Decree No. 422 / 2008 Coll.
Ordinance on the establishment of closer requirements to ensure the quality and safety of human tissues and cells intended for human use
Valid
Order
Effective from 08.12.2008
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422
DECLARATION
of 28 November 2008
laying down closer requirements to ensure the quality and safety of human tissues and cells intended for human use
According to Section 29 of 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 (Human Tissue and Cell Act), hereinafter referred to as "the Act":
Subject matter
This decree implements the relevant European Unionregulations (1) and sets out further requirements for:
(a) the quality system,
(b) the procurement and reception of human tissues and cells in a tissue establishment;
(c) assessment of donor medical fitness, selection of tissue and cell donors and laboratory tests required by the donor;
(d) processing, storage and distribution of tissues and cells, and related quality and safety checks;
(e) monitoring, addressing and reporting serious adverse reactions and events;
(f) traceability and identification of tissues and cells;
(g) provision of reports on the activity of the tissue establishment;
(h) the authorisation of tissue establishments, sampling facilities and diagnostic laboratories and the authorisation to distribute tissues and cells;
(i) good distribution practice rules for the distribution of tissues and cells;
(j) imports of tissues and cells and importing tissue establishments;
(k) the extent of the information given in the certificate of authorisation for the activity of the importing tissue establishment; and
(l) the coding of tissues and cells and the allocation of unique donation numbers.
Basic concepts
For the purposes of this decree:
(a) reproductive cells of all tissues and cells intended for assisted reproduction purposes;
(b) written instructions by standard working procedures describing the stages of the specific procedure, including materials and methods to be used, and the expected final product.
Quality system
[K § 5 (1) (a) and (f) of the Act]
The quality system requirements for tissue establishment, sampling establishment or diagnostic laboratory are set out in Annex 1 to this Decree. The establishment of a quality system shall take into account those requirements to the extent appropriate to the activities to be carried out and the approval of which is requested by the operator concerned. Subsequently, compliance with these requirements shall be maintained to an extent consistent with the authorised activities.
Tissue and cell care
[K § 7 (1) (c) and (e) of the Act]
The requirements for the procurement and provision of tissues and cells to tissue processing facilities are set out in Annex 2 to this Decree.
Donor selection and laboratory testing of donor samples
[K § 7 (1) (c) and (d) of the Act]
(1) The criteria for assessing the medical fitness and selection of donors of tissues and cells for autologous and allogeneic use, with the exception of donors of reproductive cells, are set out in Annex 3 to this Decree. The requirements for laboratory testing of samples taken from these donors, including those for such tests, are set out in Annex 4 to this Decree.
(2) The criteria for assessing the medical fitness and selection of donors of reproductive cells and the requirements for laboratory testing of samples taken from such donors are set out in Annex 5 to this Decree.
(3) If organ, tissues and cells are collected from the same donor and used with the same recipient, the criteria set for organ donors (2) shall apply when assessing the medical fitness and selection of the donor.
Requirements for processes provided by tissue establishments
[Articles 5 (1) (c), (d) and (f) and 5 (3) (a) of the Law]
(1) The requirements for the reception, control, approval or disposal of tissues and cells intended for treatment by tissue establishments and the records of such tissues and cells are set out in Annex 6, point 1, to this Decree.
(2) The requirements for the processing, packaging, labelling, release, storage, distribution and withdrawal procedures for distributed tissues and cells are set out in Annex 6, points 2 to 6 of this Decree.
(3) The scope of the quality and safety checks carried out in the framework of the activities leading to the provision of tissues and cells and the requirements for them are set out in Annex 6, point 7, to this Decree.
Requirements for tissue and cell distribution procedures
[Articles 5 (1) (k) and 20a (4) of the Act]
The rules of good distribution practice for the distribution of tissues and cells are set out in Annex 9 to this Decree.
Serious adverse reactions and events
[K § 3 (3) (b) of the Act]
(1) In the event of a serious adverse reaction or suspected reaction ("serious adverse reaction '), proceed to:
(a) serious adverse reactions in living donors that could affect the quality and safety of tissues and cells have been reported without delay to the tissue establishment to which tissues and cells are provided for processing,
(b) following the use of tissues and cells in the treatment of the recipient, serious adverse reactions observed during or after clinical use have been reported without delay to the tissue establishment indicated on the tissue and cell label if they may be related to the quality and safety of the tissues and cells;
(c) serious adverse reactions have been assessed, evaluated and their causes and measures taken under the guidance of the tissue establishment referred to in points (a) and (b); These measures concern all tissues and cells concerned, including those already distributed, and include measures to prevent the causes of serious adverse reactions.
