Decree No. 422 / 2025 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
Order
Effective from 01.01.2026
Text versions:
01.01.2026
17.10.2025
422
DECLARATION
of 6 October 2025
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 and the Ministry of Agriculture provides, pursuant to Article 114 (2) of Act No. 378 / 2007 Coll., on medicinal products and on amendments to certain related laws (Act on Medicines), as amended by Act No. 70 / 2013 Coll., Act No. 66 / 2017 Coll., Act No. 262 / 2019 Coll., Act No. 314 / 2022 Coll. and Act No. 456 / 2023 Coll., and to implement § 5 (4), § 77 (5) (b), § 79 (1) (c), § 79 (2) and (8) (a), § 79 (10), § 82 (1), § 82 (4), § 83 (2) and (3), § 83 (6) (b) and § 85 (1) of the Act on medicinal products:
Decree No. 84 / 2008 Coll., on the correct practice of pharmaceuticals, closer treatment conditions in pharmacies, medical devices and other medicinal product-issuing operators and establishments, as amended by Decree No. 254 / 2013 Coll., Decree No. 414 / 2017 Coll., Decree No. 204 / 2018 Coll., Decree No. 32 / 2020 Coll., Decree No. 526 / 2021 Coll. and Decree No. 459 / 2023 Coll., are amended as follows:
1. In Article 2, at the end of point (f), the dot is replaced by a comma and the following point (g) is added:
"(g) the storage by the carrier of the medicinal product before its delivery to the client, including its storage in the self-service box provided for in Article 18 (2) (b), in the case of carriage by the carrier of the consignment."
2. in Article 3 (2), the words "except for stock solutions of antimicrobial additives in eye drops" shall be added at the end of the text in point (e).
3. In Article 3 (2) (f), the words "clean and control 'are replaced by the words" clean, control, calibrate, validate or verify'.
4. In Paragraph 3 (7), the word "radiators' is replaced by the word" sources'.
5. footnote 7 shall read:
"7) Decree No. 422 / 2016 Coll., on Radiation Protection and Security of Radionuclide Source, as amended. ';
6. In Article 3 (8) (d) (2), the word "injected 'is replaced by" parenterally'.
7. In Article 3, paragraphs 9 and 10 are added, including footnote 41:
"(9) The preparation of parenteral gene therapy medicinal products shall comply with the requirements for the preparation of sterile medicinal products and the requirements resulting from the specific nature of their components.
(10) In the preparation of medicinal products at increased risk for the health care professionals who prepare them, including parenteral medicinal products of the cytostatic group, radiopharmaceuticals and parenteral medicinal products for gene therapy, the requirements arising from the nature of the active substance and the conditions of protection of health at work under another legislation (41) shall be complied with.
41) Government Regulation No. 361 / 2007 Coll., laying down conditions for health protection at work, as amended. '
8. In Article 4 (1), the words "not referred to in Article 3 (8) (d) 'are deleted.
9. in Article 5 (f):
"(f) for gene therapy is carried out in vacuum safety boxes with vertical laminar flow of air purity class A reserved for this purpose and by towing outside the premises which are located in the air purity class B or C; in the case of products of hazard class 1 and risk class 2 without replication capability, time and mode separation is possible from preparations carried out in the same clean spaces; in the case of products of a hazard class higher than 2 or with a reproductive capacity, preparation shall be ensured in vacuum safety boxes with vertical laminar flow of the air purity class A and withdrawal outside the space which are located in the air purity class B area used exclusively for the treatment of medicinal products with gene therapy. ';
10. In Article 5, the current text becomes paragraph 1 and the following paragraph 2 is added:
"(2) Where the preparation of sterile medicinal products is carried out in closed automatic systems with a working area of the air purity class A, these automatic systems may be located in the air purity class D reserved for this purpose. ';
11. in Article 8 (2) (i), the words "have been added during preparation" shall be replaced by the words "the prepared medicinal product contains it."
12. in Article 8, paragraph 6 is deleted;
Paragraph 7 shall become paragraph 6.
