What is Act No. 296 / 2008 Coll.?

Act No. 296 / 2008 Coll., on the quality and safety of human tissues and cells intended for human use and on the amendment of related laws (Act on Human tissues and cells) — Act on the quality and safety of human tissues and cells intended for human use and on the amendment of related laws (Act on human tissues and cells).

When it became Act No. 296 / 2008 Coll. effectiveness?

Act No. 296 / 2008 Coll. became effective 18.10.2008.

Is Act No. 296 / 2008 Coll. still valid?

Yes, Act No. 296 / 2008 Coll. is still valid and effective.

How many times was it Act No. 296 / 2008 Coll. amended?

Act No. 296 / 2008 Coll. has 10 time versions of the text.

Act No. 296 / 2008 Coll. - Act on the quality and safety of human t...

296

THE LAW

of 16 July 2008

on ensuring the quality and safety of human tissues and cells intended for human use and amending related laws (Human Tissue and Cell Act)

Parliament has decided on this law of the Czech Republic:

ČÁST PRVNÍ

HUMAN SUGAR AND CULTURES

HLAVA I

INTRODUCTORY PROVISIONS

§ 1

Subject matter

(1) This Act incorporates the relevant European Union1 provisions and lays down the conditions for ensuring the quality and safety of human tissues and cells intended for human use, possibly for the manufacture of human tissue products, or human cells intended for human use, in their donation, procurement, investigation, processing, storage and distribution. That law was notified in accordance with Directive 98 / 34 / EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and rules and of rules on information society services, as amended by Directive 98 / 48 / EC.

(2) This law does not apply to conditions for ensuring quality and safety

(a) tissues and cells to be collected and used by the same person in a single surgical procedure;

(b) human blood and its composition (2);

(c) organs (3) or parts of organs (3) if they are intended to serve the same purpose as the whole organ in the human body.

(3) Where human tissues and cells are intended for use in products covered by other legislation, this law shall apply only to the conditions for:

(a) their donation, procurement and investigation;

(b) ensuring their traceability from donor to recipient and from recipient to donor; and

(c) their imports from a third country.

Basic provisions

§ 2

For the purposes of this Act:

(a) human use of human tissues and cells, or human tissues or cells (hereinafter referred to as "tissues and cells") in the body or on the body of the human recipient of tissues and cells (hereinafter referred to as "recipients") and out-of-body use;

(b) by procuring the collection of tissues and cells and the associated processes by which tissues and cells are obtained;

(c) processing of processes carried out in the treatment and packaging of tissues and cells intended for human use and processes for the preservation of tissues and cells consisting of the use of chemical substances, modification of environmental conditions or processes carried out to prevent or slow down biological or physical damage to tissues and cells;

(d) storage of tissues and cells under appropriate and controlled conditions until their distribution;

(e) distribution of the transport and supply of tissues and cells intended for human use;

(f) the treatment of the reception and use of tissues and cells for the treatment of the recipient by a health service provider (hereinafter referred to as "provider"), as well as the procurement, investigation, processing, storage and distribution,

(g) traceability

1. identify the location of the tissues and cells and identify them during each stage of treatment and also remove them;

2. identify the living or deceased person who is the source of tissues and cells (hereinafter referred to as the donor),

3. identify the provider who procures, processes, stores, distributes or uses tissues and cells in the treatment of the recipient or, where appropriate, the legal or business natural person who supplies the tissues and cells;

4. identify the recipient with the health service provider; and

5. find and identify all necessary data concerning products and materials that come into contact with tissues and cells,

(h) validated documented evidence which provides a high assurance that the process evaluated, the standard working procedure, parts of equipment or the environment repeatedly produces a product complying with pre-specified specifications and quality indicators; the validation process means an evaluation of the performance of the system required for its use;

(i) any serious adverse event related to the procurement, investigation, processing, storage or distribution which could cause hospitalisation or disease, possibly an extension of hospitalisation or disease, or which could lead to death, to life-threatening, health-impaired, reduced capacity, or to disease transmitted by tissues and cells;

