296/2008 Sb.
LAW
of 16 December 2002. July 1, 2008
to ensure the quality and safety of human tissues and cells intended for
human applications and amending related laws
(Act on human tissues and cells)
Change: 41/2009 Sb.
Change: 281/2009 Sb.
Change: 375/2007 Coll. 77/2012 Sb.
Change: 64/2014 Sb.
Parliament has passed the following Act of the United States:
PART THE FIRST
HUMAN TISSUES AND CELLS
TITLE I OF THE
INTRODUCTORY PROVISIONS
§ 1
The subject of the law
(1) this Act incorporates the relevant provisions of the European Union ^ 1) and
lays down the conditions for ensuring the quality and safety of human tissues and
cells intended for human applications, where applicable, to the making of products from
human tissue or human cells intended for human applications,
for their donation, procurement, testing, processing, storage and
the distribution. This Act has been notified in accordance with the directive of the European
Parliament and Council Directive 98/34/EC of 22 December 2004. June 1998 on the procedure for the provision of
information in the field of technical standards and regulations and of rules on services,
the information society, as amended by Directive 98/48/EC.
(2) this Act does not apply to conditions to ensure the quality and
safety
a) tissues and cells, whose collection and use will be carried out by the same man
within the same surgical procedure,
b) human blood and its components ^ 2)
(c)) ^ 3) institutions or parts of institutions, if they are to be used for the same purpose as the
the entire organ in the human body.
Basic provisions
§ 2
For the purposes of this Act, means the
and human use) by using human tissues and cells, or
human tissues and cells (hereinafter referred to as "tissues and cells") in the body or on the
a human recipient tissues and cells (hereinafter referred to as "the recipient") and extra-
use,
(b)) the provision of tissue and cell procurement and related procedures
tissues and cells are obtained,
(c) the procedures carried out in) by processing the treatment and packaging of tissues and cells
intended for human applications and practices for the preservation of tissues and cells
consisting in the use of chemicals, changing environmental conditions or in
the procedures performed in order to prevent biological or physical
damage to tissues and cells or slow down this damage,
(d) the storage of maintenance) of tissues and cells under appropriate controlled
conditions until their distribution,
e) distribution means transportation and delivery of tissues or cells intended for use in
man,
(f)) or by receiving and use of tissues and cells for the treatment of the recipient
health care services provider ("provider") and
procurement, testing, processing, storage and distribution,
g) traceability option
1. find a place where tissues and cells are located, and the key is
during each stage of the treatment, and also remove them,
2. identify a deceased person, whether living or that is the source of tissues and
cells (the "donor"),
3. identify the provider that provides, handles, stores,
distributes or uses the tissues and cells in the treatment of the recipient, where appropriate,
legal entity or natural person-entrepreneur, which are tissues and cells
supplied,
4. identify recipients in health facilities and
5. find and identify all the necessary data about products and
materials that come into contact with tissues and cells,
h) validation documented evidence which provides a high assurance that
the investigational process, standard operating procedure, part of the equipment or
environment repeatedly produces product that meets a predetermined
specifications and quality indicators; the process of validation of the means
evaluation of the performance of the system, which is required for its use,
I) serious adverse event any untoward occurrence
related to the procurement, testing, processing, storage or
distribution, which might result in hospitalization or illness,
where appropriate, the extension of the hospitalization or illness, or that could
lead to death, life-threatening, damage health, ability,
or to diseases transmitted by tissues and cells,
j) serious adverse reaction an unexpected response of the donor or recipient,
including a communicable disease, related to the procurement or use of tissues and
in human cells, which results in hospitalization, illness, or
prolongation of hospitalization or illness, or that results in the
death, life-threatening, damage to health or ability,
k) tissue provider, whose business is in
processing, storage and distribution of tissues and cells, as appropriate, in
procurement or testing of tissues and cells; tissue establishment is also
Tissue Bank ^ 4); This activity can also be done to one site
the provider,
l) rotations of the device provider, whose business is the taking
tissues and cells or in the implementation of this operation, and does not provide
the other activities referred to in subparagraph (k)); This activity can also perform one
site provider
m) diagnostic laboratory, laboratory, which performs laboratory
the examination of samples of biological material taken to donors for
assessment of the medical fitness and donor selection,
n) Member State of the European Union (hereinafter referred to as "Member State") and Contracting
State to the agreement on the European economic area.
§ 3
(1) the tissue establishment, sampling devices and diagnostic laboratory may
to carry out activities under this Act only if the
provider authorisation granted pursuant to § 19 of the activity, if not
unless otherwise provided for. This permit is not required for reception equipment,
carried out by the procurement of tissues and cells for the tissue establishment pursuant to § 10
paragraph. 2 (a). (b)); This does not apply in the case of laboratory investigations for the
assess the eligibility and selection of donors of tissues and cells.
(2) Physical persons handling tissues and cells are required to
and ensure maximum usefulness) tissues and cells when you use them in
humans and reduce to the lowest possible level of inherent risks for
man,
(b)) in the event of serious adverse events, serious adverse
reactions suspected or perform promptly all available
measures to provide redress and to limit the adverse
exposure to the lowest possible level,
(c)) to communicate information in accordance with the procedures referred to in paragraph 3 (b). (e)),
(d)) to dispose of the packaging of tissues and cells, in accordance with the indications and instructions
listed on the packaging or attached to the packaging.
(3) providers handling of tissues and cells shall ensure
and) tracking serious adverse events, serious adverse reactions or
suspicion on them,
(b)) the notification, assessment, recording and reporting of serious adverse
events, serious adverse reactions suspected or according to § 5
paragraph. 3 and the provision of information about them; at the same time urgently ensure that restrictions
adverse impacts of these events, reactions or suspected on
the lowest possible level; the method and scope of the reporting of serious adverse
event or serious adverse reaction or suspicion on them, their
assessment and evaluation, including the determination of causes and the adoption of measures
down implementing legislation,
(c)) and protection of the data anonymization, including genetic information,
gathered under the compliance with the requirements of this Act so that the donor
nor the consignee could not be identified; permission to access the data
required for the handling of tissues and cells in a healthcare facility
provides a service provider
d) leadership and maintain records of tissues and cells and dealing with them,
including the keeping and preservation of records that enable traceability at
they have undertaken activities in a way that does not infringe the
data protection under subparagraph (c)); traceability must be ensured after
for at least 30 years from the use of tissues and cells; the minimum range of records
that enable traceability, the way their leadership and retention provides
the implementing legislation,
e) introduction and use procedures for the provision of information, which is not
violated data protection under subparagraph (c)), and measures against illegal
the provision of this information, including the provision of information for
traceability and carrying out checks on quality and safety.
(4) a tissue establishment, sampling devices and operator of diagnostic
the laboratory shall immediately notify the findings of the risk of transmission of diseases of tissues and
cells or doubts as to whether some laboratory tests should be
properly done, the responsible person of the tissue establishment or reception
device for which examined samples of biological material taken
donors (hereinafter referred to as "sample from the donor").
(5) providers are required to ensure compliance with the written instructions
tissue establishment, the handling of tissues and cells of total
This tissue establishment for distribution and use, and in the case of
assisted reproduction, also written instructions of the provider, in whose
the medical equipment was carried out the artificial insemination of a woman on
the disclosure of the pregnancy and newborn health
where appropriate, of the fetus.
(6) persons handling of tissues and cells are required to proceed
in accordance with the instructions of the uveřejňovanými State Institute for drug control
(hereinafter referred to as "the Institute"), pursuant to section 24.
TITLE II
TISSUE ESTABLISHMENT, SAMPLING DEVICE, DIAGNOSTIC LABORATORY, THE CONTRACTING
SOME OF THE ACTIVITIES OF THE TISSUE ESTABLISHMENT
Part 1
Tissue establishment, sampling device, diagnostic laboratory
The tissue establishment
§ 4
(1) the tissue establishment processes 1. March of each year, an annual report
on the activities of the tissue establishment for the previous calendar year. This
report no later than that date, shall be published in a manner allowing
remote access. The form and content of the annual report sets out the detailed legal
prescription.
