Decree No. 204 / 2018 Coll.
Ordinance amending Decree No. 84 / 2008 Coll., on good pharmacy practice, closer treatment conditions in pharmacies, medical devices and other operators and devices issuing medicinal products, as amended
Valid
Effective from 01.12.2018
204
DECLARATION
of 5 September 2018
amending Decree No. 84 / 2008 Coll., on good pharmacy practice, closer treatment conditions for medicinal products in pharmacies, medical devices and for other operators and devices issuing medicinal products, as amended
The Ministry of Health shall determine, pursuant to Article 114 (1) of Act No. 378 / 2007 Coll., on medicinal products and on amendments to certain related laws (Act No. 378 / 2007 Coll.), as amended by Act No. 50 / 2013 Coll., Act No. 70 / 2013 Coll. and Act No. 66 / 2013 Coll., and Act No. 66 / 2017 Coll., and Act No. 66 / 2017 Coll.:
Decree No. 84 / 2008 Coll., on the correct practice of pharmaceuticals, closer treatment conditions for medicinal products in pharmacies, medical devices and other medicinal product-issuing operators and establishments as amended by Decree No. 254 / 2013 Coll. and Decree No 414 / 2017 Coll., is amended as follows:
1. in Article 3 (1) (a), the words "and provided" shall be replaced by the words "or whose use has been authorised by the Ministry of Health pursuant to Article 11 (b) of the Law on Medicines or the Central Veterinary Administration pursuant to Article 15 (d) of the Law on Medicines, provided for."
2. in Article 3 (1), the following point (b) is inserted after point (a):
"(b) authorised medicinal products4) in accordance with the conditions laid down in the SPC;"
Points (b) to (d) shall be renumbered (c) to (e).
3. In Article 3 (1) (c), the words "approved 'are replaced by the words" v' and the words "marked 'are replaced by the words" or the method of submission which is indicated'.
4. In Article 3 (2), the words "and shall be followed by the manufacturer's instructions to ensure that their functional characteristics are maintained 'shall be added at the end of the text in point (f).
5. In Article 3 (5), the words "and using equipment 'shall be inserted after the words" premises'.
6. In Article 3 (9) (c) (2), the word "injected 'is replaced by" parenterally'.
7. In Section 8 (1) of the Introductory Part of the provision, the words "and excipients' are replaced by the words", excipients or mixtures of excipients intended for the preparation of medicinal products'.
8. In Section 8 (1) of the final part of the provision, a comma is inserted after the word "certificate ', the word" a' is deleted and at the end of the text the words "and the indication of the period of application 'are added.
9. In Paragraph 9 (2), the words "and excipients' are replaced by the words", excipients or mixtures of excipients intended for the preparation of medicinal products'.
10. In Article 9, the following paragraphs 5 and 6 are inserted after paragraph 4:
"(5) The preparation of sterile medicinal products shall be carried out:
(a) checking the sterility of mass-produced medicinal products in batches;
(b) qualifications and at least every 12 months the validation of premises, apparatus and equipment with a specified air purity class;
(c) periodic checks on microbiological purity of premises reserved for their preparation.
(6) The checks referred to in paragraph 5 (a) and (c) shall be carried out in accordance with the technology regulation referred to in Article 22 (3) or the standard operating procedure developed in advance for this purpose. ';
Paragraphs 5 to 7 shall be renumbered paragraphs 7 to 9.
11. in Paragraph 9 (8), the words "and excipients" are replaced by the words ", excipients or mixtures of excipients intended for the preparation of medicinal products."
12. in Article 10 (2), the words "the State Institute for Drug Control" shall be replaced by the words "the Institute."
13. in Article 12 (1), the comma at the end of point (c) is replaced by a dot and point (d) is deleted, including footnote 16.
14. in Article 13 (1) (b), Article 18 (3), Article 22 (2) (a) (1) and (12), Article 22 (2) (k) and (m), the words "the State Institute for Drug Control" shall be replaced by "the Institute."
15. in Paragraph 17 (5), the words "State Institute for Drug Control" are replaced by the words "Institute."
16. in Articles 20 (3) and 21 (4), the words "other legislation24)" are replaced by the words "other legislation24)."
Footnote 24 reads:
"24) Act No. 167 / 1998 Coll., as amended. Act No. 272 / 2013 Coll., on drug precursors, as amended. '
17. in Paragraph 21 (1), the words "and excipients" shall be replaced by the words "the excipients and mixtures of excipients intended for the preparation of medicinal products."
18. In Article 21 (2), the words "or mixtures of excipients intended for the preparation of medicinal products' shall be inserted after the words" the excipients'.
19. in Paragraph 22 (1), the words "and mixtures of excipients intended for the preparation of medicinal products" shall be inserted after the words "excipients."
20. in Paragraph 22 (2) (a) (2), the words "and excipients" shall be replaced by the words ", excipients and mixtures of excipients intended for the preparation of medicinal products."
21. in Article 22 (2) (a) (3), the words "packaging and" shall be deleted, after the word "preparations" shall be inserted the word "packaging," and at the end of the text of point 3 the words "and the records of drying of packaging, articles and equipment" shall be added.
