On February, 18, 2014 we published the notification on approval by way of the Ordinance of the Ministry of Health Protection of Ukraine of 05.02.2014 # 100 of Guidelines ‘Medications. Good Distribution Practice. ST- N MHPU- 42-1.0:2014’. As noted before, the ordinance was not published on the official portal of the Ministry of Health Protection of Ukraine.
The Guidelines ‘Medications. Good Distribution Practice. ST- N MHPU- 42-1.0:2014’ was adopted to update current normative regulations and is considered a Ukrainian version of EU regulation - Guidelines on Good Distribution Practice оf Medicinal Products for Human Use, version of 2013, (2013/С68/01), however, presenting a few deviations from the corresponding English document that are caused by legal requirements of the Ukrainian legislation.
However, by way of the Ordinance of the Ministry of Health Protection of Ukraine of 13/03/2014 #180 ‘As Regards to Repeal of Some Ordinances of the Ministry of Health Protection of Ukraine and Introduction of Amendments to the Ordinance of the Ministry of Health Protection of Ukraine of 11.01.2014 #23 the Ordinance #100 of the Ministry of Health Protection of Ukraine was repealed.
According to the press service of the Ministry of Health Protection of Ukraine, the Ordinance #100 of the Ministry of Health Protection of Ukraine was repealed to bring the normative and legal act in compliance with the legislation of Ukraine. Specifically, it is noted: ‘The Ministry of Health Protection of Ukraine shall take all the necessary action to adopt the present document as a normative and technical document in line with subclause ‘g’ clause 5 of Regulation for State Registration of Normative and Legal Acts of Ministries, Other Executive Agencies approved by Ordinance # 731 of the Cabinet of Ministers of Ukraine of 28.12.1992 that is not subject to state registration in the Ministry of Justice of Ukraine.
Therefore, at present the Guidelines ‘Medications. Good Distribution Practice. ST- N MHPU- 42-5.0 2008’ remain in effect being adopted based on Guidelines on Good Distribution Practice оf Medicinal Products for Human Use, version 1994 (94/С 63/03). The Ministry of Health Protection of Ukraine promises that further work for harmonization of Ukraine’s and EU legislation will continue.
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