Act No. 136 / 2017 Coll.
Act amending Act No. 296 / 2008 Coll., on ensuring the quality and safety of human tissues and cells intended for human use and amending related laws (Act on Human tissues and cells), as amended
Valid
Effective from 17.05.2017
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136
THE LAW
of 4 April 2017
amending Act No. 296 / 2008 Coll., on ensuring the quality and safety of human tissues and cells intended for human use and amending related laws (Act on Human tissues and cells), as amended
Parliament has decided on this law of the Czech Republic:
Act No. 296 / 2008 Coll., on ensuring the quality and safety of human tissues and cells intended for human use and amending related laws (Act on Human tissues and cells), as amended by Act No. 41 / 2009 Coll., Act No. 281 / 2009 Coll., Act No. 375 / 2011 Coll., Act No. 77 / 2012 Coll. and Act No. 64 / 2014 Coll., is amended as follows:
1. At the end of footnote 1, the following sentence is added:
"Commission Directive (EU) 2015 / 565 of 8 April 2015 amending Directive 2006 / 86 / EC as regards certain technical requirements for coding human tissues and cells.
Commission Directive (EU) 2015 / 566 of 8 April 2015 implementing Directive 2004 / 23 / EC as regards procedures for verifying equivalent quality and safety standards for imported tissues and cells. ';
2. in Article 1, the following paragraph 3 is added:
"(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 importation from a third country. "
3. In Section 2 (g) (4), the words "in health care establishments' are replaced by the words" for a health service provider '.
4. in Article 2 (n):
"(n) a Member State shall mean a Member State of the European Union and a Contracting State to the Agreement on the European Economic Area;"
5. in Article 2, the following points (o) to (w) are added:
"(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. ';
6. in Article 3 (3) (b), "3" is replaced by "4."
7. in Articles 4 (2), 7 (2) and 9 (2), "3" is replaced by "5."
8. in Article 5 (1) (d), the words "the European Commission (" the Commission ")" shall be replaced by the words "the Commission."
9. in Article 5 (1) (e), the words "where such an assignment is compulsory under this law, the single European code" shall be added at the end of the text of point 1.
10. in Article 5, the following paragraph 2 is inserted after paragraph 1:
"(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 in the manufacture of advanced therapi2 medicinal products, traceability must be ensured at least to the manufacturer of advanced therapy medicinal products. ';
Paragraphs 2 and 3 shall become paragraphs 3 and 4.
11. in Article 5 (4) of the introductory part of the provision, the words "imported by him from a country other than a Member State (" third country ")" shall be replaced by "imported from a third country";
12. in Article 5 (4) (a) (3), the words "from a third country" shall be inserted after the words "supplier."
13. in Paragraph 6 (3) (g), "§ 5 (3)" is replaced by "§ 5 (4)."
14. in Article 7 (1) (c) of the final part of the provision, the words "in the case of collection of tissues and cells by teams of two or more tissue establishments," shall be inserted after the words "governing the performance of transplants"; in the case of collection of tissues and cells to a deceased donor, by teams of two or more tissue establishments, the sampling facilities shall ensure an appropriate traceability system for all such samples. "
15. The group title above the title of Section 11 reads:
"Imports of tissues and cells from third countries'.
16. In Paragraph 11 (1) of the Introductory Part of the provision, the words "authorised to provide 'are replaced by the words" secured'.
17. in Article 11 (1) (b), the words "to import tissues and cells" shall be inserted after the words "to import tissues and cells," the words "entitled to release and distribute" shall be replaced by the words "referring to" and, where appropriate, the words "comparable types of tissues and cells," shall be deleted;
18. in Article 11 (1) (d) to (f):
"(d) imported tissues and cells meet 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). ';
19. Paragraph 11 (2) is deleted.
Paragraphs 3 and 4 shall become paragraphs 2 and 3.
