Unofficial transfer (c) Soyuzpravoinform LLC
of January 21, 2025 No. 55
About modification of the Procedure of the state quality control of the medicines imported into Ukraine
The Cabinet of Ministers of Ukraine decides:
Bring in the Procedure of the state quality control of the medicines imported into Ukraine, No. 902 approved by the resolution of the Cabinet of Ministers of Ukraine of September 14, 2005 (The Official Bulletin of Ukraine, 2005, No. 37, Art. 2297; 2012, No. 65, Art. 2654; 2015, No. 82, Art. 2714; 2021, No. 60, the Art. 3783) change which is applied.
Prime Minister of Ukraine
D. Shmygal
Approved by the Resolution of the Cabinet of Ministers of Ukraine of January 21, 2025 No. 55
State Item 6 in the following edition:
"6. Action of Item 5 of this Procedure does not extend to subjects of managing who import active pharmaceutical ingredients (substances), radioactive, radio pharmaceutical medicines and products of "in bulk".
Subjects of managing perform sampling of active pharmaceutical ingredients (substance) and products of "in bulk" for carrying out the laboratory analysis and control of their quality on compliance to requirements of the specification of quality of methods of quality control of medicine to the registration certificate (or to requirements of the State pharmacopeia of Ukraine - for active pharmaceutical ingredients) independently and bear responsibility for quality of the specified medicines according to the law.
The laboratory analysis (except radioactive, radio pharmaceutical medicines) is carried out in laboratories on quality control and safety of the medicines certified in the procedure established by the Ministry of Health.
Disclaimer! This text was translated by AI translator and is not a valid juridical document. No warranty. No claim. More info
Database include more 50000 documents. You can find needed documents using search system. For effective work you can mix any on documents parameters: country, documents type, date range, teams or tags.
More about search system
If you cannot find the required document, or you do not know where to begin, go to Help section.
In this section, we’ve tried to describe in detail the features and capabilities of the system, as well as the most effective techniques for working with the database.
You also may open the section Frequently asked questions. This section provides answers to questions set by users.