise, and required the remission of part of the refund

expenditure in accordance with § 112 para. 3 (b). (b) section 4 of the Act) on pharmaceuticals, then

the applicant shall pay the reimbursement of expenses in accordance with a directly applicable regulation

The European Union ^ 6) up to 50% of the refund fixed tariff for the

the professional Act referred to in annex 2 of this order by

calculation formula referred to in annex 3.



(7) in the case of changes to the marketing authorisations relating to detailed description

pharmacovigilance system or risk management system, which has introduced

the marketing authorisation holder, reimbursement of expenses, provides it.



(8) If this is the case of grouping changes, the reimbursement of expenses for the

type IA variations decrease so that



and when) the request involves one change for multiple registration

numbers, be paid in reimbursement of expenditure for the first registration number in full,

for all remaining registration numbers, the applicant may request a 50%

the reduction of the refund of expenditure,



(b)) in the case of groups of identical changes for multiple registration numbers for

the first amendment from the Group of identical changes to the IA shall be borne by the reimbursement of the full

amount for all remaining changes from the groups of identical changes can

the applicant apply for a 50% reduction of compensation for expenses.



Common provisions



§ 5



(1) the amount of reimbursement for professional acts carried out by the Institute or

The Veterinary Institute at the request of the competent authorities of the Member States

The European Union, the European Commission or the European Medicines Agency in

individual cases on the basis of contractual arrangements of this

with the competent authority by the Institute; the starting point for such a contractual clause is

tariff item of Annex No. 1 code O-005, in the case of acts carried out by

The Institute, or tariff item of Annex No. 2 code E-01, in the case of acts

carried out by the Veterinary Institute.



(2) For micro, small and medium-sized enterprise, for the purposes of this Ordinance shall be deemed to

an undertaking which meets the criteria in terms of other legislation ^ 6)

^ 8).



(3) for the purpose of examining the application for remission of part of the reimbursement of expenses for the

Professional acts pursuant to § 3 and § 4, paragraph 4. 6 the applicant shall submit, together with the

requests for documentation demonstrating the last accounting period



and an average post-) information on the number of their employees,



(b) data on the annual turnover) of the applicant,



(c)) the financial statements the applicant and if the applicant is part of the

the consolidated body, whether the consolidated financial statements; If so

provided by other legislation, must be financial statements, where applicable,

the consolidated financial statements verified by an auditor,



(d)) that the Declaration by the applicant is not in any business or other relationship

or link with any other entity that does not meet the criteria laid down

for inclusion into the category of micro, small or medium-sized businesses, while

as being linked to the undertaking in which shall be deemed to own 25% or more

of the share capital or voting rights of another enterprise, or jointly

several enterprises, falling outside the criteria of a micro, small or medium

the enterprise,



(e) a declaration by the applicant that) does not carry out activities related to the

requested of the Act, on the basis of a contractual or other similar relationship

for a body which does not fulfil the criteria for inclusion in the

the category of micro, small or medium-sized enterprise,



(f)), the concession instrument business license, certificate of incorporation,

button is clicked. founding Charter or statute issued by the competent authority of the United

Republic or another Member State, which must not be at the time of

earlier more than 3 months, or other evidence of the business and



(g)) the Declaration by the applicant that all the reported data and presented

documents are up-to-date, complete and correct.



(4) the Documents referred to in paragraph 3 (b). a), (b)), and (c)) is not required in the

the cases, which have already been presented by the applicant in the same year to other

applications submitted to the competent institution. Institute of animal health or Department of

According to its competence shall examine the documentation provided, and in the case that

the applicant fulfilled the criteria referred to in section 3, in the case of medicinal products for human use

or pursuant to § 4 paragraph 2. 6 in the case of veterinary medicinal products

preparations will pay the applicant the reimbursement of a fixed tariff for the

the professional Act referred to in annex 1 of this order, if the

medicinal products, or of annex 2 of this order, if the

veterinary medicinal products.



(5) for the purpose of considering an application for a reduction or waiver of reimbursement of expenditure

for professional acts related to the request for an assessment of the clinical trial

the applicant shall submit a written declaration that the clinical trial is

are not participating manufacturers of medicinal products or of the person with them commercially

linked and reviews do not serve to collect data for registration

control. At the same time, the applicant shall provide a procedure to ensure the rated

medicinal products within the framework of the clinical trial.



§ 6



(1) the amount of the refund of expenses for professional acts carried out by the Institute or

The animal health Institute, which are not listed in Schedule 1 or 2 of this

a decree or a requested method is not provided, shall be adopted in accordance with

the formula set out in annex 3 of this order.



(2) in the case of overlapping of individual provisions, on the basis of which it can be

waive the whole or part of the reimbursement of expenses shall apply the provisions of

more favourable to the applicant.



(3) in cases where the specific laboratory tests

supplies must be used, which does not have a Department or veterinary

the Institute available by default, is the cost of shipping supplies

the amount of the expenses which the applicant will pay. Similarly, the applicant is added

the amount of the expenditure as well as the price for laboratory analyses, which Institute or

The animal health Institute, where necessary, concludes the supplying laboratories. In such

cases prior to the examination, the applicant shall be informed and consulted is

his consent.



§ 7



The effectiveness of the



This Decree shall take effect on the date of 15. December 2008.



Minister of health:



Mudr. Julínek, MBA in r.



Minister of agriculture:



Mgr. Gandalovič in r.



Annex 1

A. Tariff of reimbursement for professional activities pursued within the scope of the Institute



---------------------------------------------------- --------------------------------------------------------

GENERAL

---------------------------------------------------- --------------------------------------------------------

Code of a category or Subcategory of the acts carried out by the expert clarification of the amount of the refund

---------------------------------------------------- --------------------------------------------------------

U-001 annual maintenance payment Perform professional acts 19 500 Eur

related to the duration of the

the registration of the medicinal product

with the exception of the cases referred to in

codes-002,-003, U-004 and in-

005



U-002 annual maintenance payment Perform professional acts 39 100 Eur

related to the duration of the

the registration of the medicinal product

in the case of the Czech Republic

is the reference state



U-003 annual maintenance payment to Perform professional tasks 3 000 CZK

related to the duration of the

the registration of homeopathic remedies



U-004 annual maintenance payment to Perform specialized operations 5 000 CZK

related to the duration of the

the registration of the medicinal product

in the event that the holder of the

registration is a micro enterprise



U-005 annual maintenance payment to Perform specialized operations 9 500 Czk

related to the duration of the

the registration of the medicinal product

in the event that the holder of the

registration is a small busi

This is not about homeopathics



About-001 Provide hourly oral consultations 3 100 Czk

or the issue of a written opinion in the

regulatory area at the request of the scope

the corresponding hourly oral consultation

(unrelated to the already submitted

applications).



About-002 Provide hourly oral consultation E.g.. the resolution, whether it is 3 600 Czk

or issue a written expert clinical evaluation, hospital

opinions requested by the scope of the exception, the use of

the corresponding hourly oral consultation to pure alcohol on one product,

the question related to the activity of the opinion on the interchangeability of

The Institute for the area of pharmaceuticals. the name of the medicinal product

pull out the registration

control of not more than 3 different

names to one of

at the same time, the opinion on the draft

ads on the medicinal product for

product distributed outside

radio and television broadcasting

and the preliminary assessment of the advertising

material.




O-003 Provide hourly oral science E.g.. assessment of the design of the 12 500 Czk

consultation or release of the written proposed clinical studies,

expert opinion on the application range of preklinického testing

the corresponding hourly oral consultation, analytical methods, statistical

(unrelated to the already submitted to analysis, evaluation of the proposed

applications). texts (SPC, PIL) of vocational

point of view.



O-004 preparation and provision of lectures Spread enlightenment (the drugs) to 2 000 CZK/hour.

at the request of a person who is an entrepreneur specialized seminars and

lectures



O-005 Professional acts performed on the request of professional úkonův hour $ 100/hour.

foreign companies rate.



About-006 on the processing of the application-specific processing outputs outputs 1 000 CZK/hour.

of database systems generated about distributed and issued by

on the basis of the reports of the competent medicinal products distributors

and operators of authorized databases using expert perspectives

to supply medicinal products according to the required criteria and beyond

customarily and regularly published data.

---------------------------------------------------- --------------------------------------------------------

REGISTRATION

---------------------------------------------------- --------------------------------------------------------

Code of a category or Subcategory of the acts carried out by the expert clarification of the amount of the refund

---------------------------------------------------- --------------------------------------------------------



R-001 a request for a marketing authorisation for a medicinal product the separate registration of 250 000 CZK

supported by full

experimental or

literary figures (with the exception of

separate registration referred

under code R-002), fixed

the combination of the

* registration of homeopathics

* registering traditional herbal preparation

* registration podobnéhobiologického of the product.

R-002 * registration of generic and 200 000 CZK

registration with the agreement of another

the holder and a separate literary

registration of solutions of electrolytes

ATC group B05BB01, if

It's not about complex cases

* hybrid registration, i.e..

the registration of generic data

beyond the essential similarity

* registration of homeopathics

simplified procedure



R-003 * registration completely identical 70 000 CZK

the product under a different name

(duplicate)



R-004 * additional strength or pharmaceutical 100 000 CZK

a form of



R-007 registration change request type II 70 000 CZK



R-049 request for type II variation 90 000 CZK

in module 3, which includes a new

bioequivalence study



R-008 registration change request type I and 6 000 CZK

request a change to the labelling

or package leaflet,

is not related to the summary of the product characteristics,

request for change in parallel imported

of the medicinal product



R-040 registration change request type and (B) 15 000 CZK



R-009 application for renewal of all medicinal products to 150 000 €

the registration of the medicinal product. In addition to the homeopath



R-010 * homeopathics 35 000 CZK

R-011 transfer request authorisation of 20 000 CZK

of the product.



R-012 application for authorisation of the placing of a batch of a medicinal 3 900 Czk

product with foreign markings on the

packaging.



R-013 the request of an authorized person for the issue of 70 000 CZK

opinions on the medicine, which is an integral

part of the medical device.