(j) a serious adverse reaction of an unexpected response by a donor or recipient, including a communicable disease, related to the procurement or use of tissues and cells in humans, which causes hospitalisation, disease or prolongation of hospitalisation or disease, or which results in death, life-threatening, harm to health or reduced capacity;

(k) tissue establishment by a provider whose activities consist in the processing, storage or distribution of tissues and cells, and, where appropriate, in the procurement or investigation of tissues and cells; the tissue establishment is also a tissue bank4); this activity may also be carried out by one provider's workplace,

(l) a collection facility by a provider whose activity consists in the procurement of tissues and cells or in the conduct of part of that activity, without providing for other activities referred to in point (k); this activity may also be carried out by one provider's workplace,

(m) a diagnostic laboratory of a laboratory where laboratory testing of samples of biological materials taken from donors for medical assessment and selection of donors is carried out;

(n) a Member State means a Member State of the European Union and a Contracting State to the Agreement on the European Economic Area;

(o) a third country other than a Member State;

(p) a supplier from a third country of a tissue establishment or another person established in a third country which ensures the export of tissues and cells and supplies them to the European Union;

(q) one-off imports of specific types of tissues or cells from a third country intended for use by a specific consignee or recipients known to the importing tissue establishment and third country supplier before their import; imports from the same third country supplier which are made on a regular or repeated basis shall not be considered as one-off imports;

(r) by the tissue establishment code, a unique identifier consisting of the ISO code of the Czech Republic and the tissue establishment number given in the European Union tissue establishment database;

(s) a unique donation number, a unique number assigned to the specific donation of tissues and cells in accordance with the system for allocating these numbers;

(t) a product code identifier of a specific type of tissues and cells, consisting of a coding system identifier of the preparation indicating the coding system used by the tissue establishment and the number of the tissue and cell product in the relevant coding system for the product type;

(u) the fraction number of the number distinguishing and uniquely identifying tissues and cells having the same donation number, the same product code and coming from the same tissue establishment;

(v) the European Union coding platform, the information technology platform used by the European Commission ("the Commission"), which operates the European Union tissue establishment database and the European Union tissue and cell product database,

(w) release into circulation of distribution or transport to another tissue establishment.

§ 3

(1) A tissue establishment, a sampling facility and a diagnostic laboratory may carry out activities under this law only if it has been granted to a provider under Paragraph 19 of the permit of activity, unless otherwise specified. This authorisation shall not be required for a sampling facility which carries out the procurement of tissues and cells for the tissue establishment referred to in Article 10 (2) (b); This does not apply when it comes to laboratory investigations to assess the eligibility and selection of donor tissues and cells.

(2) Natural persons handling tissues and cells are required to:

(a) ensure the maximum benefit of tissues and cells when used in humans and limit the risks associated with them to the lowest possible extent for humans;

(b) in the event of a serious adverse event, a serious adverse reaction or suspected adverse reaction, carry out without delay all available measures to ensure that the remedy is rectified and to minimise adverse effects;

(c) communicate information in accordance with the procedures referred to in paragraph 3 (e);

(d) handle the packaging of tissues and cells in accordance with the data and instructions given on the packaging and, where appropriate, accompanying the packaging.

(3) Providers handling tissues and cells shall ensure:

(a) monitoring or suspected serious adverse events;

(b) notification, assessment and recording of, and the provision of data on, serious adverse events, serious adverse reactions or suspected reactions pursuant to Article 5 (4); ensure at the same time, without delay, that the adverse effects of such events, reactions or suspicions are reduced to the lowest possible level; the manner and extent of notification, assessment and evaluation of serious adverse events or serious adverse reactions, including the determination of causes and the adoption of measures, shall be laid down in implementing legislation,

(c) the anonymisation and protection of data, including genetic information, collected as part of compliance with the requirements of this law so that neither the donor nor the recipient can be identified; the authorisation to access the data needed for the treatment of tissues and cells in a health facility shall be determined by the provider;

(d) keeping and handling records of tissues and cells, including keeping and maintaining records that allow traceability in their activities, in a manner that does not infringe data protection under (c); traceability shall be ensured for at least 30 years from the use of tissues and cells; the minimum extent of the records allowing traceability, the manner in which they are maintained and kept shall be laid down in the implementing legislation;

(e) the establishment and use of procedures for the provision of information which does not infringe the protection of data referred to in (c) and measures to prevent the illicit provision of such information, including the provision of information for the traceability and implementation of quality and safety checks.