(2) in the event of termination of the activity of the tissue establishment shall ensure that the provider
retention of samples from the donor and documentation on the traceability and
the availability of the stored tissues and cells for the purpose of their use.
Provider within 15 days from the date of termination of the activity of the tissue establishment
the Institute shall notify the way to ensure the obligations under the first sentence and request
cancellation of an authorisation of activities under section 20 (2). 3.
§ 5
(1) the tissue establishment shall ensure
and) create and maintain a quality system for security requirements
1. Organization and management of the tissue establishment with a focus on quality,
2. the selection, assessment, and professional competence and training personnel
involved in the activities of the tissue establishment
3. documentation, including records, so that the activity of tissue
the device identified, recorded and properly conducted, documentation
4. the premises and equipment used by the products and materials to
correspond to the purpose of their use and for the recipient and the person referred to in paragraph 2
represented a minimal risk, including requirements for workflows, and
5. review of the efficiency of the quality system, the implementation of internal controls and
the adoption of any measures to remedy, in order to prevent
adverse deviations, as appropriate, their repetition, and in order to
improvement of the quality system; the implementing legislation lays down requirements
on the establishment and maintenance of a quality system that directly or indirectly
contribute to the quality and safety of tissues and cells, in accordance with paragraphs 1 to
5,
(b)), the selection and use of such products and materials coming into
contact with tissues and cells,
1. which does not adversely affect the quality and safety of tissues and cells,
2. that are listed in the procedures approved in the context of enabling activities
the tissue establishment or its changes and
3. the quality is validated before use,
(c)) in the procurement procedures and requirements pursuant to § 7 para. 1 (b). b) to (d))
and use only the tissues and cells that meet the requirements for approval for
processing; the requirements for the receipt, review and approval, or decommissioning of
tissues and cells to be processed, and the records of these tissues
and cells laid down detailed legislation,
(d)) that the procedures, which may influence the quality and safety of tissues and cells,
have been
1. implemented and carried out in accordance with the European Pharmacopoeia and the Czech
the guidelines of the European Pharmacopoeia Commission (hereinafter referred to as "the Commission") and the European Medicines Agency
Agency (hereinafter referred to as "the Agency"),
2. follow the standard operating procedures of the tissue establishment and
under controlled conditions so as to ensure consistency between the
each of the products of the same type,
3. validated before their introduction, and before the introduction of any changes that
may influence the quality and safety of tissues and cells, and validations
at regular intervals,
and so that was the guaranteed quality and safety; the requirements for the
procedures, in particular effects on the quality and safety of tissues and cells,
including procedures for processing, packaging, labelling, dismissal for
distribution and use, storage, distribution and distributed download
tissues and cells, lays down the law so as to
ensure that it cannot be adversely affected by the quality and safety of tissues
and cells
(e)) a system for the identification and traceability
1. tissues and cells and donors; to that end, each, every
donation and each pack of tissues and cells, which it assigned
a unique code,
2. each package of tissues and cells during their collection, processing,
When you release and distribution, or disposal,
3. products and materials that come into contact with tissues and cells,
and
4. all legal and natural persons engaged in business that made him
or take the tissue and cells;
How to create unique codes for the identification of the donation and
the final packaging of tissues and cells laid down detailed legal prescription,
f) control system of quality and safety, and for the implementation of these
checks must be
1. the necessary equipment, facilities and procedures
2. the use of the in vitro diagnostic medical devices according to the law
on medical prostředcích5), or that have been validated for
the intended purpose of use,
3. the laboratory checks carried out by persons who are independent
the tissue establishment to other workplaces, and
4. the records kept, allowing to reconstruct the conditions, performance,
the evaluation and the conclusions of the inspection; the records must be retrievable;
quality control and safety range and the requirements for their implementation,
including the scope of the laboratory tests on the samples from donors and
their implementation, and the retention period of records down detailed legal
prescription,
g) how packaging, including the packaging and storage processes, which is
guaranteed maintenance of the quality and safety of tissues and cells, and the functionality and
the integrity of each package of tissues and cells,
h) the procedures and conditions that guarantee the maintenance of the quality and safety of
tissues and cells in their distribution, and the procedures and conditions for precise
fast download of demonstrable and distributed tissues and cells from the next
use,
I) procedures for processing of applications for the provision of tissues and cells, including
the rules for allocation of tissues and cells for the beneficiary and for the
the provider of the medical device with the tissues and cells
provide, and documenting these procedures and also to the rules
put forward for allocation of tissues and cells has been informed by the patient,
where appropriate, the provider, and on request,
(j)) to avoid confusion of tissues and cells and their pollution; shall establish a
procedures for the handling of tissues and cells to be discarded,
including the protection of the environment and the people and pollution of these tissues
cells,
PS) at the distribution of tissues and cells adhering to the rules of good distribution
practice; the rules of good distribution practice for distribution of tissues and cells
down detailed legislation.
(2) the tissue establishment, in the case of tissues and cells by redundant for
distribution and use, shall ensure that the
and) have been established, validated and applied the criteria of quality and safety
tissues and cells and the shelf-life of tissues and cells following the
the conditions of storage; in the case that during the period of application of the
as a result of new knowledge changes the criteria the quality or safety of tissues
and the cells so that it can be adversely affected by the safety and
the effectiveness of treatment, based on a risk assessment, the unused tissue and
cells from therapeutic use; the scope of the criteria of quality and safety
down implementing legislation,
(b)) was established and validated therapeutic and adverse effect of the tissues and cells
in the case of tissues and cells intended for use in the treatment of the recipient,
(c)), were available from a donor retained samples for laboratory examination,
d) each package of tissues and cells to be made redundant was accompanied by guidelines for the
their customer, and details of the packaging, including the packaging and identification
identification of the tissue establishment packaging; sacked the guidelines and the
particulars on the packaging of tissues and cells, where applicable, are included as
part of each package,
(e)) will not be released, distributed and applied to a man no
Pack of tissues and cells are not met the quality requirements, and
the safety of these tissues and cells and the requirements of this Act,
(f)) of each package of tissues and cells were kept traceable records
enabling the creation and reconstruct his use, or removal,
g) procedures and data correspond to the procedures and the data referred to in the application for
enabling activities pursuant to § 17 para. 3 (b). a) and b) authorized under section 19
paragraph. 1.
(3) a tissue establishment if it made redundant tissue and cells for
distribution and use by or on the tissues and cells distributed it from a Member
the State or imported from a country other than the Member State (hereinafter referred to as
"third country"), shall ensure
and in the case of) serious adverse events, serious adverse reactions or
suspected
1. notification of this fact immediately to the Institute,
2. their investigation without undue delay, including analysis of the causes,
3. notification without delay the conclusions of the investigation under point 2 and of the measures taken
Of the Institute and to the persons concerned; in the case of risk of diseases transmitted by
tissues and cells, or to subsequently identified a risk,
shall notify the Institute, suppliers and customers of tissues and cells and
the competent authority to protect public health ^ 6)
(b)) that the provider that to treat the beneficiary uses these tissues and
the cells will be provided written instructions on how
1. how to be traceability requirements are no longer met,
2. How should be followed when reporting of serious adverse
events, serious adverse reaction or suspicion on them and
3. which data on the information referred to in points 1 and 2, and how to
be provided to the tissue establishment.
§ 6
(1) the tissue establishment shall ensure the proper carrying out of the activities referred to in paragraph 3
the responsible person of the tissue establishment.
(2) a professional prerequisite for the performance of functions of the responsible person of the tissue
the device is properly completed undergraduate studies involving at least 4
years of theoretical and practical training in the field of pharmacy or General
medicine ^ 7), biochemistry or biology, and at least 2 years of professional experience in the
the tissue establishment or donor device, or 2 years of vocational
experience in the activities of similar activities of the tissue establishment.