R-050, a subsequent application of an authorized person, a change that could affect the 15 000 CZK

to issue an opinion to the medicine, the quality, safety or usefulness

that is an integral part of the active substances in the health

medical resource for the resource, for example. change manufacturer

that has already been issued the opinion of the active substance, change, production of medicinal

previously (change) of the substance, to change the way of sterilization,

extension of the shelf life



R-014, the request to cancel the registration, without further requirements 0



R-015 * with the requirement of gradual 6 100 Czk

doprodeje



R-017 MRP-RMS the request for initiation of the separate registration of 250 000 CZK

the mutual, supported by a full 350 USD *

recognition of registration with the CZECH experimental or

as a literary reference data (with the exception of

Member State)-separate registraceuvedené

This request is under code R-018), fixed

presented after their combination

the national procedure

the authorization of the

of the medicinal product

(see R-R-001 to 004).



R-018 R-017-R-018: the registration of generic, 200 000 CZK

In the event that the application for registration, with the agreement of another 300 000 Kč *

the marketing authorisation holder and samostatnáliterární

for which application is made for registration of solutions of electrolytes

opening of the ATC group B05BB01 (if

mutual recognition is not about complex cases)

registration with the Czech Republic as

the reference member

the State was

submitted to the Institute before the

5.6.2003 (when it was

the amendment of the law

No. 79/1997 Coll., on

Pharmaceuticals established

the obligation to respect

instructions issued by the

The European Commission and

The European Agency

for the evaluation of medicinal products

preparations),

the amount of ~ 50%

with regard to the need

verification of compliance with

the requirements of all

the relevant instructions

in the submitted

the documentation.

* hybrid registration, i.e..

the registration of generic data

beyond the essential similarity

* registration of traditional

the herbal preparation

* registration of homeopathics



R-020 additional strength or pharmaceutical 100 000 CZK

a form of



R-021 * registration completely identical 80 000 CZK

the product under a different name

(duplicate)



R-022 request for the application of this type of solution to 100 000 Eur

repeated procedure involves how the decision on the

the mutual recognition of the relevant amendment or

registration with the Czech Republic as the renewal and

reference to the Member to ensure procedures of mutual

by the State. recognition for the given request.



R-023 application for amendment of an application of this type of solution to 100 000 Eur

Type II includes both the decision to

in the framework of the relevant amendment or

mutual recognition with the CR renewal, as well as

as the reference procedures of mutual assurance

the Member State concerned. recognition for the given request.



R-051 application for type II variation applications Solutions of this type 120 000 CZK

in module 3, which is a new decision includes both a opříslušné

bioequivalence study in the framework of the amendment or renewal of the authorisation,

mutual recognition with the Czech as well as ensuring the proceduryvzájemného

Republic as the reference member recognition for the given request

by the State



R-024 request for amendment of the application of this type of solution, 25 000 CZK

registration type IB includes both the decision to

in the framework of the relevant amendment or

mutual recognition of the renewal, and

with the Czech Republic as the reference procedures of mutual assurance

the Member State concerned. recognition for the given request.



R-025 change request application Solutions of this type 12 000 CZK

type IA registration includes both the decision to


and the change request, the change or

labelling of renewal, as well as

safety ensure procedures or mutual

the information that the recognition for the given request.

nothing to do with the summary

Summary of product characteristics,

in the context of the procedure

mutual recognition with the Czech Republic

as the reference

the Member State concerned.



R-026 application for an extension of the application of this type of solution, 200 000 CZK

in the context of registration includes both the decision to

the change in procedure or

recognition with the Czech Republic as the renewal and

reference to the Member to ensure procedures of mutual

by the State. recognition for the given request.



¨

R-027 DECENTRALIZED application for recognition of a separate registration supported by 110 000 CZK

PROCEDURE/MRP-decision on the full experimental or

CMS marketing authorization issued by literary figures (with the exception of

for the medicinal product separate registration referred

by the competent authority under the code R-028), fixed

another Member State, combinations

or for recognition of registration of traditional

the decision about the herbal preparation

registration registration of a similar

decentralised biological product

the procedure.

R-028 * registration of generic, 90 000 CZK

registration souhlasemjiného

the holder and a separate literary

registration of solutions of electrolytes

ATC group B05BB01, if

It's not about complex cases

* hybrid registration, i.e..

the registration of generic data

beyond the essential similarity

* registration of homeopathics

simplified procedure



R-030 * additional strength or pharmaceutical 40 000 CZK

a form of



R-031 * registration completely identical 30 000 CZK

the product under a different name

(duplicate)



R-032 request for change of 50 000 CZK

Type II

in the context of the procedure

the mutual recognition of

the decision issued by the

for the medicinal product

the competent authority of

another Member

State.



R-033-$ 4 700 change request

registration type IB

or about the change in designation

on the packaging or

the package leaflet,

that is not related to

a summary of the data in the context

the mutual

recognition of a decision

issued for the medicinal product

preparation by the competent

authority of another

of a Member State.



R-034 change request 4 700 Czk

registration of type IA

in the context of the procedure

the mutual recognition of

the decision issued by the

for the medicinal product

the competent authority of

another Member

State.



R-052 change request type II 70 000 CZK

in module 3, which includes a new

bioequivalence study in the framework of the

the mutual recognition of decisions

issued for the medicinal product

the competent authority of another Member

State



R-033 change request 10 000 CZK

registration type IB

in the context of the procedure

the mutual recognition of

a decision issued to the

medicinal product

the competent authority of

of another Member State.



R-034 change request 4 000 CZK

registration of type IA

and the change request

labelling

or package leaflet,

that is not related to

with the summary

of product characteristics,

in the context of the procedure

the mutual recognition of

the decision issued by the

for the medicinal product

the competent authority of

another Member

State.



R-035 request for extension of 80 000 CZK

registration under the

the mutual

recognition of a decision

issued for the medicinal product

preparation by the competent

authority of another

of a Member State.



R-036 application for authorisation the parallel import authorisation for one State, 60 000 Czk

medicinal product from which the medicinal

the product is being imported

R-037 * authorisation for each additional 25 000 CZK

the strength of the same product from the

the same State of import

R-038 authorisation for one State, 80 000 Czk

from which the medicinal

the product is imported, with

demanding an assessment of the data on the

therapeutic comparability

(e.g., bioequivalence study

or a separate stability

study)



R-039 the request for extension to enable concurrent 30 000 CZK

imports of the medicinal product



R-041 DECENTRALIZOVANY a request for the initiation of the separate registration of 390 000 Eur

Procedure-decentralised-based RMS full

registration process, experimental or

with the Czech Republic as a literary reference data (with the exception of

Member State a separate registration referred

under code R-018), fixed

the combination of the

* registration of traditional

the herbal preparation



R-042 * registration of generic, 310 000 Eur

registration souhlasemjiného

the holder and a separate literary

registration of solutions of electrolytes

ATC group B05BB01 (if

It's not about complex cases) or

hybrid registration, i.e..

the registration of generic data

beyond the essential similarity of the

* hybrid registration, i.e..

the registration of generic data

beyond the essential similarity

* registration of homeopathics

simplified procedure

R-044 * additional strength or pharmaceutical 170 000 CZK

form extensions (registration)

R-045 registration completely identical 120 000 CZK

the product under a different name

(duplicate)



R-046 to take over from another registration 0

the Member State of



R-047 the request for renewal, taken 0

from another Member State



R-048 to take over the task change from a CMS (100 000 CZK

on the RMS)



Calculation formula for the calculation of the total amount of refunds

expenses for registration of changes made under the so-called. grouping

changes and the process of the Division of labour within a single

application:

Individual reimbursement for each variation

submitted in the same application for the first

registration number of paid in full, for each additional registration

number within this request for each change

the registration applies 50% discount from the amount of compensation laid down

expenditure.



The amount of the refund of expenditure (in €) = (IA * mIA) + (IB mIB) +

(II * mII) + (n-1) * 0.5 * ((mIA IA + IB * mIB) +

(II * mII))



where:

IA, IB, II = the amount of reimbursement of expenses for the change

to unregister a type IA, IB, or (II)

MIA, mIB, mII = number of changes to the registration of each

types within a single application and

(n-1) = number of other registration numbers within a single

request.



---------------------------------------------------- --------------------------------------------------------

INSPECTION

---------------------------------------------------- --------------------------------------------------------

Code of a category a subcategory of or refine the amount of the refund

---------------------------------------------------- --------------------------------------------------------



I-001 request for authorisation for the production of pharmaceutical imports from third countries 31 700 Czk

investigational medicinal product/release release only

or a change to enable manufacture of other medicinal

to manufacture with control preparations


In case of change of authorisation for manufacture of manufacture of investigational medicinal

change the required type and the range of products

production including quality control tests, to manufacture medicinal products authorised

to be carried out or the address or vice versa

all the places of production and quality control (sterile and non sterile)



I-002 * non-sterile medicinal 56 200 Czk

products-one pharmaceutical form

and/or one production

Unit/line in jednommístě

the production of primary packaging,

secondary packaging and

layoffs



I-003 * non-sterile medicinal 13 300 Czk

products-increase zakaždou

additional production and different

pharmaceutical form and/or production

Unit/line

cannot be used alone

including the primary packaging,

secondary packaging and

layoffs



I-004 * sterile medicinal products 74 200 Czk

-one pharmaceutical form and/or

one production unit/line

in one place of production

including secondary packaging

and layoffs



I-005 * sterile medicinal products 17 900 Kč

the increase for each additional

different pharmaceutical production plant

and/or a production unit/line

cannot be used alone

including secondary packaging

and layoffs



I-006 * increase 38 600 Czk

the fee in the cases referred to

above, as regards the

biotechnology or

technology-intensive manufacturing

biological preparations

cannot be used alone



I-007 * separately carried out primary 33 100 Czk

packaging of non-sterile products

-one pharmaceutical form and/or

one production unit/line in

one place of production



I-008 * separately carried out 13 900 Czk

the primary packaging of non-sterile

products-increase zakaždou

additional production by a different pharmaceutical

form and/or production unit/line

cannot be used alone

does not apply to item I-001



I-009 * separately carried out 30 600 Czk

secondary packaging in one

place of manufacture

does not apply to item I-001



I-010 change request permission to change the production identification data 9 000 CZK

medicinal products without checking the change, or other qualified person

In the case of manufacturing changes as to the change, or other contractual partner

change the following data: for the production or quality control

* name or names, last names, in the case of a narrowing of the nature and extent of

place of business and identification number, production, or the cancellation of a