(4) The tissue establishment, the sampling establishment and the diagnostic laboratory operator shall without delay notify the relevant tissue establishment or collection facility responsible for examining samples of biological material collected from donors (hereinafter referred to as the donor sample) of the risk of transmission of disease by tissues and cells or of any doubt as to whether any laboratory examination has been carried out properly.

(5) Providers shall ensure compliance with the written instructions of the tissue establishment where they treat tissues and cells released by that tissue establishment for distribution and use and, if assisted reproduction, with the written instructions of the provider in whose health establishment the artificial insemination of the woman has been carried out, concerning the provision of information on pregnancy and the state of health of the newborn or foetus, as appropriate.

(6) Persons handling tissues and cells are required to comply with the guidelines published by the State Institute for Drug Control (hereinafter referred to as "the Institute") pursuant to Section 24.

HLAVA II

LIQUIDITY EQUIPMENT, COLLECTION EQUIPMENT, DIAGNOSTIC LABORATOR, CONTRACTING INSURANCE OF CERTAIN ACTIVITIES OF THE FIXED EQUIPMENT

Díl 1

Tissue, sampling, diagnostic laboratory

Tissue equipment

§ 4

(1) The tissue establishment shall, before 1 March each year, prepare an annual report on the activity of the tissue establishment for the previous calendar year. It shall publish this report by that date at the latest in a way that allows remote access. The form and content of the annual report shall be laid down in implementing legislation.

(2) In the event of cessation of the tissue establishment, the donor sample provider and the documentation shall ensure traceability and availability of stored tissues and cells for their use. Within 15 days of the date of termination of the tissue establishment, the provider shall notify the Institute of the way in which the obligation is ensured under the first sentence and shall request the cancellation of the permit under Paragraph 20 (5).

§ 5

(1) The tissue establishment shall ensure:

(a) the establishment and maintenance of a quality system for ensuring the requirements of:

1. the organisation and management of tissue establishments with a focus on quality,

2. the selection, assessment of health and professional competence and training of persons involved in tissue establishment activities;

3. documentation, including records, so that the activities of the tissue establishment are defined, recorded and properly maintained;

4. premises and equipment, products and materials used to match the purpose of their use and to the beneficiaries and persons referred to in point 2 represent a minimum risk, including requirements for working procedures; and

5. reviewing the effectiveness of the quality system, carrying out internal controls and taking any measures to remedy it, with a view to preventing and, where appropriate, revising undesirable deviations and improving the quality system;

the implementing legislation lays down requirements for the establishment and maintenance of a quality system which directly or indirectly contribute to the quality and safety of tissues and cells in accordance with points 1 to 5;

(b) the selection and use of such products and materials in contact with tissues and cells;

1. which do not adversely affect the quality and safety of tissues and cells,

2. which are listed in procedures approved in the framework of the authorisation of the activity of the tissue establishment or its modifications; and

3. the quality of which is verified before use,

(c) when procuring the procedures and requirements referred to in Article 7 (1) (b) to (d) and using only tissues and cells which meet the requirements for approval for processing; the requirements for the reception, inspection and approval or disposal of the tissues and cells to be processed and the records of those tissues and cells shall be laid down in the implementing legislation;

(d) procedures which may affect the quality and safety of tissues and cells shall be:

1. introduced and implemented in accordance with the European Pharmacopoeia and the Czech Pharmacopoeia, the guidelines of the Commission and the European Medicines Agency (the Agency),

