The Ministry of Health of Ukraine issued an order #896 concerning the renewed GMP-certificate by vendors for selling drugs on the territory of Ukraine.
“Good manufacturing practice” or “GMP” is part of a quality system covering the manufacture and testing of active pharmaceutical ingredients, diagnostics, foods, pharmaceutical products, and medical devices. GMPs are guidelines that outline the aspects of production and testing that can impact the quality of a product. Many countries have legislated that pharmaceutical and medical device companies must follow GMP procedures, and have created their own GMP guidelines that correspond with their legislation.
Order from 20.10.2010, № 896
On ensuring the quality of drugs imported into the territory of Ukraine
According to the Law of Ukraine “On Medicines” and in pursuance of the Cabinet of Ministers of Ukraine dated 28.10.2004 № 1419 “Some measures to ensure the quality of medicines”, order:
1. To the State Inspectorate for Quality Control of Drugs of the Ministry of Health of Ukraine (hereinafter – Goslekinspektsiya MOH):
1.1. To check the availability of documents confirming the conformity of manufacturer’ (s) production requirements of Good Manufacturing Practice (GMP), issued by the (recognized) under the current legislation of Ukraine or the requirements of the international system of cooperation pharmaceutical inspection (PIC / S), EU, U.S. and Japan.
Dead line 10/25/2010
1.2. To inform the producers (s) of drugs who have no documents confirming GMP-certificate the accordance of requirements of Ukrainian legislation or the requirements of the international system of cooperation pharmaceutical inspection (PIC / S), EU, U.S. and Japan, on necessary to provide such documents within two months from the date of notification or contact Goslekinspektsiya MOH statement, the certification of drug production in compliance with good manufacturing practices.
Dead line 01/11/2010
1.3. Ensure the decision to withdraw from circulation the products on the territory of Ukraine on the basis of the requirements of the Law of Ukraine “On Medicines”. The order of prohibition (stopping) the retirement of medicines and the resumption of circulation in the territory of Ukraine, approved by Decree of the Ministry of Health of Ukraine from 12.12.2001, № 497, in case of failure by the manufacturer (applicant) within two months from the date of the communication of documents referred to in paragraph 1 of this order, any statements regarding the certification of drug production in compliance with good manufacturing practices.
2. Control the execution of this order assigned to the Deputy Minister of A.P. Gudzenko.
Minister Z.M. Tamozhennyk
Our company provides services in recognition of the GMP certification in Ukraine. Detailed information about the service can be found here