(2) In the event of or suspected of serious adverse events ("serious adverse events'),
(a) in such a way that a serious adverse event is immediately notified to a tissue establishment to which tissues and cells are provided for processing, if this is a serious adverse event occurring during or following procurement and which could affect the quality and safety of tissues and cells;
(b) in such a way that a serious adverse event is notified without delay to the tissue establishment indicated on the tissue and cell label, if it is a serious adverse event that is detected in the course of the treatment of the tissues and cells distributed to their customer and could affect the quality and safety of the tissues and cells;
(c) mutatis mutandis as in paragraph 1 (c), even if it is a serious adverse event that is detected in the course of the activity of the tissue establishment and could affect the quality and safety of tissues and cells.
(3) In the event of a serious adverse reaction and serious adverse events in tissues and cells delivered from abroad, the tissue establishment shall proceed mutatis mutandis to ensure that those tissues and cells are supplied in accordance with paragraphs 1 and 2.
(4) For the notification of serious adverse reactions and serious adverse events to the State Institute for Drug Control (hereinafter referred to as "the Institute ') pursuant to Section 5 (3) of the Act, the notification models and the reports in Annex 7 in which they are:
(a) in Part A, the models for notification, in point 1, the template for notification of a serious adverse reaction and in point 2, the template for notification of a serious adverse event,
(b) in Part B, the models of the assessment report, the evaluation report and the measures taken are given in point 1 of the template for the serious adverse reaction report and in point 2 of the template for the serious adverse event report.
(5) The notifications and reports referred to in paragraph 4 are kept by the Constitution.
(6) In the case of assisted reproduction, any incorrect identification or substitution of semen, ova or embryos shall also be considered as a serious adverse event and shall be treated mutatis mutandis in accordance with paragraph 2.
Traceability
[K § 3 (3) (d) of the Act]
(1) In the tissue establishment, records enabling at least the minimum
(a) identification of the donor;
(b) identification of the donation of tissues and cells involving:
1. identification of the sampling or tissue establishment carrying out the procurement;
2. unique donation number,
3. Date of collection,
4. place of collection; and
5. the type of donation, in particular if it is one or more types of tissues and cells, of autologous or allogeneic donation, of donation from a living or deceased donor,
(c) identification of tissues and cells during the processing and final packaging of tissues and cells (hereinafter referred to as "tissue and cell preparation"), including:
1. identification of the tissue establishment;
2. the type of tissues and cells or the type of tissue and cell preparation according to the European Union basic nomenclature,
3. the mixture number, where appropriate,
4. the fraction number, where appropriate,
5. expiry date,
6. the state of the tissues and cells, particularly in quarantine, released for use,
7. the description and origin of the tissues and cells used in the processing, materials and products that have come into contact with the tissues and cells and may affect their quality and safety; and
8. Data identifying the tissue establishment that provided the packaging with a final label and released tissues and cells for use;
(d) human use involving:
1. the date of distribution or removal of tissues and cells from use; and
2. data identifying the physician, the health service provider and the natural or legal person doing business to whom the tissue and cellular product has been provided for use;
(e) identification of the single European code.
(2) For providers of health services responsible for human use, records covering at least the data identifying, in order to meet the traceability requirements of Section 3 (3) (d) of the Act,
(a) the tissue establishment which supplied the tissue and cell preparation,
(b) doctors, health service providers and business natural or legal persons to whom the tissue and cellular product has been provided for use;
(c) the type of tissues and cells;
(d) tissue and cell preparation,
(e) the consignee,
(f) date of application,
(g) the single European code.
(3) The keeping and storage of records shall be carried out using means of recording from which the records are available and legible throughout the period of retention provided for in Section 3 (3) (d) of the Act, including ensuring the protection of the records. Where compliance with this condition is ensured, data may be stored, for example, in electronic form.
Identification and codes
[K § 5 (1) (e), § 20b (3) of the Act]
(1) In order to ensure a clear identification in accordance with § 5 (1) (e) of the Act,
(a) the donation of tissues and cells by a marking which includes a unique donation number and the identification of the tissue establishment allocated by the Institute;
(b) the tissue and cellular product shall be labelled, including:
1. product identification code,
2. the number of the share where applicable;
3. The expiry date.
(2) The product identification code shall be chosen according to the nomenclature of the European coding system published by the Institute's order pursuant to Section 24 (1) (d) of the Act. The identification referred to in paragraph 1 shall be entered in the records kept on tissues and cells and the handling thereof so that they are unmistakable, including donor records, tissue and cell characteristics and records for compliance with traceability requirements.