(3) the responsible person of the tissue establishment shall be responsible for the
a) tissues and cells are procured, processed, stored, evaluated and
distributed and each pack of tissues and cells is placed in accordance with the
This Act; release of tissues and cells and the purpose for which the tissues and
the cells are released, the responsible person shall acknowledge his signature,
(b)) the quality system of the tissue establishment is operated and managed in accordance with the
This law,
(c)) is provided, traceability
(d) the Institute provided information) for the purpose of enabling activities
tissue establishment and authorization changes
(e)) are carried out by the measures required by the Institute, which is about their
the implementation of informed,
(f)) are collected data for the annual report referred to in section 4, paragraph 4. 1,
g) is fed the obligation of notification according to § 5 para. 3 (b). and)
h) access to the protected data is permitted only in accordance with the permissions
According to § 3 (2). 3 (b). (c)).
(4) if the Department submits a complaint because of serious violations of the
the duties of the responsible person of the tissue establishment referred to in paragraph 3
(a). and) shall immediately notify the tissue establishment and the responsible
to the person that the person responsible not to the termination of the proceeding in the matter
to carry out the activities referred to in paragraph 3.
Sampling device
§ 7
(1) reception equipment shall ensure
and) procedures and requirements referred to in § 5 para. 1 (b). a), b), (d)) to (f)), and (j))
extent appropriate to the activities carried out,
(b)) the procurement of tissues and cells from the donor to the donation of tissues and cells
It was not a source of financial or other compensation; the donor may only receive
refund efficiently, economically and demonstrably incurred expenses related
with your donation,
(c)) in the procurement of tissues and cells
1. identification of the donor
2. lessons learned by the donor, his legal representative or relatives and
the provision of information about donation and procurement under the law governing
implementation of the transplantation ^ 3), in the case of tissues and cells intended for
transplantation, or under the law governing the provision of health
Services ^ 8), including the provision of information about capturing data on donors and about
their protection,
3. the donor, his legal representative, where appropriate, of the right to request
information on the findings resulting from laboratory tests and the
explanation, including the provision of information and explanations when they
required,
4. consent to collection and the conditions and admissibility of the subscription according to the law
relating to the implementation of the transplantation or the law governing health
care,
5. assessment of the health of the donor and donor selection,
6. the collection, marking, packing, transport and transfer of tissue and cells
tissue establishment; a subscription makes the only requirements are met
in accordance with points 1 to 5;
in the case of tissues and cells that are not subject to modification according to the law
relating to the implementation of the transplantation or the law governing health
care and that are intended for processing under this Act and to use
in the treatment of the recipient, shall apply to the procedure provided for in points 2 and 4 apply mutatis mutandis
the law regulating the implementation of the transplantation; the scope of the requirements for the
procurement and on the procedures to be performed when the procurement of tissues and cells referred to in
points 1 to 6, including the scope of the data to identify the donor, the range
the information provided in the donation of tissues and cells and the definition of criteria
for the assessment of medical fitness and selection of donors of tissues and cells for
autologous use of tissues and cells, which means the tissue and cell procurement and
their use by the same person, and the use of tissues and cells of allogeneic,
which means the tissue and cell procurement to one and their use in
another man, lays down the law so as not to
adversely affected by the quality and safety of tissues and cells and ensure the
protection of the donor, recipient and of the future child of assisted reproduction,
(d)) the implementation of sampling from the donor, including collection of samples, retained
and unambiguous identification of the sample from the donor for each donation of tissues and
cells; requirements for samples from the donor lays down implementing legislation,
e) to tissues and cells have been provided only a tissue establishment which
tissue and cell processing and be released, including tissues and cells
intended for use in the manufacture of medicinal products ^ 2); the requirements for the
the provision of tissues and cells in a tissue establishment shall lay down detailed legal
prescription.
(2) in the event of termination of activities of reception equipment shall ensure
the persistence provider documentation and traceability. Provider within 15
days from the date of termination of the activities of the Institute shall notify the way sampler
to ensure the obligations under the first sentence and request revocation of authorisations
activities under section 20 (2). 3.
§ 8
(1) the Sampling device shall ensure the proper carrying out of the activities referred to in paragraph
3 the person responsible reception equipment.
(2) a professional prerequisite for the performance of functions of the responsible person of the sampler
the device is properly completed undergraduate studies involving at least 4
years of theoretical and practical training in the field of pharmacy or General
medicine, biochemistry or biology and at least 1 year of professional experience in the
the tissue establishment or donor device.
(3) the responsible person reception equipment is responsible for that
a) tissues and cells are procured in accordance with this Act,
(b) the quality system) reception equipment is operated and managed in accordance with the
This law,
(c)) are the Institute provided information for the purpose of enabling activities
sampler and the changes to the authorization,
(d)) are carried out the measures required by the Institute, which is about their
making informed.
§ 9
Diagnostic laboratory
(1) the operator of a diagnostic laboratory, which may be a legal
or individual entrepreneur, shall ensure that the procedures and requirements referred to in § 5
paragraph. 1 (b). a), d) and (f)) to the extent appropriate for your work.
(2) in the event of termination of the activities of the diagnostic laboratory shall ensure that its
the operator maintaining the documentation. The operator shall, within 15 days from the date of
termination of the activities of the Institute shall notify the way diagnostic laboratories
to ensure the obligations under the first sentence and request revocation of authorisations
activities (section 20 (3)).
Part 2
Contracting to ensure some of the tissue establishment
§ 10
(1) the tissue establishment that tissues and cells processes and be released for
distribution and use, an activity that consists in procuring,
investigation or distribution, or part of an activity that is part of the
procurement, testing, processing, storage or distribution, enter
on the basis of a written contract.
(2) the tissue establishment may conclude the contract referred to in paragraph 1 only with
and) tissue establishments, rotations of the device or by the operator
diagnostic laboratories, where they are to enable permission for
the activity concerned,
(b)) rotations of the facility which carried out the procurement of tissues and cells
the conditions and in accordance with the requirements and procedures established tissue establishment,
which of these tissues and cells, and if it takes over the Department verifies and approves this
the procurement of tissues and cells under the authorisation of the activity of tissue
equipment referred to in section 17 to 20, or
(c)), which is the provider holds a document like an authorisation under
(a)) issued by the authority of the Member State competent for tissues and
of the cell.
(3) if it is only for distribution pursuant to section 2 (a). (e)), the tissue establishment
enter into a contract of carriage of tissues and cells with a legal or
entrepreneurial natural person who is not an operator referred to in
paragraph (2). This person shall be the holder of a permit to distribution of tissues and
cells issued pursuant to section 20a.
(4) the tissue establishment may conclude the contract referred to in paragraph 1 whether or not
the provider that is authorised in accordance with the law on pharmaceuticals ^ 2)
in which this activity is included and it is an activity carried out within the
the investigation of laboratory samples, or a part of the activities carried out in the
the processing of tissues and cells.
(5) the tissue establishment referred to in paragraph 1 shall lay down the requirements for the supplied
products, materials and services, in a written contract concluded with the
the supplier, if this is necessary to ensure the quality and safety of tissues and
cells.
(6) the treaties referred to in paragraphs 1, 3 or 5 must be demonstrated to be accomplished
for the activities provided on the basis of the requirements of this Act and that
There is no change that could have an impact on the findings of the quality and
the safety of tissues and cells of the tissue establishment; Tissue establishment leads
registration of contracts and provide a copy of the contract the Institute upon request.
(7) the liability of the tissue establishment that tissues and cells are permeable to
distribution and use, in compliance with the requirements of this Act and for the quality and
the safety of these tissues and cells is not the provisions of paragraphs 1, 5 and 6
without prejudice to the.
