On March, 23 this year on the web-site of the Ministry of Healthcare of Ukraine the draft of the Order of the Ministry of Healthcare of Ukraine “On amendment to the Order of confirmation of the compliance of manufacturing conditions for medicinal products with GMP requirement” was published for public discussion. The draft proposes to change the Order of confirmation of the compliance of manufacturing conditions for medicinal products with GMP requirement, set by the Order of the Ministry of Healthcare of Ukraine, dated 27.12.2012 N 1130.
The Draft considers the numerous PIC/S recommendations, extends the definitions (several new definitions were added, such as “medicinal products with critical risk level”, “medicinal products with high risk level”, “medicinal products with low risk level”, “complicated operating process”, “pharmaceutical quality system”, several definitions were amended, such as “official document on compliance of manufacturing conditions for medicinal products with GMP requirement”, “material violation”), and also to change documents titles, which confirm the compliance with GMP requirements on follows: the certificate of compliance of manufacturing conditions for medicinal products with GMP requirement and the conclusion concerning compliance of manufacturing conditions for medicinal products with GMP requirement by the form according to the Annex 4 to this Order.
In addition, the Draft provides special order for compliance of GMP requirement with manufacturing conditions for medicinal products served only to treatment of tuberculosis, HIV/AIDS, viral hepatitis, oncologic and rare (orphan) diseases registered as medicinal product by qualified authorities of the USA, Switzerland, Japan, Australia, Canada or EU. Thus, primary and specialized expertise, except of documents set by the relevant Order, will be conducted based on official document concerned the last control, executed based on WHO re-qualification program for such medicinal products. In this case the period of primary and specialized document expertise, concerned such medicinal products, is shortened for 2 and 3 business days respectively.
Within this Draft, it’s emphasized the necessity of termination of critical, material and non-material violations found during previous controls and the account of found violations in the terms of elaboration the plan and the control program.
In the case of adoption the Draft in current edition the order of confirmation of the compliance of manufacturing conditions for medicinal products with GMP requirement concerned medicinal products of restricted using will be changed also. For example, such confirming will be provided at the general order and with controls.
The draft proposes to change the Order of confirmation of the compliance of manufacturing conditions for medicinal products with GMP requirement, set by the Order of the Ministry of Healthcare of Ukraine, dated 27.12.2012 N 1130.
The Draft considers the numerous PIC/S recommendations, extends the definitions (several new definitions were added, such as “medicinal products with critical risk level”, “medicinal products with high risk level”, “medicinal products with low risk level”, “complicated operating process”, “pharmaceutical quality system”, several definitions were amended, such as “official document on compliance of manufacturing conditions for medicinal products with GMP requirement”, “material violation”), and also to change documents titles, which confirm the compliance with GMP requirements on follows: the certificate of compliance of manufacturing conditions for medicinal products with GMP requirement and the conclusion concerning compliance of manufacturing conditions for medicinal products with GMP requirement by the form according to the Annex 4 to this Order.
In addition, the Draft provides special order for compliance of GMP requirement with manufacturing conditions for medicinal products served only to treatment of tuberculosis, HIV/AIDS, viral hepatitis, oncologic and rare (orphan) diseases registered as medicinal product by qualified authorities of the USA, Switzerland, Japan, Australia, Canada or EU. Thus, primary and specialized expertise, except of documents set by the relevant Order, will be conducted based on official document concerned the last control, executed based on WHO re-qualification program for such medicinal products. In this case the period of primary and specialized document expertise, concerned such medicinal products, is shortened for 2 and 3 business days respectively.
Within this Draft, it’s emphasized the necessity of termination of critical, material and non-material violations found during previous controls and the account of found violations in the terms of elaboration the plan and the control program.
In the case of adoption the Draft in current edition the order of confirmation of the compliance of manufacturing conditions for medicinal products with GMP requirement concerned medicinal products of restricted using will be changed also. For example, such confirming will be provided at the general order and with controls
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