Decree No. 180 / 2019 Coll.
Decree amending Decree No. 229 / 2008 Coll., on the production and distribution of medicines, as amended by Decree No. 252 / 2018 Coll.
Valid
Order
Effective from 18.08.2019
180
DECLARATION
of 11 July 2019
amending Decree No 229 / 2008 Coll., on the production and distribution of medicines, as amended by Decree No 252 / 2018 Coll.
The Ministry of Health and the Ministry of Agriculture provides, pursuant to § 114 paragraphs 1 and 2 of Act No. 378 / 2007 Coll., on Medicines and on amendments to certain related laws (Act on Medicines), as amended by Act No. 50 / 2011 Coll., Act No. 70 / 2013 Coll., Act No. 66 / 2017 Coll. and Act No. 44 / 2019 Coll., for implementation of § 64 (j) and § 77 (1) (g) of the Act on Medicines:
Decree No. 229 / 2008 Coll., on the production and distribution of medicinal products, as amended by Decree No. 252 / 2018 Coll., is amended as follows:
1. in Article 2 (a), the words "Article 57 (1) or" shall be deleted;
2. In Article 2 (b), the words "and investigational medicinal products' are deleted.
3. in Article 2, points (c) and (d) are deleted;
Points (e) to (h) shall be renumbered as points (c) to (f).
4. In Article 3 (1), the text ', Article 57 (3)' is deleted.
5. In Article 3, at the end of paragraph 2, the sentence "In the case of advanced therapy medicinal products, account shall be taken of the specific guidelines for good manufacturing practice concerning advanced therapy products issued by the Commission (15)."
Footnote 15:
"(15) Rules for medicinal products in the European Community, EUDRALEX Volume 4 - Human and veterinary medicinal products: Good Manufacturing Practice in the current version published by the European Commission."
6. In the first sentence of Paragraph 4, the words "and investigational medicinal products' are deleted, in the second sentence the word" such 'is deleted and the third sentence is deleted.
7. In Article 5 (1), the second sentence is deleted.
8. In Article 5 (2), the words "or a change in the documentation submitted in the context of a clinical trial application 'and the words" or the sponsor of a clinical trial' are deleted.
9. In Article 7 (1), the words "or import" shall be inserted after the words "place of production," and the words "powers," shall be inserted after the words "place of production," in order to be able to perform their duties properly and. "
10. in Article 7 (3), the words "and, where appropriate, the specific requirements for the manufacture of investigational medicinal products" shall be deleted;
11. in Paragraph 9 (1), the sentence "The documentation system must ensure the quality and integrity of the data," shall be inserted after the words "must be";
12. in Paragraph 9 (1), the fifth sentence "and the changes introduced during the development of the investigational medicinal product" shall be deleted and the seventh and eighth sentences shall be deleted, including footnote 4.
13. in Article 9 (2), the words "or against unauthorised access" shall be inserted after the words "or damage."
14. in Paragraph 10 (2), the second sentence is deleted;
15. in Paragraph 10, paragraph 4 is deleted;
16. in Article 11 (2), the sentences of the second and third paragraphs are deleted;
17. in Article 11 (3), the words "sale or use in a clinical trial" shall be replaced by the words "or sales."
18. in Article 11 (4), the third sentence is deleted;
19. In Article 11, paragraphs 5 and 6, including footnote 5, are deleted.
Paragraph 7 shall become paragraph 5.
20. The heading of Section 12 reads: "External activities."
21. in Article 12 (1), the words "or import" shall be inserted after the words "or imports" and the words "or imports" shall be inserted after the words "with production."
22. The heading of Section 13 reads: "Complaints and downloads."
23. in Article 13 (1), the words "and (g)" and the words "including investigational medicinal products" shall be deleted;
24. Paragraph 13 (2) is deleted and paragraph 1 is deleted.
25. In Section 14, the words "and preventive 'shall be inserted after the words" necessary corrective'.
Article 26 (15) is deleted.
27. in Paragraph 39 (11):
"(11) The withdrawal of a medicinal product ordered or notified by the relevant institute or carried out in cooperation with the manufacturer or the marketing authorisation holder shall be governed by the written procedures of the distributor's withdrawal system in accordance with Section 77 (1) (d) of the Medicines Act. This system shall include in particular:
(a) the definition of responsibility for the implementation and coordination of downloads;
(b) a description of the communication with the competent authorities, the marketing authorisation holder and, where appropriate, the manufacturer and the suppliers and customers of the medicinal product during the withdrawal and, where appropriate, after the withdrawal,
(c) a description of the download process itself, including the procedure for the immediate identification and contact of all users of the medicinal product;
(d) the manner in which records of all withdrawal activities are kept and kept;
(e) the method of evaluating the withdrawal and the measures to be taken where withdrawal is not possible;
(f) ensuring the separate location of withdrawn medicinal products;
(g) the procedure for ensuring the exchange of a medicinal product withdrawn because of a quality defect for a medicinal product without a quality defect, including the way in which records of such exchange are kept and kept; and
(h) control and evaluation of the effectiveness of the download system at least once a year. "
Efficacy
This Decree shall take effect on the 30th day following its publication, with the exception of the provisions of Article I (1), (2), (3), (4), (6), (7), (8), (10), (12), (14), (15), (17), (18), (19), (22), (24), (26), which shall take effect 6 months after the date of publication of the Commission notice in the Official Journal of the European Union pursuant to Article 82 (3) of Regulation (EU) No 536 / 2014 of the European Parliament and of the Council of 16 April 2014 on clinical evaluations of medicinal products for human use and repealing Directive 2001 / 20 / EC; the date on which that notice is published, the Ministry of Health in the Notice.
Minister for Health:
Mgr. et Mgr. Vojtěch, MHA, v. r.
Minister for Agriculture:
Ing. Toman, CSc., v. r.
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Regulation Information
| Citation | Decree No. 180 / 2019 Coll., amending Decree No. 229 / 2008 Coll., on the Production and Distribution of Drugs, as amended by Decree No. 252 / 2018 Coll. |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 19.07.2019 |
|---|---|
| Effective from | 18.08.2019 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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