If it was allocated, the natural person who performs production refund as

requesting such authorization; If this changes without checking

the authorisation asks the legal person business common remuneration for all changes

the company, where applicable, the name, registered office, address

for the delivery and the identification number,

If it was allocated, the

* name or name, last name,

education and practice of qualified persons,

* name or name, last name,

place of business and identification number,

If it was allocated, of the natural person

on the basis of the Treaty, will take over part of the production

or quality control; for legal persons

commercial name, where appropriate, the name, address,

address for service and the identification

number, if assigned;

in the event of a change of the identification number is

usually necessary to request a new

enable



I-011 application for authorization to distribute medicinal with control of one warehouse 25 300 Czk

or a change to enable the change of the desired type and

to distribute with the control. the distribution range neboadresy

all the sites from which it is

performed distribution



I-012 * for each additional warehouse 13 300 Czk

within a single authorisation



I-013 application for extension to enable it to distribute with the control of one warehouse 25 300 Czk

for the distribution of medicinal substances and

auxiliary substances, gases used

in the provision of health

services or for distribution

of blood, its components and intermediate products



I-014 * for each additional warehouse 13 300 Czk

within a single authorisation



I-015 change request permission to distribute 7 400 Czk

medicinal products without checking * narrowing of the nature and extent of

distribution of nebozrušení

one of the places from which the

performed distribution

* reducing the distribution

space without interfering with their

the layout of the

* change of name, last name, or

place of business of fyzickéosoby,

who is the holder of the authorisation

* change of trade firm,

where appropriate, the name, location, or

address for service of legal

persons

the name change, if applicable

names and surnames of the qualified

persons



I-016 Request for authorisation to the monitoring of the implementation of the subtests 31 400 Czk

the lab or amendment of an authorisation

the activity control laboratories

with scrutiny

In the case of modification of authorisations

laboratory tests are changed

quality control, to be

carried out or the addresses of all places

quality control; in case of cancellation

some of the tests of control allowed

the quality or the cancellation of a

quality control is carried out as a replacement

the changes without checking.

I-017 * testing in a complex 40 000 CZK

range (physico-chemical,

Microbiological testing, biological

one payment for the testing) checking

the manufactured and/or imported

medicinal products and/or investigational

medicinal products



I-018 change request activity permit Review of investigational medicinal products 9 000 CZK

control laboratories without checking for allowed inspection of medicinal products

In the case of changes to the authorisations or vice versa, in the same range.

control laboratories of change of control of imports to production and vice versa

the following data: name, or clarification in the same range:

name, last name, place of business and change of identification data of the applicant

the identification number, if assigned, new/change, or other contractual partner

a natural person who applies for this payment for the quality control of common

the authorisation; If such authorisation is sought for all changes

a legal entity, its business name,

where appropriate, name, address, address for

the delivery and the identification number,

If allocated; in the event of a change

the identification number is usually

necessary to apply for a new licence;

in the case of contractual control of medicinal products in the

third countries which result cannot be accepted

the Inspection Department shall be

as for the application for refund certificate

compliance with the requirements of good manufacturing

practice in carrying out the inspection at the

foreign producer.



I-019 request for authorisation to manufacture blood production blood 40 000 CZK

products and raw materials for further production of products and raw materials for the

transfusion service or device for the production of

change to enable the production of blood

products and raw materials for further production

with scrutiny

In the event of a change of the manufacturing authorization

blood products and raw materials for the


the continued production of the desired change

the type and scale of production, including tests

quality control, to be

carried out or the addresses of all the production sites

and quality control; in the case of narrowing

the type and scale of production or cancellation

a place of manufacture shall be made

as for the changes without refund checks.



I-020 * separate subscriptions blood 27 000 CZK

or its constituents without further

processing and/or production of full

blood for autotransfusions



I-021 * for each additional place of 7 400 Czk

production under a single permit



I-022 request for change of the manufacturing authorization 9 000 CZK

blood products and raw materials for the

another production facility in transfusion

services without checking

In the event of a change of the manufacturing authorization

blood products and raw materials for the

the next production with respect to change the following

data:

* name or name, last name,

place of business and identification number,

If it was allocated, of the natural person

requesting such authorization; If this

the authorisation asks the legal person business

the company, where applicable, the name, registered office, address

for the delivery and the identification number,

If it was allocated, the

* name or name, last name,

education and practice of qualified persons,

* name or name, last name,

place of business and identification number,

If it was allocated, of the natural person

on the basis of the Treaty, will take over part of the production

or quality control; for legal persons

commercial name, where appropriate, the name, address,

address for service and the identification

number, if assigned;

in the event of a change of the identification number is

usually necessary to request a new

the authorisation; in the case of contract manufacturing and

drug control in third countries where

cannot recognize the outcome of another

the authority shall refund such as for an application

for a certificate of compliance with the proper

production practice in carrying out the inspection at the

foreign producer.



I-023 application for issue of a certificate for a certificate 1 700 Czk

compliance with the conditions of good manufacturing practice

in the manufacture of medicinal products, imports from

third countries, the activities of the control

laboratory and good distribution practice

for holders of the relevant authorisations



I-024 request for issue of a certificate for a certificate, Certificate for and 2 200 Czk

compliance with the conditions of good manufacturing practice Pharmaceutical Product in

the schema for a specific medicinal product.



I-025 certificate issuance request on the certificate with the control of one production 38 900 Czk

compliance with the conditions of good manufacturing practice units/lines

in the production of active substances



I-026 * for each additional production 13 300 Czk

Unit/line



I-027 the certificate request for a certificate of partial exams, study for 31 400 Czk

compliance with the conditions of good laboratory use physical, chemical

practice and good clinical practice and the biological test

systems with the exception of

laboratory animals

examination of a clinical 31 400 Czk

place of work, the contracting authority and

laboratories for the purpose of the assessment

compliance with the conditions of the correct

clinical practice



I-028 studies using 38 900 Czk

laboratory animals



I-029 a cancellation request of authorizations 0



I-030 application for a certificate of compliance on the reimbursement of travel and payment by

good manufacturing practice to carry out subsistence expenses may be requested type

visits to the foreign producer to participate in inspection, plus a few applicants

("certificate") in the event that, in the course of one 20% + refund

If the application for a certificate path can be done more inspections of travel and

compliance with the requirements of good manufacturing subsistence expenses

the practice of requiring inspections for

foreign producer submitted in the framework of the

registration procedures for medicinal

the product of the manufacturer, are

dealt with completely, regardless of the

ongoing registration procedure. Request

without adequate proof of registration

compliance with the requirements of good manufacturing

the practice cannot be positively concluded and is

Therefore, irrelevant to present at the same time

or, subsequently, the request type I-030 are

the purpose to verify the conditions of the correct

manufacturing will take place in parallel

with the ongoing registration.



I-031 the certificate request for a certificate, 1 700 Czk

terms and conditions:

* good manufacturing practice in the production of

active substances

* good laboratory practice

without on-site inspections



I-037 application for entry in the registry to 3 300 Czk

providers of medicinal products



I-038 change request data in the register 1 500 Czk

providers of medicinal products



I-039 for issuing a certificate of compliance on the reimbursement of travel 55 000 Kč

requirements of good clinical practice and subsistence expenses can + refund

in carrying out an inspection on the basis of several applicants participate in travel

application for marketing authorisation of a medicinal product in the event that, in the course and accommodation

company/entity of the clinical one path can be made of the expenditure

the evaluation within the DCP more inspections, in case

inspections on the territory of the United

Republic and the participation of inspectors

other Member States, the calculation

the cost of translators



I-040 for issuing a certificate of compliance for each other instead of 30 000 CZK

requirements of good clinical practice inspections in the context of a single request

in carrying out an inspection on the basis of + allowance

application for marketing authorisation of a medicinal product and subsistence expenses

company/entity of the clinical

the evaluation within the DCP



I-041 application for a permit for the manufacture of medicinal products, the application for authorisation of a separate warehouse 25 300 Czk

preparations or for amendment of the authorisation of medicinal products manufacturer

to manufacture with control with control of one warehouse

a separate manufacturing warehouse



I-042 a request for permission to manufacture medicinal products for each additional warehouse 13 300 Czk

products or amendment of an authorisation in a single permit

to manufacture with control

Application for authorisation of a separate warehouse

manufacturer of medicinal products



---------------------------------------------------- --------------------------------------------------------

PHARMACIES, RETAILERS, LABORATORY ANALYSIS, BATCH RELEASE

---------------------------------------------------- --------------------------------------------------------

Code of a category a subcategory of or refine the amount of the refund

---------------------------------------------------- --------------------------------------------------------



L-001 request for issue of the certificate of the certificate 7 400 Czk

compliance with the conditions of practice vendors

dedicated to medicinal products



L-002 request to issue binding opinions in the case of pharmacies or dispensaries 22 100 Eur

the technical and factual equipment medical devices

medical equipment, which will be set up in the new premises

provided by the pharmaceutical care



L-003 * in the case of pharmacies or dispensaries 7 400 Czk

medical devices

in areas that are already

previously enabled pharmacies

the establishment of the separated departments

for the supply of medicinal products

and medical devices

to change the scope of the activities of the Pharmacy

or set up a scientific workplace

associated with changing the disposition

the arrangement of the Pharmacy



L-004 * changing scope of activity 1 500 Czk

pharmacies or dispensaries

medical devices

* change of the technical and

substantive facilities pharmacies

or dispensaries of medical

resources

a formal change to the data in the

binding opinion



L-005 laboratory analysis at the request of Refund in accordance with


the methodology used (part

(B) of this annex)



L-006 the certificate request for a certificate, 22 100 Eur

compliance with the conditions of good laboratory

practice



L-007-examination of the lot of the medicinal product with the presentation of the attestation of 800 Czk

prior to its release on the market of a Member State of the EU



L-008 * $ 800 without proof of clearance + refund

the EU Member State in accordance with the methodology used

(part (B) of this

Annex)



L-009 Release Pharmacopoeia reference substances for one bottle-$ 800

with a certificate at the request of

---------------------------------------------------- --------------------------------------------------------

THE CLINICAL TRIAL, DRUG TREATMENT PROGRAMS, THE DISTINCTION FROM OTHER PRODUCTS

---------------------------------------------------- --------------------------------------------------------

Code of a category a subcategory of or refine the amount of the refund

---------------------------------------------------- --------------------------------------------------------

A-001 clinical trial application for authorisation of medicinal 67 300 Czk

a clinical trial of the medicinal product

of the product

Reimbursement of expenses in this amount is

is true even if the previously

authorised/notified study

not started within 12 months

and experiencing great changes

originally submitted by the

documentation.