13. in Article 9 (7) (a) (1), the words "or at least every 6 months, if the conductivity of the water is measured at least once a day and the apparatus for the preparation of purified water is equipped with a conductivity gauge which is continuously controlled;"
14. in Article 9 (7) (b):
'(b) microbiological,
1. at least once every 2 months; and
2. after each intervention in the apparatus for its preparation. ';
15. in Article 11 (3) (c), the words "and prescribing physician" shall be deleted and the words "and prescribing doctor has given prior consent to be replaced in an electronic recipe note or express consent at the time of issue" shall be added.
16. in Article 18 (2) (b) of the part of the sentence after the semicolon, the words "or use of self-service storage boxes" shall be inserted after the word "products," and, at the end of the text (b), the words "compliance with the temperature established by the summary of product characteristics for the storage of medicinal products is continuously monitored and recorded during transport and, where appropriate, their storage prior to delivery by the transporter to the client throughout the transport and storage period of the medicinal product; the responsibility of the pharmacy for the quality of the medicinal products transported and the medicinal products placed on the market shall remain unaffected. ';
17. In Article 21, the following paragraph 6 is added:
"(6) In the case of contractual arrangements for the transport of medicinal products and the use of self-service dispensing boxes pursuant to Article 18 (2) (b), the temperature conditions for the storage of medicinal products during transport and any storage prior to delivery to the client shall be governed by the summary of product characteristics. ';
18. in Paragraph 22 (2) (a) (5) of the sentence in front of the semicolon, the words "medicinal products" shall be inserted after the word "control," and the words "and may be kept and recorded electronically" shall be added at the end of the text of point 5.
19. in Paragraph 22 (2) (a) (15):
"15. temperature of storage of medicinal products, active substances and excipients, including records of temperature measurements in the case of contractual arrangements for the transport of medicinal products and their possible storage in accordance with Article 18 (2) (b), ';
20. In Paragraph 22 (2), the words "including documents and records for orders which have not been delivered to the client or have not been taken over or returned to the pharmacy 'shall be added at the end of the text in point (c).
21. in Paragraph 22 (2), the following point (e) is inserted after point (d):
"(e) letters issued by the health service provider,"
Points (e) to (m) shall be renumbered as points (f) to (n).
22. in Article 22 (2) (j), the words "further dossiers" are replaced by the words "regularly revised and updated dossiers" and the words "preparation and presentation of medicinal products" are deleted;
23. in Article 22 (2), the words "and the record of communication with the restricted registry of medicinal products" shall be added at the end of the text in point (m).
24. in the second and third sentences of Paragraph 22 (3), the words "or the pharmacist authorised by him" shall be inserted after the words "pharmacist."
25. in Article 22 (4), the words "and records" shall be inserted after the words "documents."
(26) footnotes 27, 28 and 32 read:
"27) For example, Act No. 263 / 2016 Coll., Atomic Act, as amended, Act No. 258 / 2000 Coll., on the Protection of Public Health and on the Amendment of Certain Related Acts, as amended.
28) Act No. 263 / 2016 Coll., as amended.
32) For example, Act No. 263 / 2016 Coll., as amended, Decree No. 422 / 2016 Coll., as amended, Decree No. 49 / 1993 Coll., on technical and material requirements for medical equipment, as amended, Decree No. 359 / 2016 Coll., on details to ensure the management of radiological emergencies. '
27. in Paragraph 37 (2) (a), point 3 is deleted;
Points 4 and 5 shall become points 3 and 4.
28. in Paragraph 37 (2) (a) (3), the words "in the case of medicinal products requiring reduced storage temperature" shall be replaced by the words "where" and after the word "records" shall be inserted the words "with."
29. in Article 38b, the words "the Chamber of Veterinary Physicians of the person prescribing the veterinarian or" shall be inserted at the beginning of point (c).
Efficacy
This Decree shall take effect on 1 January 2026.
Minister for Health:
Prof. MUDr. Válek, CSc., MBA, EBIR, v. r.
Minister for Agriculture:
Mgr. Excellent v. r.
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Regulation Information
| Citation | Decree No. 422 / 2025 Coll., 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 |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 17.10.2025 |
|---|---|
| Effective from | 01.01.2026 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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