EAEU GMP inspection: a step-by-step guide for foreign manufacturers
How EAEU GMP inspections of foreign sites work: applying, Decision 83 timelines, the 3-year EAEU GMP certificate, remote inspections and the 2026 GMP updates.
Short answer
To register a medicine in the Eurasian Economic Union (EAEU), the manufacturing site must be shown to comply with the Union's Good Manufacturing Practice Rules (EEC Council Decision No. 77 of 3 November 2016). For sites in third countries such as Türkiye, this is done through an inspection by a member state's pharmaceutical inspectorate, which leads to an EAEU-format GMP certificate. The procedure is set by the Rules for Pharmaceutical Inspections approved by Decision No. 83 of 3 November 2016, whose new edition was adopted by Decision No. 127 of 19 August 2022. Decision No. 82 covers the inspectorates' quality system and Decision No. 91 covers joint inspections.
How to apply
The manufacturer may apply to the pharmaceutical inspectorate of any member state; if that inspectorate formally declines, it may go to another member state (Rules, para. 9). Inspections linked to a marketing authorisation are handled by the member state determined under the registration rules of Decision No. 78. According to the EEC, the 2022 edition allows the inspection to run in parallel with filing the registration dossier. Inspection costs are borne by the inspected entity (para. 4).
Timelines
The inspection programme is sent no later than 10 working days before the inspection; a critical risk to health must be reported within 24 hours. Part I of the report is due within 30 calendar days after the inspection; the manufacturer has 60 calendar days to respond with corrective and preventive actions (CAPA); Part II follows within 30 calendar days of the response. The certificate is issued within 10 working days of the decision, and a refusal is notified within 10 working days (paras. 12, 16, 19, 23, 26, 27).
Certificate and grounds for refusal
The EAEU GMP certificate is valid for no more than 3 years from the end of the inspection and may be shortened on a risk basis. Certificate data are published in member-state databases and the Union's integrated information system, and suspensions are reported to the other member states and the EEC. Unresolved critical or major deficiencies, a missing or late response, or obstruction of inspectors are grounds for refusal. Remote inspection is allowed only in special cases such as emergencies, epidemic threats or danger to inspectors, with the site's geolocation confirmed; an on-site inspection is arranged once restrictions end.
The transition is over
According to the EEC, since 2022 all member states have issued GMP certificates only under Union rules; national documents could be used until they expired, which, given their 3-year validity, meant moving to the Union format by 31 December 2024. The EEC has stated that the Union does not unconditionally recognise GMP certificates issued by third countries, so a TİTCK GMP certificate alone does not replace an EAEU inspection.
2026 updates and preparation
EEC Council Decision No. 67 of 20 May 2026 renewed Annex 1 on sterile products: the main part applies 180 days after official publication, and some provisions that require significant modernisation apply after 1,095 days (three years). Decision No. 103 of 9 September 2026 added requirements for manufacturing high-tech medicinal products to the GMP Rules and entered into force on 28 October 2026. Practical steps for Turkish manufacturers: a gap analysis against the EAEU GMP Rules, an inspection budget, and a team ready for the 60-day CAPA window. CSC follows EAEU regulation; to request a quote, please use the Medicine Request Form on our website.
Source: EEC Council Decisions No. 77, 82, 83 and 91 of 3 November 2016; Decision No. 127 of 19 August 2022 (new edition of the Rules for Pharmaceutical Inspections; consolidated text at zakon.uchet.kz/rus/docs/H16EV000083); Decisions No. 67 of 20 May 2026 and No. 103 of 9 September 2026 (ppt.ru summaries); EEC news of 23.04.2021 (GMP transition), 19.08.2022 (new edition of the inspection rules) and 20.05.2026 (Annex 1 update), eec.eaeunion.org; EEC statement reported by Pharmvestnik, 06.07.2016.