TITLE III
IMPORTS AND EXPORTS OF TISSUES AND CELLS BETWEEN THE CZECH REPUBLIC AND THIRD COUNTRIES AND
THE DISTRIBUTION BETWEEN THE CZECH REPUBLIC AND THE MEMBER STATE
§ 11
(1) imports of tissues and cells from third countries for their use in the treatment of
the recipient is authorized to ensure that tissue establishments, if
and) are not available suitable tissue and cells originating in the United
Republic or from another Member State meeting the requirements of this
the law,
(b) the holder of the authorization) is the activity with permission to lay off workers and
distribute type of tissues and cells, which are the subject of imports, or
comparable type of tissues and cells,
(c)) the conditions for importation under the provisions of the law governing
implementation of the transplantation ^ 3), even in the case where the imported tissues and
the cells are not intended for transplantation,
(d)) at the taking, testing, processing, storage, transport and
delivery of imported tissues and cells quality requirements are met, and
security equivalent to the requirements under this Act; compliance with these
the requirements of the operator proves that the importation is carried out; If it is not
operator requirements on quality and safety show examines the compliance with
These requirements on the basis of his application the Institute; for the submission of the application
and a decision on it shall apply the provisions of § 17-19 and § 20 para. 1 and 2
Similarly,
e) device in a third country, which carries out the operations referred to in point (d)),
similar authorization is holds a document under section 19 and
(f)) ensures that the part of the individual packages of tissues and cells are information about
packaging and instructions according to § 5 para. 2 (a). (d)) that are listed in the Czech language;
They shall also ensure unique identification of each package so that this marking
It was equivalent to code according to § 5 para. 1 (b). (e)), point 1.
(2) the export of tissues and cells to third countries for their use in the treatment of
the recipient is authorized to ensure that tissue establishments, if it
redundant tissue and cells for use, if the
and) exported tissues and cells comply with the requirements of this Act and the requirements of the
the legislation of the third country; meet the requirements of the legislation of the third
the country of the operator, proves the export takes place, the document issued by the
the competent authority of the third country; does not issue to such a document, you can
the fact attested Declaration of the operator,
(b) the holder of the authorization) is the activity with permission to distribute tissue and type
cells, which are the subject of the export; the tissue establishment can provide
distribution of tissues and cells from the tissue establishment to a third country
through a person, to be a tissues and cells in a third country
delivered, or in writing to the designated person, provided that the
distribution of tissues and cells under the legislation of the State in which they have
tissues and cells are to be delivered, and
(c)) the conditions for export under the provisions of the law governing
implementation of the transplantation ^ 3), even in the case where the imported tissues and
the cells are not intended for transplantation.
(3) imports of tissues and cells for use in the manufacture of medicinal products
preparations can be made, subject to the conditions referred to in paragraph 1
(a). (c)) and the requirements of the law on pharmaceuticals ^ 2).
(4) the export of tissues and cells for their use in the manufacture of medicinal products
preparations can be made, subject to the
and the conditions in paragraph 2) (a). (c)), and
(b) the requirements of this Act governing) the donation, procurement, testing
and the release of tissues and cells for use in the manufacture of medicinal products
products and the requirements of the legislation of the third country; meet the requirements of
the legislation of the third country can prove a tissue establishment of entry
these tissues and cells for the export document issued by the competent authority of the third
country; does not issue to such a document, you can certify this fact to the
Declaration of the tissue establishment.
§ 12
When the distribution of tissues and cells between the Czech Republic and the other Member
the State shall apply section 11 apply mutatis mutandis.
section 13 of the
Urgent need for tissues and cells
(1) the distribution of the Member State, or importation from a third country in the case of
urgent needs of the tissues and cells for use in treating a specific
the recipient ensures a tissue establishment which is the holder of the authorisation
activity. As part of this authorization must be permission to distribute type
tissues and cells, or comparable type of tissues and cells, and in the case of
imports from a third country, whether or not permission to batch these tissues and cells.
(2) implementation of distribution or import referred to in paragraph 1 shall notify the tissue
equipment Ministry of health immediately, but no later than 3
working days from delivery of the tissues and cells to the provider for use in
the treatment of the recipient. Notification shall determine the form and extent of detailed legal
prescription.
(3) when the distribution referred to in paragraph 1 may be tissue and cells are removed
only from a device that holds a similar authorisation document
the activity of the tissue establishment issued by the authority of the Member State competent
for tissues and cells.
(4) it is necessary to make the imports referred to in paragraph 1, it is a condition of importation
consent of the responsible person of the tissue establishment and the treating physician,
After evaluating the risks and benefits of the use of tissues and cells for
a particular recipient.
TITLE IV
THE AUTHORITIES OF THE EXECUTING STATE ADMINISTRATION IN THE AREA OF TISSUES AND CELLS
§ 14
The Ministry of health
The Ministry of health
and) supports the procurement of tissues and cells to non-profit manner and measures for
to ensure availability and self-sufficiency in their field of application,
(b)) decides on appeals against decisions of the Institute issued pursuant to
This law,
(c)) shall inform the Commission about the
1. measures taken for the development of voluntary unpaid donation
tissues and cells every three years,
2. legislation adopted in the field governed by the laws of the
The European Union ^ 1).
§ 15
The State Institute for drug control
(1) the Institute
and, decisions) under this Act,
(b) compliance monitoring) of this Act,
c) monitors the occurrence of, solutions and reviews of serious adverse reactions,
serious adverse events or suspected; of the notified
serious adverse reactions and events shall be provided once per year
the report of the Commission; information about any serious adverse reactions and events
provides the competent authorities of the Member States to ensure the
appropriate measures to ensure that any defective tissue and cells are not used,
(d)) shall be decided in cases of doubt, whether it is a tissue and cells
the processing, storage and distribution provisions of the
of this Act.
(2) in the area of quality and safety of tissues and cells, the Institute provides
and) cooperation with the relevant authorities of the Member States, the Commission and the Agency,
including representation in working groups and committees of these bodies;
on a reasoned request by the competent authority of another Member State, or
The Commission Department of inspections and provides information about the results of
the checks and, where appropriate, the control measures carried out in accordance with this
the law,
(b)) it held information systems link with information systems
the Member States and in relation to these systems ensures the exchange of information
required by the regulations of the European Union, as well as the exchange of other information
requested by the Commission,
(c) submission of reports to the Commission in accordance with) its requirements on the activities
carried out under this Act, including a report on the measures taken in
connection with the exercise of control, every 3 years by 7.
April of the year concerned,
(d) publication of the information, instructions) and other records under § 24 para. 1.
TITLE V OF THE
CONDITIONS FOR THE HANDLING OF TISSUES AND CELLS
Part 1
Eligibility for the handling of tissues and cells
section 16 of the
(1) to dispose of the tissues and cells in their donation, procurement,
testing, processing, storage and distribution can only physical
persons over 18 years of age, eligible legal capacity, good repute, disabled and
competent for a specific kind of activity in accordance with the requirements of
created and maintained by the operator within the quality system.
(2) the condition of completion of 18 years of age referred to in paragraph 1 shall not apply to persons
handling of tissues and cells when teaching.
(3) Physical persons handling of tissues and cells that are not
health care professionals or other professionals under the laws
governing the competence to work in the medical profession ^ 9)
considered to be good for the purposes of this Act, if you have not been
condemned to imprisonment for an intentional criminal offence
committed in connection with the handling of tissues and cells, or with
human drugs. Meet the conditions of integrity shall be evidenced by a statement of
criminal record or document corresponding to the extract from the register of
Criminal record issued by both the State, which is a natural person
citizen, as well as the States on whose territory the natural person in the last
3 years continuously resided for more than 6 months. If the State specified
in the sentence the second condition of integrity does not endorse, this shall be documented
meet the natural person its Declaration. Documents or statements in a foreign
the language must be accompanied by a notarized translation into the Czech language.
Part 2
Enabling activities
§ 17
(1) an application for a permit activity shall contain the
and) a document certifying that it is a service provider, or a document certifying
that it is a legal entity or a natural person-entrepreneur who operates
Laboratory,
(b) the proof of right to use) premises and equipment for activities that are
the subject of the request, and
(c)) the data and documentation demonstrating the applicant's prerequisites to fulfil
obligations under this Act.
(2) an application for authorization of the activity of the tissue establishment or reception
the device also contains
and advanced data types) tissues and cells and
(b)) documents certifying performance requirements for the responsible person
According to § 6 paragraph 1. 2 or § 8 para. 2, including the data necessary for its
identify, to the extent the name or names, and surname and
contact details.
