Patent and Trademark Attorneys

COVID-19 caused the amendments into the procedure of conducting the GMP conformity assessment in Ukraine

July 28, 2020

The Order of the Ministry of Health of Ukraine dated June 9, 2020 No. 1346 introduces significant amendments into the procedure of conducting the GMP conformity assessment as well into the procedure of recognition of the GMP Certificate in Ukraine described by the Order No. 1130 of December 27, 2012 "On Procedure for conducting confirmation of the conformity of manufacturing conditions of medicinal products with good manufacturing practice requirements".

First and foremost, in times of national or global crisis caused by the Covid-19 outbreak where travel is restricted or prohibited the Order provides for the possibility of a remote inspection service for the purpose of further issuance of a GMP certificate on the basis of a documented survey of the manufacturer. Other situations stipulated by the Order that presuppose the possibility of remote inspection, except for pandemic, are state of emergency, state of war and natural disasters. Remote inspection allows leveraging modern communication technologies such as video teleconferencing. The decision to issue a GMP certificate shall be based on the report reflecting the results of such remote inspection.

At the same time, it should be noted that in terms of the recognition procedure the Order provides the recognition of only official documents on the manufacture of medicinal products compliance with GMP requirements issued by the authorized bodies of EU member states, Great Britain or countries that have a mutual recognition agreement (MRA) with the EU or with Ukraine. Currently, these are all EU countries, UK, USA, Canada, Switzerland, New Zealand, Australia, Japan and Israel. Earlier Ukrainian authorities accepted documents from all PIC/S countries.

GMP Certificates or other Official Documents on the Compliance of Medicinal Products with GMP Requirements issued by regulatory authorities of other countries not mentioned above are no longer subject to the recognition procedure for obtaining a GMP Certificate in Ukraine .

The Order also mentions that in case any manufacturing stage of the medicinal product is carried out outside the EU, UK, USA, Canada, Switzerland, New Zealand, Australia, Japan, Israel the copies of the Marketing Authorizations issued by the competent authorities in these countries have to be provided for the recognition procedure in Ukraine. In case of absence of the above-mentioned Marketing Authorization, the manufacturing site shall be inspected for compliance with GMP requirements by Ukrainian authorities.

The Order came into force on July 21, 2020 with respect to all applications filed as of this date. All previously filed applications will be examined in accordance with the old procedure as per the Order No. 452 as of July 22, 2015.

In order we could provide you with the information on costs associated with GMP conformity assessment in Ukraine together with the detailed information and the list of documents required from your side, such as sample of the Power of Attorney for execution etc. please contact our specialists.