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
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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.