Changes to the Order on conducting confirmation of compliance of the medicinal products manufacture conditions to the GMP requirements came into force

The order of the Ministry of Health of Ukraine as of 09.06.2020 № 1346 registered by the Ministry of Justice of Ukraine on 03.07.2020 № 616/34899 approves changes to the Order on conducting confirmation of compliance of the medicinal products manufacture conditions with good manufacture practice requirements that was approved by the order of the Ministry of Health of Ukraine as of 27.12.2012 № 1130 and registered by the Ministry of Justice of Ukraine of 21.01.2013 № 133/22665 (order of the Ministry of Health of Ukraine as of 22 July 2015 № 452 with changes). Order of the Ministry of Health of Ukraine as of 09.06.2020 № 1346 came into force on 21.07.2020 (Official Bulletin of Ukraine № 56).

The Order provides conducting remote assessment (remote inspection) with further issuance of certificates on compliance of medicinal products manufacture conditions with good manufacture practice requirements (GMP certificate) by the State Service of Ukraine on Medicines and Drugs Control based on documented manufacturer interview. The remote assessment can be conducted in case when Ukraine or any other country-manufacturer declares emergency, martial law, in case of natural disaster, when a disease is declared by the WHO as a pandemic and in case of healthcare emergency that makes impossible conduct of inspections including sanitary-epidemiological situation that increases risks for inspectors (including risks for inspector’s life and health or any other reasons).

According to the Order the applicant / applicant’s representative requests the State Service of Ukraine on Medicines and Drugs Control for GMP certificate submitting set of necessary documents. Based on expertise results and in case when it’s impossible to conduct the inspection by the State Service of Ukraine on Medicines and Drugs Control at the place of carrying out activities, the applicant receives an official letter with a list documents that should be provided for further remote assessment. While conducting remote assessment the means of videoconferencing may be applied to assess manufacturing area / laboratory / warehouses (including contracted), manufacturing and quality system documentation on compliance with the GMP requirements. By results of remote assessment the report should be prepared and decision on GMP certificate issuance is to be taken.

The Order provides recognition of official documents on compliance of medicinal products manufacture with GMP requirements, issued by an authorized authority of a country-member of the EU, Great Britain and countries which possess agreements on mutual recognition with EU and Ukraine. Currently this list of countries includes all countries of EU, Great Britain, countries that possess MRA agreement with EU (USA, Canada, Swiss, New Zealand, Australia, Japan) and ACAA agreement with EU (Israel).

Official documents on compliance of medicinal products manufacture with GMP requirements issued by regulatory authorities of other countries are not subject to the procedure of recognition with further obtaining of GMP conclusion.

Manufacturers which do not have certificates issued by authorized authorities of a country-member of the EU, Great Britain and countries which possess agreements on mutual recognition with EU and Ukraine may request the State Service of Ukraine on Medicines and Drugs Control to confirm compliance of medicinal products manufacture with GMP requirements submitting application for GMP certificate issuance and set of necessary documents.

The Order contains the provision on necessity to submit copies of registration certificates issued by authorities of a country-member of the EU, Great Britain or countries that possess agreements on mutual recognition with EU (USA, Canada, Swiss, New Zealand, Australia, Japan, Israel) or with Ukraine while applying for GMP conclusion for medicinal products, when manufacturing of at least one stage is conducted not in a country of EU, Great Britain USA, Canada, Swiss, New Zealand, Australia, Japan, Israel.

According to the Order in the case of absence of copies of registration certificates the medicinal products manufacture inspection heeds to be conducted, except for the period when a disease is declared by the WHO as a pandemic and except for healthcare emergency case that makes impossible to conduct inspections at the place of carrying out activities. During this period the applicant / applicant’s representative may apply for GMP certificate and remote assessment of compliance of the medicinal products manufacture conditions with the GMP requirements.

Copies of registration certificates are not subject to submission for manufacturers from the EU countries, Great Britain or countries that possess agreements on mutual recognition with the EU (USA, Canada, Swiss, New Zealand, Australia, Japan, Israel) or with Ukraine.

This Order updates such terms as “critical violation”, “substantial violation”, “non-fundamental violation” and updates Annex 10 to the Algorithm for violations classification. According to the new version of the Order, following conduct of inspections at the place of carrying out activities, the GMP certificate or GMP conclusion can be issued after providing the State Service of Ukraine on Medicines and Drugs Control with a plan of adjustment and preventive actions to address violations identified while conducting inspections of manufacturing sites or certain medicinal products.

The term of conducting the forthcoming inspection on compliance of manufacture with the GMP requirements is calculated in accordance with the methodology of conducting risk assessment as provided by the Annex 15 to this Order. The validity period of GMP certificate is three years starting with the date of inspection and can be shortened according to the minutes of risk assessment on calculation of conducting next inspection of medicinal product manufacture on compliance with GMP requirements.

The Order sets out that at times when a disease is declared by the WHO as a pandemic and in case of healthcare emergency that makes impossible to conduct inspections at the place of carrying out activities including sanitary-epidemiological situation it is possible to submit to the State Service of Ukraine on Medicines and Drugs Control a letter regarding conducting risk assessment in order to shift the term of the forthcoming inspection on compliance of medicinal products manufacture with GMP requirements and issuance of GMP certificate based on information about the latest scheduled inspection on compliance with license requirements (for resident producers, if confirmation of compliance of medicinal products manufacture conditions with GMP requirements was performed by the State Service of Ukraine on Medicines and Drugs Control based on results of scheduled inspection on abidance with the license requirements). The GMP certificate is issued considering conducted risk assessment in accordance with the Annex 15 of this Order.

For medicinal products used for prevention, diagnostics and treatment of tuberculosis, HIV/AIDS, viral hepatitis, oncological diseases and rare (orphan) diseases and for medicinal products registered by the EMA, for medicinal products that were prequalified by the WHO and were included to the WHO List of Prequalified Medicinal Products and for medicinal products registered in accordance with the simplified procedure for the registration based on the Law of Ukraine “On Medicinal Products”, for medicinal products included into treatment protocols of Ukraine and in case when a disease is declared by the WHO as a pandemic and in case of healthcare emergency, if this information contains in the submitted application, the specialized expertise is conducted out of turn.

Meanwhile, the applications submitted for confirmation of compliance of medicinal products manufacture conditions with GMP requirements registered prior to 21.07.2020 will be considered by the State Service of Ukraine on Medicines and Drugs Control in accordance with the Order on conducting confirmation of compliance of the medicinal products manufacture conditions to the GMP requirements with amendments approved by the order of the Ministry of Health of Ukraine as of 22.07.2015 № 452.