(3) the application for authorisations for the activities of the tissue establishment of tissue
and cells for distribution and use also includes data and documentation
and about to be made redundant) tissues and cells directive and procedures provided by the tissue
the device,
(b)) about the therapeutic effect, where appropriate, tissues and cells, and on its
validation and
(c)) for the assessment of the risks that tissues and cells may represent.
(4) the structure, scope and requirements of the data and documentation
referred to in paragraphs 1 to 3 shall adopt detailed legislation.
section 18
(1) the Institute shall decide on the application for authorisation of activities within 90 days of its
delivery.
(2) the Institute may request from the applicant additional information and documentation for the
decision on the application. The Department may carry out investigations on the spot
the projected activities of the applicant for the purpose of verification of the facts referred to
in the application and prerequisites to fulfil the provisions of this Act. If it finds the Institute
deficiencies in writing ask the applicant to remove them within a specified
the time limit and procedure for issue of the permit activity is interrupted. If the applicant
deficiencies within the prescribed period, the Institute shall reject the application.
§ 19
(1) the Institute shall issue the authorisation after verification of the facts referred to in
application and verification of the assumptions of the applicant to fulfil the obligations laid down in
This Act.
(2) the Institute in the authorization decision shall indicate the scope of activities and activity type
tissues and cells, for which the permit is issued. The Institute may, in a decision on the
enable save specific obligations, where appropriate, conditions,
resulting in particular from the specific nature of tissues and cells, or
their use, or from the specific nature of the procedures.
section 20
(1) the tissue establishment, sampling equipment or operator of diagnostic
the laboratory is obliged to ask the Department of a change enabling activities
the case of the proposed changes from the conditions under which authorization was
released; Similarly, in the case of changes to the proceeds of the responsible person or changes
activities, or part of the activity, provided by contract under s. 10
paragraph. 1. The change request must contain information about a requested change in
extent provided in section 17. The Institute on the application shall decide within 30 days from the date of
its delivery, and shall proceed pursuant to section 18 and 19 shall apply mutatis mutandis. In the case of
When it is necessary to perform investigations on the spot, makes this a period of 90 days.
(2) changes to the information necessary to ensure the cooperation of the Institute with the holder
enabling activities, and especially the change of telephone connection, a fax number,
e-mail addresses and home pages of the information resource
enabling remote access, is the holder of the authorization of the activity required to
immediately notify the Institute. The amendments referred to in the first sentence of paragraph 1
does not apply.
(3) the activities of the Institute shall cancel, on request, to whom it was issued,
where applicable, under the conditions provided for in § 22 para. 3.
(4) if the holder of the authorization of the activity for at least 3 years from the date of
legal force of this authorization does not carry out the activities referred to in this
permit or for 3 years breaks the conduct of these activities,
permit activity ceases.
section 20a
(1) the authorization of activities may be restricted only to the authorization to distribute
tissues and cells. For the content of the request for authorisation to distribution of tissues and cells
the provisions of § 17 he; the request shall be submitted to the Institute and shall contain
and) a document certifying that it is a legal entity or a physical business
person,
(b)) the procedures and conditions that guarantee the maintenance of the quality and safety of
tissues and cells in their distribution,
(c)) the procedures and conditions for precise, fast, and available for download
distributed to tissues and cells from further use,
(d)) the data and documentation demonstrating the applicant's assumptions when you distribute
of tissues and cells comply with the obligations under this Act.
(2) the structure, scope and requirements of the data and documentation
referred to in paragraph 1 shall lay down detailed legislation.
(3) when deciding on the application for a permit to distribution of tissues and cells
referred to in paragraph 1, the Institute shall proceed pursuant to section 18 and 19 apply mutatis mutandis and for changes
This permit, its cancellation and termination of section 20 shall apply mutatis mutandis.
(4) for the holder of the authorization for distribution of tissues and cells are present when their
distribution of the same obligations as the operator in its implementation
the tissue establishment. The holder of the authorization for distribution of tissues and cells is
obliged to distribute them to follow the rules of good distribution
the practice laid down by the implementing regulation issued pursuant to § 5 para. 1
(a). k).
TITLE VI OF THE
CONTROL ACTIVITIES AND MEASURES
section 21
The Institute checks whether compliance with the requirements of this Act; checks
performs
and) in medical establishments in which is treated with tissues and
cells; in the case of tissue or sampling device at least once every 2
for years,
(b)) if there has been or there is a suspicion that there has been a serious adverse reaction
or serious adverse events
(c)) for legal or natural persons-entrepreneurs, which provide
performance resulting from contracts concluded in accordance with § 10.
section 22
(1) the Institute will disable the distribution of tissues and cells, imports of tissues and cells from third
country or the use of tissues and cells, or require their withdrawal from the use of,
If appropriate, remove them and at the same time lays down the scope of the prohibition, withdrawal
or delete, if
a) tissues and cells are or may be under normal conditions of use
harmful,
(b)) tissues and cells have therapeutic efficacy,
c) health risks outweigh the advantages of tissues and cells, or
(d) a serious breach of) the obligations laid down in this law.
(2) the Institute may, depending on the nature and seriousness of the findings, suspend or
cancel the permit activity in whole or for a specific
action, procedure, or for a particular type of tissues and cells, if
and the data is changed or) conditions to enable authenticated and is not
obligation to report changes, or
(b)) the obligations laid down in violation of this Act. In the decision
the suspension of the Institute provides for limitations of rights and duties during the suspension and
define the time limit for the removal of the causes of the suspension. The appeal against the
the decision to suspend does not have suspensory effect.
(3) the Institute in the case of danger to life and health of human tissues and cells
forthwith inform the persons whose activities are
risk refers to, and persons who may be affected. The authorities of the executing
State administration in the area of tissues and cells and health care, the regional offices,
a professional organization of physicians, health insurers and providers ^ 10)
on request, the Institute shall provide the data necessary for the
search for exposed persons.
Article 23 of the
(1) a natural person who is entrusted with the activities of the Institute, (hereinafter referred to
"the Inspector") shows evidence of the Inspector, if the employee
The Institute, or a written authority to the individual inspection, if it is a different
person.
(2) inspectors may in the event of a finding that the person violated the controlled
seriously the conditions and obligations laid down by this law,
pause
1. the authorisation of activities
2. the exercise of permissions resulting from decisions issued in accordance with the laws of the
governing health care ^ 12)
3. the distribution or use of tissues and cells.
TITLE VII
PUBLICATION OF DATA
section 24
(1) the Institute exposes the way allowing remote access
and lists of permit holders) activities, with an indication of the range of activities
(b)) information about serious adverse events and serious adverse
the responses and information on the actions of the Institute,
(c)) for information about decisions taken under this Act,
(d)) the Commission guidelines, the Agency and the Institute relating to the conditions for
ensure the quality and safety of tissues and cells.
(2) disclosure or provision of information relating to the quality and
the safety of tissues and cells with a major impact on the health or life of persons
It is not considered a violation of business secrets by the Special
legal regulation ^ 1).
TITLE VIII
ADMINISTRATIVE OFFENCES
§ 25
(1) a legal entity or individual entrepreneur is committed by the administrative
tort by improperly treated with tissues and cells.
(2) tissue establishments, sampling device, or other provider
handling of tissues and cells committing an administrative offense to the fact that
contrary to the
§ 3 (1)). 3 (b). (b)) does not ensure
1. the notification of serious adverse events, serious adverse reactions or
suspicion on them, or
2. the provision of data,
(b)) § 3 (1). 3 (b). (c)) does not provide data anonymization, or
(c) section 3 (2)). 3 (b). (d)) does not ensure traceability for at least 30 years
from the use of tissues and cells.
(3) tissue establishments, sampling device, or other provider
handling of tissues and cells, or the operator of a diagnostic
the lab is guilty of an administrative offense that does not delete lack of,
which was imposed pursuant to § 23 para. 2 (a). and).
authorization for the distribution of tissues and cells in commits an administrative offense by
contrary to section 20a para. 4 when their distribution violates the rules
good distribution practices.
