Obligatory GMP certification of manufacturing site(s) responsible for bulk finished product and batch release manufacturing stages is required for any EAEU registration of finished drug product and bulk drug product, as well as for any national registration (Enrollment to the Russian State Register of Medicines) of any commercial API in Russia.
Regulatory Guidelines of EAEU GMP certification
EAEU GMP certification is governed by the Resolution № 77 dd. Nov 03, 2016 of the Council of the Eurasian Economic Commission "On Adoption of the Rules of Good Manufacturing Practice of the Eurasian Economic Union".
Eurasian Economic Union GMP certificate
EAEU GMP certificate by its format is "site activities"-wise. The duration of EAEU GMP certificate is 3 years starting the last date of the latest GMP inspection of the corresponding site. Despite the format of the certificate, indicating the (inspected) site activities only, the format of the GMP application is product-and-activity sensitive. Within the obligatory forms that accompany EAEU GMP application, an applicant should provide details of exact product(s), their registration status and corresponding on-site activities per each product to be inspected.
Absence of EAEU GMP certificate (at least at the final review stage) of submitted registration dossier of a finisheddrug product or a commercial API results in automatic refusal for the registration of the the corresponding product(s) by the Ministry of Health (MoH) of concerned EAEU member country.
Regulatory Bodies for EAEU GMP certification
Regulatory Bodies for GMP applications submitted in Russia as the reference country
Federal State Institution “State Institute of Drugs and Good Practices” ("FSI SID&GP") was officially empowered by the Ministry of Industry and Trade (MIT) of the Russian Federation as the only dedicated institution that performs EAEU GMP inspections and GMP certification expertise for all international manufacturers' GMP applications submitted in Russia.
MIT elaborates ultimate decision on issuance/refusal of EAEU GMP certificate after obtaining the corresponding GMP inspection(s) report(s) that officially comes to MIT from FSI SID&GP for every GMP application.
Regulatory Bodies for EAEU GMP applications submitted in Belarus, Kazakhstan, Kyrgyzstan or Armenia as reference state
EAEU Member States other than Russia (Belarus, Kazakhstan, Kyrgyzstan and Armenia) have their own GMP certification authorities and GMP expertise institutions that provide GMP inspections and official GMP expertise within current EAEU regulations.
EAEU GMP certification process
FSI SID&GPpractices comprehensive approach and well-established procedures for the GMP certification since 2016 being the only official institute in Russia that provides the corresponding GMP-compliance expertise and GMP inspections as such.The institution also can coordinate EAEU GMP inspections performed by the authorities of other EAEU member states, the institute reviews any other member-states GMP inspection reports in case of EAEU MRP submission with Russian Federation as a recognition (not reference) member.
Some Type II CMC variations (addition of new manufacturing site, any significant changes of QC testing methods, any significant changes in product's release specification, major changes in manufacturing process etc.) require EAEU GMP certification for the affected site(s) in order to obtain official approval of such variation.
MIT regularly uploads publicly available list of issued EAEU GMP Certificates. The list of previously issued National Russian GMP Conclusions is also publicly available.
We provide all organizing and supporting activities for before, during and after Russian GMP inspection procedure:
- Preparing the application and all supporting documents for the GMP certification (GMP dossier);
- Submitting the GMP dossier to the authorized body of the relevant Member State (by default - Ministry of Industry and Trade of Russia);
- Paying official state duties where applicable;
- Signing and acting as the agent in official contract with the GMP expertise institution
- Managing official communications with FSI SID&GP;
- Coordinating the date of official GMP inspection and "queue" time with FSI SID&GP;
- Performing industry-certified audit for the compliance with EAEU GMP requirements before the official inspection.
- Accompanying the inspection team if needed;
- Providing on-site interpreting by qualified professional interpreters (required to be provided by the applicant side as per EAEU regulations);
- Providing recommendations for the CAPA and managing additional expertise for CAPA with FSI SID&GP and the authorized executive body (MIT for Russia)
- Communication with the inspection team after the audit, resolving questions;
- Obtaining the EAEU GMP certificate from Ministry of Industry and Trade of Russia.
Complete EAEU GMP certification procedure from the initial submission to MIT to the issuance of the certificate typically takes 6 to 12 months, depending on the queue of applicants, complexity and coverage of the activities for a particular site, as well as services plans and service features that we propose.
Due to managing EAEU GMP certification as integral part of our service for a finished product or API registration since 2016, as well as our time optimization of every single regulatory affairs process (thorough gap analysis of all initial documents and dossiers, parallel execution of processes, import and customs clearance of samples, preliminary QC testing of samples for compliance to product's Normative Document; use of biowaiver studies etc.), we minimize the overall timeline of the GMP certification procedure.
In all cases we provide EAEU GMP certification services that can be integrated into the overall registration timeline "seamlessly", without necessarily extending the planned registration timeline, where activities can be run in parallel.