+38 044 332-42-94,
+38 044 221-71-29,
Medicines: human drugs and biologics
— Market requirements for medicines
— Establishment of new registration
— Variations (changes)
— Renewal of registration
— Inspection of manufacturing site
— Pharmacological vigilance
— State registry of medicines
— Ukrainian legislation
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Ukrainian legislation

 

Procedures of marketing authorization, quality control and marketing of medicinal products are regulated by lots of Orders, Decrees and other legal acts. Ukraine has chosen it's development towards step-by-step harmonization of the legislation with system of European Union, that leads to changes and amendments of legal acts every 2-3 months.  

 Ukrainian legislation | Cratia

Nevertheless, main legal acts that we use in our everyday work are: 

1. Law of Ukraine "On medicines"
[ MS Word in Ukrainian | MS Word in English | On website of Parliament]

2. Decree of Cabinet of Ministers of Ukraine No 902 as of 14.09.2005 "On approval of the Order of state quality control of medicines imported to Ukraine"

[ MS Word in Ukrainian | On website of Parliament]

3. Decree of Cabinet of Ministers of Ukraine No 376 as of 26.05.2005 "On approval of the Order of state registration (renewal) of medicinal products and amount of state fees for state registration (renewal)" 

[ MS Word in Ukrainian | MS Word in English | On website of Parliament]

4. Order of Ministry of Health of Ukraine as of 26.08.2005 No 426 "On approval of Order of expertise of materials for medicinal products that are submitted for state registration (renewal), and expertise of materials for variations to registration materials during validity of marketing authorization certificate"

[ MS Word in Ukrainian | MS Word in English RAR Archive | On website of Parliament]

5. Order of Ministry of Health of Ukraine No 898 as of 27.12.2006 "On approval of Order of evaluation of vigilance on side effects (adverse events) of medicines allowed for medicinal use" 

[ MS Word in Ukrainian | MS Word in English RAR Archive | On website of Parliament]

6. Order of Ministry of Health of Ukraine No. 722 as of 25.08.2010 "On approval of the Braille labeling of package labeling of medicines" 

[ MS Word in Ukrainian | On website of Parliament]

 

More than hundred of legal acts, letter and normative documents adjust registration process, quality control and marketing of medicines in Ukraine. We use and recomend you following websites: State Expert Center, State Inspection of quality of medicines, and search engine of Parliament of Ukraine. 

English text of legal acts are taken from website of State Expert Center. 

 

You can contact us by e-mail info@cratia.ua, telephone +38 (044) 332-42-94, 221-71-29 or at the meeting in our office.