GMP inspection of a foreign site from 1 March 2026. What has changed, which documents to submit and how much an inspection costs
Resolution of the Government of the Russian Federation No. 1314 of 3 December 2015 «On Determining the Compliance of Manufacturers of Medicines with the Requirements of Good Manufacturing Practice Rules» (hereinafter Resolution No. 1314) ceased to have effect on 1 March 2026. It was repealed by Resolution of the Government of the Russian Federation No. 1766 of 8 November 2025 «On Recognizing Certain Acts of the Government of the Russian Federation as Repealed» (hereinafter Resolution No. 1766).
Under Federal Law No. 61-FZ of 12 April 2010 «On the Circulation of Medicines» (hereinafter 61-FZ), organizing and (or) conducting inspections of the manufacture of medicines for medical use for compliance with the requirements of the good manufacturing practice (GMP) rules of the Eurasian Economic Union (the EAEU or the Union), and issuing certificates, are among the powers of federal executive bodies. The inspection procedure is established by the Rules for Conducting Pharmaceutical Inspections for Compliance with the Requirements of the Union’s Good Manufacturing Practice Rules (hereinafter the Inspection Rules), approved by Decision of the Council of the Eurasian Economic Commission (EEC) No. 83 of 3 November 2016 «On Approval of the Rules for Conducting Pharmaceutical Inspections».
Under the Inspection Rules, the inspection report is prepared within 30 calendar days instead of 25 working days under the Rules approved by Resolution No. 1314 (hereinafter the Rules under Resolution No. 1314). The response to identified deficiencies is submitted within 60 calendar days instead of 60 working days. If the response is not submitted within that period, the manufacturing operations are deemed non-compliant with GMP requirements.
What has changed compared with Resolution No. 1314
Table 1 compares the procedure under the Rules under Resolution No. 1314 (as amended on 5 September 2020) with the procedure under the Inspection Rules (as amended on 1 August 2025) as of 18 October 2026.
Table 1. Inspection of a foreign site under the Rules under Resolution No. 1314 and under the Inspection Rules
| Issue | Before (Rules under Resolution No. 1314) | After (Inspection Rules) |
|---|---|---|
| Applicant and inspecting body | The foreign manufacturer or its authorized representative submits an application to the Russian Ministry of Industry and Trade. An authorized institution conducts the inspection at the foreign manufacturer’s expense | The applicant is the entity subject to inspection (an organization holding a manufacturing authorization from the country of manufacture), the registration holder, the applicant for registration, or their authorized representative. The inspection is conducted by the pharmaceutical inspectorate of a member state of the Union. Under the General Requirements for the Quality System of Pharmaceutical Inspectorates, approved by Decision of the EEC Council No. 82 of 3 November 2016, an inspectorate is a structural unit of the authorized body (authorized organization) of a member state in the sphere of the circulation of medicines that conducts pharmaceutical inspections. For a site in a third country, the applicant may apply to the inspectorate of one of the member states |
| Document issued following the inspection | Conclusion | Certificate of compliance |
| Fee for the document | RUB 7,500 for issuing the conclusion | Under 61-FZ (as amended on 4 August 2026), the fee for issuing a certificate for medicines for medical use is not named. For medicines for veterinary use, the amount of the fee for issuing certificates (conclusions) is set by the Government of the Russian Federation. Inspection expenses are borne by the entity subject to inspection or its authorized representative. The calculation of the fee for the inspection service is given in the section «How much an inspection costs and who pays» |
| Review of the application and documents | 10 working days for review, 20 working days to remedy shortcomings and 3 working days to forward the documents to the authorized institution | No review period is set: the time limits for individual stages are established under the legislation of the member state, taking the Inspection Rules into account |
| Payment of expenses | 30 working days from the date the agreement is concluded; failure to pay within that period is among the grounds for refusing to issue a conclusion | An inspection may be refused if the expenses are not paid within the established period, where this applies. The Inspection Rules do not name that period |
| Inspection plan or program | The inspection plan is sent no later than 10 working days before the inspection | The program is sent no later than 10 working days before the inspection begins |
| Inspection time limit | Up to 160 working days from the decision to conduct the inspection; the inspection itself lasts no more than 10 working days, excluding travel time | The Inspection Rules do not name a maximum duration. The time limit for an unscheduled inspection at registration is given in the section «When an inspection is required for registration and dossier variations» |
| Report | 25 working days from completion of the inspection | 30 calendar days from completion of the inspection or, where samples are taken, from the date the lead inspector receives their test results. For critical and (or) major deficiencies, this is the deadline for Part I of the report |