20. In Article 11 (2), the words "from third countries' shall be inserted after the words" cells'.
21. in Article 11, paragraph 3 shall be deleted;
22. After Paragraph 11, the following Sections 11a and 11b are inserted:
(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:
(a) the quality and safety requirements of tissues and cells, the fulfilment of which ensures that the quality and safety requirements of imported tissues and cells are equivalent to those laid down by this law;
(b) agree that the Institute may carry out checks on the activities of a supplier from a third country, including its equipment, during the period of validity of this Treaty and for a further period of 24 months from the date of expiry of the contract and the corresponding obligation of the Contracting Parties to allow the Institute to carry out such checks;
(c) detailed information on the requirements of the importing tissue establishment in order to ensure that the quality and safety requirements of imported tissues and cells laid down by law and the mutually agreed roles and responsibilities of both parties in ensuring equivalence of quality and safety requirements for imported tissues and cells;
(d) arrangements to ensure that a third-country supplier provides the importing tissue establishment with documentation relating to the activity of that third-country supplier containing at least the following information:
1. a detailed description of the criteria used for the identification and evaluation of the donor, the information provided to the donor or his family, the manner in which the consent of the donor or his family is obtained and whether or not the donation was voluntary and unpaid;
2. detailed information on the diagnostic laboratory or other similar workplace used by a third-country supplier for the investigation of tissues and cells and on the tests carried out in this investigation;
3. details of the procedures used during the treatment of tissues and cells, including details of the validation of the processing process;
4. for each activity carried out by a third country supplier, a detailed description of the premises, the most important equipment, materials and criteria used for quality control and environmental control;
5. detailed information on the conditions for the release of tissues and cells by a supplier from a third country;
6. details of any subcontractors used by a third-country supplier, including the name, location and activities carried out;
7. a summary of the last inspection carried out with a third country supplier by the competent authority of the third country, including the date, type of inspection and the main conclusions;
8. Summary of the last audit carried out on or on behalf of a third country supplier importing tissue establishments;
9. any relevant national or international accreditation;
(e) arrangements to ensure that the supplier from a third country informs the importing tissue establishment of any serious adverse event or reaction or suspicion which may affect the quality and safety of the tissues and cells which have been or are to be imported by the importing tissue establishment;
(f) arrangements to ensure that the supplier from a third country informs the importing tissue establishment of any material changes to its activities, including the partial or total cancellation or suspension of authorisation to export tissues and cells or other such decisions by the competent authority of the third country concerning non-compliance with conditions which may affect the quality and safety of tissues and cells which have been or are to be imported by the importing tissue establishment;
(g) agree that the Institute may carry out an inspection of the activities of a supplier from a third country, including on-the-spot inspections, if the Institute would like to proceed with the inspection of the importing tissue establishment;
(h) an arrangement guaranteeing the right of the importing tissue establishment to carry out a regular audit of the supplier from a third country;
(i) the conditions on which the Parties agree and which must be fulfilled when transporting tissues and cells between a supplier from a third country and an importing tissue establishment;
(j) arrangements to ensure that donor records relating to imported tissues and cells are kept by a third country supplier or subcontractor in accordance with the legislation on the protection of personal data for a period of 30 years from the date of collection of tissues or cells and to ensure that they are properly preserved in the event that the third country supplier ceases to operate;
(k) provisions on periodic review and, where necessary, amending this written contract, including adjustments to reflect any changes in the quality and safety requirements of tissues and cells provided for by law;
(l) a list of all standard working practices of a third country supplier related to the quality and safety of imported tissues and cells and an undertaking to provide, upon request, a description of such standard working practices by the Institute or importing tissue establishment.
(2) A tissue establishment in case of urgent need under Article 13 (1) or a single import is not required
(a) conclude a written contract with a supplier from a third country in accordance with paragraph 1 where:
1. traceability from donor to recipient and from recipient to donor is ensured; and
2. Imported tissues and cells shall only be used for the consignee for whom they were specifically imported;
(b) provide the Institute with the information and documentation provided for in the implementing act referred to in Article 17 (5), provided that the conditions referred to in (a) (1) and (2) are met.
One-off imports to a particular consignee may only be made by tissue establishments once.