(4) a tissue establishment, sampling equipment or operator of diagnostic
the lab is guilty of an administrative offense, by
and fails to comply with the notification requirement) section 3 (2). 4,
(b)) does not provide the records referred to in § 5 para. 1 (b). (f)), paragraph 4
or their traceability,
(c)) does not ensure that the tissue and cells treated with a natural person complying with the
the requirements pursuant to § 16 para. 1, or
(d)) performs an activity contrary to the enabling activities under this Act.
(5) the tissue establishment or sampling device is guilty of an administrative
offense that does not ensure
and the use of such products only) or materials that are defined in the
§ 5 para. 1 (b). (b)),
(b) under section 5) identification of the paragraph. 1 (b). (e)),
(c)) to the responsible person function performed by a person meeting the requirements of
According to § 6 paragraph 1. 2 or § 8 para. 2,
d) contrary to section 7 (2). 1 (b). (b)), to the donation of tissues and cells could not
source of financial or other compensation, or
(e)) in the procurement of tissues and cells, the procedure under § 7 para. 1 (b). (c)).
(6) the tissue establishment commits an administrative offense, by
and) contrary to section 4 (4). 1 shall not publish an annual report,
(b)) does not ensure in violation of § 5 para. 1 (b). (c)) use only such
tissues and cells comply with the requirements for their approval for
processing,
(c)) shall ensure that the import, export or distribution of tissues and cells, contrary to section 11
or in violation of § 5 para. 1 (b). PS) at the distribution of tissues and cells
violates the rules of good distribution practice, or
(d) fails to comply with the notification obligation) in accordance with § 13 para. 2.
(7) a tissue establishment, in the case of tissues and cells by redundant for
distribution and use, is guilty of an administrative offense that does not ensure in
conflict
and) § 5 para. 2 (a). Download unused) tissues and cells,
(b)) § 5 para. 2 (a). (e)), not to be released, distributed or
used in humans, a pack of tissues and cells, which does not meet the requirements for
the quality and safety of tissues and cells, or the requirements of this Act, or
(c)) § 5 para. 2 (a). (g)), to procedures or data reflect the data or
procedures referred to in the request.
(8) a tissue establishment, in the case of tissues and cells by redundant for
distribution and use by or distributed by the tissue and cells from a Member
the State or imported from a third country, is guilty of an administrative offense
that fail to comply with the obligation of notification according to § 5 para. 3 (b) of point 1)
or 3.
(9) the Sampling device is guilty of an administrative offense that does not ensure
the provision of tissues and cells referred to in § 7 para. 1 (b). (e)) only the tissue
device.
(10) the provider is guilty of an administrative offense by that, in the case of
termination of the activity of the tissue establishment does not provide contrary to section 4 (4). 2
meet the requirements for keeping the documentation or traceability or
the availability of the stored tissues and cells for the purpose of use.
(11) an administrative offense shall be fined
and the 500 000 CZK), in the case of an administrative offence referred to in paragraph 2 (a). and)
paragraph 4 (b). (b)), paragraph 5 (b). and paragraph 6 (a)). and) and (d)), and
paragraph 8,
(b)) to 1 0000 0000 CZK in the case of an administrative offence referred to in paragraph 2 (a). (b)), and
(c)), paragraph 3, paragraph 4 (b). a), c) and (d)), paragraph 5 (b). b), c), and
(e)), paragraph 6 (a). (b)), paragraph 7 (b). a) and (c)), paragraph 9
paragraph 10,
(c)) to $ 3 0000 0000, in the case of an administrative offence referred to in paragraph 1, paragraph
5 (b). (d)), paragraph 6 (a). (c) and paragraph 7 (b)). (b)).
section 26
(1) a legal person for an administrative offence is not liable if he proves that
made every effort, that it was possible to require that the infringement of the
a legal obligation is prevented.
(2) in determining the amount of the fine on a legal person shall take account of the seriousness of the
the administrative offense, in particular, the way a criminal offence and its consequences, and
circumstances in which it was committed.
(3) the liability of a legal person for an administrative offense shall cease, if the
the administrative authority has commenced proceedings about him within 2 years from the date on which it
learned, but not later than 5 years from the day when it was committed.
(4) administrative offences under this law in the first instance hearing
The Institute, with the exception of administrative offences pursuant to § 25 para. 6 (a). (c))
committed by ensuring the import, export or distribution of tissues and cells
contrary to section 11 (1) 1 (b). (c)), section 11 (1) 2 (a). (c)), section 11 (1) 3
or section 11 para. 4 (b). and) and administrative offences pursuant to § 25 para. 6 (a).
(d)), the Ministry of health.
(5) The liability for the acts, which took place in the business
person ^ 14) or in direct connection with the applicable provisions of the Act
on the liability of legal persons and sanctions.
(6) income from fines is the State budget revenue.
TITLE IX OF THE
COMMON AND TRANSITIONAL PROVISIONS
section 27 of the
Reimbursement of expenses
(1) for the performance of professional acts at the request of the Institute chooses reimbursement of expenses.
The person on whose application to perform technical tasks connected with
enabling activities, the change in this permit, with the issuance of the certificate or
the opinions of, or with the control activities is required to pay the expenses,
incurred by the Institute. List of professional tasks and the amount of reimbursement of expenses for them
down detailed legislation.
(2) reimbursement of expenses referred to in paragraph 1 shall be kept in a special account
Of the Institute. The funds in this account uses the Institute directly to ensure your
activity.
(3) the Institute
and) is entitled to demand from the person on whose application the professional acts
to do this, or even a reasonable advance payment of expenses in advance,
It is clear that it will be carried out and what will be the amount thereof,
(b)) may, on application, waive the reimbursement of expenses or any part thereof, in the case of
actions whose implementation is in the public interest, or may have a particularly
significant implications for a wider range of people.
(4) the Institute returns to the person who provide reimbursement of expenses referred to in paragraph
1, at its request,
and the full amount of compensation), if the person has paid, without it being
obliged to, or required by a professional Act, has not been performed
(b)) the difference between the amount of the refund and the amount of the allowances provided
the implementing regulation,
c) a proportion of the paid compensation corresponding to the professional acts
until the end of the proceedings were not conducted.
(5) the Institute is also entitled to demand reimbursement of expenses for the execution of
Professional acts from the non-fulfilment or breach of duty
established by this Act has caused the need to perform such acts.
section 28
The use of social security numbers
The tissue establishment or sampling device is authorized under the conditions
stipulated by special legislation governing the protection of personal
^ 15) data record social security number for identification purposes of the donor. For
to this end, the operator shall be entitled to require the presentation of a document, in
where is your social security number. Social security number of the donor is kept for the purposes of
traceability in accordance with § 3 (1). 3 (b). (d)).
section 29
Powers of execution
The Department of health will issue a decree to implement section 3 (2). 3 (b).
(b)), and (d)), section 4, paragraph 4. 1, § 5 para. 1 (b). and (c)),) to (f)) and to), § 5 para. 2
(a). and, § 7 (1)). 1 (b). c) to (e)), § 13 para. 2, § 17 para. 4, section 20a
paragraph. 2 and section 27 para. 1 (a). 4 (b). (b)).
section 30
Transitional provisions
(1) operators of tissue establishments, power devices and
diagnostic laboratories, who on the date of entry into force of this Act
carrying out the activities covered by this law, under the law governing
implementation of the transplantation or under the law governing health care,
can carry out these activities for 6 months from the date of entry into force of this
the law. If within the time limit under the first sentence shall submit an application for authorisation
activities, they may carry out this activity until the acquisition of legal power
the decision on their application.
(2) operators of tissue establishments shall establish a system for the designation of
individual packages of tissues or cells, according to § 5 para. 1 (b). point 1 (e))
clear codes no later than six months from the date of entry into force of
of this Act.