K-002 * reporting clinical 15 800 Czk

reviews of the registered

of the medicinal product (30 days)

Reimbursement of expenses in this amount is

is true even if the previously

authorised/notified study

not started within 12 months

and experiencing great changes

originally submitted by the

documentation.



K-003 * other reporting 33 900 Czk

a clinical trial of the medicinal

(60 days)

Reimbursement of expenses in this amount is

is true even if the previously

authorised/notified study

not started within 12 months

and experiencing great changes

originally submitted by the

documentation.



The k-004 notification on the appendix to the Protocol. 15 800 Czk

Appendix to the Protocol that require an assessment of the

because of the significant amendments to the Protocol for which the

It is likely to affect the safety of the

subjects or changes the scientific

the hypothesis of the clinical trial,

Alternatively, if the change is significant from

Another reason.

Reimbursement of expenses in this rate applies

in the event that previously allowed/announced

the study was not initiated within 12 months, and

small changes initially occur

the documentation submitted.



K-005 application for an opinion, the conditions of 15 800 Czk

the use of the medicinal product, the manner of its

distribution, supply and monitoring and for urgent

the evaluation of its quality, safety, opinions

and efficiency in the context of a specific payment is not required

the treatment program. in advance



K-006 a request for dispute resolution, whether it is about 6 900 Eur

the drug, including the distinction between therapeutic

product and the active substance, a

product subject to registration or

another product, or whether it is a

homeopathic medicine.



To Enable the hospital exemption-90 EUR



K-008 change in hospital exception-changes to 20 000 CZK

in the production process, quality

the starting material



K-009 change in hospital-adding 2 500 $ exception

the next site, where it was

does the hospital exemption

administered, or increase the maximum

the number of patients

---------------------------------------------------- --------------------------------------------------------



B. refund of expenses for laboratory analyses of pharmaceuticals and Excipients, carried out in the scope of

Of the Institute

--------------------------------------------------------------------------------------------

Test item the amount of compensation

--------------------------------------------------------------------------------------------

PREPARATORY AND AUXILIARY WORK

1. the Income of the sample for analysis, including developing a plan to test 500 Czk

2. the preparatory work prior to the analysis of the 610 Czk

3. Validation of biological methods 1 950 Eur

PHYSICAL AND CHEMICAL TESTS

4. Clarity and degree of opalescence of fluids-for each prohlédnutou jednotku40 Czk

5. the degree of coloration liquid-for each prohlédnutou jednotku40 Czk

Potentiometric determination of pH 6 810 €

7. the density and relative density of 1 010 €

8. Index of refraction 810 €

9. the optical rotation of 1 010 €

10. the Viscosity-measuring capillary viskozimetrem 1 620 Czk

11. Viscosity-measuring Rotary viskozimetrem 1 620 Czk

12. tělískovým viskozimetrem-measuring the Viscosity 1 210 Eur

13. The distillation range 610 Czk

14. Boiling point 610 Czk

15. Determination of water by distillation 610 Czk

16. the melting point-capillary method

16A. for substances declared 610 Czk

16B. for an undeclared $ 1 210

17. the temperature dropping 610 Czk

18. the temperature of solidification of 610 Czk

19. determination by potentiometric titration in aqueous substances and 1 620 Czk

non-aqueous media

20. determination of the identity of the substances infrared 2 830 Czk

21. determination of UV-VIS spectrophotometry 2 020 Czk

22. The determination of identity, purity of the substance and the content of thin layer chromatography

22A. qualitative determination-for each system 1 130 Czk

22B. semi-quantitative determination-for each system 1 740 €

23. The determination of identity, purity and content of compounds by gas chromatography

23A. determination of simple 5 660 Czk

23B. determination of more complex 6 460 Czk

24. The determination of identity, purity and content of substances by high performance liquid chromatography

24A. determination of simple $ 5 040

24B. the determination of the complex 7 460 Czk

25. The determination of the identity of the substances by high performance liquid chromatography

with mass detector 12 740 Eur

26. The exclusion chromatography

26A. exclusion chromatography albumin 10 040 Czk

26B. exclusion chromatography of immunoglobulins 12 740 Eur

27. Zone electrophoresis of albumin and immunoglobulins 4 040 Czk

28. The unit of electrical conductance 810 €

29. testing the identity of ions and groups-$ 480

30. The smell of 200 Czk

31. Ammonium (limit test) 480 Czk

32. Arsenic (limit test) 2 020 Czk

33. Calcium (limit test) 480 Czk

34. Chlorides (limit test) 480 Czk

35. Fluoride (limit test) 480 Czk

36. Magnesium (limit test) 480 Czk

37. Magnesium and alkaline earth metals (limit test) 480 Czk

38. Heavy metals (limit test) 480 Czk

39. Iron (limit test) 480 Czk

40. Phosphates (limit test) 480 Czk

41. Potassium (limit test) 480 Czk

42. Sulfates (limit test) 480 Czk

43. Sulphated ash 2 420 Czk

44. The total ash 2 420 Czk

45. free formaldehyde

45A. method and 480 Czk

45b. method B 1 620 Czk

46. The identity and control of residual solvents 6 460 Czk

47. The residual ethylene oxide and dioxane 6 460 Czk

48. the acid Number 1 210 Eur

49. The number of the ester 1 210 Eur

50. The number of the hydroxyl 1 210 Eur

51. The number of iodine 1 210 Eur

52. peroxide Number 1 210 Eur

53. saponification Number 1 210 Eur

54. Nitrogen mineralization with sulfuric acid 4 040 Czk

Chelatometric titration of 1 010 55. Eur

56. Semimikrostanovení water 2 020 Czk

57. Phenol in immune serums and vaccines 1 620 Czk


58. Oxidants 1 010 €

59. Total protein 1 620 Czk

60. Test rozpadavosti tablets and capsules (no determination)

60A. crumbling of in water-$ 400

60B. crumbling of the gastric juice 1 010 €

60 c. crumbling of the duodenal 1 820 Czk

61. rozpadavosti rektálních Test and vaginal preparations-$ 400

(no determination)

62. dissolution test for solid dosage forms (no determination)

62A. dissolution short-term 1 010 €

62B. dissolution long-term 4 850 Eur

63. the dissolution Test of transdermal preparations (no determination) 4 850 Eur

64. the weight uniformity of solid single-dose drug 100 Czk

forms-for each portion of the

65. Abrasion for the tablet-$ 400

66. strength tablets 200 Czk

67. determination of ethanol in liquid preparations 6 460 Czk

68. determination of methanol and 2-propanol in liquid preparations 6 460 Czk

69. The test on the usable volume of parenteral products 200 Czk

70. the weight uniformity of single doses in multidose containers 100 Czk

71. The uniformity of dosage units of 100 Czk

72. Volumetric determination of substances

72A. Titration 1 010 €

72B. Retitrace 1 210 Eur

72c. titration in a heterogeneous environment 1 210 Eur

72d. titration in a water-free environment (without insulation) 1 210 Czk

73. The weighing of individual doses of-100 Czk for each portion of the

74. Macroscopic description of the appearance of 200 Czk

--------------------------------------------------------------------------------------------

MICROBIOLOGICAL AND BIOLOGICAL TESTS

--------------------------------------------------------------------------------------------

75. sterility Test

75A. sterility test-method of direct inoculation into the nutrient soils 1 210 Eur

(protimikrobních effects)

75B. sterility test-method of direct inoculation into the nutrient soils 1 410 Czk

(products with protimikrobními effects)

75 c a sterility test-method of membrane filtration 2 210 Czk

75d. test for sterility of membrane filtration method of antibiotic-2 210 Czk

76. the non-sterile Microbiological testing products (the total number of

Live aerobů)

microbiological examination of non-sterile 76A. products-category 2 2 020 Czk

microbiological examination of non-sterile 76B. products-category 3B 2 020 Czk

microbiological examination of non-sterile 76 c. products-category 4A 1 620 Czk

microbiological examination of non-sterile 76 d. products-category 4B 2 020 Czk

77. The microbiological quality of non-sterile products and substances for

pharmaceutical use (the total number of living aerobů TAMC and hub

TYMC, tests for specified micro-organisms)

77A. non-aqueous oral preparations 2 020 Czk

77B. aqueous oral preparations 2 020 Czk

77c. preparations for rectal use 2 020 Czk

77 d. preparations for oral administration, on the gums, skin, in the nose, ear, 2 020 Czk

77e. preparations for vaginal administration of 2 020 Czk

77f. transdermal patches 2 020 Czk

77 g. preparations for inhalation 2 020 Czk

77h. the dosage form containing the raw materials of the natural character of 2 020 Czk

77i. substances for pharmaceutical use 2 020 Czk

78. The microbiological quality of vegetable LP for oral use

78A vegetable LP categories and 2 020 Czk

78B. vegetable LP category B 2 020 Czk

78c. vegetable LP category C 2 020 Czk

79. the effectiveness of preservatives 6 protimikrobních 000 CZK

80. Bacterial endotoxins 1 620 Czk

81. indirect method for determination of hemaglutininů anti-A and anti-B-2 830 Czk

The indirect Coombs test

82. Immunochemical methods

82A. methods of using radiolabelled antigen or antibody (ELISA) 4 040 Czk

82B. imunoprecipitační method-Ouchterlony 4 040 Czk

82c. imunoprecipitační method-Mancini 2 420 Czk

83. Determination of adsorbed tetanus vaccine 70 000 CZK

84. the tests of identity, the test temperature stability and determination of

the effects on tissue cultures

84A. Monovakcína 5 460 Czk

84b. Divakcína 7 850 Czk

84c. Trivakcína 13 090 Czk

85. the cytotoxicity Tests on tissue cultures 11 850 Czk

--------------------------------------------------------------------------------------------

Note: If a single act or the sum of the incremental rates for individual acts in accordance with the table amount was

less than $ 1,000, the amount of the refund is $ 1,000.