Exports of tissues and cells to third countries
(1) Exports of tissues and cells to third countries for their use for the treatment of the recipient are provided by the tissue establishment, if the tissue and cells released by it are used for the treatment of the recipient, provided that:
(a) the exported tissues and cells comply with the requirements of this law and the requirements of the legislation of a third country; compliance with the requirements of the legislation of the third country is demonstrated by a document issued by the competent authority of the third country; where no such document is issued, this may be certified by declaration of tissue establishment,
(b) is the holder of an authorisation for an activity authorised to distribute the type of tissues and cells or, where appropriate, the comparable type of tissues and cells which are the subject of export; the tissue establishment may provide for the distribution of tissues and cells to a third country through the person to be supplied or in writing by the person authorised by that third country, provided that they are the distribution of tissues and cells under the legislation of the State to which the tissues and cells are to be exported; and
(c) the conditions for export are fulfilled under the Transplant Transplants Act (3), even if the exported tissues and cells are not intended for transplantation.
(2) Exports of tissues and cells to third countries for their use in the manufacture of medicinal products may be made if they are met
(a) the conditions referred to in paragraph 1 (c); and
(b) requirements under this Act for the donation, procurement, investigation and release of tissues and cells for use in the manufacture of medicinal products and the requirements of the legislation of a third country; compliance with the requirements of the legislation of a third country is demonstrated by a tissue establishment releasing those tissues and export cells by a document issued by the competent authority of the third country; where no such document is issued, this may be certified by declaration of tissue establishment. ';
23.
Distribution of tissues and cells between the Czech Republic and another Member State
The distribution of tissues and cells between the Czech Republic and another Member State is ensured by the tissue establishment where:
(a) tissues and cells comply with quality and safety requirements equivalent to those laid down in this law;
(b) is the holder of an authorisation for an activity authorised to release and distribute a given type of tissues and cells, possibly a comparable type of tissues and cells; and
(c) conditions for import or export are fulfilled under the Transplant Transplants Act (3), even if tissues and cells are not intended for transplantation. ';
24. in Paragraph 13 (1):
"(1) Distribution from a Member State or imports from a third country in case of an urgent need for tissues and cells for use in the treatment of a specific recipient shall be provided by a tissue establishment which is the holder of an activity authorised to release and distribute the type of tissues and cells concerned, or, where appropriate, by a comparable type of tissues and cells. The authorisation to import from a Member State or import from a third country shall be issued by the Ministry of Health in case of urgent need under the law governing the implementation of transplantation. In case of urgent need for tissues and cells for use in the treatment of a particular recipient, the quality and safety of tissues and cells and the coding requirements for tissues and cells for imported tissues and cells shall not apply. Urgent need shall mean any unexpected situation for which there is no other solution than to import or distribute immediately tissues and cells for immediate use with a specific recipient or recipients whose health would be seriously compromised without such import or distribution. ';
25. in Article 13, paragraph 3 is deleted;
Paragraph 4 shall become paragraph 3.
26. In Article 13 (3), the words "distribution or" and the words "distribution or" shall be inserted after the word "condition."
27. In Article 15, at the end of paragraph 2, the dot is replaced by a comma and the following point (e) is added:
"(e) on the basis of a reasoned request from the competent authority of another Member State to which tissues and cells imported into the Czech Republic from a third country are subsequently distributed, carry out a check
1. at the importing tissue establishment; and
2. a third-country supplier who has concluded a contract pursuant to Paragraph 11a (1). ';
28. In Article 15, paragraphs 3 and 4 are added:
"(3) In the field of tissue and cell coding, the Institute provides the activities listed in Section 20c.
(4) The Institute shall notify:
(a) a finding to the competent authority of another Member State that:
1. the European Union's tissue establishment database contains incorrect information on that other Member State; or
2. there has been a serious breach of the provisions relating to the single European code concerning that other Member State;
(b) the Commission and the competent authority of another Member State find that the European Union's tissue and cell product database needs to be updated. "
29. In Article 17, the following paragraphs 4 and 5 are inserted after paragraph 3:
"(4) The application for authorisation of the activity of a tissue establishment within the scope of imports of tissues and cells from a third country shall contain the particulars and documentation referred to in paragraphs 1 to 3 and in addition to the general requirements of the administrative rules.