(3) the information referred to in section 14 (a). (c)) and the report referred to in article 15, paragraph 2. 2 (a). (c))
the Commission will for the first time presented to the 7. April 2009.
PART TWO
cancelled
section 31
cancelled
PART THREE
cancelled
§ 32
cancelled
PART FOUR
cancelled
§ 33
cancelled
PART FIVE
Amendment of the Act on regulation of advertising
§ 34
Act No. 40/1995 Coll., on regulation of advertising and amending and supplementing Act No.
468/1991 Coll., on radio and television broadcasting, in
amended by Act No. 258/2000 Coll., Act No. 231/2001 Coll., Act No.
256/2001 Coll., Act No. 138/2002 Coll., Act No. 320/2002 Coll., Act No.
132/2003 Coll., Act No. 222/2004 Coll., the Act No. 326/2004 Coll., Act No.
480/2004 Coll., Act No. 384/2005 Coll., Act No 444/2005 Coll., Act No.
25/2006 Coll., Act No. 109/2007 Coll., Act No. 160/2007 Coll. and Act No.
36/2008 Coll., is amended as follows:
1. the following section is inserted after section 5b, 5 c, including the title and notes
line no. 17b is inserted:
"§ 5 c
Advertising promoting the donation of human tissues and cells
(1) advertising promoting the donation of human cells or tissues for the financial
remuneration or other comparable benefits shall be prohibited.
(2) advertising on the need for or availability of human tissues and cells
intended for use in humans, the purpose of which is, or which may
be used to obtain financial gain or comparable advantage, other
prohibited.
(3) paragraph 1 or 2 shall not preclude the provision of information and the prohibition
advertisement and advertising under the law governing the implementation of the
^ transplantation 17b).
17B), section 27 and 28 of law no 289/2002 Coll., on the donation, subscriptions, and
transplantation of tissues and organs and on amendments to certain laws
(the transplant law). ".
2. In article 7 (2). 1 (b). (b)), after the words "medicinal products"
the words "on human tissues and cells".
3. In § 8 para. 1 at the end of the letter m) deleted the word "or" at the end of
the letter n) dot replaced with a comma and following the word "or" and
the letter n) shall be supplemented with the letter o) is added:
"on the advertising that supports donation spread) of human tissues and cells that is
According to § 5 c disabled. ".
4. In section 8 paragraph 1. 4, after the words "paragraph 1 (b). and) "is inserted after the word",
about) ".
5. In section 8a of the paragraph. 1, the letter l) the following new point m) is added:
"m) spreads an ad promoting the donation of human tissues and cells, which is
According to § 5 c disabled ".
Letters m) to r) are known as the letters n) up to).
6. In section 8a of the paragraph. 5 (b)), the words "or q)" shall be replaced by ",
q) or r) ", and in subparagraph (c)), the words" or r) "shall be replaced by the words" or
with) ".
PART SIX
Change the transplant law
§ 35
Law no 289/2002 Coll., on the donation, subscriptions and transplantation of tissues and
authorities and on amendments to certain acts (the Transplant Act), as amended by
Act No. 228/2005 Coll. and Act No. 129/2008 Coll., is amended as follows:
1. in article 2 letter a) is added:
"a separate and viable) part of the human body, formed by
a structured arrangement of various tissues, which has zachovánu its
structure, blood supply and capacity to develop physiological functions with
a significant degree of autonomy, ".
2. In section 6 paragraph 2, including the footnote 7a is inserted:
"(2) for the assessment of medical fitness to the donor organ donation is
the responsibility of the medical device that performs the subscription. In the case of
the donation of tissues, an assessment of the medical fitness of the donor shall proceed
under the Act on human tissues and cells ^ 7a).
7A) Act No. 297/2008 Coll., on ensuring the quality and safety of human
tissues and cells intended for human applications and amending related
laws (law on human tissues and cells). ".
3. In section 6 (1). 5 after the word "donor" is inserted after the word "bodies".
4. In paragraph 7, at the end of paragraph 4, the following sentence "included with the consent of the
in connection with the collection of tissues is the definition of the purpose of its
use. ".
5. in paragraph 7, the following paragraph 7 is added:
"(7) medical device, in the case of consent in the context of sentencing
collection of the tissues, it shall provide a copy of this consent, or its amendment,
tissue establishment ^ 7a), which passes the tissue. A copy of the compliance agreement to the
the original confirm relying medical facility. "
6. In article 11 (1) 1 (b). (b)) and in section 11 (1) 3, the word "donor" is inserted
the word "authorities".
7. In article 11 (1) 1 (b). (b)), after the word "subscription", the words "; in
the case of the donation of tissues, an assessment of medical fitness
deceased donor shall proceed according to the law governing human tissues and
the cells ".
8. in section 18 para. 1, after the words "donors" and "transplantation", the words "tissues and"
be deleted and the word "donation" is added after the word "bodies".
9. in section 18 para. 3 and 4, after the words "donors" and "transplants" words
' tissues and ' shall be deleted.
10. in section 21 para. 1 (b). and) after the word "subscription" is inserted after the word "bodies", and
the words ' tissues and ' shall be deleted.
11. in paragraph 21 (1) (a). (b)) after the word "transplant" shall be replaced
"the authorities ' and the words ' tissues and ' shall be deleted.
12. section 21 para. 1 letter c) is added:
"(c)) in the case of tissues, provide data which will require Coordination
Transplant Center; the data provided must be anonymized,
so that neither donors nor recipients of tissues could not be identified, ".
13. in section 21 para. 1 (b). f), the words ' tissues and ' and ' tissues and ' shall be deleted.
14. in section 21 para. 1 letter i) reads as follows:
"i) have to import or export authorities, import or export permit (sections
26A to 26 g). ".
15. in article 21 paragraph 2 reads as follows:
"(2) healthcare professionals who participated in the collection or
organ transplantation, recorded with the removed management authority to the
the Protocol, which is attached to the removed organ. To this Protocol
in particular, the record date and place of sampling, and the final destination of the removed
authority. If the removed organ used for transplant, the log
to record the date, the place and the person to whom it was made to transplant.
If it was decided that the authorities are collected for transplantation
inappropriate log records the reason why they were found to be
inappropriate, and how the next load with them. The Protocol must be within 7
days after the final determination of the removed body sent to the coordinating
the transplantation Centre. ".
16. in section 22 para. 3, the words ", with the exception of subparagraph (d))," are replaced by the words
"paragraph. 1 (b). (c)), g) and (h)) ".
17. in article 23 paragraph 1 reads:
"(1) the Tissue Bank is intended to provide donations, further processing,
the investigation, preservation, storage and distribution of tissues for
transplantation; in these activities it shall proceed according to the law of human
tissues and cells ".
Footnote 18 is hereby repealed.
18. in paragraph 23 of the paragraph. 2 (a). (b)), the word "donor" of the word "tissue and"
shall be deleted.
19. in article 23 paragraph 1. 2 at the end of subparagraph (c)) the comma is replaced by a dot and the
subparagraph (d)) shall be deleted.
20. in § 24 para. 2 (c)) shall be deleted.
Subparagraph (d)), and (e)) shall become points (c) and (d)).)
21. in § 25 para. 2 (a). (b)), and (c)), the words ' tissues and ' shall be deleted.
22. in § 25 para. 2 (a). (h)), the words "tissue" and "if it's not working
According to § 24 para. 2 (a). (b)), "be deleted.
23. in section 26 para. 1, the words ' tissues and ' shall be deleted.
24. in section 26 para. 2, in the first sentence and the second the word "or" and "tissue tissues
and "are deleted.
25. in section 26 para. 3, the words "or" shall be deleted.
26. in section 26 para. 4, the words "the tissue or body" shall be replaced by "authorities"
and the words ' tissues and ' shall be deleted.
27. in section 26a para 1 shall read:
"(1) the import or export of tissues or organs in the import or export of
framework of international exchange or quotation in accordance with § 26 para. 1 to 3 (hereinafter referred to as
"the import or export of tissues or organs") issued by the Ministry of the import or
export permit. The request for an import or export authorisation shall be presented
the Ministry of health facility, which the import or export operation takes place
(hereinafter referred to as "the applicant"), at least 90 calendar days prior to the intended
the start of imports or exports. ".