22. the words "and equipment" shall be added at the end of Paragraph 22 (2) (a).
23. in Article 22 (2) (a) (8), the words "instruments and equipment" shall be inserted after the words "space."
24. in Paragraph 22 (2), the word "complete" shall be inserted at the beginning of point (k) and the words "and batch numbers shall be added at the end of the text (k); the records must be kept in such a way as to ensure the traceability of the medicinal product '.
25. in Article 23 (1), the text "paragraph 1" shall be inserted after the number "7."
26. In Article 23 (2), the words "or specific treatment programme 'shall be added at the end of the text of point 3.
27. In the first sentence of Article 25 (1), the words "a label with unambiguous identification details excluding their substitution 'shall be inserted after the words" an issue'. The outer packaging shall be marked '.
28. in Paragraph 25 (1), the third sentence is deleted;
29. In the last sentence of Paragraph 25 (1), the word 'otherwise' is replaced by 'otherwise'.
30. in Article 26 (1) (a), the following point 5 is inserted after point 4:
"5. inspection of premises, apparatus and equipment with a specified air purity class, ';
Points 5 to 8 shall be renumbered 6 to 9.
31. in Article 27, the following paragraph 4 is added:
"(4) When preparing radiopharmaceuticals, they shall be checked in accordance with paragraphs 1 to 3. The check of the sterility of mass-prepared radiopharmaceuticals in batches and the periodic check of microbiological purity of the premises reserved for their preparation shall be carried out in accordance with the technological regulation referred to in Article 22 (3) or the standard operating procedure prepared in advance for this purpose. ';
32. in Paragraph 30 (2), the dot is replaced by a comma at the end of point (d) and the following point (e) is added:
"(e) records of the inspection of premises, apparatus and equipment with a specified air purity class.";
33. In Section 34, the words "the operator of another workplace or establishment preparing 'are replaced by the words" another health service provider authorised to prepare'.
34. the following Part Seven is inserted after Part Six:
PROVISION OF DATA ON ISSUED MEDICINAL PREPARATORS AUTHORISED TO SUPPLY MEDICINAL PRODUCTS
(1) An operator authorised to supply medicinal products shall provide the Institute with data on medicinal products issued by electronic notification no later than 168 hours after the issue of the medicinal product.
(2) An operator authorised to supply medicinal products shall provide the reports referred to in paragraph 1 through the communication interface of the Institute in a way that allows remote access in an open data format. Access data and the unique identifier of the authorised operator shall be assigned by the Institute to that operator upon request.
The report pursuant to § 38a contains:
(a) the identification of the operator authorised to supply medicinal products to the extent:
1. the unique identification code of the authorised operator; and
2. workplace code,
(b) the identification of the prescribing health service provider to the extent that the identification number allocated by the health insurance undertaking has been assigned;
(c) identification of the medicinal product issued to the extent:
1. the code of the medicinal product, where assigned, the name of the medicinal product, its strength, pharmaceutical form, package size, number of packages or quantity details,
2. the lot number,
3. the method of dispensing the medicinal product indicating whether the medicinal product is authorised or not, pursuant to Article 39 (2) of the Law on Medicines, medicinal products issued without a prescription with a restriction under Article 39 (5) of the Law on Medicines or medicinal products issued on demand from health service providers;
4. the date of issue of the medicinal product,
5. the pharmaceutical forms of the medicinal product and the level of the taxy laboratory where the medicinal product is being prepared; and
6. the amount of the payment of the health insurance company or the sign of the payment by the patient, if not the supply of the medicinal product to the health service provider,
(d) the identity of the entity to which the medicinal product has been issued, within the scope of the year of birth and the sex of the patient, if not the supply of the medicinal product on the request of the health service provider. "
Parts seven and eight shall become parts eight and nine.
38. In Paragraph 40 (3), at the end of the first sentence, the words "and the progress and outcome of the withdrawal, if requested, shall be reported to the Institute for State Control of Veterinary Bioprafts and Medicines'.
39. in Paragraph 40 (3), the words "State Institute for Drug Control" are replaced by the words "Institute."
40. Footnote 36 reads:
"36) Decree No 344 / 2008 Coll., on the use, prescription and supply of medicinal products in the provision of veterinary care, as amended by Decree No 139 / 2011 Coll. '.
Technical Regulation
This Decree was notified in accordance with Directive (EU) 2015 / 1535 of the European Parliament and of the Council of 9 September 2015 laying down a procedure for the provision of information in the field of technical and information society services.
Efficacy
This Regulation shall enter into force on the first day of the third calendar month following its publication, with the exception of Article I (37) as regards Article 38b (c) (2), which shall take effect on 9 February 2019.
Minister for Health:
Mgr. et Mgr. Vojtěch v. r.
Minister for Agriculture:
Ing. Toman, CSc., v. r.
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Regulation Information
| Citation | Decree No. 204 / 2018 Coll., amending Decree No. 84 / 2008 Coll., on Good Drug Practice, Closer Treatment Conditions in Pharmacy, Medical Devices and Other Operators and Medicinal Products Issuers, as amended |
|---|---|
| Regulation Type | - |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 20.09.2018 |
|---|---|
| Effective from | 01.12.2018 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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