2. carried out in accordance with standard working practices of the tissue establishment and under controlled conditions in order to ensure consistency between different products of the same type;

3. Validated before their introduction and before any change which may affect the quality and safety of tissues and cells, and that validation is regularly verified,

in such a way as to guarantee this quality and safety; the requirements for procedures affecting in particular the quality and safety of tissues and cells, including processing, packaging, labelling, release for distribution and use, storage, distribution and withdrawal of distributed tissues and cells, shall be laid down in implementing legislation to ensure that the quality and safety of tissues and cells cannot be adversely affected;

(e) a system enabling identification and traceability

1. tissues and cells and donors; to that end, each donor, each donation and each packaging of tissues and cells derived from it shall be assigned a unique code which, if such assignment is mandatory under this law, shall be a single European code,

2. any packaging of tissues and cells during their collection, processing, release and distribution, or disposal,

3. products and materials which come into contact with tissues and cells; and

4. all legal and business natural persons who have supplied or received tissues and cells from him;

the method of establishing clear codes for identifying donation and final packaging of tissues and cells is laid down in the implementing legislation;

(f) a system of quality and safety checks, which must be:

1. the necessary equipment, premises and procedures are available,

2. in vitro diagnostic medical devices used under the Health Devices Act 5), or which have been validated for the intended purpose of use;

3. laboratory checks are carried out by persons who are independent of other tissue facilities; and

4. records shall be kept allowing the conditions, execution, evaluation and conclusion of the check to be reconstructed; the records shall be traceable;

the scope of the quality and safety checks and the requirements for their implementation, including the scope of laboratory tests of samples from donors and the requirements for their implementation, and the retention period of the records shall be laid down in the implementing legislation;

(g) packaging procedures, including packaging, and storage procedures ensuring the quality and safety of tissues and cells and the functionality and integrity of each packaging of tissues and cells;

(h) procedures and conditions which ensure the quality and safety of tissues and cells in their distribution, and procedures and conditions for the accurate rapid and verifiable withdrawal of distributed tissues and cells from further use;

(i) procedures for the handling of applications for the provision of tissues and cells, including rules for the allocation of tissues and cells to the recipient and for the provider to whom the tissues and cells are provided, and for the documentation of those procedures, and for the patient and, where appropriate, the provider to be informed of the rules applied for the allocation of tissues and cells at their request;

(j) to avoid confusion and contamination of tissues and cells; establish procedures for the management of tissues and cells to be discarded, including protection of the environment and persons from pollution by those tissues and cells;

(k) in the distribution of tissues and cells, compliance with good distribution practice rules; the rules of good distribution practice for the distribution of tissues and cells are laid down in implementing legislation.

(2) The tissue establishment shall ensure the identification and traceability of tissues and cells referred to in paragraph 1 (e) (1) and (2) by using a single European code from collection to human use or disposal and vice versa. For tissues and cells used for the manufacture of advanced therapi2 medicinal products, traceability must be ensured at least to the manufacturer of advanced therapy medicinal products.

(3) The tissue establishment, if it is the tissues and cells released by it for distribution and use, shall further ensure that:

(a) criteria for the quality and safety of tissues and cells and the shelf life of tissues and cells are established, verified and applied, following their storage conditions; where the quality or safety of tissues and cells changes during the shelf life as a result of new knowledge, the risk of unused tissue and cells from therapeutic use may be adversely affected by the safety and efficacy of the treatment; the scope of the quality and safety criteria is laid down in the implementing legislation;

(b) the therapeutic and adverse effects of tissues and cells have been established and verified, if they are tissues and cells intended for use in the treatment of the recipient;

(c) samples from the donor kept for laboratory testing are available;

(d) each package of released tissues and cells is accompanied by instructions for their customers and packing details, including identification of the packaging and identification of the tissue establishment which released the packaging; the instructions and data are provided on the packaging of tissues and cells, if any, attached as part of each package;

(e) no packaging of tissues and cells can be released, distributed and used in humans unless the quality and safety requirements of these tissues and cells and the requirements of this law are met;

(f) any packaging of tissues and cells is subject to traceable records enabling it to be reconstructed and used or disposed of;

(g) the procedures and data correspond to the procedures and data specified in the application for authorisation of an activity pursuant to Article 17 (3) (a) and (b) verified in accordance with Article 19 (1).