28. section 26 g:
"section 26 g
For the import or export of tissues or organs between the Czech Republic and
Member countries of the European Union, the provisions of section 26a to 26 d shall apply
accordingly. ".
29. in § 28 para. 3, the words ' tissues and ' shall be deleted.
30. in section 29 para. 2 (a). and) points 3 and 4, the words ' or ' shall be deleted.
PART SEVEN
Amendment of the Act on administrative fees
section 36
Act No 634/2004 Coll., on administrative fees, as amended by Act No.
217/2005 Coll., Act No. 228/2005 Coll., Act No. 361/2005 Coll., Act No.
361/2005 Coll., Act No 444/2005 Coll., Act No. 545/2005 Coll., Act No.
553/2005 Coll., Act No. 48/2006 Coll., Act No. 56/2006 Coll., Act No.
57/2006 Coll., Act No. 81/2006 Coll., Act No. 109/2006 Coll., Act No.
112/2006 Coll., Act No. 130/2006 Coll., Act No. 137/2006 Coll., Act No.
137/2006 Coll., Act No. 159/2006 Coll., Act No. 179/2006 Coll., Act No.
186/2006 Coll., Act No 215/2006 Coll., Act No. 227/2006 Coll., Act No.
227/2006 Coll., Act No. 235/2006 Coll., Act No. 309/2006 Coll., Act No.
575/2006 Coll., Act No. 106/2007 Coll., Act No. 261/2007 Coll., Act No.
269/2007 Coll., Act No. 374/2007 Coll., Act No. 379/2007 Coll., Act No.
38/2008 Coll., Act No. 130/2008 Coll., Act No. 140/2008 Coll., Act No.
182/2008 Coll., Act No. 189/2008 Coll., Act No. 230/2008 Coll., Act No.
239/2008 Coll. and Act No. 254/2008 Coll., is amended as follows:
1. in tariff item is added at the end of subparagraph (d)) 102A to (f)),
that including footnote # 61b are added:
"(d) the authorisation or amendment of an authorisation)
the activity of the tissue establishment ^ 61b) $ 2 000
(e) the permit or modification of an authorisation)
the activities of the sampler ^ 61b) $ 2 000
(f) permit or modification of an authorisation)
the activities of the diagnostic laboratory ^ 61b) CZK 2 000 ".
2. At the end of item 102A is added to this text:
"The liberation of
From the fee referred to in d), (e)), and (f)) for this item is exempt receipt
applications for authorisation of activities lodged within three months from the date of acquisition
the effectiveness of the special legal regulation defining the requirements for the
ensure the quality and safety of human tissues and cells ^ 61b)
the operator shall submit to the tissue establishment or reception equipment, or
diagnostic laboratories, which on the date of entry into force of this
special legislation has pursued these activities according to the law No.
285/2002 Coll., on the donation, subscriptions and transplantation of tissues and organs, and the
amendments to certain acts (the Transplant Act), as amended
legislation, Act No. 20/1966 Coll., on the health care of the people, as amended by
amended, or pursuant to law No 160/1992 Coll., on health
care in non-State health establishments, as amended
regulations.
61B) Act No. 297/2008 Coll., on ensuring the quality and safety of human
tissues and cells intended for human applications and amending related
laws (law on human tissues and cells). ".
PART EIGHT
Changing the law on pharmaceuticals
§ 37
Act No. 378/2007 Coll., on pharmaceuticals and on amendments to some related
laws (law on medicinal products), as amended by Act No 124/2008 Coll., is amended
as follows:
1. In article 2 (2). 2 at the end of the text of the letter n), the words "and
lymphocytes donor hematopoietic stem cells intended for recipients of these
the cells ".
2. In article 2 (2). 3 at the end of the text of subparagraph (a), the words "human)
human cell and tissue preparations from human tissues or cells.
3. under section 24 shall be added to § 24a, including footnote # 39a
added:
"§ 24a
(1) in the case of the medicinal product, shall be used in the manufacture of human
tissue, or cells, that are covered by special legislation
governing the requirements to ensure the quality and safety of human tissues
and cells ^ 39a), it must be registration and manufacture of such medicinal
product shown also that the conditions in the donation, procurement,
testing of human tissues and cells and their release for use in
the manufacture of a medicinal product covered by this specific legal
provision.
(2) If a clinical trial is conducted with the investigational medicinal product,
shall be used in the manufacture of human tissue or cells to which the
covered by the specific legislation governing the requirements to ensure
the quality and safety of human tissues and cells ^ 39a), it must be demonstrated
whether or not the conditions of the donation, procurement and testing of human
tissues and cells and their release for use in the manufacture of the medicinal
the product covered by this specific legislation.
39A) Act No. 297/2008 Coll., on ensuring the quality and safety of human
tissues and cells intended for human applications and amending related
laws (law on human tissues and cells). ".
4. In § 25 para. 2, letter e) the following new subparagraph (f)), which read as follows:
"(f)) or tissues or cells of human origin provided by the tissue establishment
under special legislation governing the requirements to ensure
the quality and safety of human tissues and cells ^ 39a), ".
Subparagraph (f)) to (h)) are known as the letters g) to (i)).
PART NINE
The EFFECTIVENESS of the
§ 38
This Act shall take effect 60 days after the date of its publication.
Vaidya in the r.
Klaus r.
in z. Čunek in r.
1) European Parliament and Council Directive 2004/23/EC of 31 October. March
2004 establishing quality and safety standards for the donation, procurement,
testing, processing, preservation, storage and distribution of human
tissues and cells.
Commission Directive 2006/17/EC of 8 June 2004. February 2006 implementing
European Parliament and Council Directive 2004/23/EC, with regard to certain
technical requirements for the donation, procurement and testing of human
tissues and cells.
Commission Directive 2006/86/EC of 24 September 1998. October 2006 implementing
European Parliament and Council Directive 2004/23/EC, with regard to the requirements of the
traceability, notification of serious adverse reactions and events and
some of the technical requirements for the coding, processing, preservation,
storage and distribution of human tissues and cells.
2) Act No. 378/2007 Coll., on pharmaceuticals and on changes of some
related laws (law on medicinal products), as amended by Act No 124/2008
SB.
3) Law No 289/2002 Coll., on the donation, subscriptions and transplantation of tissues
and authorities and on amendments to certain acts (the Transplant Act), as amended by
amended.
4) § 23 of law no 289/2002 Coll., as amended by Act No. 297/2008 Coll. on
ensure the quality and safety of human tissues and cells intended for
human applications and amending related laws (Act on human
tissues and cells).
6) Act No. 258/2000 Coll., on the protection of public health and amending
some related laws, as amended.
7) Act No. 95/2004 Coll., on conditions for the acquisition and recognition of professional
competence and specialized competence to perform the medical
the professions of doctor, dentist and pharmacist, as amended
regulations.
8) Law No. 372/2007 Coll., on health services and conditions of their
provision (law on health services).
9) Act No. 95/2004 Coll., as amended.
Law No. 96/2004 Coll., on conditions for the acquisition and recognition of eligibility for
the exercise of paramedical professions and to pursue activities
related to the provision of health care and on amendments to certain
related laws (the law on the paramedical professions),
in the wording of later regulations.
10) Act No. 553/1991 Coll., on the Czech General health insurance company
Republic, as amended.
Act No. 280/1992 Coll., on departmental, industry, corporate, and other
health insurance companies, as amended.
12) Act No. 20/1966 Coll., as amended.
Law No 160/1992 Coll., on health care in non-State medical
devices, as amended.
Law No. 245/2006 Coll., on public nonprofit constitutional health
devices and amending certain laws, as amended.
13 for example, Act No.) 513/1991 Coll., the commercial code, as amended by
amended.
14) § 2 (2). 2 of the commercial code.
15) Act No. 101/2000 Coll., on the protection of personal data and on amendments to certain
laws, as amended.