| Response to deficiencies | The foreign manufacturer may submit a corrective and preventive action (CAPA) plan no later than 60 working days from receipt of the report | The entity subject to inspection submits a response with a CAPA plan, a report on its implementation and evidence of remediation within 60 calendar days from receipt of Part I of the report. If the response is not submitted on time, the manufacturing operations are deemed non-compliant |
| Completing the report after the response | The CAPA plan is assessed no later than 25 working days from receipt | Part II of the report is prepared within 30 calendar days from the date the response is submitted or, if there is no response, on the 61st calendar day from receipt of Part I |
| Issuing the document | The decision to issue a conclusion is taken within 10 working days from signing of the report or its receipt from the institution | The certificate is issued no later than 10 working days from the decision to issue it |
| Validity of the document | 3 years from completion of the inspection | No more than 3 years from completion of the inspection; the term may be shortened under risk management principles, with a record in the certificate |
Compliance conclusions on a manufacturer’s compliance with GMP requirements, issued as documents before the day Federal Law No. 304-FZ of 31 July 2025 «On Amendments to Certain Legislative Acts of the Russian Federation» (hereinafter 304-FZ) entered into force, remain valid until their validity period ends. No other entry-into-force date is set for this provision, so the general entry-into-force date of 304-FZ applies: 1 March 2026. Resolution No. 1766 contains no transitional provisions: it enters into force on 1 March 2026 without reservations. As of 18 October 2026, 304-FZ and Resolution No. 1766 contain no provisions on applications filed before 1 March 2026 or on inspections begun before that date. The Inspection Rules (as amended on 1 August 2025) also contain no transitional provisions on such applications.
When an inspection is required for registration and dossier variations
When applying for registration, confirmation of registration (renewal) and dossier alignment with Union requirements (the procedure for medicinal products registered under the rules of a member state, hereinafter dossier alignment), the applicant must include in the dossier a valid document confirming compliance with Union GMP. The requirement is set out in the Rules for Registration and Regulatory Review of Medicines for Medical Use, approved by Decision of the EEC Council No. 78 of 3 November 2016 «On the Rules for Registration and Regulatory Review of Medicines for Medical Use» (hereinafter the Registration and Review Rules). The document is needed for the site where the finished dosage form is manufactured and release quality control is carried out. Instead of a Union document, the applicant may submit a GMP compliance document issued to the manufacturer by the authorized body of a member state, until its validity period ends.
If a valid document cannot be submitted, the applicant, when applying for registration or dossier alignment, submits the following documents and information instead, under the Registration and Review Rules:
valid GMP compliance documents for the sites where the finished dosage form is manufactured and release quality control is carried out, issued to the manufacturer by the authorized body of the country of manufacture;
a copy of the report on the latest inspection of the sites carried out by the authorized body of the country of manufacture and (or) another authorized body within the last 3 years;
information on the results of all inspections of these sites for GMP compliance over the last 3 years;
information on quality complaints about medicinal products manufactured at these sites over the last 3 years;
consent to a pharmaceutical inspection for compliance with Union GMP;
a copy of the site master file (main dossier) of the sites.
On the basis of these documents and taking a risk assessment into account, the reference state (the member state that prepares the assessment report on the safety, efficacy and quality of the medicinal product) decides whether to conduct an unscheduled inspection within the time frame of the registration procedures or to include the site in the inspection plan for the first 3 years after they are completed. At registration, the decision on the need for an unscheduled inspection is taken for medicinal products from sites that have not previously been inspected by the authorized body of any member state. At dossier alignment, such a decision is taken when such a site is specified, introduced or changed. The application for dossier alignment of the registration dossier of a medicinal product registered under the rules of a member state had to be submitted to the reference state by 31 December 2025 (under the Registration and Review Rules as amended on 26 November 2025).
The decision to initiate an unscheduled inspection may be taken no later than 70 working days from the date the registration application is submitted. After such a decision, the reference state sends the applicant a request to arrange the inspection, stating the reasons and citing the acts of Union bodies. The review is not interrupted for the duration of such an inspection, but the reference state may prepare the final assessment report only taking the inspection results into account.
