Documents in force
| Document | Status | What matters for temperature |
|---|---|---|
| Federal Law No. 61-FZ of 12 April 2010 “On the Circulation of Medicines” | in force | the foundation: powers to approve storage and transportation rules |
| EAEU Good Distribution Practice Rules (EEC Council Decision No. 80 of 3 November 2016) | mandatory in Russia | qualification, initial mapping of premises before use (clause 39), control of conditions during transportation |
| EAEU Good Manufacturing Practice Rules (EEC Council Decision No. 77 of 3 November 2016, as amended 4 July 2023) | mandatory for manufacturers; from 1 March 2026, the sole basis for inspections in Russia | qualification of premises and equipment, control of storage conditions; root cause analysis of deviations and corrective actions (clauses 1.4 (xiv), 8.16–8.19) |
| Rules for Storage of Medicinal Products for Medical Use (Order of the Russian Ministry of Health No. 260n of 29 April 2025) | from 1 September 2025 to 1 September 2031 | default conditions +15…+25 °C and humidity not above 65 % (clause 17); daily monitoring with a logbook or an automated system; wholesalers place monitoring devices based on mapping results and repeat mapping (clause 18) |
| Good Pharmacy Practice Rules (Order of the Russian Ministry of Health No. 259n of 29 April 2025) | in force | temperature and humidity logbook in the pharmacy; no obligation to perform mapping |
| Guideline on Temperature Mapping of Storage Areas for Medicinal Products (EEC Board Recommendation No. 8 of 20 April 2026) | applies from 23 May 2026, advisory | detailed methodology: data loggers, grid, duration, analysis, report |
| OFS.1.1.0010 “Storage of Medicinal Products”, State Pharmacopoeia (Ministry of Health Order No. 377 of 20 July 2023) | in force | definitions of storage conditions: cold place, cool place, room temperature, dry place |
| Roszdravnadzor inspection checklists (Order No. 5803 of 2 December 2025) | apply from 21 March 2026 | questions used to inspect storage, including mapping at wholesalers |
| SanPiN 3.3686-21 “Sanitary and Epidemiological Requirements for the Prevention of Infectious Diseases” | in force until 1 September 2027 | transportation and storage conditions for immunobiological medicinal products (vaccines), cold chain, temperature indicators, emergency plan |
| Methodological Guidelines MU 3.3.2.3970-23 | in force | use of temperature monitoring equipment for vaccines at all levels of the cold chain |
| Federal Law No. 102-FZ of 26 June 2008 “On Ensuring the Uniformity of Measurements” | in force | type approval and verification of measuring instruments, FSIS Arshin |
Detailed reviews of individual documents: Roszdravnadzor inspection checklist, vaccine cold chain under SanPiN, requirements for pharmacies, computerized system validation.
Repealed documents
| Document | What happened | Replaced by |
|---|---|---|
| Ministry of Health Order No. 646n of 31 August 2016 “Rules of Good Practice for Storage and Transportation of Medicinal Products” | repealed from 31 May 2025 (Ministry of Health Order No. 191n of 11 April 2025) | EAEU GDP Rules (Decision No. 80) and Storage Rules No. 260n |
| Order of the Ministry of Health and Social Development No. 706n of 23 August 2010 “Rules for Storage of Medicinal Products” | repealed by Order No. 260n | Storage Rules No. 260n from 1 September 2025 |
| Ministry of Health Order No. 647n of 31 August 2016 (good pharmacy practice) | replaced | Good Pharmacy Practice Rules No. 259n |
| Order of the Russian Ministry of Industry and Trade No. 916 of 14 June 2013 “Good Manufacturing Practice Rules” (national GMP) | not applied from 1 March 2026; repealed by Order of the Russian Ministry of Industry and Trade No. 3093 of 25 June 2026 | EAEU GMP Rules (EEC Council Decision No. 77) |
Many websites and SOP templates still cite clause 22 of Order No. 646n as the basis for mapping. During inspections and audits such references look outdated: the current bases are clause 39 of the EAEU GDP Rules and clause 18 of Storage Rules No. 260n.
Who must do what
| Organization type | Mapping | Daily T and RH monitoring | Sensor placement based on mapping |
|---|---|---|---|
| Pharmaceutical manufacturer | yes | yes | yes, as part of GMP qualification |
| Wholesale distributor | yes (EAEU GDP, 260n) | yes | yes (260n, clause 18) |
| Pharmacy | not explicitly required | yes | recommended on the same logic |
| Healthcare facility | not explicitly required; for vaccines, SanPiN requirements apply | yes | recommended |
Pharmacopoeial storage conditions
| Label statement | Temperature | Comment |
|---|---|---|
| Store in a cold place / in a refrigerator | +2…+8 °C | per OFS.1.1.0010 |
| Store in a cool place | +8…+15 °C | a refrigerator may be used, except for products whose properties change below +8 °C |
| Store at room temperature | +15…+25 °C | up to +30 °C depending on climatic conditions |
| No storage conditions specified | +15…+25 °C, RH ≤ 65 % | Storage Rules No. 260n, clause 17 |
| Store in a dry place | RH ≤ 50 % | at room temperature, per OFS.1.1.0010 |
| Store in a freezer | per the manufacturer’s regulatory documentation | the specific range is stated in the product’s regulatory documentation |
Liability
Compliance with storage rules is part of the licensing requirements for pharmaceutical activities. A gross violation of licensing requirements entails liability under Part 4 of Article 14.1 of the Russian Code of Administrative Offenses: for legal entities, a fine of 100,000 to 200,000 RUB or administrative suspension of operations for up to 90 days. Lack of mapping at a wholesaler, or placing sensors without regard to mapping results, is one of the items on the inspection checklist.
International references
Russian and Eurasian documents are harmonized with international practice, so foreign sources are useful for methodological details. They are not legally binding in Russia and cannot serve as the basis either for an inspector’s requirement or for your own procedure: your SOPs should cite the acts in the tables above, and use these documents only to explain the methodology.
- EU Guidelines on Good Distribution Practice of medicinal products for human use (2013/C 343/01);
- WHO technical supplements to the model guidance for the storage and transport of time- and temperature-sensitive pharmaceutical products, including the supplement on temperature mapping of storage areas;
- ISPE Good Practice Guide on controlled temperature chamber mapping and monitoring;
- GAMP 5, for validation of computerized monitoring systems.
This material is for reference only. Before applying it, check the official texts on pravo.gov.ru and the EAEU legal information portal.
Frequently asked questions
Is Order 646n still in force in 2026?
No. Order No. 646n was repealed with effect from 31 May 2025 by Ministry of Health Order No. 191n. Storage and transportation requirements are now based on the EAEU GDP Rules and Storage Rules No. 260n.
What replaced Order 706n?
The Rules for Storage of Medicinal Products for Medical Use approved by Order of the Russian Ministry of Health No. 260n of 29 April 2025. They are in force from 1 September 2025 to 1 September 2031.
Is EEC Recommendation No. 8 on mapping mandatory?
Recommendations of the EEC Board are not legally binding. However, it is the official methodology, and both inspectors and auditors will compare your procedure against it. The obligation to perform mapping itself is established by mandatory acts: the EAEU GDP Rules and Rules No. 260n.
Does a pharmacy need temperature mapping?
There is no direct obligation: mapping requirements are addressed to manufacturers and wholesalers. A pharmacy must monitor temperature and humidity daily and keep a logbook.
What humidity is acceptable in a pharmaceutical warehouse?
Unless the manufacturer specifies otherwise, no more than 65 % under Rules No. 260n. For products labeled “store in a dry place”, no more than 50 % per OFS.1.1.0010.