Annex 2

A. Tariff of reimbursement for professional activities pursued under the responsibility of the Veterinary Institute



---------------------------------------------------------------------------- -----------------

Category code (Act) payment

---------------------------------------------------------------------------- -----------------

ANNUAL MAINTENANCE PAYMENT

---------------------------------------------------------------------------- -----------------



U-001 annual maintenance payment of 6 500 Czk

---------------------------------------------------------------------------- -----------------

GENERAL

---------------------------------------------------------------------------- -----------------



O-01 request for hourly oral consultations at the request of 2 600 Czk

(unrelated to the already submitted applications)

O-02 application for the issue of a written expert opinion at the request of the question 5 400 Eur

related to the activity of the Institute for animal health area

Pharmaceuticals

O-03 request to issue a decision unrelated to the already submitted 7 100 Czk

applications, whether it is about the drug, including the distinction between therapeutic

the active ingredient, medicine, veterinary medicine

subject to registration or for any other product, or whether it is a

homeopathic medicine

---------------------------------------------------------------------------- -----------------

REGISTRATION

---------------------------------------------------------------------------- -----------------

NATIONAL REGISTRATION

---------------------------------------------------------------------------- -----------------

RN-01 application for authorization for a veterinary medicinal product-separate 111 100 Czk

registration-based full experimental or literary

information-veterinary medicine for more than two target

the animal species (national register)

RN-(D)-51 other tasks that are performed only in cases when they are 24 500 Czk

submitted requests that do not contain data and documentation

(the registration dossier) that conform to the requirements of the

RN-02 application for authorization for a veterinary medicinal product-separate 85 700 Czk

registration-based full experimental or literary

information-veterinary medicine for max. two target

the animal species (national register)

RN-D-52 other tasks that are performed only in cases when they are 24 500 Czk

submitted requests that do not contain data and documentation

(the registration dossier) that conform to the requirements of the 52 400 Czk

RN-03 application for authorization for a veterinary medicinal product-registration

presented on the basis of incomplete documentation with reference to

the original registration of the product after the expiry of the length of the protection

data (generic application) or on the basis of informed consent

a holder of

RN-D-53 other tasks that are performed only in cases when they are 9 800 Czk

submitted requests that do not contain data and documentation

(the registration dossier) that conform to the requirements of 75 900 Czk

RN-04 application for authorization for a veterinary medicinal product-hybrid

registration, i.e.. presented on the basis of incomplete registration

registration dossier referring to the original product after

the expiry of the délkyochrany data (generic application) or on the basis of

informed consent of another holder with the information above and beyond the fundamental

similarities (national register)

RN-D-54 other tasks that are performed only in cases where there are 19 600 Czk

submitted requests that do not contain data and documentation

(the registration dossier) that conform to the requirements of the

RN-05 Multiple registration request completely identical veterinary 17 600 Czk

medicinal product under a different name (repeat registration

the veterinary medicinal product under a different name and, where appropriate, for

another holder-double or a copy)

RN-D-55 other tasks that are performed only in cases when they are 4 900 Eur

submitted requests that do not contain data and documentation

(the registration dossier) that conform to the requirements of the


RN-06 application for the authorisation of veterinary medicinal product-in-$ 58 800

provided for the cases where, with regard to a major change in the nature,

the property or method of the use of the veterinary medicinal product

You cannot apply for a variation of the-extensions

authorization for a veterinary medicinal product for more than one

property (e.g. strength, pharmaceutical form, add the target species

food animal)

RN-D-56 other tasks that are performed only in cases when they are 7 300 Czk

submitted requests that do not contain data and documentation

(the registration dossier) that conform to the requirements of the

RN-07 an application for the registration of veterinary medicinal products-in-$ 31 800

provided for the cases where, with regard to a major change in the nature,

the property or method of the use of the veterinary medicinal product

You cannot apply for a variation of the-extensions

the registration of veterinary medicinal products by a maximum of one

property (e.g. strength, pharmaceutical form, add the target species

food animal))

RN-D-57 other tasks that are performed only in cases when they are 4 900 Eur

submitted requests that do not contain data and documentation

(the registration dossier) that conform to the requirements of the

RN-08 application for the registration of veterinary medicinal products-marketing authorisation-$ 48 500

homeopathics for simplified procedure

RN-(D)-58 other tasks that are performed only in cases when they are 9 800 Czk

submitted requests that do not contain data and documentation

(the registration dossier) that conform to the requirements of the

RN-09 application for registration of homeopathic veterinary medicinal 25 000 CZK

of the product-in specific cases, when having regard to the significant

the change of the nature, properties, or how to use homeopathic

the veterinary medicinal product, you cannot apply for a variation of

the-extension of the registration (national register)

RN-D-59 other tasks that are performed only in cases where the 3 900 Czk

submitted requests that do not contain data and documentation

(the registration dossier) that conform to the requirements of the

RN-10 application for amendment of registration-type II (national) 24 000 CZK

RN-D-60 other acts that are performed only in cases when they are 4 900 Eur

submitted requests that do not contain data and documentation

(the registration dossier) that conform to the requirements of the

RN-11a-application for amendment of registration of type IA (national) 3 900 Czk

RN-44 application for amendment of registration-type IB (national) 5 900 Eur

RN-12 application for renewal of the authorisation of veterinary medicinal product-43 600 Czk

all medicinal products, in addition to the homeopath (national)

RN-D-62 other tasks that are performed only in cases when they are 14 700 Czk

submitted requests that do not contain data and documentation

(the registration dossier) that conform to the requirements of the

RN-13 an application for renewal of the authorisation of veterinary medicinal product 23 500 Eur

-homeopathic remedies (national)

RN-D-63 other tasks that are performed only in cases when they are 4 900 Eur

submitted requests that do not contain data and documentation

(the registration dossier) that conform to the requirements of the

RN 14-request for conversion of the veterinary medicinal product registration 4 900 Eur

on another holder

R-15 application for the unregistering VLP-without further requirements is not remuneration

RN-16 application for the unregistering veterinary medicinal product-2 900 Czk

with the requirement of gradual doprodeje

---------------------------------------------------------------------------- -----------------

Czech Republic as the reference Member State

---------------------------------------------------------------------------- -----------------

RRMS/NR request for initiation of the procedure of mutual recognition of registration with the Czech 197 800 Czk

-17a Republic as the reference Member State-registration

supported by full experimental or literary figures. The case,

When a veterinary medicinal product is not authorised in the Czech Republic

and is included in the procedure max. 5 CMS.

RRMS/NR request for initiation of the procedure of mutual recognition of registration with the Czech 227 200 Czk

-17b Republic as the reference Member State-registration

supported by full experimental or literary figures. The case,

When a veterinary medicinal product is not authorised in the Czech Republic

and is included in the procedure max. 6-15 CMS.

RRMS/NR request for initiation of the procedure of mutual recognition of registration with the Czech 256 500 Czk

Republic of-17 c as the reference Member State-registration

supported by full experimental or literary figures. The case,

When a veterinary medicinal product is not authorised in the Czech Republic

and is included in the procedure more than 15 CMS.

RRMS/NR-(D) other acts which are carried out only in cases in which 24 500 Czk

-67 are submitted requests that do not contain data and documentation

(the registration dossier) that conform to the requirements of the

RRMS/R request for initiation of the procedure of mutual recognition of registration with the Czech 107 700 Czk

-18a Republic as the reference Member State-registration

supported by full experimental or literary figures. The case,

When a veterinary medicinal product has a valid registration in the Czech Republic

and is included in the procedure max. 5 CMS.

RRMS/R request for initiation of the procedure of mutual recognition of registration with the Czech 137 100 Czk

-18b Republic as the reference Member State-registration

supported by full experimental or literary figures. The case,

When a veterinary medicinal product has a valid registration in the Czech Republic

and is included in the procedure max. 6-15 CMS.

RRMS/R request for initiation of the procedure of mutual recognition of registration with the Czech 166 500 Czk

Republic of-18 c as the reference Member State-registration

supported by full experimental or literary figures. The case,

When a veterinary medicinal product has a valid registration in the Czech Republic

and is included in the procedure more than 15 CMS.

RRMS/R-(D) other acts which are carried out only in cases when they are 14 700 Czk

-68 requests that do not contain the presented data and documentation

(the registration dossier) that conform to the requirements of the

RRMS/NR request for initiation of the procedure of mutual recognition of registration with the Czech 102 300 Czk

-19a Republic as the reference Member State-registration submitted

on the basis of incomplete documentation with reference to the original registration

of the product after the expiry of the length of the data protection (generic application) or

on the basis of informed consent of another holder. Case when

the veterinary medicinal product is not authorised in the Czech Republic

and is included in the procedure max. 5 CMS.

RRMS/NR request for initiation of the procedure of mutual recognition of registration with the Czech 117 000 CZK

-19b Republic as the reference Member State-registration submitted

on the basis of incomplete documentation with reference to the original registration

of the product after the expiry of the length of the data protection (generic application) or on

the basis of the informed consent of another holder. Case when

the veterinary medicinal product is not authorised in the Czech Republic

and is included in the procedure max. 6-15 CMS.

RRMS/NR request for initiation of the procedure of mutual recognition of registration with the Czech 131 700 Czk

-Republic of 19 c as the reference Member State-registration submitted

on the basis of incomplete documentation with reference to the original registration

of the product after the expiry of the length of the data protection (generic application) or on

the basis of the informed consent of another holder. Case when

the veterinary medicinal product is not authorised in the Czech Republic

and is included in the procedure more than 15 CMS.