The Registration and Review Rules name two time limits for such an inspection. One provision requires the inspection to be conducted within no more than 180 calendar days from the date of the decision to initiate it. Another provision of the same Rules requires the inspection to be conducted, and the report sent, within a period no longer than the registration period, and gives 180 working days from the same date in parentheses. The text of the two provisions does not show which of the time limits applies to the same inspection.
If the reference state has documented that it cannot conduct the inspection within the time frame of the registration procedures, the applicant may, in agreement with it, apply for an inspection to one of the member states. If the authorized bodies of the states of recognition (the member states in which the medicinal product is registered with a review that includes evaluation of the reference state’s assessment report) refuse in writing, the reference state must organize and conduct the unscheduled inspection within the time frame of the registration procedures.
Under 61-FZ, if the manufacturing site of a registered medicinal product manufactured outside Russia changes and the change requires a quality review, the applicant additionally submits a copy of the license of the country of manufacture and its translation into Russian, certified in the established manner. The applicant adds one of the following documents to the license and the translation: a copy of a conclusion or certificate issued by the federal body for the changed or added site, or a copy of the federal body’s decision to conduct a pharmaceutical inspection of that site. For a change in quality indicators or quality control methods that requires a review, the following are added to the copy of the license with the translation: the date and registration number of the conclusion, or a copy of the certificate, or the date and registration number of the decision to conduct an inspection. For confirmation of registration, a copy of the decision to conduct an inspection is allowed instead of a copy of the conclusion or certificate.
Under 61-FZ, if the applicant has submitted a copy of the decision to conduct an inspection when the manufacturing site of a medicinal product changes or when a pharmaceutical substance is included in the State Register of Medicines, a copy of the conclusion or certificate is submitted to the expert before the results of the review are formalized. The applicant must send this copy to the personal account of the expert institution within no more than 180 working days. The period is counted from the day the expert institution receives an electronic notification that the applicant has received the request for the document, signed by the head (authorized person) of the expert institution. The time from sending the request to sending the copy is not counted in the review period.
Who conducts the inspection and where to apply
Under the Inspection Rules, an inspection is conducted on the basis of a decision of the authorized body of a member state and (or) an application of the entity subject to inspection, for example for licensing, registration or an investigation related to the quality of medicinal products. It is conducted by the pharmaceutical inspectorate of the member state in whose territory the site is located. For a site in a third country (a state that is not a member of the Union), the applicant may apply to the inspectorate of one of the member states. If the inspectorate gives a documented refusal, the applicant may apply to the body of another member state. An inspection initiated at registration is conducted by the inspectorate of the state determined under the Registration and Review Rules.
The powers of federal executive bodies on inspections and certificates are exercised by the Russian Ministry of Industry and Trade. It organizes and (or) conducts pharmaceutical inspections of the manufacture of medicines for medical use for compliance with Union GMP, including jointly with the pharmaceutical inspectorates of another member state, and also issues certificates, suspends, resumes or terminates their validity and amends them. These powers are set out in the Regulation on the Ministry of Industry and Trade of the Russian Federation, approved by Resolution of the Government of the Russian Federation No. 438 of 5 June 2008 (as amended on 11 June 2026, hereinafter the Regulation on the Ministry of Industry and Trade).
The Federal Budgetary Institution «State Institute of Medicines and Good Practices» (FBU GILS i NP) is authorized to conduct inspections of manufacturing outside Russia, including jointly with the inspectorates of another member state. The institution’s authority is stated in Order of the Russian Ministry of Industry and Trade No. 90 of 20 January 2021, which approves the methodologies for determining the fee for pharmaceutical inspections (hereinafter Order No. 90).
The Rules under Resolution No. 1314 required an application in the form approved by the Russian Ministry of Industry and Trade, with the details of the payment document. After 1 March 2026, the form of a foreign manufacturer’s application and the procedure for filing it are not defined by the acts reviewed, including the Inspection Rules and the Regulation on the Ministry of Industry and Trade.
Which documents to submit
Under the Inspection Rules, to organize an inspection the applicant ensures that the following documents of the non-resident manufacturer are submitted to the inspectorate:
an application for an inspection;
a copy of the site master file (the manufacturing site dossier) under the Good Manufacturing Practice Rules of the Union, approved by Decision of the EEC Council No. 77 of 3 November 2016 (hereinafter the GMP Rules);
a certified copy or an electronic copy of a valid authorization (license) for the manufacture of medicines, issued by the authorized body of the third country where the site is located, or an extract from the register of that country;
a certified copy of a document of the authority of the country of manufacture on compliance of manufacturing with the GMP requirements applied in the country of manufacture (where available), or an electronic copy or an extract from the register of that country;
a list of the medicines manufactured or planned for manufacture at the site.
