Act No. 36 / 2018 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 07.03.2018
36
THE LAW
of 15 February 2018
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:
Amendment to the Drug Act
Act No. 378 / 2007 Coll., Act No. 141 / 2009 Coll., Act No. 281 / 2009 Coll., Act No. 291 / 2009 Coll., Act No. 75 / 2011 Coll., Act No. 375 / 2011 Coll., Act No. 50 / 2013 Coll., Act No. 70 / 2013 Coll., Act No. 250 / 2014 Coll., Act No. 80 / 2015 Coll., Act No. 243 / 2016 Coll., Act No. 65 / 2017 Coll., Act No. 66 / 2017 Coll., Act No. 183 / 2017 Coll., Act No. 251 / 2017 Coll., is amended as follows:
1. At the end of footnote 1, the sentence "Commission Directive (EU) 2016 / 1214 of 25 July 2016 amending Directive 2005 / 62 / EC as regards standards and specifications of the quality system for blood establishments is added to the new line. '.
2. In Section 67 (4) of the introductory part of the provision, the text "(i) and (j) 'is replaced by" and (i)'.
3. In Paragraph 67 (4) (l), the text "(a) and 'is deleted.
4. In Paragraph 67 (4), the semicolon is replaced by a comma at the end of point (l) and the following point (m) is inserted, including footnote 105:
"(m) to operate in accordance with the production permit, to comply with the rules of good manufacturing practice for transfusions, including the guidelines for good manufacturing practice established in accordance with the European Union Code on Standards and Specifications relating to the Quality System for Transfusions Devices (105) (hereinafter referred to as" Good Manufacturing Practice Rules for Transfusions Devices ") and Commission Guidelines; This provision shall also apply to transfusion preparations intended for export only;
105) Article 2 of Commission Directive 2005 / 62 / EC, as amended by Commission Directive (EU) 2016 / 1214. '
5. In Section 67 (4), at the end of the text of the final part of the provision, the words "and the rules of good manufacturing practice for the transfusion service facility referred to in point (m) 'shall be added.
6. In Article 104 (2), "§ 67 (4) and § 64 (j) 'is replaced by" § 67 (4) (m)';
7. in Article 104 (8) (e), the text "(a) and" shall be deleted;
8. in Article 108 (2) (a), the words "or, in the course of the prescription of medicinal products, in contravention of Article 80 (1)" shall be deleted;
9. In Article 108 (2), at the end of the text in point (a), the words "or, when prescribing medicinal products, in contravention of Article 80 (1) 'shall be added.
Transitional provision
The infringement procedure under Section 108 (2) (a) of Act No. 378 / 2007 Coll., as effective until the date of publication of this Act, initiated for the prescription of a medicinal product in breach of Section 80 (1) of Act No. 378 / 2007 Coll., as amended by Act No. 70 / 2013 Coll., between 1 January 2018 and the date of publication of this Act, is hereby terminated.
Efficacy
This Law shall take effect on the day of its publication, with the exception of point 9, which shall take effect on 1 January 2019.
Z. Hamáček v. r.
Zeman v. r.
Babiš v. r.
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Regulation Information
| Citation | Act No. 36 / 2018 Coll., amending Act No. 378 / 2007 Coll., on Medicines and on Changes to Certain Related Acts (Law on Medicines), as amended |
|---|---|
| Regulation Type | - |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 07.03.2018 |
|---|---|
| Effective from | 07.03.2018 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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