(a) information on the importing tissue establishment,
1. the name of the workplace where the tissue establishment carries out its activity;
2. the address of the medical establishment where the tissue establishment carries out its activities;
3. the address of the place where the importation takes place; and
4. the status of the tissue establishment; the status means whether the applicant is already in possession of an authorisation for the activity of the importing tissue establishment, whether he is applying for a new authorisation for an activity or whether he is applying for a change in the existing authorisation for an activity,
(b) contact details of the applicant,
1. e-mail address, telephone number and fax number,
2. the name of the person authorised to act on behalf of the applicant, if he is a legal person, and the name of the person responsible pursuant to Article 6 (2);
3. Internet address of the importing tissue establishment, if any; and
4. the postal address, if different from the location of the tissue establishment or address referred to in (a) (2) and (3);
(c) details of tissues and cells to be imported,
1. the list of types of tissues and cells to be imported;
2. the name of the third country supplier for each type of tissue and cells to be imported;
(d) specifications of activities by type of tissues and cells and by persons carrying them out,
1. indicating, for each type of tissue or cell, the donation, collection, investigation, processing, preservation or storage activities carried out prior to import by a supplier from a third country or subcontractor from a third country,
2. a list of all activities carried out by the importing tissue establishment after importation for each type of tissue or cell; and
3. for each type of tissue or cell, the names of the third countries in which activities are carried out prior to importation;
(e) information on suppliers from third countries with which tissue establishments have a written contract pursuant to Article 11a (1),
1. name of third country supplier;
2. the name of the person authorised to act on behalf of a third-country supplier;
3. the address of the third country supplier's registered office;
4. the postal address of the supplier from a third country, if different from the supplier's registered office from a third country; and
5. the electronic address and telephone number of the supplier from the third country;
(f) documentation to accompany the application,
1. a copy of the written agreement with the supplier or suppliers from the third country;
2. a detailed description of the movement of imported tissues and cells from their collection to their acceptance at the importing tissue establishment; and
3. a copy of the certificate of authorisation to export a supplier from a third country or, where no specific certificate of export is issued, a certificate from the competent authority or authorities of a third country authorising the activities of a supplier from a third country in the tissues and cells sector, including exports. This documentation shall also contain contact details for the competent authority or authorities of the third country. In the case of third countries where this documentation is not available, it is necessary to provide other documents supporting the third country supplier's export authorisation under the legislation of that third country, such as in particular the third country supplier's audit reports.
(5) The importing tissue establishment shall, at the request of the Institute, submit and, where necessary, provide documentation concerning the importing tissue establishment and documentation concerning the supplier or supplier from third countries. ';
Paragraph 4 shall become paragraph 6.
30. In Paragraph 17 (6), "3 'is replaced by" 5'.
31. In Paragraph 19 (2), the following sentence is inserted after the first sentence: "In the decision to authorise the activity of tissue establishments in the scope of imports of tissues and cells from a third country, the type of imported tissues and cells and suppliers from a third country shall be inserted:" Where the decision authorises the activity of tissue establishments in the scope of imports of tissues and cells from a third country, the Institute may further restrict the types of tissues and cells that may be imported or suppliers from third countries that may be used by such a decision. "
32. In Article 19, paragraphs 3 to 5 are added:
"(3) The Institute, after having acquired legal power, shall issue a tissue establishment authorisation certificate to the tissue establishment for the purpose of importing tissues and cells from a third country.
(4) The certificate of authorisation for the activity of a tissue establishment within the scope of imports of tissues and cells from a third country issued by the Institute shall include the following elements:
(a) the name of the importing tissue establishment;
(b) the European Union tissue establishment database code;
(c) contact details of the importing tissue establishment;
(d) the type of imported tissues and cells;
(e) the activities of the importing tissue establishment in third countries;
(f) the conditions laid down for importation;
(g) information on third country suppliers;
(h) the date of issue 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; and
(i) the date of expiry of the certificate of authorisation for the activity of the tissue establishment within the scope of imports of tissues and cells from a third country.