The documents are submitted in Russian and (or) in the state language of the member state, if its legislation requires this, or in translation into those languages. The list of medicines is prepared in the form given in the Inspection Rules. The form shows the trade name and (or) the name of the pharmaceutical substance, the international nonproprietary name (INN) or the grouping (chemical) name, the dosage form and strength, details of the registration certificate and the product type.
An inspection may be refused if the information in the application or in documents submitted on request is incomplete or inaccurate, if the applicant has not provided the conditions for inspection and the procedure cannot be carried out, or if the inspection expenses are not paid within the established period, where this applies.
The list of documents of a foreign manufacturer under the Rules under Resolution No. 1314 included documents that are not in the list of the Inspection Rules: a document confirming the authority of the representative, information on identified quality deficiencies and on recalls of medicines from civil circulation over a period of at least 2 years, and a letter of consent of the foreign manufacturer to the inspection. Under the Registration and Review Rules, information on inspections and complaints over 3 years and consent to the inspection are submitted together with the application for registration or dossier alignment if a valid document on GMP compliance of the Union cannot be submitted.
The site master file is prepared under the GMP Rules. Where possible, its length does not exceed 25-30 pages, excluding annexes. It states the version number, the date it takes effect and the date of the next review, and annexes may have separate effective dates. The site master file contains sections on general information about the manufacturer, the quality management system, personnel, premises and equipment, documentation, production, quality control, distribution, complaints, product defects and recalls, and self-inspection. The general information includes a list of inspections of the site for GMP compliance over the last 5 years, with dates and the names of the bodies that conducted them, and a copy of the valid certificate of compliance, if there is one.
How much an inspection costs and who pays
Inspection expenses are borne by the entity subject to inspection or its authorized representative. The fee for the service is determined under the methodologies approved by Order No. 90 (hereinafter the Methodologies). The service is paid by the applicant, that is, the manufacturer of medicines or its authorized representative.
The cost is calculated by the formula C = t × Ce × (1 + (Knz + Kkr) / 100) + Skr + VAT. The formula includes the labor input in person-hours (t), the cost of one hour of work of a pharmaceutical inspector (Ce), the coefficient of payroll charges (Knz), the coefficient of indirect expenses of the authorized institution (Kkr), business trip expenses (Skr) and value added tax (VAT).
Business trip expenses consist of travel, accommodation, daily allowances and other expenses. Travel and accommodation are accepted at the amount of actual expenses confirmed by documents, with limits on travel class and hotel category. Material costs that are not included in the calculation are paid by the applicant. They include transport costs for travel to the site if the accommodation is far from the place of the inspection, and expenses caused by rescheduling at the applicant’s initiative, namely penalties, service and consular fees, the airline ticket system fee and the cost of third-party services for arranging business trips. The fee, including material costs, must not exceed the maximum amount.
The maximum fee for an inspection of manufacturing outside Russia, including business trip expenses and VAT of 20 percent, is RUB 4,734,277.05 under Order No. 90. Where a CAPA plan and a report on its implementation are received, the maximum fee is RUB 1,241,222.54 including VAT of 20 percent. These amounts are given in the version of Order No. 90 of 25 June 2025, which applies from 26 September 2025. The fee is reviewed once a year before 1 September of the current financial year, and also when regulatory legal acts change.
Under the Inspection Rules, the entity subject to inspection bears the costs of transporting samples, of customs operations and customs control for samples moved across the customs border of the Union, and of testing the samples. The cost of the samples taken is not compensated.
Federal Law No. 324-FZ of 4 August 2026 «On Amendments to the Federal Law ‘On the Circulation of Medicines’ and Certain Legislative Acts of the Russian Federation» (hereinafter 324-FZ), in force from 15 August 2026, supplemented the provisions of 61-FZ on the procedure for importing and exporting medicines. Under 61-FZ, samples of medicines taken during pharmaceutical inspections for compliance with Union GMP may be imported into Russia under the procedure and on the conditions that the law provides for importing a specific lot of medicines. The permit for such an import is issued by the authorized federal executive body on applications of legal entities permitted to import medicines into Russia. The application is reviewed, and the decision to issue the permit or to refuse it is taken, within a period not exceeding five working days. No fee is charged for issuing the permit.
