Act No. 77 / 2012 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 01.04.2012
77
THE LAW
of 7 February 2012
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. and Act No. 281 / 2009 Coll., is amended as follows:
1. In Paragraph 1 (1), the words "the European Communities (hereinafter referred to as Community rules) 'are replaced by the words" the European Union'.
2. In Article 2 (n), the words "the European Communities' are replaced by the words" the European Union 'and the words "the Community' are deleted.
3. In Article 5 (1), the dot at the end of point (j) is replaced by a comma and the following point (k) is added:
"(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 shall be laid down in implementing legislation. ';
4. in § 5 (3) of the introductory part of the provision, § 10 (2) (c), § 11 (1) (a), § 12, § 13 (1) and (3), § 15 (1) (c), § 15 (2) (a) and Article 25 (8), the word "Community" shall be deleted;
5. In Article 10, the following paragraph 3 is inserted after paragraph 2:
"(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 be the holder of a permit to distribute tissues and cells granted under § 20a. '
Paragraphs 3 to 6 shall be renumbered paragraphs 4 to 7.
6. In Article 10 (6), the words "from a contract as referred to in paragraph 1 and from a contract as referred to in paragraph 4 'are replaced by the words" from a contract as referred to in paragraphs 1, 3 or 5' and the words "secured by virtue of it 'are replaced by the words" secured by virtue of it'.
7. In Article 10 (7), "paragraphs 1, 4 and 5 'are replaced by" paragraphs 1, 5 and 6'.
8. In Part One, in Title III, the word "COMMUNITY 'is deleted.
9. In Article 11 (2), the words "; tissue establishment may provide for the distribution of tissues and cells from a tissue establishment to a third country through the person to be supplied or by a person to whom the tissues and cells are to be supplied in a 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 supplied 'shall be added at the end of the text of point (b).
10. in Article 14 (c) (2), the word "Community" shall be replaced by the words "European Union."
11. in Article 15 (2) (b), the words "Community States" are replaced by the words "States" and the words "Community rules" are replaced by the words "European Union rules."
12. The following Section 20a is inserted after Section 20:
(1) The authorisation of the activity may be limited to the authorisation for the distribution of tissues and cells. Paragraph 17 shall not apply to the content of the application for authorisation to distribute tissues and cells; the application shall be submitted to the Constitution and shall contain:
(a) a document certifying that it is a legal or commercial natural person;
(b) procedures and conditions which guarantee the quality and safety of tissues and cells in their distribution;
(c) procedures and conditions for the accurate, rapid and verifiable withdrawal of distributed tissues and cells from further use;
(d) the data and documentation supporting the applicant's assumptions for the distribution of tissues and cells to fulfil the obligations under this Act.
(2) The structure, scope and necessary details of the data and documentation referred to in paragraph 1 shall be laid down in implementing legislation.
(3) When deciding on an application for authorisation for the distribution of tissues and cells referred to in paragraph 1, the Institute shall proceed mutatis mutandis in accordance with Sections 18 and 19 and shall apply mutatis mutandis to changes to that authorisation, its revocation and termination.
(4) The holder of a tissue and cell distribution permit shall be subject to the same obligations for the distribution of tissues and cells as the tissue establishment operator in its implementation. The holder of the authorisation for the distribution of tissues and cells shall comply with the rules of good distribution practice laid down in the implementing legislation issued pursuant to Article 5 (1) (k). ';
13. In Article 25, at the end of paragraph 3, the sentence "The holder of the authorisation to distribute tissues and cells shall commit an administrative offence by violating the rules of good distribution practice in contravention of Article 20a (4) in their distribution."
14. in Article 25 (6), the words "or contrary to Article 5 (1) (k) in the distribution of tissues and cells," shall be added at the end of the text in point (c). "
15. in Article 29, "§ 5 (1) (a), (c) to (f)" is replaced by "§ 5 (1) (a), (c) to (f) and (k)" and after "§ 17 (4)" is replaced by "§ 20a (2)."
Efficacy
That law shall take effect on the first day of the calendar month following its publication.
Germany
Klaus v. r.
Nausea v. r.
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Regulation Information
| Citation | Act No. 77 / 2012 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 | 12.03.2012 |
|---|---|
| Effective from | 01.04.2012 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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