(5) A model certificate of authorisation for the activity of a tissue establishment in the scope of imports of tissues and cells from a third country is laid down in the implementing legislation. "
33. in Paragraph 20 (1), the sentences of the third and fourth shall be deleted;
34. In Paragraph 20, the following paragraphs 2 and 3 are inserted after paragraph 1:
"(2) The importing tissue establishment shall, in the event of a material change in its activities intended, request prior modification of the authorisation of the activity in the scope of imports of tissues and cells from a third country. In particular, changes to the type of imported tissues and cells, activities carried out in third countries that may affect the quality and safety of imported tissues and cells, or suppliers from third countries, are considered to be such changes. Where an importing tissue establishment carries out a single import of tissues or cells originating from a third country supplier not covered by an existing authorisation to operate in the scope of imports of tissues and cells from a third country, such imports shall not be considered as a material change if the importing tissue establishment is authorised to import the same type of tissues or cells from another third country supplier or supplier. The application for a modification of the authorisation of an activity shall contain details of the change requested to the extent set out in Section 17.
(3) The Institute shall take a decision on the application referred to in paragraph 1 or 2 within 30 days of the date of its notification, acting mutatis mutandis in accordance with paragraphs 18 and 19. If the Constitution is aware of new facts, it may initiate an ex officio procedure to amend the authorisation and decide within 30 days of the date of initiation of the procedure, acting mutatis mutandis in accordance with paragraphs 18 and 19. Where an on-the-spot investigation is necessary, the periods referred to in the first and second sentences shall be extended to 90 days. ';
Paragraphs 2 to 4 shall be renumbered paragraphs 4 to 6.
35. in Article 20 (5), "§ 22 (3)" is replaced by "§ 22 (2)";
36. In Part One, the following Title VI is inserted after Title V:
CODONING OF PRESSURE AND BLOOD
(1) The single European code covers all distributed tissues and cells that are released into circulation for human use. The single European code shall be a unique identifier consisting of:
(a) the donation identification sequence; the donation identification sequence consists of a tissue device code and a unique donation number; and
(b) the sequence of product identification; the product identification sequence consists of a product code, fraction number and expiry date.
In cases other than those referred to in the first sentence, unless otherwise specified, at least the donation identification sequence shall be used in the accompanying documentation.
(2) The single European code referred to in paragraph 1 shall not apply if:
(a) donating reproductive cells between a man and a woman who together form an infertile pair and undergo fertility treatment together;
(b) tissues and cells, if they remain within one tissue establishment and in one medical establishment;
(c) tissues and cells imported from a third country if they remain from import to human use within a single tissue establishment and in a single medical establishment.
(3) The production and structure of the single European code, the requirements for its use, the structure of the product code and the technical rules for the allocation of unique donation numbers are laid down in the implementing legislation.
(4) The tissue establishment shall ensure:
(a) the allocation of the single European code to all tissues and cells for which the code must be used, at the latest before their distribution for human use;
(b) the allocation of a sequence of tissue and cell donation identification after collection or import of tissues and cells from a third country; in the case of a collection, a new donation identification number shall be assigned to the final product, the traceability of each donation case being ensured by the tissue establishment in which the collection is carried out; collection means physical contact or mixing of tissues and cells from one or more withdrawals from the same donor or from two or more donors in a single container; the donation identification sequence after allocation cannot be changed except when an error caused by incorrect input needs to be corrected, any correction being properly documented;
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Regulation Information
| Citation | Act No. 136 / 2017 Coll., amending Act No. 296 / 2008 Coll., on the Quality and Safety of Human Tissue and Cell for Human Use and on the Amendment of Related Acts (Human Tissue and Cell Act), as amended |
|---|---|
| Regulation Type | - |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 02.05.2017 |
|---|---|
| Effective from | 17.05.2017 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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