Inspection stages and preparation for the inspection
Under the Inspection Rules, the inspection procedure includes the following stages:
acceptance and review of the documents submitted;
agreeing the inspection dates with the entity subject to inspection or its representative;
forming the inspection team;
preparing and sending the inspection program;
inspecting the site, including sampling and laboratory testing of samples where necessary;
preparing the report;
assessing the CAPA plan, the report on its implementation and evidence of remediation of deficiencies where necessary;
the decision to issue or refuse to issue the certificate;
issuing the certificate.
The inspection team includes at least two pharmaceutical inspectors. The lead inspector and team members must study the documents in advance, including the site master file, and information on complaints, quality defects and recalls of products from state registers, databases and other authorized bodies. The inspection program is prepared in the form given in the Inspection Rules and sent to the entity subject to inspection no later than 10 working days before the inspection start date. The form shows the grounds and objectives of the inspection, its scope, date and place, the composition of the team and the inspection schedule. The inspection areas are listed by section of the GMP Rules (pharmaceutical quality system, personnel, premises and equipment, documentation, production, quality control, outsourced activities, complaints, quality defects and product recalls, self-inspection) and by other parts of the GMP Rules.
The contract or agreement between the inspectorate and the entity subject to inspection must reflect, among other things, the following rights of the inspector:
access to any premises under the program and to the site master file;
obtaining evidence, including documentation, photo and video materials of premises and equipment;
access to any object within the scope of the inspection;
measures, or a requirement for measures, in respect of items that may indicate non-compliance, including restricting access and ensuring safekeeping;
inspecting objects, reviewing documentation and records, questioning responsible persons and observing work at workplaces;
terminating the inspection if these rights are obstructed.
Under the Inspection Rules, the entity subject to inspection designates a person responsible for assisting with the inspection and must undertake by contract to ensure that the actions provided for in the program can be carried out. The manufacturing operations are deemed non-compliant with GMP requirements, including if the inspector is obstructed in exercising the rights listed above. The decision to terminate the validity of a previously issued certificate is taken, among other cases, if the entity subject to inspection, at the request of the authorized body, refused to undergo an inspection or did not ensure that it was carried out.
How often repeat inspections take place
Recommendation of the EEC Board No. 27 of 14 October 2025 «On the Guideline on Risk-Based Planning of Pharmaceutical Inspections for Compliance with the Requirements of the Good Manufacturing Practice Rules of the Eurasian Economic Union» (hereinafter Recommendation No. 27) is addressed to the member states. They are recommended, after 30 calendar days from its publication on the official website of the Union, to take into account the Guideline annexed to Recommendation No. 27 (hereinafter the Guideline) when assessing risks related to planning inspections for compliance with the GMP Rules. The Recommendation was published on 17 October 2025. The Guideline is recommended for application from 16 November 2025. The Guideline does not apply to inspections of sites that have not been inspected before, or to planning inspections ordered during registration procedures.
The rating of a site (A, B or C) depends on two risks: intrinsic risk and the risk of non-compliance with the GMP Rules. Intrinsic risk is determined by the complexity and criticality of the site, and each factor is given 1, 2 or 3 points. The risk of non-compliance is based on the results of the last inspection carried out as scheduled. The risk of non-compliance is high if 1 or more critical or more than 5 major deficiencies were identified, medium if from 1 to 5 major deficiencies were identified, and low if there are no critical or major deficiencies. The rating for the combination of the two risks is given in Table 2.
Table 2. Site risk rating under the Guideline
| Risk of non-compliance with the GMP Rules | Low intrinsic risk | Medium intrinsic risk | High intrinsic risk |
|---|---|---|---|
| Low | A | A | B |
| Medium | A | B | C |
| High | B | C | C |
The recommended frequency of inspections is every 2-3 years for sites with rating A, every 1-2 years for sites with rating B, and at least once a year for sites with rating C. The actual frequency within a rating depends on the number and classification of deficiencies from the last inspection. The manufacturer’s response to the last inspection report is treated as new information. The pharmaceutical inspectorate may decide that individual information from the response is to be checked thoroughly during the next inspection, and this decision affects the scope of the next inspection. The rating is also reviewed when there is new information on quality defects, product recalls, test results, investigations and changes at the site.
