Decree No. 332 / 2022 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 Effective from 01.01.2023
332
DECLARATION
of 26 October 2022
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 provides pursuant to § 114 (2) of Act No. 378 / 2007 Coll., on Medicines and on amendments to certain related laws (Act on Medicines), as amended by Act No. 70 / 2013 Coll., Act No. 66 / 2017 Coll. and Act No. 262 / 2019 Coll., for the implementation of § 79 (8) (a) of the Act on Medicines:
The Annex to 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. and Decree No 168 / 2022 Coll., reads as follows:

"Annex to Decree No 85 / 2008 Coll.
List of active substances and excipients used for the preparation of medicinal products
Active substances and excipients, including so-called herbal drugs, are listed in this List with pharmacopoeia.
Mezinárodní názevČeský název
ACIDUM MALICUM LAEVOGYRUMKYSELINA JABLEČNÁ, L-FORMA
ACIDUM PENTETICUMKYSELINA PENTETOVÁ
ACIDUM POLYACRYLICUMKYSELINA POLYAKRYLOVÁ
ACRIFLAVINII CHLORIDUMAKRIFLAVINIUM-CHLORID
AGRIMONIAE PROCERAE HERBANAŤ ŘEPÍKU VONNÉHO
ALPINIAE RHIZOMAGALGANOVÝ ODDENEK
AMYLUM MODIFICATUMMODIFIKOVANY ŠKROB
ANTAZOLINI MESILASANTAZOLIN-MESILÁT
ARSENI TRIOXIDUMOXID ARSENITÝ
BARDANAE RADIXLOPUCHOVÝ KOŘEN
BENZODODECINII BROMIDUMBENZODODECINIUM-BROMID
BISMUTHI TRIBROMPHENOLASTRIBROMFENOLÁT BISMUTITÝ
BROMISOVALUMBROMISOVAL
BRONOPOLUMBRONOPOL
BUCCO FOLIUMLIST TĚHOZEVU
CALAMI RADIXPUŠKVORCOVÝ KOŘEN
CANNABIS INDICAE EXTRACTUMEXTRAKT Z KONOPÍ INDICKÉHO
CANNABIS INDICAE FLOSKVĚT KONOPÍ INDICKÉHO
CANNABIS SATIVAE EXTRACTUMEXTRAKT Z KONOPÍ SETÉHO
CANNABIS SATIVAE FLOSKVĚT KONOPÍ SETÉHO
CAPSAICINUMKAPSAICIN
CARDAMOMI FRUCTUSKARDAMOMOVÝ PLOD
CARDAMOMI SEMENKARDAMOMOVÉ SEMENO
CITRI PERICARPIUM RECENSČERSTVÉ CITRONOVÉ OPLODÍ
CLOROXINUMKLOROXIN
COCAMIDOPROPYLBETAINIKOKAMIDOPROPYLBETAIN
COFFEINI CITRASKOFEIN S KYSELINOU CITRONOVOU
COLLODIUMKOLODIUM
CUPRI CHLORIDUM DIHYDRICUMCHLORID MĚĎNATÝ DIHYDRÁT
CYAMOPSIDIS TETRAGONOLOBAE SEMENSEMENO CYAMOPSISU ČTYŘHRANNÉHO
DRONABINOLDELTA-9-TETRAHYDROKANABINOL
DROSERAE HERBAROSNATKOVÁ NAŤ
EPILOBII HERBAVRBOVKOVÁ NAŤ
ETOFYLLINUMETOFYLIN
EUPHRASIAE HERBASVĚTLÍKOVÁ NAŤ
FOENICULI ETHEROLEUMFENYKLOVÁ SILICE
FUCHSINUM BASICUMFUCHSIN ZÁSADITÝ
GALEGAE HERBAJESTŘÁBINOVÁ NAŤ
GLYCEROLI MONOSTEARAS 60GLYCEROLMONOSTEARÁT 60
GONADOTROPINUM SERICUM EQUINUM AD USUM VETERINARIUMGONADOTROPIN SÉROVÝ KOŇSKÝ PRO VETERINÁRNÍ POUŽITÍ
HYDRARGYRI AMIDOCHLORIDUMAMIDOCHLORID RTUŤNATÝ
HYDROXYETHYLMETHYLCELLULOS UMHYDROXYETHYLMETHYLCELULOSA
ICHTAMMOLUM ALBUMICHTAMOL BÍLÝ
INDICARMINUMINDIGOKARMIN
INULAE RADIXOMANOVÝ KOŘEN
INULINUMINULIN
JUGLANDIS FOLIUMOŘEŠÁKOVÝ LIST
LECITHINLECITIN
LINI OLEUM VIRGINALELNĚNÝ OLEJ PANENSKÝ
MANGANOSI CHLORIDUM TETRAHYDRICUMCHLORID MANGANATÝ TETRAHYDRÁT
MERCAPTAMINI HYDROCHLORIDUMCYSTEAMIN HYDROCHLORID
METHOXSALENUMMETHOXSALEN
MYRISTICAE SEMENMUŠKÁTOVÉ SEMENO
NATRII GLUCONASNATRIUM-GLUKONÁT
OLAMINUMOLAMIN
PARAFORMALDEHYDUMPARAFORMALDEHYD
PHASEOLI FRUCTUS SINE SEMINEFAZOLOVÝ PLOD BEZ SEMEN
PHENACETINUMFENACETIN
PHENYLIS SALICYLASFENYL-SALICYLÁT
PHYTOMENADIONUMFYTOMENADION
PLUMBI ACETAS TRIHYDRICUSOCTAN OLOVNATÝ TRIHYDRÁT
PLUMBI OXIDUMOXID OLOVNATÝ
PODOPHYLLI RADIXNOHOLISTOVÝ KOŘEN
PODOPHYLLI RESINAPODOFYLOVÁ PRYSKYŘICE
POLIHEXANIDUMPOLIHEXANID
PRIMULAE FLOSPRVOSENKOVÝ KVĚT
PROPAN-1,3-DIOLUMPROPAN-1,3-DIOL
PROPIVERINUM HYDROCHLORIDUMPROPIVERIN-HYDROCHLORID
RUBI FRUTICOSI FOLIUMOSTRUŽINÍKOVÝ LIST
SULFACETAMIDUMSULFACETAMID
TARTRAZINUMTARTRAZIN
THEOBROMINUMTHEOBROMIN
TRICLOSANUMTRIKLOSAN
TRIGLYCOLUMTRIETHYLENGLYKOL
URTICAE HERBAKOPŘIVOVÁ NAŤ
VIRIDE NITENSBRILANTNÍ ZELEŇ
VISCI ALBI HERBANAŤ JMELÍ
"
Efficacy
This Decree shall take effect on 1 January 2023.
Minister for Health:
Prof. MUDr. Válek, CSc., MBA, EBIR, v. r.
Minister for Agriculture:
Ing. Nekula v. r.

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Regulation Information

CitationDecree No. 332 / 2022 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-
Author-
CollectionCode of Laws
Date of Promulgation07.11.2022
Effective from01.01.2023
Effective until-
Status Valid
The regulation text is for informational purposes only.
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