(4) The tissue establishment, if it is the tissue released and the cells for distribution and use or the tissues and cells distributed by it from a Member State or imported from a third country, shall ensure:

(a) in the event of a serious adverse event, a serious adverse reaction or suspected event;

1. without delay notification of that fact to the Constitution,

2. without undue delay in their investigation, including the analysis of the causes;

3. without delay notification of the findings of the investigation referred to in point 2 and the measures taken by the Constitution and the persons concerned; if there is a risk of tissue and cell disease and, where appropriate, an additional risk identified, it shall immediately notify the Constitution, suppliers from a third country and users of tissues and cells and the competent public health6),

(b) that written instructions shall be provided to the provider who uses these tissues and cells to treat the recipient;

1. how traceability requirements are to be met,

2. how to proceed when reporting or suspected serious adverse events, serious adverse reactions, and

3. which facts referred to in points 1 and 2 and how they are to be provided to the tissue establishment.

§ 6

(1) The tissue establishment shall ensure that the activities referred to in paragraph 3 are properly carried out by the responsible person of the tissue establishment.

(2) The professional condition for the performance of the function of the responsible person of a tissue establishment is a duly completed university course covering at least 4 years of theoretical and practical teaching in the field of pharmacy or general medical science (7), biochemistry or biology, and at least 2 years of professional experience in a tissue establishment or sampling establishment, or 2 years of professional experience in the activity of similar tissue establishment activity.

(3) The person responsible for the tissue establishment shall be responsible for:

(a) tissues and cells shall be provided, examined, processed, stored and distributed and any packaging of tissues and cells shall be released in accordance with this law; the release of tissues and cells and the purpose for which the tissues and cells are released shall be confirmed by the responsible person by his signature,

(b) the tissue establishment quality system is operated and managed in accordance with this law;

(c) traceability is ensured;

(d) information is provided to the Institute for the purpose of authorising the activity of a tissue establishment and amending the authorisation;

(e) the measures required by the Constitution are implemented, which shall be informed of their implementation;

(f) data are collected for the annual report referred to in Article 4 (1);

(g) the notification obligation under Article 5 (4) (a) is fulfilled;

(h) access to the protected data shall be granted only in accordance with the authorisation provided for in Article 3 (3) (c).

(4) If the Institute makes a criminal complaint because of a serious breach of the duties of the responsible person of the tissue establishment referred to in paragraph 3 (a), it shall immediately notify the tissue establishment and the responsible person concerned that the responsible person may not carry out the activity referred to in paragraph 3 until the end of the proceedings in question.

Sampling equipment

§ 7

(1) The sampling device shall ensure:

(a) the procedures and requirements referred to in Article 5 (1) (a), (b), (d) to (f) and (j) to the extent appropriate to the activities carried out;

(b) the procurement of tissues and cells from the donor so that the donation of tissues and cells is not a source of financial or other compensation; the donor may receive only compensation for the expenses of giving and, in the absence of donors of sex cells, the difference between the income forgone and the salary, salary or remuneration received and the sickness benefit received from the sickness insurance, which has been temporarily incapacitated in relation to the collection of tissues or cells and the provision of the health services required by the transplant law,

(c) in the procurement of tissues and cells

1. identification of the donor;

2. the instruction of the donor, his legal representative, or of the person close to him, and the provision of information on the donation and procurement under the law governing transplants (3), if it is the tissues and cells intended for transplantation, or the law governing the provision of health services (8), including the provision of information on the recording and protection of donor data;

3. informing the donor or, where appropriate, his legal representative of the right to request information on the findings resulting from the laboratory tests and its explanations, including the provision of information and explanations, where required;

4. consent to the collection and conditions and admissibility of the collection under the law governing the implementation of transplants or the law governing health care;