When inspections are conducted remotely
The Inspection Rules allow an inspection using remote interaction tools in special cases. The inspectorate may decide to conduct such an inspection in the event of a threat of an emergency, an emergency or the elimination of an emergency, and (or) in the event of a threat of the spread of epidemic diseases dangerous to others, or of diseases and injuries caused by adverse chemical, biological or radiation factors, and also in force majeure circumstances or circumstances beyond the control of the parties that threaten the life and health of inspectors, for example for political, medical or other reasons.
A remote inspection is conducted under the procedure included in the Inspection Rules. The inspectorate takes the decision on it under the risk criteria of its quality system. If the inspectorate has taken such a decision, the applicant submits additional documents and information from the list of the remote inspection procedure:
information on the product type;
the total number of inspections of the site and the frequency of inspections by the inspectorate of the state of the site;
the number of inspections by the inspectorates of member states and the types of dosage forms;
the number of complaints and recalls over 3 years;
for a repeat inspection, a list of significant changes in manufacturing over 3 years;
a list of critical and major deviations and out-of-specification batch results over 3 years;
the CAPA plan on inspections by the inspectorates of member states over 3 years;
information on the registration of medicinal products new to the Union and on their circulation in third-country markets, if the medicinal product is not registered in the member states but is registered in third countries.
These documents may be omitted if the applicant has attached a letter stating that they are in the site master file and are up to date at the time the inspection application is submitted.
The inspectorate notifies the entity subject to inspection of the need for a technical connection test before the inspection begins. The entity subject to inspection provides the connection and its security in agreement with the inspectorate. When assessing the readiness of the entity subject to inspection, the possibility should be taken into account of using communication platforms to transfer large files, holding an audio or video conference, showing the screens of computerized systems or giving remote read-only access to them, and providing recordings from surveillance cameras, as well as time zones, geolocation data, the location of the inspectors and the arrangements for an interpreter. Recording the video conference and the materials presented during the inspection is not allowed without the consent of the entity subject to inspection. Before the inspection begins, the manufacturing organization must confirm the geolocation data of the site, that is, its latitude and longitude.
Before the inspection begins, the entity subject to inspection places the documents and materials under the program in electronic form, with a translation into Russian or English, in cloud storage or in another way agreed with the inspectorate. At the end of each day, the inspectors send the entity subject to inspection by e-mail a list of questions and a list of the documentation needed. The documentation named at the closing meeting is submitted by the entity subject to inspection within 5 working days from the date the inspection ends or within another agreed period. The certificate states that the inspection was remote. An on-site inspection needs to be carried out after the restrictions introduced in the special cases that allow a remote inspection are lifted, taking the validity period of the certificate into account. For sites that are inspected for the first time, the next inspection is conducted on site if 1 or more critical or more than 5 major deficiencies were identified.
Recommendation No. 27 also allows a remote inspection in cases that are not among the special cases named in the Inspection Rules, if the overall risk rating of the site is determined as low, that is, rating A.
What to do
Identify the basis for the inspection and the inspectorate. Find out whether the inspection is ordered at registration or dossier alignment or is conducted on the manufacturer’s application, and to which inspectorate the application is submitted. Ask the Russian Ministry of Industry and Trade and FBU GILS i NP in writing how and in what form a foreign manufacturer’s application is submitted: the Inspection Rules do not give an application form. If an application was filed under Resolution No. 1314 before 1 March 2026, ask them in the same way under which procedure it is reviewed.
Collect the documents under the list in the Inspection Rules. Prepare the application, the site master file with the version number, the date it takes effect and the review date, a copy of the license of the country of manufacture or an extract from its register, a GMP compliance document of the authority of the country of manufacture if there is one, and the list of medicines in the form given in the Inspection Rules. Translate the documents into Russian and (or) the state language of the member state if its legislation requires this. If you are applying for registration or dossier alignment and have no valid GMP document, add the set under the Registration and Review Rules: the report on the last inspection, information on all inspections and complaints over 3 years, and consent to the inspection.
Estimate the budget and find out the payment deadline. Calculate the cost by the formula of the Methodologies and check it against the maximum amounts under Order No. 90. Allow for expenses on samples and on rescheduling at the applicant’s initiative. The Inspection Rules do not name the payment deadline, so clarify it with the inspectorate: failure to pay within the established period is among the grounds for refusing an inspection.
Prepare the site for the inspection program. Appoint a person responsible for assisting with the inspection, check that the contract reflects the inspector’s rights, and prepare documents and records by section of the program. For a remote format, check technical readiness and prepare translations into Russian or English.
