Act No. 75 / 2011 Coll.
Act amending Act No. 378 / 2007 Coll., on Medicines and on Amendments to Certain Related Acts (Law on Medicines), as amended
Valid
Effective from 25.03.2011
75
THE LAW
of 3 March 2011
amending Act No. 378 / 2007 Coll., on Medicines and Changes to Certain Related Acts (Law on Medicines), as amended
Parliament has decided on this law of the Czech Republic:
Act No. 378 / 2007 Coll., on Medicines and on Amendments to Certain Related Acts (Law on Medicines), as amended by Act No. 124 / 2008 Coll., Act No. 296 / 2008 Coll., Act No. 141 / 2009 Coll., Act No. 281 / 2009 Coll. and Act No. 291 / 2009 Coll., is amended as follows:
1. In Paragraph 1 (1) of the Introductory Part of the provision, the words "the European Communities (hereinafter referred to as the Community) 'and the words" the Community' are replaced by the words "the European Union '.
2 (1) (5) (a) (5) (5) (5) (a) (5) (5) (a) (5) (5) (5) (a) (5) (5) (5) (5) (a) (5) (5) (5) (5) (a) (5) (5) (5) (5) (5) (5) (5) (5) (5) (5) (5) (5) (5) (5) (5) (5) (a) (5) (5) (5) (5) (5) (5) (5) (5) (5) (5) (5) (5) (5) (5) (5) (5) (5) (5) (5) (5) (5) (5) (5) (5) (5) (5) (5) (5) (5) (5) (5) (5) (5) (5) (5) (5) (5) (5) (5) (5) (5) (5) (5) (5)
3. In Article 2, at the end of paragraph 2, the dot is replaced by a comma and the following points (p) and (q) are added:
"(p) gene therapi86 medicinal products) which mean biological medicinal products containing or consisting of recombinant nucleic acid, used or administered to humans for the control, repair, replacement, addition or elimination of a genetic sequence, the therapeutic, preventive or diagnostic effect of which relates directly to the recombinant nucleic acid sequence or to the genetic expression product of that sequence; gene therapy medicinal products do not include vaccines against infectious diseases,
(q) somatocellular therapy medicinal products which mean biological medicinal products determined on the basis of or consisting of the pharmacological, immunological or metabolic action of their cells or tissues for the treatment, prevention or diagnosis of diseases in humans,
1. which have undergone a change in their physiological functions, biological or structural properties relevant to the intended clinical use, in particular where the manipulation referred to in Annex 1 to the directly applicable European Union regulation on advanced therapi87 medicinal products is not considered to be essential manipulation; or
2. which are not intended to be used by the recipient in the same basic function or functions as the donor.
86) Commission Directive 2009 / 120 / EC of 14 September 2009 amending Directive 2001 / 83 / EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use as regards advanced therapy medicinal products.
87) Regulation (EC) No 1394 / 2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001 / 83 / EC and Regulation (EC) No 726 / 2004. ';
4. in Article 2 (3) (a), the words "human tissues, human cells and preparations of human tissues or cells" shall be deleted;
5. in Paragraph 13 (3) (k), the words "with the Community" shall be replaced by the words "with the European Union."
6. In Article 16 (3) (l), the words "the European Communities' are replaced by the words" the European Union '.
Article 7 (24a) is deleted.
8. Paragraph 25 (2) (f), including footnote 39a, is deleted.
Points (g) to (i) shall be renumbered as points (f) to (h).
9. in Paragraph 26 (5) (k), "outside the Community" is replaced by "outside the European Union";
10. In Articles 26 (5) (s), 27 (2) (b), 30 (3) (d) and (e), 30 (4), 65 (3), 66 (1) (b), 91 (2) (a), 92 (1), 94 (2) and (6), 95 (2) and 96 (1), the words "in the Community" shall be replaced by "in the European Union."
11. in Article 27 (1), the words "Community rules" shall be replaced by the words "European Union rules," the words "European Union rules," the words "Community" shall be replaced by "European Union" and the words "or Community" shall be replaced by the words "or European Union."
12. in Article 27 (7), the words' in the Community 'shall be replaced by' in the European Union 'and the words' by a Community regulation 'shall be replaced by' by a European Union regulation ';
13. In Paragraph 42 (1), the words "Community law 'are replaced by the words" European Union law' and the words "Community 'are replaced by the words" European Union'.
14. in Articles 50 and 92 (6), the words "Community Regulation" shall be replaced by the words "European Union Regulation" and the words "Community" shall be replaced by "European Union."
15. in Paragraph 66 (2), the word 'Community' is replaced by 'European Union';
16. In Paragraph 74 (10), the words "in the Community 'are replaced by the words" in the European Union' and the words "Community rules' are replaced by the words" European Union rules'.
17. in Paragraph 77 (1) (c) (11), the word "or" shall be deleted and the word "or" shall be added at the end of point 13. "
18. in Paragraph 77 (1) (c), the following point 14 is added:
"14. Physicians who directly use them in the provision of health care, and only advanced therapy medicinal products,"
19. In the second sentence of Paragraph 88 (2), the words "and modern therapy products' shall be inserted after the words" transfusions'.
Efficacy
This Act shall take effect on the day of its publication.
Germany
Klaus v. r.
Nausea v. r.
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Regulation Information
| Citation | Act No. 75 / 2011 Coll., amending Act No. 378 / 2007 Coll., on Medicines and on Amendments to Certain Related Acts (Law on Medicines), as amended |
|---|---|
| Regulation Type | - |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 25.03.2011 |
|---|---|
| Effective from | 25.03.2011 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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