Government Decree No. 552 / 2025 Coll.
Government Regulation on the conditions for prescribing, dispensing and use of individually prepared medicinal products containing psilocybin for therapeutic use
Valid
Regulation
Effective from 01.01.2026
Text versions:
01.01.2026
17.12.2025
552
GOVERNMENT REGULATION
of 10 December 2025
on the conditions for prescribing, dispensing and using individually prepared psilocybin-containing medicinal products for therapeutic use
The Government orders pursuant to § 33l (4) of Act No. 167 / 1998 Coll., on addictive substances and on the amendment of certain other laws, as amended by Act No. 270 / 2025 Coll., and pursuant to § 79a (3) of Act No. 378 / 2007 Coll., on medicinal products and on amendments to certain related laws (Act on Medicines), as amended by Act No. 270 / 2025 Coll.:
Subject matter
This Regulation provides for
(a) the conditions for prescribing, dispensing and using an individually prepared medicinal product containing psilocybin for therapeutic use;
(b) the specialist competence of a physician who may prescribe an individually prepared psilocybin-containing medicinal product for therapeutic use;
(c) the duration of the special supervision.
Prescription and administration of an individually prepared medicinal product containing psilocybin for therapeutic use
[For the implementation of Section 79a (3) (a) and (c) of the Drug Act and Section 33l (1) of the Drug Addiction Act]
(1) Individually prepared psilocybin-containing medicinal product for therapeutic use may only be prescribed and administered by a physician with specialised competence in the field of psychiatric specialisation or specific specialisation in medical psychotherapy in the extension field, in the absence of efficacy or documented intolerance to the treatment of authorised medicinal products and in accordance with the clinical recommended procedure for assisted psychotherapy with psilocybin for therapeutic use, in the indication:
(a) depressive disorder associated with cancer,
(b) clinically serious depressive disorder without psychotic symptoms; or
(c) sudden deterioration of other serious neuropsychiatric or mental disorders that are seriously life-threatening, provided that such use of psilocybin for therapeutic use is sufficiently justified by scientific knowledge.
(2) An individual formulation containing psilocybin for therapeutic use can only be prescribed and administered as an oral drug.
(3) The prescriber is required to indicate on the request with a blue stripe, in addition to the data provided by the prescription decree on medicinal products when providing health services, the strength, pharmaceutical form and dosage of the individually prepared medicinal product containing psilocybin for therapeutic use.
Determination of restriction of psilocybin containing medicinal product for therapeutic use
[For the implementation of Section 79a (3) (b) of the Drug Act and Section 33l (1) of the Drug Addiction Act]
(1) Psilocybin may be used for the prescription, delivery and use of an individually prepared medicinal product containing psilocybin for therapeutic use for therapeutic use in a total quantity of not more than 75 mg psilocybin for therapeutic use in a period of 1 calendar month.
(2) The individual dose must not contain more than 35 mg psilocybin for therapeutic use and must not exceed 0,4 mg / kg body weight of the patient.
(3) Individually prepared psilocybin-containing medicinal product for therapeutic use may be administered no more than three times per month with a minimum interval of 7 days between doses.
(4) If a patient does not experience a clinically significant positive effect even after 3 consecutive doses, further use of an individually prepared medicinal product containing psilocybin for therapeutic use is excluded.
Duration of special supervision
(For the implementation of Section 33l (4) of the RMS)
(1) Special supervision during the administration of the individually prepared psilocybin-containing medicinal product for therapeutic use by the physician who administered it takes
(a) at doses up to 14,99 mg psilocybin for therapeutic use for at least 4 hours,
(b) at a dose of 15 mg psilocybin for therapeutic use for at least 6 hours.
(2) Special supervision may be completed only after the effects of the individually prepared medicinal product containing psilocybin for the therapeutic use established by the physician who administered it have completely resolved.
Technical Regulation
This Regulation has been 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 take effect on 1 January 2026.
Prime Minister:
Prof. PhDr. Fiala, Ph.D., LL.M., v. r.
Deputy Prime Minister and Minister for Health:
Prof. MUDr. Válek, CSc., MBA, EBIR, v. r.
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Regulation Information
| Citation | Government Decree No. 552 / 2025 Coll., on the conditions for prescribing, dispensing and using individually prepared medicinal products containing psilocybin for therapeutic use |
|---|---|
| Regulation Type | Regulation |
| 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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