(3) The use of the European coding system may not apply to reproductive cells, if it is about donating reproductive cells between a man and a woman who declare in writing that they intend to undergo assisted reproduction together (hereinafter referred to as "partner donation ').
(4) The production and structure of the single European code, the requirements for its use, the structure of the product code and the technical rules of the system for the allocation of unique donation numbers are set out in Annex 10 to this Decree.
Annual tissue establishment report
(K § 4 (1))
(1) The annual report on the activity of tissue establishments contains a set of data relating to tissues and cells released by tissue establishments for use in the treatment of the recipient, which include:
(a) the number of donors who donated the tissues and cells transmitted for processing in the tissue establishment and the number of withdrawals of such donors; the total number of donors and withdrawals separately for the living donor and deceased donor shall be reported; for living donors, the number of donors and the number of autologous and allogeneic withdrawals shall be reported separately; the number of donors and withdrawals shall also be given for each type of tissue and cell referred to in paragraph 4;
(b) the quantity of tissue and cell products
1. processed and released for use in the treatment of the recipient;
2. distributed in their own medical establishment or other medical facilities in the Czech Republic, if not returned,
3. exported abroad,
4. stored at the end of the year by suitable products for distribution;
5. eliminated, including the reason for elimination,
(c) the total number of recipients of tissue and cell preparations;
(d) the number of recipients affected by a serious adverse reaction;
(e) the number of serious adverse reactions in the recipient according to the nature of the serious adverse reaction;
(f) the names and addresses of the health establishments to which the tissue and cellular products have been distributed.
(2) The annual report on the activity of tissue establishments also contains a set of data relating to tissues and cells released by tissue establishments for the manufacture of medicinal products or other products intended for human use, which include:
(a) the number of donors and the number of withdrawals of such donors within the scope of the data referred to in paragraph 1 (a);
(b) the amount of tissues and cells
1. processed and released for further production;
2. supplied by producers in the Czech Republic,
3. exported abroad,
4. stored at the end of the year for satisfactory tissues and cells intended for delivery;
5. eliminated, including the reason for elimination,
(c) a list of processors to whom tissues and cells are supplied for further production.
(3) The annual report on the activity of tissue establishments also contains:
(a) a set of other activity data relating to tissues and cells that the tissue establishment treats but does not release, including the quantity of tissue and cell products supplied to the Czech Republic from abroad;
(b) the total number of serious adverse events reported and the total number of serious adverse reactions reported.
(4) The entries in paragraph 1 (a), (b), (d) and (e), (2) (a) and (b) and (3) (a) shall be given for the different types of tissues and cells set out in the Constitution guideline in accordance with the reporting requirement to the European Commission. The number of tissues and cells or tissue and cell preparations in paragraphs 1 to 3 shall mean the number of packages, including the content of tissues and cells in the pack, or any other quantitative indication, unless the quantity expressed in the number of packages is commonly used and understood for the relevant type of tissues and cells.
Notification of distribution or import for urgent need of tissues and cells
(Paragraph 13 (2) of the Law)
(1) Notification of distribution or import in case of urgent need of tissue and cell preparation for a specific recipient, pursuant to Paragraph 13 (2) of the Act, contains:
(a) the identification of the notifying tissue establishment operator which the tissues and cells have supplied, including the name, surname, place of business and identification number, if any, with the natural person or business firm, or the name, registered office, address of service and identification number, if any, with the legal person, as well as the identification of the tissue establishment and the name and surname of the responsible person of the tissue establishment;
(b) the name and quantity of the tissue and cell preparation and its identification code, the name of the country of origin of the tissues and cells and the data needed to identify the foreign tissue establishment which processed and released tissues and cells for use in the treatment;
(c) the purpose of use, the date and the reason for delivery of the tissue and cell preparation;
(d) data identifying the health care establishment and its workplace, where there is an urgent need for the tissue and cellular preparation, and an internal anonymised indication for identifying the recipient;
(e) the date of notification, the name and surname of the person authorised to act on behalf of the operator referred to in (a) and his signature.
(2) The notification referred to in paragraph 1 shall be provided in any way that is verifiable.
Application for authorisation of an activity and amendments thereto
(Paragraph 17 (6) of the Law)
(1) The application for authorisation of the activity of a tissue establishment, a sampling establishment or a diagnostic laboratory shall contain the particulars and documents listed in Annex 8 (A) (1) to (4) to this Decree.
(2) The application for modification of an activity authorisation contains the particulars and documents listed in Annex 8 (A) (5) and (6) to this Order, in which the amendments shall be indicated and marked.
