Decree No. 167 / 2017 Coll.
Decree amending Decree No. 422 / 2008 Coll., on establishing closer requirements for ensuring the quality and safety of human tissues and cells intended for human use, as amended by Decree No. 339 / 2012 Coll. and Decree No. 45 / 2014 Coll.
Valid
Effective from 24.06.2017
167
DECLARATION
of 5 June 2017
amending Decree No. 422 / 2008 Coll., laying down closer requirements for the quality and safety of human tissues and cells intended for human use, as amended by Decree No. 339 / 2012 Coll. and Decree No. 45 / 2014 Coll.
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 (Act on Human tissues and cells), as amended by Act No. 77 / 2012 Coll. and Act No. 136 / 2017 Coll.:
Decree No. 422 / 2008 Coll., establishing closer requirements to ensure the quality and safety of human tissues and cells intended for human use, as amended by Decree No. 339 / 2012 Coll. and Decree No. 45 / 2014 Coll., is amended as follows:
1. In Section 1 of the introductory part of the provision, the words "European Community1) 'are replaced by the words" European Union1)'.
Footnote 1:
"(1) Directive 2004 / 23 / EC of the European Parliament and of the Council of 31 March 2004 laying down quality and safety standards for the donation, collection, investigation, processing, preservation, storage and distribution of human tissues and cells. Commission Directive 2006 / 17 / EC of 8 February 2006 implementing Directive 2004 / 23 / EC of the European Parliament and of the Council as regards certain technical requirements for the donation, procurement and investigation of human tissues and cells. Commission Directive 2006 / 86 / EC of 24 October 2006 implementing Directive 2004 / 23 / EC of the European Parliament and of the Council as regards traceability, notification of serious adverse reactions and effects and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells. 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, at the end of point (i), the dot is replaced by a comma and the following points (j) to (l) are added:
"(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) coding of tissues and cells and allocating unique donation numbers. ';
3. In Section 6, the words "and § 5 (2) (a) of the Act 'are replaced by the words" and § 5 (3) (a) of the Act'.
4. In Article 8 (1) (b) (2), the words "identification 'and" tissues and cells' are deleted.
5. in § 8 (1) (c) (1):
"1. identification of the tissue establishment,"
6. In Paragraph 8 (1) (c) (2), the words "the European Communities' are replaced by the words" the European Union '.
7. In Article 8 (1) (d) (2), the words "medical establishments' are replaced by the words" health service providers'.
8. In Article 8, at the end of paragraph 1, the dot is replaced by a comma and the following point (e) is added:
"(e) identification of the single European code."
9. In Section 8 (2) of the Introductory Part of the provision, the word "operators' is replaced by" health service providers'.
10. in Paragraph 8 (2) (b), the words "medical establishments" are replaced by the words "health service providers."
11. in Paragraph 8 (2) (e), "a" is deleted;
12. In Article 8, at the end of paragraph 2, the dot is replaced by a comma and the following point (g) is added:
"(g) the single European code."
13. In the title of Section 9, "the text '," Article 20b (3)' is inserted after "K 5 (1) (e) '.
14. in Paragraph 9 (1) (a), "identification number" is replaced by "number."
15. in Article 9, the following paragraph 4 is added:
"(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 Regulation."
16. In Section 12, the text "paragraph 4 'is replaced by" paragraph 6'.
17. The following Sections 12b and 12c are inserted after Section 12a, including the headings:
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 Regulation. '
18. In Annex No 2, point 7, at the end of point (e), the dot is replaced by a comma and the following point (f) is added:
"(f) donation identification sequence."
19. In Annex 2, point 7, in the final part of the provision, the words "to (e) 'are replaced by the words" to (f)'.
20. In Annex 6, point 5.1, at the end of point (f), the dot is replaced by a comma and the following point (g) is added:
"(g) the single European code."
21. In Annex 6, point 5.1, the words "and (e) 'are replaced by", (e) and (g)' and the words "to (f) 'are replaced by the words" to (g)'.
22. In Annex 6, point 5.2, at the end of point (j), the dot is replaced by a comma and the following point (k) is added:
"(k) for imported tissues and cells of the country of collection and the exporting country, if different from the country of collection."
23. Annex 7, including the title, reads:
"Annex No 7 to Decree No 422 / 2008 Coll.
Notifications and reports
NOTIFICATION
1. Model for notification or suspected serious adverse reaction
2. Model for notification or suspected serious adverse event
REPORTS
1. Model of the serious adverse reaction report
2. Model of the Serious Adverse Event Report
"
24. The following Annexes 10 to 12 are inserted after Annex 9, including the headings:
"Annex No 10 to Decree No 422 / 2008 Coll.
