Decree No. 545 / 2025 Coll.
Decree amending Decree No. 85 / 2008 Coll., on the establishment of a list of active substances and excipients which may be used for the preparation of medicinal products, as amended
Valid
Order
Effective from 01.01.2026
Text versions:
01.01.2026
16.12.2025
545
DECLARATION
of 9 December 2025
amending Decree No 85 / 2008 Coll., establishing the list of active substances and excipients which may be used for the preparation of medicinal products, as amended
The Ministry of Health and the Ministry of Agriculture shall determine, pursuant to § 114 (2) and in order to implement § 79 (8) (a) of Act No. 378 / 2007 Coll., on medicinal products and on amendments to certain related laws (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.:
Decree No. 85 / 2008 Coll., on the establishment of a list of active substances and excipients which may be used for the preparation of medicinal products, as amended by Decree No. 270 / 2013 Coll., Decree No. 168 / 2022 Coll. and Decree No. 332 / 2022 Coll., are amended as follows:
1. In the Annex, the following row is inserted after the row under the column "International name ':" EUPHRASIAE HERBA':
„
“.
| FAMCICLOVIR | FAMCIKLOVIR |
2. In the Annex, the following row is inserted after the row in the column "International name ':
„
“.
| GS-441524 | GS-441524 (AKTIVNÍ METABOLIT REMDESIVIRU, ANALOG ADENOSINU) |
3. In the Annex, the following row is inserted in the table after the row "International name ':
„
“.
| PSILOCYBIN | PSILOCYBIN PRO LÉČEBNÉ POUŽITÍ |
4. In the Annex, the following row is inserted after the row under the column "International name ':
„
“.
| REMDESIVIR | REMDESIVIR |
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 545 / 2025 Coll., amending Decree No 85 / 2008 Coll., on the establishment of a list of active substances and excipients which may be used for the preparation of medicinal products, as amended |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 16.12.2025 |
|---|---|
| Effective from | 01.01.2026 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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