Roszdravnadzor Updated Its Warehouse Checklist Twice in Six Months. Here Is What Your SOPs Need to Match
In 2026, a Roszdravnadzor inspector does not gauge whether a warehouse is in order «by eye.» They open the approved checklist and verify every point against the wording of a specific regulatory order. A warehouse whose standard operating procedures (SOPs) were written three years ago under Order No. 646n is no longer answering the questions the inspector actually asks.
Since March 21, 2026, new checklist forms have been in effect, approved by Roszdravnadzor Order No. 5803 dated December 2, 2025. The document has already changed once: on June 1, 2026, the first amendment was introduced under Order No. 483, registered with the Ministry of Justice on July 1, 2026. This is a living inspection tool that changes faster than most warehouses can update their quality documents.
How Warehouses Were Inspected Before 2025
For a long time, Ministry of Health Order No. 646n served as the foundation for the document package. Inspectors worked from the checklist approved by Roszdravnadzor Order No. 8700 dated September 16, 2022. The logic of the inspection was built around the presence of documents and general storage requirements, without a rigid link between each checklist question and a specific clause of the rules.
Under this logic, standard operating procedures were often written once, at the time of licensing, and went unreviewed for years. As long as the underlying regulatory acts stayed the same, this worked. As soon as the foundation changed, outdated wording became an inspection risk.
What Order No. 260n and the New Checklists Have Brought
Since September 1, 2025, rules for the storage of medicinal products have been in effect, approved by Ministry of Health of Russia Order No. 260n dated April 29, 2025. It works together with Council of the Eurasian Economic Commission (EEC) Decision No. 80 dated November 3, 2016, which sets out the rules of Good Distribution Practice (GDP) for a warehouse as a participant in the supply chain.
Order No. 260n established several specific requirements that are checked on-site immediately:
Minimum storage area: the storage premises of a wholesale distributor must total at least 150 sq. m, excluding administrative and utility areas;
No floor storage: placing medicinal products directly on the floor without a pallet is prohibited; pallets are allowed in a single row on the floor or in multiple tiers on racks, but not stacked without rack structures;
Standard storage conditions: unless the manufacturer specifies otherwise, standard conditions mean a temperature of +15°C to +25°C and humidity of no more than 65%;
Reception control: reception control now includes verifying product data in the state system for monitoring the movement of medicinal products for medical use, known under the brand name «Chestny Znak»;
Co-storage with other goods: co-storage of medicinal products with other pharmacy assortment goods is permitted, provided they are identified and cross-contamination is prevented;
WMS instead of physical zoning: physical zoning of the warehouse can be replaced by a validated computerized warehouse management system (WMS), provided it delivers the required level of data security.
The new checklist (Order No. 5803, registered with the Ministry of Justice on March 10, 2026, under No. 85580) contains a separate appendix on the storage of medicinal products with no fewer than 138 control questions, and a separate appendix on transportation. Every question refers to a specific clause of Order No. 260n or Decision No. 80. For example, the question on the pest control prevention program refers directly to Clause 36 of EEC Decision No. 80, a topic the checklist did not single out before.
| Parameter | Before September 2025 | Since 2026 |
|---|---|---|
| Primary regulatory act on storage | Order No. 646n | Order No. 260n dated April 29, 2025 |
| Inspector’s checklist | Roszdravnadzor Order No. 8700 dated September 16, 2022 | Roszdravnadzor Order No. 5803 dated December 2, 2025 (in effect since March 21, 2026), amendment No. 483 registered July 1, 2026 |
| Co-storage with pharmacy goods | Not addressed as a separate clause | Explicitly permitted subject to identification and protection from contamination (Clause 23 of Order No. 260n) |
| Pest control program | Part of general sanitary requirements | A separate checklist question, referencing Clause 36 of EEC Decision No. 80 |
How the Warehouse Document Package Is Structured
There is no single legally mandated figure for exactly how many SOPs a warehouse needs. EEC Decision No. 80 lays out a nine-section functional structure for a distributor’s quality system, and the document package is built on top of it. The number of SOPs themselves depends on the warehouse’s scale and product range, but each block below has to be covered by at least one document.
| Block | What It Covers | Regulatory Basis |
|---|---|---|
| Quality and document management | SOP for developing and revising SOPs, records management, quality risk management, self-inspection, quality manual | Decision No. 80, Sections 1, 4, and 8 |
| Personnel | Training, personal hygiene, evaluation of the responsible person, job descriptions | Decision No. 80, Section 2 |
| Premises and equipment | Zoning, instrument calibration, temperature monitoring, computerized systems, equipment qualification and validation | Decision No. 80, Section 3; Order No. 260n, Clauses 9-14 |
| Operational processes | Reception, storage/placement, sampling, preparation for shipment, delivery, export | Decision No. 80, Section 5; Order No. 260n, Clauses 24-25 |
| Special product groups | Temperature-sensitive, flammable, staining and odorous substances, quantity-tracked substances | Order No. 260n, Chapter IV |
| Complaints, returns, recalls | Handling falsified products, returns, batch recalls from circulation | Decision No. 80, Section 6 |
| Outsourcing and transportation | Evaluation of contractors, transportation, in-transit temperature monitoring | Decision No. 80, Sections 7 and 9 |
| Sanitary regime | Cleaning, disinfection, pest control | Decision No. 80, Clauses 35-37 |
Action Plan
Compare your current SOPs against the new checklist. Take the storage appendix of Order No. 5803 and go through it clause by clause, noting which document backs up each answer.
Update the reception and storage SOPs for Order No. 260n. Add verification against the «Chestny Znak» tracking system and the pallet storage rule, if they are not already in the text.
Add a pest control program as a standalone document. The checklist now asks about it directly, referencing Clause 36 of Decision No. 80.
Check for references to outdated acts. Replace mentions of Order No. 646n and Order No. 8700 with Order No. 260n and Order No. 5803 everywhere they appear in your procedures.
Keep a log of checklist validity. Track the order number, Ministry of Justice registration date, and effective date, so you don’t miss the next revision, the way amendment No. 483 landed in mid-2026.
A warehouse’s document package is no longer something you close out once, when you get the license. The checklist changes more often than before, and every amendment turns straight into a specific question from the inspector. A company that keeps its SOPs in sync with the current version of Order No. 260n and the current checklist gets through an inspection without surprises. A company still working off three-year-old documents risks a non-compliance notice for a clause it didn’t even know existed.
Regulatory Framework:
1. Federal Law No. 61-FZ dated April 12, 2010, «On the Circulation of Medicinal Products» (Articles 33, 55, 57, 58)
2. Ministry of Health of Russia Order No. 260n dated April 29, 2025, «On Approval of the Rules for the Storage of Medicinal Products for Medical Use»
3. Council of the Eurasian Economic Commission Decision No. 80 dated November 3, 2016, «On Approval of the Rules of Good Distribution Practice within the Eurasian Economic Union»
4. Roszdravnadzor Order No. 5803 dated December 2, 2025, «On Approval of Checklist Forms… in the Field of Circulation of Medicinal Products for Medical Use»
5. Roszdravnadzor Order No. 483 dated June 1, 2026, «On Amending Order… No. 5803»