5. assessment of donor medical fitness and selection of donor,

6. the collection, marking after collection, packaging, transport and transmission of tissues and cells to the tissue establishment; the collection shall be carried out only if the requirements of points 1 to 5 are met;

if tissues and cells are not subject to treatment under the Transplant Act or Health Care Act and are intended for processing under this Act and for use in the treatment of the recipient, the Transplant Act shall apply mutatis mutandis for the procedure under points 2 and 4; in the case of collection of tissues and cells carried out by teams of two or more tissue establishments by the deceased donor, the sampling facility shall ensure an appropriate traceability system for all such samples; the extent of the procurement requirements and procedures for the procurement of tissues and cells referred to in points 1 to 6, including the extent of data identifying donors, the range of information provided for the donation of tissues and cells and the definition of the criteria for assessing the medical fitness and selection of donors of tissues and cells for the autologous use of tissues and cells, which means the collection and use of tissues and cells in the same person, and the allogeneic use of tissues and cells, which means the collection and use of tissues and cells in the same person, and the use of tissues and cells of tissues and cells which means the collection of tissues and cells in one person and their use in another, shall be subject to a non-adverse effect to the quality and safety of tissues and the safety of cells and protection of donors, the future child from assisted reproduction,

(d) the taking of samples from the donor, including the collection of stored samples, and the unambiguous identification of the sample from the donor for each donation of tissues and cells; the donor sample requirements are laid down in the implementing legislation;

(e) that tissues and cells are provided only to tissue establishments which process and release tissues and cells, including tissues and cells intended for use in the manufacture of medicinal production2); the requirements for the provision of tissues and cells to the tissue establishment are laid down in the implementing legislation.

(2) In the event of cessation of the operation of the sampling facility, the provider shall ensure the preservation of documentation and traceability. The provider shall, within 15 days of the date of termination of the operation of the sampling facility, notify the Institute of the way in which the obligation is ensured in accordance with the first sentence and request the cancellation of the permit in accordance with Paragraph 20 (5).

§ 8

(1) The sampling facility shall ensure the proper execution of the activities referred to in paragraph 3 by the responsible person of the sampling facility.

(2) The professional condition for the performance of the duties of the responsible person of the collection establishment shall be a duly completed university course covering at least 4 years of theoretical and practical teaching in the field of pharmacy or general medicine, biochemistry or biology and at least 1 year of professional experience in the tissue establishment or collection establishment.

(3) The responsible person of the sampling facility shall be responsible for:

(a) tissues and cells are provided in accordance with this law;

(b) the quality system of the sampling facility is operated and managed in accordance with this law;

(c) information is provided to the Institute for the purpose of authorising the operation of the sampling facility and amending the authorisation;

(d) the measures required by the Constitution are implemented, which shall be informed of their implementation.

§ 9

Diagnostic laboratory

(1) An operator of a diagnostic laboratory which may be a legal or an undertaking natural person shall ensure the procedures and requirements referred to in Article 5 (1) (a), (d) and (f) to the extent appropriate to the activities carried out.

(2) In the event of termination of the diagnostic laboratory, its operator shall ensure that the documentation is kept. The operator shall, within 15 days of the date on which the diagnostic laboratory ceases its activities, notify the Institute of the means of ensuring the obligation under the first sentence and request the cancellation of the permit for the activity (Section 20 (5)).

Díl 2

Contractual reinsurance of certain tissue establishment activities

§ 10

(1) A tissue establishment which processes and releases tissues and cells for distribution and use may provide an activity consisting in the procurement, investigation or distribution, or part of an activity which is part of the procurement, investigation, processing, storage or distribution, under a written contract.

(2) A tissue establishment may conclude a contract under paragraph 1 only with:

(a) tissue establishment, sampling establishment or diagnostic laboratory operator, if they are authorised to carry out an activity authorised for the activity in question;

(b) a collection facility which carries out the procurement of tissues and cells under the conditions and according to the requirements and procedures established by the tissue establishment which take over those tissues and cells, provided that the Institute verifies and approves such procurement of tissues and cells in the context of the authorisation of the tissue establishment in accordance with § 17 to 20; or

(c) by a provider holding a document similar to the authorisation referred to in (a) issued by the authority of the Member State responsible for tissues and cells.

