Decree No. 553 / 2025 Coll.
Decree amending Decree No. 329 / 2019 Coll., on the Prescription of Medicinal Products for the Provision of Health Services, as amended
Valid
Order
Effective from 01.01.2026
Text versions:
01.01.2026
17.12.2025
553
DECLARATION
of 11 December 2025
amending Decree No 329 / 2019 Coll., on the prescription of medicinal products for the provision of health services, as amended
According to Article 114 (1) of Act No. 378 / 2007 Coll., on Medicines and on Amendments to Certain Related Acts (Act on Medicines), as amended by Act No. 50 / 2013 Coll., Act No. 70 / 2013 Coll., Act No. 66 / 2017 Coll., Act No. 44 / 2019 Coll., Act No. 262 / 2019 Coll., Act No. 366 / 2021 Coll., Act No. 314 / 2022 Coll., Act No. 456 / 2023 Coll., and Act No. 270 / 2025 Coll., Act No. 270 / 2025 Coll., Act No. 262 / 2019 Coll., Act No. 2, § 80 (a) to (d) and (f) to (i), § 81 (4) and (b), § 81a (1) and § 81e (6) Act on Medicines:
Decree No. 329 / 2019 Coll., on the Prescription of Medicinal Products for the Provision of Health Services, as amended by Decree No. 53 / 2020 Coll., Decree No. 522 / 2021 Coll., Decree No. 421 / 2022 Coll., Decree No. 458 / 2023 Coll. and Decree No. 260 / 2024 Coll., are amended as follows:
1. in Paragraph 19 (1) (b) (2):
"2. on the request, the information referred to in Article 18 (1) shall be given, the number of packages or doses of the prescribed medicinal products shall be indicated by Roman numerals and in Latin language words and, in the case of an individually prepared medicinal product containing cannabis for medical use, the name or, where applicable, the name, surname and number of the insured person for whom the medicinal product is intended, or, in the case of an individually prepared medicinal product containing psilocybin for therapeutic use, the name, or surname and date of birth of the patient for whom the medicinal product is intended."
2. In Article 19, the following paragraph 5 is added:
"(5) The prescriber in the patient 's indication of a depressive disorder associated with oncological disease, due to possible interactions with the treatment provided, shall inform the patient' s treating physician with specialist competence in clinical oncology, haematooncology, oncogyno or radiation oncology of the intention to prescribe the patient's individually prepared psilocybin-containing medicinal product for therapeutic use, at least 5 working days before prescribing. If the prescribing physician receives observations from the treating physician within the time limit referred to in the first sentence, he shall record it in the patient 's medical file and inform the patient thereof without delay. If the prescriber does not receive the second sentence, an individually prepared medicinal product containing psilocybin for therapeutic use may be prescribed to the patient.'
Efficacy
This Decree shall take effect on 1 January 2026.
Minister:
Prof. MUDr. Válek, CSc., MBA, EBIR, v. r.
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Regulation Information
| Citation | Decree No. 553 / 2025 Coll., amending Decree No. 329 / 2019 Coll., on the Prescription of Medicinal Products for the Provision of Health Services, as amended |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 17.12.2025 |
|---|---|
| Effective from | 01.01.2026 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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