GMP Compliance in Medicinal Product Manufacturing
In accordance with Decree of the Cabinet of Ministers of Ukraine dated May 26, 2005 No. 376 the compliance of production of medicinal products with Good Manufacturing Practice shall be checked during the examination of the registration materials submitted for state registration (re-registration).
According to the Order No. 1130 of December 27, 2012 with the last amendments as of July 21, 2020 "On approval of the Procedure for conducting confirmation of the conformity of manufacturing conditions of medicinal products with the Good Manufacturing Practice requirements" for manufacturing sites that have a GMP certificate issued by the competent authority of the EU member states, the Great Britain or countries that have a mutual recognition agreement with the EU or with Ukraine (the USA, Canada, Switzerland, New Zealand, Australia, Japan and Israel), GMP conformity assessment is carried out by examination of provided documents only, while for manufacturing sites that do not have GMP certificate issued by the competent authority of the above-mentioned countries, GMP conformity assessment is made both by examination of provided documents and conducting of mandatory inspection of the manufacturing site with the departure to the plant.
In case any manufacturing stage of the medicinal product is carried out outside the EU, the Great Britain or countries that have a mutual recognition agreement with the EU or with Ukraine the copies of the Marketing Authorizations issued by the competent authority of one of these countries that has issued GMP Certificate for manufacturing site responsible for batch release 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.
Required Documents for GMP Conformity Assessment
The procedure of examination of the documents on GMP conformity assessment is conducted by the State Administration on Medicines and Drugs Control of Ukraine and is free.
For initiating the procedure of GMP conformity assessment it is necessary to provide Application for issuance of the certificate or the conclusion of compliance together with the following documents:
- legalized Power of Attorney from the applicant to the representative;
- copy of the application form for State registration (re-registration) of medicinal product that has been submitted to the State Expert Centre of Ministry of Health Protection of Ukraine (if available);
- legalized copies of the Manufacturer's Authorizations for all manufacturing sites involved in manufacturing process and issued by the competent authorities of countries-manufacturers or their printouts from the official database;
- legalized copies of the official documents issued by the state authorities of the countries where the manufacturing sites are located about the compliance of manufacturing site to GMP requirements and/or legalized GMP certificates issued by the competent authorities of the EU member states, the Great Britain or countries that have a mutual recognition agreement with EU or with Ukraine or their printouts from the official database.
- certified copies of dossiers of the manufacturing sites - Site Master Files (for manufacturing sites located outside the EU member states, the Great Britain or countries that have a mutual recognition agreement with the EU or with Ukraine);
- certified copies of last reports on inspections of the manufacturing sites by the competent authorities of the EU member states, the Great Britain or countries that have a mutual recognition agreement with the EU or with Ukraine that were conducted within 3 years before submitting the Application (for manufacturing sites located outside the EU member states, the Great Britain or countries that have a mutual recognition agreement with the EU or with Ukraine);
- certificate on the quality of medicinal products that are registered in Ukraine or have been submitted for State registration (re-registration);
- certificate on the results of all inspections conducted by the competent authorities within 3 years before submitting the Application for issuance of the certificate or conclusion;
- general list of medicinal products that are registered in Ukraine and/or have been submitted for State registration (re-registration);
- certified copies of certificates of a pharmaceutical product (free sale certificates) issued by the competent authorities of country of applicant/manufacturer or by other Regulatory Bodies from EU member states, the Great Britain or a countries that have a mutual recognition agreement with the EU or with Ukraine and where the said products are marketed (for medicinal products not registered in Ukraine), etc..
- copies of the Marketing Authorizations issued for medicinal products by the competent authorities of the EU, the Great Britain, or countries that have a mutual recognition agreement with the EU or with Ukraine that have issued GMP Certificate for manufacturing site responsible for batch release (in case any manufacturing stage of the medicinal product is carried out outside the aforementioned countries), etc..
Procedure for GMP Conformity Assessment
Procedure of GMP conformity assessment includes the following steps:
- submission of the application form and documents to obtain a certificate or conclusion;
- inspection of manufacturing sites (if required);
- receipt of a certificate or conclusion of compliance to the GMP requirements and/or report of compliance or non-compliance to the GMP requirements.
It should be noted that last amendments into the Order No. 1130 as of July 21, 2020 caused by the COVID-19 worldwide outbreak allow the possibility for the above-mentioned inspection to be conducted remotely under certain circumstances. Specifically, in times of national or global crisis caused by Coronavirus where travel is restricted or prohibited the Order now 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 by means of giving access to the manufacturing site/laboratories /warehouses (including those under contract), production documentation and quality system documentation for compliance with GMP requirements. The decision to issue a GMP certificate shall be based on the report reflecting the results of such remote inspection.
Remote inspection may supersede the site inspection only once and is possible only if the manufacturing site had already been inspected in the past by the Ukrainian authority or competent authorities of the EU member states, the Great Britain or countries that have a mutual recognition agreement with the EU or with Ukraine.
Validity and Timeframe
The timeframe required to obtain a GMP Certificate in Ukraine is from about 4 to 7 months after submission of the dossier. The procedure of obtaining the conclusion on recognition of GMP certificate where no inspection of the manufacturing site is required takes approximately 3 months after submission of the dossier.
The validity term of the certificate is three years from the date of the end of the inspection, from remote inspection two years..
The validity term of the conclusion may not exceed the term of recognized GMP certificate issued by the competent authority of one of the EU member states, the Great Britain or a country that has a mutual recognition agreement with the EU or with Ukraine. Nevertheless it may be extended to 6 months in case of timely submission of information about the dates settled for new inspection to be conducted by the aforesaid competent authority.
In order we could provide you with the information on costs associated with GMP conformity assessment in Ukraine together with the detailed information and list of documents required from your side, sample of the Power of Attorney for execution, etc. please contact our specialists.