RRMS/NR-(D) other acts which are carried out only in cases where the 9 800 Czk

-69 requests that do not contain the presented data and documentation

(the registration dossier) that conform to the requirements of the

RRMS/R request for initiation of the procedure of mutual recognition of registration with the Czech 78 300 Czk

-20a Republic as the reference Member State-registration submitted

on the basis of incomplete documentation with reference to the original registration

of the product after the expiry of the length of the data protection (generic application) or on

the basis of the informed consent of another holder. Case when

the veterinary medicinal product has a valid registration in the Czech Republic

and is included in the procedure max. 5 CMS.

RRMS/R request for initiation of the procedure of mutual recognition of registration with the Czech 93 000 Eur

-20b Republic as the reference Member State-registration submitted

on the basis of incomplete documentation with reference to the original registration

of the product after the expiry of the length of the data protection (generic application) or on


the basis of the informed consent of another holder. Case when

the veterinary medicinal product has a valid registration in the Czech Republic

and is included in the procedure max. 6-15 CMS.

RRMS/R request for initiation of the procedure of mutual recognition of registration with the Czech 107 700 Czk

Republic of-20 c as the reference Member State-registration submitted

on the basis of incomplete documentation with reference to the original registration

of the product after the expiry of the length of the data protection (generic application) or on

the basis of the informed consent of another holder. Case when

the veterinary medicinal product has a valid registration in the Czech Republic

and is included in the procedure more than 15 CMS.

RRMS/R-(D) other acts which are carried out only in cases where the 9 800 Czk

-70 applications submitted that do not contain data and documentation

(the registration dossier) that conform to the requirements of the

RRMS/NR request for initiation of the procedure of mutual recognition of registration with the Czech 137 600 Czk

-21a Republic as the reference Member State-hybrid registration,

presented on the basis of incomplete registration dossier referring to the

that is, the original registration of the product after the expiry of the length of the data protection

(generic application) or else on the basis of informed consent

the holder with the information above and beyond the essential similarity. Case when

the veterinary medicinal product is not authorised in the Czech Republic

and is included in the procedure max. 5 CMS.

RRMS/NR request for initiation of the procedure of mutual recognition of registration with the Czech 157 200 Czk

-21b Republic as the reference Member State-hybrid registration,

i.e. registration presented on the basis of incomplete documentation with reference

the original registration of the product after the expiry of the length of the data protection

(generic application) or else on the basis of informed consent

the holder with the information above and beyond the essential similarity. Case when

the veterinary medicinal product is not authorised in the Czech Republic

and is included in the procedure max. 6-15 CMS.

RRMS/NR request for initiation of the procedure of mutual recognition of registration with the Czech 176 700 Czk

-Republic of 21 c as a reference Member State-hybrid registration,

i.e. registration presented on the basis of incomplete documentation with reference

the original registration of the product after the expiry of the length of the data protection

(generic application) or else on the basis of informed consent

the holder with the information above and beyond the essential similarity. Case when

the veterinary medicinal product is not authorised in the Czech Republic

and is included in the procedure more than 15 CMS.

RRMS/NR-(D) other acts which are carried out only in cases where there are 19 600 Czk

-71 requests that do not contain the presented data and documentation

(the registration dossier) that conform to the requirements of the

RRMS/R request for initiation of the procedure of mutual recognition of registration with the Czech 93 000 Eur

-22a Republic as the reference Member State-hybrid registration,

i.e. registration presented on the basis of incomplete documentation with reference

the original registration of the product after the expiry of the length of the data protection

(generic application) or else on the basis of informed consent

the holder with the information above and beyond the essential similarity. Case when

the veterinary medicinal product has a valid in the Czech Republic

registration and in the procedure included max. 5 CMS.

RRMS/R request for initiation of the procedure of mutual recognition of registration with the Czech 112 600 Czk

-22b Republic as the reference Member State-hybrid registration,

i.e. registration presented on the basis of incomplete documentation with reference

the original registration of the product after the expiry of the length of the data protection

(generic application) or else on the basis of informed consent

the holder with the information above and beyond the essential similarity. The case where the animal health

medicine has a valid registration in the Czech Republic

and in a procedure is included 6-15 CMS.

RRMS/R request for initiation of the procedure of mutual recognition of registration with the Czech 132 200 Czk

-Republic of 22 c as the reference Member State-hybrid registration,

i.e. registration presented on the basis of incomplete documentation with reference

the original registration of the product after the expiry of the length of the data protection

(generic application) or else on the basis of informed consent

the holder with the information above and beyond the essential similarity. Case when

the veterinary medicinal product has a valid registration in the Czech Republic

and is included in the procedure more than 15 CMS.

RRMS/R other tasks that are performed only in cases when they are 14 700 Czk

-72 submitted requests that do not contain data and documentation (registration

the documentation) that conform to the requirements of the

RRMS/EX request for initiation of the procedure of mutual recognition of registration with the Czech 73 400 Czk

-23a Republic as the reference Member State-in the cases provided for,

When a significant change with regard to the nature, characteristics or how

the use of the veterinary medicinal product, you cannot request a change

registration of the appropriate product-extension of the authorization for a veterinary

medicinal product of at most one property (e.g. pharmaceutical

form, add the target species of the food animal) and for

the case when in the procedure included max. 5 CMS

RRMS/EX request for initiation of the procedure of mutual recognition of registration with the Czech 88 100 Czk

-23b Republic as the reference Member State-in the cases provided for,

When a significant change with regard to the nature, properties, or how to use the

the veterinary medicinal product, you cannot apply for a variation of

the-extension of the veterinary medicinal

the product of at most one property (e.g., strength, pharmaceutical form,

Add the target species of the food animal) and, in case

When in the procedure included max. 6-15 CMS

RRMS/EX request for initiation of the procedure of mutual recognition of registration with the Czech 102 800 €

-Republic of 23 c as the reference Member State-in the cases provided for,

When a significant change with regard to the nature, characteristics or how

the use of the veterinary medicinal product, you cannot request a change

registration of the appropriate product-extension

veterinary medicinal product of at most one property

(e.g., strength, pharmaceutical form, add the target species of food

the animal) and for the case where the procedure is included more than 15 CMS

RRMS/EX-(D) other acts which are carried out only in cases where there are 7 300 Czk

-73 submitted requests that do not contain data and documentation

(the registration dossier) that conform to the requirements of the

RRMS/EX request for initiation of the procedure of mutual recognition of registration with the Czech 97 900 €

-42a Republic as the reference Member State-in the cases provided for,

When a significant change with regard to the nature, characteristics or how

the use of the veterinary medicinal product, you cannot request a change

registration of the appropriate product-extension of the authorization for a veterinary

medicinal product on more than one property (e.g. pharmaceutical

form, add the target species of the food animal) and, in case

When in the procedure included max. 5 CMS

RRMS/EX request for initiation of the procedure of mutual recognition of registration with the Czech 112 600 Czk

-42b Republic as the reference Member State-in the cases provided for,

When a significant change with regard to the nature, characteristics or how

the use of the veterinary medicinal product, you cannot request a change

registration of the appropriate product-extension of the authorization for a veterinary

medicinal product on more than one property (e.g. pharmaceutical

form, add the target species of the food animal) and, in case

When in the procedure included max. 6-15 CMS

RRMS/EX request for initiation of the procedure of mutual recognition of registration with the Czech 127 300 Czk

-Republic of 42 c as the reference Member State-in the cases provided for,

When a significant change with regard to the nature, characteristics or how

the use of the veterinary medicinal product, you cannot request a change

registration of the appropriate product-extension of the authorization for a veterinary

medicinal product on more than one property (e.g. pharmaceutical

form, add the target species of the food animal) and, in case

When in the procedure included more than 15 CMS

RRMS/EX-(D) other acts which are carried out only in cases where there are 7 300 Czk

-82 presented requests that do not contain data and documentation

(the registration dossier) that conform to the requirements of the

RRMS/CC the request for the initiation of the procedure, the mutual recognition of registration with the Czech 31 800 Czk

-24a Republic as the reference Member State-multiple request

registration is completely identical to the veterinary medicinal product under

a different name (repeat authorization for a veterinary medicinal product

under a different name and, where appropriate, to another holder-double or a copy).

The case when in the procedure included max. 5 CMS.


RRMS/CC the request for the initiation of the procedure, the mutual recognition of registration with the Czech 41 600 Czk

-24b Republic as the reference Member State-multiple request

completely identical registration veterinary medicinal product

under a different name (repeat registration of veterinary medicinal

the product under a different name and, where applicable, for a holder of-

duplicate or copy). The case when in the procedure included max.

6-15 CMS.

RRMS/CC the request for the initiation of the procedure, the mutual recognition of registration with the Czech 46 500 Eur

-Republic of 24 c as the reference Member State-multiple request

registration is completely identical to the veterinary medicinal product under a different

(repeat registration name of veterinary medicinal product under

a different name and, where appropriate, to another holder-double or a copy).

The case, when the procedure is included more than 15 CMS.

