STANDARDIZATION OF INFORMATION ON MEDICINES FROM PLANTS
DOI: https://doi.org/None
Issue:
5
Year:
2017
The creation of a unified register of registered medicines within the Eurasian Economic Union, the formation of unified databases of instructions for their medical use, graphic drug package design, and normative documents on drug quality necessitate the unification of terminologies used in the names of dosage forms (DF), the establishment of principles in giving the group names, and the bringing of drug labelling in line with international requirements. The problems of standardization of information about herbal remedies are considered since discussions about classification and identification of DF, group naming, and determination of active ingredients and excipients as parts in this group of drugs are being continued.
Keywords:
herbal materials
herbal medicines
herbal products
group names
dosage form
formulation
References:
- Soglashenie o edinyh principah i pravilah obrashheniya lekarstvennyh sredstv v ramkah Evraziyskogo e`konomicheskogo soyuza (Ratificirovan Federal`nym zakonom № 5-FZ ot 31.01.2016) [E`lektronnyy resurs]. Rezhim dostupa: http://www.eurasiancommission.org/ru/Lists/EECDocs/635550382658395383.pdf
- Informacionnoe pis`mo Roszdravnadzora № 01I-277/08 ot 04.06.2008 «O registracii farmacevticheskih substanciy».
- Federal`nyy zakon № 61-FZ ot 12.04.2010 «Ob obrashhenii lekarstvennyh sredstv».
- Gosudarstvennaya farmakopeya Rossiyskoy Federacii, XIII izd., t.2. OFS 1.5.1.0001.15. «Lekarstvennoe rastitel`noe syr`e. Farmacevticheskie substancii rastitel`nogo proishozhdeniya» [E`lektronnyy resurs]. Rezhim dostupa: http://www.femb.ru/feml
- Pravila registracii i e`kspertizy lekarstvennyh sredstv dlya medicinskogo primeneniya Evraziyskogo e`konomicheskogo soyuza [E`lektronnyy resurs]. Rezhim dostupa: https://docs.eaeunion.org/docs/ru-ru/01411969/cncd_21112016_78
- Nomenklatura lekarstvennyh form Evraziyskogo e`konomicheskogo soyuza [E`lektronnyy resurs]. Rezhim dostupa: http://www.eurasiancommission.org/ru/act/texnreg/deptexreg/oo/Pages/nomenclature.aspx
- Prikaz № 538n ot 27 iyulya 2016 g. «Ob utverzhdenii Perechnya naimenovaniy lekarstvennyh form lekarstvennyh preparatov dlya medicinskogo primeneniya».
- Perechen` nazvaniy lekarstvennyh form, ispol`zuemyh pri registracii lekarstvennyh preparatov FGU «NC E`SMP» Minzdrava RF. 2003 g. [E`lektronnyy resurs]. Rezhim dostupa: http://base.garant.ru/4179249/
- Gosudarstvennyy reestr lekarstvennyh sredstv Rossiyskoy Federacii [E`lektronnyy resurs]. Rezhim dostupa: http://grls.rosminzdrav.ru/grls.aspx
- Sakanyan E.I., Lyakina M.N., Alekseeva A.S., Shishova L.I., Shemeryankina T.B. Lekarstvennaya forma «E`liksiry» v farmacevticheskoy praktike. Himiko-farmacevticheskiy zhurnal, 2016; 11 (50): 47-50.
- Gosudarstvennaya farmakopeya Rossiyskoy Federacii, OFS 1.4.1.0008.15. «Mazi» [E`lektronnyy resurs]. Rezhim dostupa: http://www.femb.ru/feml
- Gosudarstvennaya farmakopeya Rossiyskoy Federacii, OFS (Izm). 1.4.1.0008.15. «Mazi» [E`lektronnyy resurs]. Rezhim dostupa: https://www.rosminzdrav.ru/ministry/61/11/materialy-po-farmakopee
- Federal`nyy zakon № 429-FZ ot 22 dekabrya 2014 g. «O vnesenii izmeneniy v Federal`nyy zakon «Ob obrashhenii lekarstvennyh sredstv».
- Trebovaniya k markirovke lekarstvennyh sredstv dlya medicinskogo primeneniya i veterinarnyh lekarstvennyh sredstv Evraziyskogo e`konomicheskogo soyuza [E`lektronnyy resurs]. Rezhim dostupa: https://docs.eaeunion.org/docs/ru-ru/01411918/cncd_21112016_76
- Lyakina M.N., Kovaleva E.L., Nikolaeva O.B., Krutikova N.M., Olenina N.G., Kolganov L.A. Gruppirovochnye naimenovaniya lekarstvennyh rastitel`nyh sredstv: neobhodimost` vvedeniya, racional`nost` formirovaniya. Vedomosti Nauchnogo centra e`kspertizy sredstv medicinskogo primeneniya, 2016; 3: 9–11.
- Gosudarstvennaya farmakopeya SSSR, XI izd., vyp. 2, M.: Medicina, 1990.
- Mashkovskiy M.D. Lekarstvennye sredstva. Izd. 8-e, t. I,II. M.: Medicina, 1977,
- Gosudarstvennyy reestr lekarstvennyh sredstv Respubliki Belarus` [E`lektronnyy resurs]. Rezhim dostupa: http://www.rceth.by/Refbank/
- Gosudarstvennyy reestr lekarstvennyh sredstv Respubliki Kazahstan [E`lektronnyy resurs]. Rezhim dostupa: http://test3.dari.kz/category/search_prep
- Gosudarstvennyy reestr lekarstvennyh sredstv Respubliki Kyrgyzstan [E`lektronnyy resurs]. Rezhim dostupa: http://212.112.103.101/reestr