Application for authorisation to distribute tissues and cells
(Paragraph 20a (2) of the Act)
The application for authorisation for the distribution of tissues and cells shall contain the particulars and documents set out in Annex 8, Part B, to this Order.
Application for authorisation of the activity of the importing tissue establishment
(Paragraph 17 (5) and (6) of the Law)
The scope and the necessary details of the documentation relating to the importing tissue establishment and the documentation relating to suppliers or suppliers from third countries which, at the request of the Institute, are submitted and, if necessary, provided by the importing tissue establishment of the Institute are set out in Annex 11 to this Decree.
Certificate of authorisation for the activity of the importing tissue establishment
(Paragraph 19 (5) of the Law)
The model of the certificate of authorisation for the activity of the tissue establishment in the scope of imports of tissues and cells from a third country is set out in Annex 12 to this Decree.
Final provisions
Decree No. 437 / 2002 Coll., laying down detailed conditions for the assessment of medical fitness and the extent of examination of a living or deceased donor of tissues or organs for the purpose of transplants (Ordinance on the medical fitness of a donor of tissues and organs for the purpose of transplants), shall not apply to tissues and cells.
This decree shall take effect on the day of its publication.
Minister:
Dr. Julinek, MBA v. r.
Příloha č. 1
Annex No 1 to Decree No 422 / 2008 Coll.
Quality system requirements
1. Quality system, organisation and management
1.1. The establishment of the quality system shall include a written functional organisational structure, a structure of responsibilities and reporting obligations, a written obligation of persons involved in the procurement, investigation, processing, storage, distribution in the framework of the activities of the tissue establishment, the sampling establishment or diagnostic laboratory (hereinafter referred to as the "involved person '), and a written procedure, procedures and resources for quality management; quality management means coordinated activities that manage and control the organisation from a quality perspective. The quality system shall include all activities which contribute directly or indirectly to the quality. The quality system and quality management documented shall apply to all activities whose authorisation is requested.
1.2. For the needs of the tissue establishment, at least advice shall be given to a physician who oversees medical activities such as selection of donors, examination of the clinical outputs of the tissues and cells used and contact with clinical users.
1.3. The risks associated with the use and handling of biological material, including those related to the procedures, environment and health of the persons involved, shall be identified and minimised. In case of risk minimisation, the appropriate quality and safety of tissues and cells for their intended use shall be maintained.
1.4. In the case of contractual provision of certain activities, the contracting party shall be evaluated and selected according to its ability to comply with the requirements of the law and this Decree before the contract is concluded. The contract shall specify the terms and obligations of the parties to the contract to be complied with, including detailed procedures and obligations relating to alerts. Where a contract is concluded to ensure the availability of stored tissues and cells pursuant to Article 4 (2) of the Act, the quality and safety requirements for tissues and cells and traceability shall be specified.
1.5 A documented system is established, supervised by the responsible person of the tissue facility (3), demonstrating that the tissues and cells meet the relevant quality and safety specifications for release and distribution.
1.6. A documented system shall be established guaranteeing the identification of each unit of tissues and cells at all stages of the activities to be carried out.
2. Engaged persons
2.1. Each activity shall be carried out in such a way as to ensure that a sufficient number of persons qualified for the operations to be carried out is available. Their eligibility shall be assessed at appropriate intervals, as specified in the quality system documentation.
2.2. A clear, documented description of the work shall be developed and updated for each person involved. It is ensured that responsibilities and responsibilities are clearly documented and understood.
2.3. Before carrying out activities, each person involved shall be provided with training, up-to-date training in the event of changes in procedures or developments in scientific knowledge, as well as appropriate opportunities for professional development. The training programme shall be documented. Ensuring that each individual
(a) be eligible for the tasks entrusted to him;
(b) have adequate knowledge and understand the process and principles relating to the tasks entrusted to it;
(c) understand the organisation, quality system and health and safety regulations of the establishment in which he works; and
(d) has been informed of the broader ethical, legal and regulatory context of his work.
3. Equipment, materials and products
3.1. Equipment, materials and products used in the activities carried out shall be designed and maintained in a manner suitable for their intended purpose and in a way that presents a minimum risk to the recipients of tissues and cells and to the persons involved who handle them.
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Regulation Information
| Citation | Decree No. 422 / 2008 Coll., laying down closer requirements to ensure the quality and safety of human tissues and cells intended for human use |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 08.12.2008 |
|---|---|
| Effective from | 08.12.2008 |
| Effective until | - |
| Status | Valid |
Legal Areas:
Administrative law
Health
The regulation text is for informational purposes only.
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