RRMS/RU request for initiation of the procedure of mutual recognition of registration with the Czech 68 500 Eur

-25a Republic as the reference Member State,-repeat the procedure

mutual recognition for the veterinary medicinal product has already been registered

on the basis of the mutual recognition procedure for a maximum of 5 new CMS

RRMS/RU request for initiation of the procedure of mutual recognition of registration with the Czech 78 300 Czk

-25b Republic as the reference Member State,-repeat the procedure

mutual recognition for the veterinary medicinal product has already been registered

on the basis of the mutual recognition procedure for a maximum of 6-15 new CMS

RRMS/RU request for initiation of the procedure of mutual recognition of registration with the Czech 83 200 Czk

-Republic of 25 c as the reference Member State,-repeat the procedure

mutual recognition for the veterinary medicinal product has already been registered

on the basis of the mutual recognition for more than 15 new CMS

RRMS/ZIA application for type II variation in the context of the mutual recognition of 28 400 Czk

-26a with the Czech Republic as the reference Member State for a maximum of

5 CMS

RRMS/ZIA application for type II variation in the context of the mutual recognition of the 30 800 Eur

-26b with the Czech Republic as the reference Member State for a maximum of

6-15 CMS

RRMS/ZIA application for type II variation within the mutual 33 300 Czk

-26 c recognition with the Czech Republic as the reference Member State for more

than 15 CMS

RRMS/ZIB registration change request type IB in the procedure for the mutual recognition of 6 400 Eur

-27 with the Czech Republic as the reference Member State

RRMS/ZIA application for amendment of registration of type IA in the procedure for the mutual recognition of 3 900 Czk

-28 with the Czech Republic as the reference Member State

RRMS/PR request for renewal of the authorisation in the context of the mutual recognition procedure 89 100 Czk

-29 with the Czech Republic as the reference Member State

---------------------------------------------------------------------------- -----------------

As a competent Member State (CMS)

---------------------------------------------------------------------------- -----------------

RCMS MONITORING-30 application for recognition of a marketing authorisation for the medicinal product issued 65 100 Czk

the competent authority of another Member State-registration

supported by full experimental or literary figures

RCMS MONITORING-31 an application for the recognition of a marketing authorisation for the medicinal product issued 38 200 Czk

the competent authority of another Member State-registration submitted

on the basis of incomplete documentation with reference to the original registration

of the product after the expiry of the length of the data protection (generic application) or on

the basis of the informed consent of another holder.

RCMS MONITORING-32 application for recognition of a marketing authorisation for the medicinal product issued 55 300 Czk

the competent authority of another Member State-hybrid registration,

i.e. registration presented on the basis of incomplete documentation with reference

the original registration of the product after the expiry of the length of the data protection

(generic application) or else on the basis of informed consent

the holder with the information above and beyond the essential similarity.

RCMS MONITORING-33 application for recognition of a marketing authorisation for the medicinal product issued 21 100 Czk

the competent authority of another Member State-in set

cases where, having regard to the significant change in the nature, properties,

or the way the use of a veterinary medicinal product cannot be

to apply for a variation of the-extensions

authorization for a veterinary medicinal product.

RCMS MONITORING-34 application for recognition of a marketing authorisation for the medicinal product issued 8 800 Czk

the competent authority of another Member State-multiple request

completely identical registration veterinary medicinal product

under a different name (repeat registration of veterinary medicinal

the product under a different name and, where applicable, for a holder of-

duplicate or copy).

RCMS MONITORING/ZIA application for type II variation within the mutual 16 600 Czk

-recognition of a judgment issued by the 35 for the medicinal product by the competent

authority of another Member State

RCMS MONITORING/ZIB registration change request type IB in the framework of the mutual 2 900 Czk

-recognition of a judgment issued by the 36 for the medicinal product by the competent

authority of another Member State

RCMS MONITORING/ZIA application for amendment of registration of type IA in the framework of the mutual 2 900 Czk

-37 recognition of a decision issued by the competent authority for the medicinal product

another Member State

RCMS MONITORING/PR application for renewal within the mutual 35 300 Czk

-recognition of a judgment issued by a 38 for the medicinal product by the competent authority

another Member State

---------------------------------------------------------------------------- -----------------

Parallel imports

---------------------------------------------------------------------------- -----------------

RSD-39 an application for authorisation of the parallel imports of veterinary medicinal product 14 700 Czk

RSD-40 application for renewal of the authorization decision parallel 9 300 Czk

imports of veterinary medicinal product

---------------------------------------------------------------------------- -----------------

Issuing of the certificate for the medicinal product

---------------------------------------------------------------------------- -----------------

RC-41 application for issue of a certificate for the product in accordance with 1 200 Czk

the WHO scheme

--------------------------------------------------------------------------------------------



---------------------------------------------------------------------------- -----------------

INSPECTION

---------------------------------------------------------------------------- -----------------

THE MANUFACTURE OF VETERINARY MEDICINAL PRODUCTS

---------------------------------------------------------------------------- -----------------

I-01 application for a permit for the manufacture of veterinary medicinal products or 17 700 Czk

a change in the permit-for a range of imports from third countries

I-02 application for a permit for the manufacture of veterinary medicinal products-for 26 900 Czk

the range of non-sterile medicinal products-one different pharmaceutical production plant

form or one production unit/line in one manufacturing site

I-03 application for a permit for the manufacture of veterinary medicinal products, or 13 500 Eur

a change in the permit-for a range of non-sterile medicinal products-

each additional manufacturing different pharmaceutical form and/or production

Unit/line

I-04 application for a permit for the manufacture of veterinary medicinal products-for 42 900 Czk

the range of sterile medicinal products-one different pharmaceutical production plant

form or one production unit/line in one manufacturing site

I-05 application for a permit for the manufacture of veterinary medicinal products or 19 800 Eur

a change in the permit-for a range of sterile medicinal products-each

other manufacturing different pharmaceutical form or a production unit/line



I-27 change request authorisation in the manufacture of veterinary medicinal products-8 400 Eur

Add the manufacturer's warehouse



I-06 basic fee Increase in cases, when it comes to 24 400 Czk

the product or technology-intensive manufacturing of veterinary

medicinal products of biological origin

I-07 application for a permit for the manufacture of veterinary medicinal products-for 21 000 CZK

the range of independently carried out by the primary Pack non-sterile

products-one production a different pharmaceutical form and/or one

production unit/line in one manufacturing site

I-08-application for a permit for the manufacture of veterinary medicinal products or 10 500 Eur

a change in the permit-for a range of separately by the primary

packaging of non-sterile products-every other production and different

the pharmaceutical form and/or a production unit/line

I-09 application for a permit for the manufacture of veterinary medicinal products-for 18 100 Czk

the range of secondary packaging carried out separately in one place

production

I-25 application for authorization for the manufacture of veterinary medicinal products or 8 900 €

a change in the permit-for a range of separately carried out secondary


packaging of non-sterile products-each additional place of manufacture



I-28 application for a permit for the manufacture of veterinary medicinal products-for 17 700 Czk

the range of batch release



I-29 application for a permit for the manufacture of veterinary medicinal products or 8 400 Eur

a change in the permit-for a range of batch release-each additional

instead of the batch release/pharmaceutical form

I-10 request for a change in the authorisation for the production of veterinary drugs 2 900 Czk

products without inspection at the place of production

I-24 an application for authorisation in the manufacture of veterinary medicinal products-for 12 400 Czk

the range of medicated feedingstuffs for own use-one production

Unit/line in one manufacturing site

---------------------------------------------------------------------------- -----------------

THE DISTRIBUTION OF VETERINARY MEDICINES

---------------------------------------------------------------------------- -----------------

I-11 of the application for authorization to distribute veterinary medicinal products 17 300 Czk

or a change in the authorization to distribute with the control-s control

one warehouse

I-12 application for permission to distribute or a change in the authorisation-every 8 400 Eur

other uk within one application

I-13 an application to extend the authorisation to distribute veterinary 11 400 Czk

preparations for the distribution of the active substances and Excipients, or

medicated feedingstuffs-with control of one warehouse

I-14 the application to extend the authorisation for the distribution of veterinary medicinal products 8 400 Eur

preparations for the distribution of active substances, excipients, or

medicated feedingstuffs-each additional warehouse within a single authorisation

I-15 application for amendment of an authorisation to distribute veterinary 2 900 Czk

products inspection

---------------------------------------------------------------------------- -----------------

REVIEW OF VETERINARY DRUGS

---------------------------------------------------------------------------- -----------------

I-16 application for authorisation to the activity control laboratories or a change in 16 800 Czk

authorization control laboratories with inspection-implementation

-subtests at one point of control

I-17 the application for authorisation to the activity control laboratories or a change in the 22 700 Czk

authorization control laboratories with inspection-testing in

comprehensive range (physico-chemical, microbiological and

biological testing)-a single point of control

I-26 application for authorisation to the activity control laboratories or a change in the 8 600 Czk

authorization control laboratories with inspection-each additional

instead of checking

I-18 change request authorization control laboratories without 2 900 Czk

inspection on the spot checks

---------------------------------------------------------------------------- -----------------

CERTIFICATION (CERTIFICATION) ACCORDING TO GOOD MANUFACTURING PRACTICE,

CANCELLATION OF AUTHORISATIONS AT THE REQUEST, THE APPLICATION FOR A CERTIFICATE OF COMPLIANCE

GOOD MANUFACTURING PRACTICE FOR FOREIGN PRODUCER

---------------------------------------------------------------------------- -----------------

I-20 application for issue of a certificate of compliance with the conditions of the correct certificate 1 300 Czk

manufacturing practice or good distribution practices for holders of

the relevant authorisations

I-20 application for issue of a certificate of compliance with the conditions of the correct certificate 27 800 Eur

manufacturing practice in the production of active substances-with control of one

the production unit/line

I-21 application for issue of a certificate of compliance with the conditions of the correct certificate 13 000 CZK

manufacturing practice in the production of active substances-each additional production

Unit

I-22 request for revocation of the authorisation for payment činnostinení

I-23 the increase of the basic fee in cases, when it comes to the issue of 8 400 Eur

certificate of compliance with the requirements of good manufacturing practice in carrying out

visits to the foreign producer

---------------------------------------------------------------------------- -----------------

LABORATORY ANALYSIS, BATCH RELEASE

---------------------------------------------------------------------------- -----------------

L-01 Checking a batch of a veterinary medicinal product prior to its 500 Czk

release onto the market-with the presentation of a certificate of a Member State

Of The European Union

L-02 examination of a batch of a veterinary medicinal product before its $ 700 +

release onto the market of a Member State without proof of clearance of the European recovery in accordance with

The Union used methods

(part (B) of this

Annex)



L-03 Release a batch of a veterinary medicinal product on the basis of an assessment of 500 Czk

records of production, without laboratory analysis-with the presented certificate

the Member State of the European Union-the OBPR



L-04 batch release veterinary medicinal product on the basis of assessment 1 500 Czk

records of production, without laboratory analysis-without proof of clearance

the Member State of the European Union-the OBPR



L-05 laboratory analysis at the request of Refund in accordance with the methodology used (part B of this annex)