Creation and structure of the single European code, requirements for its use, structure of the product code and technical rules for the allocation of unique donation numbers
I. Creation and structure of the single European code
| SEKVENCE IDENTIFIKACE DAROVÁNÍ | SEKVENCE IDENTIFIKACE PŘÍPRAVKU | |||||
|---|---|---|---|---|---|---|
| KÓD TKÁŇOVÉHO ZAŘÍZENÍ EU | JEDINEČNÉ ČÍSLO DAROVÁNÍ | KÓD PŘÍPRAVKU | ČÍSLO FRAKCE | DATUM UPLYNUTÍ DOBY POUŽITELNOSTI***) | ||
| Kód země ISO*) | Číslo tkáňového zařízení**) | Identifikátor kódovacího systému přípravků | Číslo přípravku | |||
| 2 alfabetické znaky | 6 alfanumerických znaků | 13 alfanumerických znaků | 1 alfabetický znak | 7 alfanumerických znaků | 3 alfanumerické znaky | 8 numerických znaků |
Explanatory notes:
*) ISO code of the Czech Republic (CZ).
* *) Number of tissue establishment that is allocated to each tissue establishment and published in the database of tissue establishments of the European Union.
* * * (a) The expiry date shall be indicated in the order of the year, month, day (YYYY-MM-DD). (b) In the case of tissues and cells for which no expiry date has been established, the place of the "00000000" date (8 numerical characters as for the expiry date) shall be indicated.
II. Requirements for the use of the single European code
The tissue establishment shall indicate the single European code in the format legible to the naked eye, the abbreviation "SEC 'indicating the single European code being given before the code. The donation identification sequence and the product identification sequence shall be separated by 1 gap or shall be indicated on two consecutive lines.
III. Structure of the product code
Product code is composed
(a) one alphabetical character identifying the coding system authorised by the European Union which has chosen the tissue establishment, namely:
1. "E" for EUTC,
2. "A" for ISBT128,
3. "B" for Eurocode, and
(b) the product number (7 alphanumeric characters) which the selected coding system provides for each type of tissue and cell.
IV. Technical rules of the system for the allocation of unique donation numbers
(a) The unique donation number assigned to the specific donation of tissues and cells shall be given in the form of 13 alphanumeric characters in the order:
1. an indication of the date of collection in the order of the last two digits of the year, month, day (RRMMDD),
2. the initials of the donor in order name, surname,
3. the registration number.
If the sum of the alphanumeric characters referred to in points 1 to 3 does not use up the number of 13 alphanumeric characters, the number of zeros required shall be reported at the end to the number of 13 alphanumeric characters.
(b) A tissue establishment may apply other technical rules for the system for the allocation of unique donation numbers than those referred to in (b), provided that they guarantee a clear identification of the specific donation of tissues and cells and that the unique donation number thus assigned contains 13 alphanumeric characters.
Příloha č. 11
Annex No 11 to Decree No 422 / 2008 Coll.
The scope and necessary details of the documentation submitted by the Institute at the request of the Institute and, if necessary, provided by the importing tissue establishment of the Institute
A. Documentation concerning the importing tissue establishment shall include:
1. The work of the responsible person and details of his or her qualifications and education under Section 6 of the Act, provided that another responsible person is appointed for the activities of the importing tissue establishment, other than for other activities of the tissue establishment.
2. Copy of the label of the primary packaging, label of the new packaging, outer packaging and container.
3. List of current versions of standard working procedures concerning third-country import of tissues and cells, including procedures for the application of a single European code, acceptance and storage of imported tissues and cells in the importing tissue establishment, procedures for adverse events and reactions, withdrawal of distribution and traceability products from the donor to the recipient.
B. Documentation concerning third-country suppliers shall include:
1. A detailed description of the criteria used to identify and evaluate the donor, the information provided to the donor or his family, the way in which the donor or his family's consent is obtained, and whether or not the donation was voluntary and unpaid.
2. Details of the diagnostic laboratory or other similar workplace used by third country suppliers and tests carried out by those laboratories.
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. Details of the conditions for release of tissues and cells by a supplier or supplier from a third country.
6. Details of any subcontractors used by suppliers from a third country, including the name, location and activities carried out.
7. Summary of the last inspection carried out with a third-country supplier by the competent authority or authorities 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. All relevant national or international accreditation.
Příloha č. 12
Annex No 12 to Decree No 422 / 2008 Coll.
Model certificate of authorisation for the activity of tissue establishments in the scope of imports of tissues and cells from a third country
"
Efficacy
This decree shall take effect on the 15th day following its publication.
Minister:
JUDr.
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Regulation Information
| Citation | Decree No. 167 / 2017 Coll., amending Decree No. 422 / 2008 Coll., on establishing closer requirements to ensure the quality and safety of human tissues and cells intended for human use, as amended by Decree No. 339 / 2012 Coll. and Decree No. 45 / 2014 Coll. |
|---|---|
| Regulation Type | - |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 09.06.2017 |
|---|---|
| Effective from | 24.06.2017 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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