(3) If only the distribution referred to in § 2 (e) is concerned, the tissue establishment may also conclude a contract for the transport of tissues and cells with a legal or commercial natural person who is not an operator referred to in paragraph 2. This person must hold a permit for the distribution of tissues and cells granted under § 20a.

(4) The tissue establishment may also conclude the contract referred to in paragraph 1 with a provider holding an authorisation under the Drug Act (2) in which this activity is included and is an activity carried out in the framework of a laboratory sample investigation or part of the activity carried out in the context of the treatment of tissues and cells.

(5) The tissue establishment referred to in paragraph 1 lays down the requirements for the products, materials and services supplied in a written contract concluded with its supplier, where this is necessary to ensure the quality and safety of tissues and cells.

(6) The contracts referred to in paragraphs 1, 3 or 5 shall indicate that they will be fulfilled for the activities covered by this Act and that there will be no change which could affect the quality and safety of tissues and cells by tissue establishments. The tissue establishment shall keep records of the contracts and provide a copy of the contract to the Institute at its request.

(7) The responsibility of tissue establishments which release tissues and cells for distribution and use for compliance with the requirements of this Act and for the quality and safety of such tissues and cells shall not be affected by the provisions of paragraphs 1, 5 and 6.

HLAVA III

IMPORTS AND EXPORTS OF TYLING AND BEEPING BETWEEN THE CZECH REPUBLIC AND THIRD COUNTRIES AND DISTRIBUTIONS BETWEEN THE CZECH REPUBLIC AND THE MEMBER STATE

Imports of tissues and cells from third countries

§ 11

(1) Imports of tissues and cells from a third country for their use in the treatment of the recipient are provided by a tissue establishment where:

(a) appropriate tissues and cells originating in the Czech Republic or in another Member State comply with the requirements of this Act are not available;

(b) is the holder of an activity authorisation in the scope of imports of tissues and cells relating to the type of tissues and cells subject to import;

(c) import conditions are fulfilled under the provisions of the Transplant Transplant Act (3), even if imported tissues and cells are not intended for transplantation;

(d) imported tissues and cells comply with quality and safety requirements equivalent to those laid down in this Act and may be monitored from donor to recipient and from recipient to donor;

(e) the individual packs of tissues and cells contain the packaging data and instructions referred to in § 5 (3) (d) in the Czech language; and

(f) has a written contract with a supplier from a third country pursuant to Article 11a (1), except in the cases referred to in Article 11a (2) (hereinafter referred to as the importing tissue establishment).

(2) Imports of tissues and cells from third countries for their use in the manufacture of medicinal products may be effected provided that the conditions laid down in paragraph 1 (c) and the requirements of the Drug Act (2) are met.

§ 11a

(1) The tissue establishment shall conclude a written contract with a supplier from a third country where at least one of the activities of donation, procurement, investigation, processing, storage or import into the European Union of tissues and cells to be imported into the European Union takes place outside it; in the written contract it must be:

Citation	Act No. 296 / 2008 Coll., on the quality and safety of human tissues and cells intended for human use and on the amendment of related laws (Act on Human tissues and cells)
Regulation Type	Law
Author	-
Collection	Code of Laws

Date of Promulgation	19.08.2008
Effective from	18.10.2008
Effective until	-
Status	Valid

Act No. 296 / 2008 Coll.

Act on the quality and safety of human tissues and cells intended for human use and on the amendment of related laws (Act on human tissues and cells)

Contents

ČÁST PRVNÍ

HLAVA I

§ 1

§ 2

§ 3

HLAVA II

Díl 1

§ 4

§ 5

§ 6

§ 7

§ 8

§ 9

Díl 2

§ 10

HLAVA III

§ 11

§ 11a

Contents

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