---------------------------------------------------------------------------- -----------------

CLINICAL REVIEWS

---------------------------------------------------------------------------- -----------------

K-01 application for a clinical trial authorisation of the veterinary 20 900 Czk

of the product

K-02 application for amendment of the conditions of the clinical veterinary 6 900 Eur

of the medicinal product

---------------------------------------------------------------------------- -----------------



ACTIVITIES IN THE FRAMEWORK OF THE EUROPEAN UNION

---------------------------------------------------------------------------- -----------------

E-01 application for performing Professional acts presented by £ 577

Medicines Agency (EMEA) *



E-02 Technical tasks carried out at the request, in accordance with the contractual specifications

The European Directorate for quality of medicines among the Veterinary Institute and the EDQM

and health care (EDQM)



---------------------------------------------------------------------------- -----------------

* the price for the cost calculation for the Czech Republic, provides for EMEA



B. refund of expenses for laboratory analyses of pharmaceuticals and Excipients, carried out in the scope of the animal health Institute:

-----------------------------------------------------------------------------------------------------

Test Payment Entry

-----------------------------------------------------------------------------------------------------

PHYSICO-CHEMICAL TESTS

-----------------------------------------------------------------------------------------------------

1 the appearance of 250 Czk

2 the determination of the particle size

2A 1 800 Czk Microscopically

2B sítováním-1 screen 1 300 Czk

2 c for each additional screen is added to the item 2b 220 Czk

3 Airtight 290 Czk

4 the determination of the solubility of 450 Eur

5 loss on drying 1 800 Czk

6, Karl Fisher titrations 2 500 Czk

7 determination of dry matter, odparku $ 1,000

8 determination of ash

8A ash 2 600 Czk total

8B sulphated ash. the more complex the cremation 2 600 Czk

9 determination of the melting temperature of 850 Czk instrumentally

10 determination of density

10A determined by Pycnometry 1 010 €

10B with a hydrometer 1 010 €

11 determination of viscosity Rotary viskosimetrem 1 700 Czk

12 determination of the refractive index (refractometry) $ 1,000

Spectrophotometric Determination of 3 700-$ 13

14 the titration determination of 2 000 CZK

15 measurement of pH (elektrometricky) 810 €

16 measurement of the electrical conductivity of 810 €

17 thin-layer chromatography 2 800 Eur

high-performance Liquid Chromatography of 18

18A 1 analyte 6 500 Czk

18B 1 analyte in two samples of 7 980 Czk

18 c 1 analyte in two or more samples of entry increases about 1 750 Czk

18 d 1-3 samples of the analyte 9 730 Czk

18E 1 analyte-4 samples 11 480 Czk

18F 2 analytes in a single determination of 8 500 Eur

18 g of 3 or more analytes in 1 determination of 10 600 €

19 gas chromatography 6 500 Czk

20 Color and precipitation 700 Czk

9 determination of the effectiveness of pepsin 6 000 CZK

22 Dissolution-UV/VIS 6 400 Eur

23 Dissolution-HPLC 7 200 Czk

24 average weight and weight uniformity of 770 Czk

25 Spectrophotometry in infrared region 3 000 CZK

26 Test the identity of ions and groups-$ 550

27 Test rozpadavosti tablets and capsules (no determination)

27A crumbling in water 480 Czk

27B crumbling in the gastric juice 1 300 Czk

27 c in the crumbling of duodenal juice 2 000 CZK

28 Test on the usable volume of parenteral products 400 Czk

-----------------------------------------------------------------------------------------------------

MICROBIOLOGICAL AND BIOLOGICAL TESTS

-----------------------------------------------------------------------------------------------------

sterility Test 29 7 210 Czk

Microbiological examination of non-sterile products 30 (the total number of live aerobů)


microbiological examination of non-sterile products and 30A-preparations for the local administration of 2 320 Czk

(skin, nose, ear administration, etc.)

microbiological examination of non-sterile products 30B-preparations for perorálnípodání, 2 390 Czk

that do not contain water

microbiological examination of non-sterile products 30 c-products containing ingredients 3 200 Czk

of natural origin that could not be treated protimikrobně

microbiological examination of non-sterile products 30 d-products from plants, to which 3 400 Czk

before using the boiling water does not add

microbiological examination of non-sterile products 30E-preparations of plants, of which 2 390 Czk

before using the hot water adds

microbiological examination of non-sterile products 30F for vaginal administration of 2 420 Czk

31 the microbiological determination of the effectiveness of antibiotics diffuse plotnovou method 3 200 Czk

32 the number of germs in live bacterial vaccines 2 200 Czk

Identification of bacterial strain 33 700 Czk

34 exclusion of bacterial and fungal contamination of 2 900 Czk

35A test-culture-6 890 Czk mycoplasmas

35B-PCR test for 3 400 Czk mycoplasmas

Bacterial endotoxins 36 2 100 Czk

determination of the effectiveness of the vaccine against 37 rabies for veterinary use 43 300 Czk

inactivated the NIH test

38 the determination of the effectiveness of the vaccine against equine influenza on Guinea-pigs (HIT, SRH) 18 500 Eur

determination of the effectiveness of the vaccine against 39 July pigs on mice-determination of 14 300 Czk

an increase in antibodies by ELISA

40 determination of the disinfectants suspension method by measuring 6 260 Czk

electrical conductivity tests on the collection strains

determine the titre of the virus 41 microtiter method on cell cultures in live 10 000 CZK

viral vaccines-in General (eg. myxomatoza)

42 determination of the effectiveness of the vaccine against rabies, inactivated 22 000 CZK for veterinary

the use of serological method with immunofluorescence detection

determine the titre of the virus 43 Newcastle disease of poultry on chicken embryos 11 100 Czk

44 the determination of hyphae in vaccines 1 500 Czk

determine the titre of the virus 45 infectious bursitis poultry 10 300 Eur

the determination of the titer of the rabies virus 46 microtiter method 12 200 Czk

-----------------------------------------------------------------------------------------------------

EXAMINATION OF BATCHES OF IMMUNOLOGICAL VETERINARY MEDICINAL PRODUCTS

-----------------------------------------------------------------------------------------------------

OC-01 Review of the vaccine against swine inactivated July (appearance, efficiency-Elisa) 14 550 Czk

OC-02 Review of the vaccine against swine (live July appearance, solubility, the number of 6 500 Czk

germs, purity, typing strain)

OC-05 Review of rabies vaccine for foxes (oral live appearance, titre 12 450 Czk

virus on TK)

OC-06 Review of rabies vaccines for veterinary use inactivated 43 550 Czk

(the appearance, efficiency)

OC-07 Review of vaccine against equine influenza (appearance, efficient) 18 750 Czk

OC-08 Review of the vaccine against rabies, inactivated for veterinary use 22 250 Czk

(determination of the effectiveness of serologically, appearance)

-----------------------------------------------------------------------------------------------------



Annex 3



Calculation formula



The amount of the refund of expenditure (in €) = x * b



When:



x = the number of hours of work (every hour)



(b) = expenditures for one hour of work, which includes payroll expenses, expenses on

the material, services, and travel in the country and is 1 500 CZK for expenditure

The Institute and $ 490 for the expenditure of the Veterinary Institute.



Selected provisions of the novel



Article. (II) Decree No. 160/2009 Sb.



Transitional provision



An applicant who has paid the reimbursement of expenses for professional activities pursued in the

the scope of the State Institute for drug control prior to the date of acquisition

the effectiveness of this Ordinance, and support operations have been started before the date of

entry into force of this order, however, to have been completed after the date of acquisition

its effectiveness, returns the State Institute for drug control pursuant to § 112 para.

4 (b). (c)) Law No 378/2007 Coll., the financial difference between the amount paid

reimbursement of expenses and the amount of the refund of expenditure laid down by this Decree.



Article. (II) Decree No 327/Sb.



Transitional provision



If it was before the date of entry into force of this order an application for

implementation of vocational Act referred to in annexes 1 to 3 of Decree No 427/2008

Coll., in the version in force before the date of entry into force of this Decree, be

is the applicant the reimbursement of expenses for the implementation of this Act pursuant to the vocational

Decree No 427/2008 Coll., in the version in force before the date of entry into force of

of this order.



1) Council Regulation (EC) No 141/2000 of 16 December 1999. December 1999 on medicinal

products for rare diseases.



2) § 25 para. 4 (b). (b)) and § 112 para. 3 (b). b) point 4 of Act No.

378/2007 Coll., on pharmaceuticals and on amendments to some related laws

(law on medicinal products).



Paragraph 9 of the European Parliament and Council Regulation (EC) No 726/2004

down Community procedures for the authorisation and supervision of

medicinal preparations and supervision, and establishing a European

Agency for medicinal products.



3) section 69 of the Act No. 258/2000 Coll., on the protection of public health and amending

some related laws, as amended.



4) Commission of the European Community Regulation No 1998/2006 of 15 March.

December 2006 on the application of articles 87 and 88 of the Treaty to de minimis aid.



5) § 51 para. 2 (a). (c)) Law No 378/2007 Coll., on pharmaceuticals and on changes

certain related laws (law on medicinal products).



6) Commission Regulation (EC) No 70/2001 of 12 January 2001. January 2001 on the application of

of articles 87 and 88 of the EC Treaty to state aid to small and medium-sized enterprises

having regard to Commission recommendation 2003/361/EC.



7) EMEA/CVMP/133672/05 Rev. 1-Introduction to the guidance Committee on veterinary

medicinal products that relate to the requirements on the information submitted with the

requests related to registrations for minor indications or

minor species.



8) Act No. 47/2002 Coll., on the promotion of small and medium businesses and the

Amendment of the Act No. 2/1969 Coll., on establishment of ministries and other Central

Government of the Czech Republic, as amended.



Commission Regulation (EC) No 2049/2005 of 15 November 2005. December 2005

According to the regulation of the European Parliament and of the Council (EC) No 726/2004

rules for the payment of fees for the benefit of the European Medicines Agency

products made by micro, small and medium-sized enterprises and for

providing administrative assistance from the Agency to these enterprises.