Include the inspection time limits in the registration schedule. For an inspection ordered at registration, the decision on it may be taken no later than 70 working days from the filing of the application. The time limit for the inspection itself is named in two provisions of the Registration and Review Rules: 180 calendar days and 180 working days. Under the Inspection Rules, the report is prepared within 30 calendar days, and where samples are taken, the period is counted from receipt of the test results. The response with the CAPA plan is submitted within 60 calendar days. The certificate is issued no later than 10 working days after the decision to issue it. If the applicant has submitted a copy of the decision to conduct an inspection, the copy of the certificate is sent to the expert institution within no more than 180 working days under 61-FZ.
Regulatory framework:
1. Federal Law No. 61-FZ of 12 April 2010 «On the Circulation of Medicines» (as amended on 4 August 2026, applicable from 1 September 2026)
2. Federal Law No. 304-FZ of 31 July 2025 «On Amendments to Certain Legislative Acts of the Russian Federation» (as amended on 4 August 2026)
3. Federal Law No. 324-FZ of 4 August 2026 «On Amendments to the Federal Law ‘On the Circulation of Medicines’ and Certain Legislative Acts of the Russian Federation»
4. Resolution of the Government of the Russian Federation No. 1314 of 3 December 2015 «On Determining the Compliance of Manufacturers of Medicines with the Requirements of Good Manufacturing Practice Rules» (as amended on 5 September 2020, ceased to have effect on 1 March 2026), including the Rules approved by it for Organizing and Conducting Inspections of Manufacturers of Medicines for Compliance with the Requirements of Good Manufacturing Practice Rules, and for Issuing Conclusions on the Compliance of a Manufacturer of Medicines with These Requirements
5. Resolution of the Government of the Russian Federation No. 1766 of 8 November 2025 «On Recognizing Certain Acts of the Government of the Russian Federation as Repealed»
6. Resolution of the Government of the Russian Federation No. 438 of 5 June 2008 «On the Ministry of Industry and Trade of the Russian Federation» (as amended on 11 June 2026), including the Regulation on the Ministry of Industry and Trade of the Russian Federation approved by it
7. Decision of the Council of the Eurasian Economic Commission No. 83 of 3 November 2016 «On Approval of the Rules for Conducting Pharmaceutical Inspections» (as amended on 1 August 2025), including the Rules approved by it for Conducting Pharmaceutical Inspections for Compliance with the Requirements of the Good Manufacturing Practice Rules of the Eurasian Economic Union
8. Decision of the Council of the Eurasian Economic Commission No. 82 of 3 November 2016 «On Approval of the General Requirements for the Quality System of Pharmaceutical Inspectorates of the Member States of the Eurasian Economic Union»
9. Decision of the Council of the Eurasian Economic Commission No. 78 of 3 November 2016 «On the Rules for Registration and Regulatory Review of Medicines for Medical Use» (as amended on 26 November 2025)
10. Decision of the Council of the Eurasian Economic Commission No. 77 of 3 November 2016 «On Approval of the Good Manufacturing Practice Rules of the Eurasian Economic Union» (as amended on 4 July 2023)
11. Recommendation of the Board of the Eurasian Economic Commission No. 27 of 14 October 2025 «On the Guideline on Risk-Based Planning of Pharmaceutical Inspections for Compliance with the Requirements of the Good Manufacturing Practice Rules of the Eurasian Economic Union»
12. Order of the Russian Ministry of Industry and Trade No. 90 of 20 January 2021 «On Approval of the Methodologies for Determining the Fee for Services for Conducting Pharmaceutical Inspections of the Manufacture of Medicines for Medical Use Located in the Russian Federation for Compliance with the Requirements of the Good Manufacturing Practice Rules of the Eurasian Economic Union, and for Conducting Pharmaceutical Inspections of the Manufacture of Medicines for Medical Use Located Outside the Russian Federation for Compliance with the Requirements of the Good Manufacturing Practice Rules of the Eurasian Economic Union, Including Jointly with the Pharmaceutical Inspectorates of Another Member State of the Eurasian Economic Union, for the Purpose of Issuing a Certificate (Certificates) of Compliance of a Manufacturer (Manufacturers) of Medicines for Medical Use with the Requirements of the Good Manufacturing Practice Rules of the Eurasian Economic Union, and the Maximum Amount of Fees for These Services» (as amended on 25 June 2025)