Russia Pharmaceutical Licensing in 2026 — Production, Pharma Activity and Controlled Substances Compared
Pharmaceutical licensing in Russia is divided into three regimes, and each has its own regulator, its own logic, and its own personnel requirements. The cost of confusion is high: the wrong authority, the wrong application form, a missed requirement for a manager — and at best the application comes back, at worst it gets rejected. Let’s break down each regime against its primary source and compare them in a single table.
Three Government Decrees of the Russian Federation define the licensing architecture of the industry. Government Decree of 06.07.2012 No. 686 (hereinafter — Decree No. 686, as amended 25.12.2025) governs the production of medicines. Government Decree of 31.03.2022 No. 547 (hereinafter — Decree No. 547) covers pharmaceutical activity. Government Decree of 02.06.2022 No. 1007 (hereinafter — Decree No. 1007) establishes the rules for the circulation of narcotic drugs and psychotropic substances (N/PS) and their precursors. The latter two remain in effect until 1 September 2028.
Who Licenses What
The production of medicines for medical use is licensed by the Ministry of Industry and Trade of the Russian Federation (Minpromtorg). Rosselkhoznadzor is responsible for veterinary drugs. This allocation is set out in Decree No. 686.
Pharmaceutical activity is distributed across three bodies. Roszdravnadzor issues licenses to wholesale medicine distributors for medical use and to pharmacy organizations under federal executive authorities. The executive bodies of Russian Federation constituent entities (regional ministries of health and healthcare departments) license everyone else: pharmacies, medical organizations, and individual entrepreneurs. Rosselkhoznadzor covers the entire veterinary segment.
For N/PS, the scheme is the same: Roszdravnadzor handles wholesalers and pharmacies under federal jurisdiction, while regional executive bodies handle other legal entities.
Production of Medicines. GMP as the Central Requirement
The manufacturing license is more demanding than the other two. Its framework is built around Good Manufacturing Practice (GMP).
For medicinal products for medical use, GMP requirements are set by Decision of the EAEU Council dated 03.11.2016 No. 77 (EAEU GMP Rules). Compliance is verified through a pharmaceutical inspection, after which Minpromtorg issues both the license and a GMP certificate simultaneously. For veterinary drugs, national GMP rules apply.
The key personnel requirement concerns the Authorized Person of the Manufacturer (Authorized Person). They must be registered in the EAEU registry of authorized persons and employed under a formal contract with the manufacturer. Those responsible for production, labeling, and quality control must hold a relevant degree: pharmaceutical, chemical, biological, medical, or veterinary.
The application is submitted via the Gosuslugi portal. Required attachments include the list of medicines to be manufactured, information on dosage forms and types of pharmaceutical substances, and the Site Master File.
Review periods were updated by Government Decree of 25.12.2025 No. 2143.
| Situation | Period |
|---|---|
| Production of medicines for medical use (standard) | No more than 27 business days |
| Production of medicines for veterinary use (standard) | No more than 30 business days |
| Applicant declares more than 3 production sites | +10 business days |
| Certain work types at a single address (batch release, labeling, medical gases, etc.) | No more than 12 business days |
| Adding substance synthesis operations under items 9 and 10 of the schedule | No more than 15 business days |
The license is indefinite, but the manufacturer must undergo periodic compliance confirmation (PCC) under Federal Law No. 99-FZ of 04.05.2011 «On Licensing of Certain Activities» (hereinafter — Law No. 99-FZ). Medicine production is listed among activities subject to mandatory PCC (paragraph 16, part 1, article 12 of Law No. 99-FZ). The procedure runs every three years and must be initiated by the licensee itself through Gosuslugi. Missing the deadline results in license suspension.
Since December 2025, the licensing control framework has introduced risk-based categorization of manufacturers: from high risk (vaccine production, chemical synthesis of substances) to low. For high-risk facilities, Minpromtorg conducts a mandatory preventive visit once a year. Scheduled inspections have been abolished and replaced by preventive visits and remote monitoring via the «Inspector» mobile application.
Pharmaceutical Activity. Flexibility Instead of Rigid Barriers
A pharmaceutical activity license covers wholesale organizations, pharmacies (including veterinary ones), medical organizations dispensing drugs to patients, and individual entrepreneurs.
The key property requirement is having premises and equipment compliant with Good Pharmacy Practice (GPP) and EAEU Good Distribution Practice (EAEU GDP). Storage outsourcing is permitted for wholesale distributors of medicines for medical use: a warehouse of another licensee may be used under a contract of at least 12 months.
Personnel requirements apply to the organization’s employees, not to its head or individual entrepreneur. Previously, a pharmacy or wholesale company director was required to hold a pharmaceutical degree; today it is sufficient to have qualified staff on payroll.
The license is issued within no more than 15 business days. Amendments to the license registry take up to 10 business days.
Pharmaceutical activity is not subject to mandatory PCC under Law No. 99-FZ. Supervision of licensees is carried out through federal state control in the sphere of medicine circulation.
Controlled Substances Circulation. The High-Control Regime
N/PS licensing differs from the previous two regimes by requiring mandatory interagency coordination. The license will not be issued without a conclusion from the Ministry of Internal Affairs (MVD) confirming that employees with access to N/PS have no outstanding criminal convictions for medium-gravity, grave, or especially grave offences, or crimes related to illicit drug trafficking.
Personnel requirements are stricter. The organization’s management must include a specialist with additional professional training in N/PS circulation. Every employee working with narcotic analgesics or psychotropic substances undergoes a clearance procedure: a medical examination confirming no drug dependency or chronic alcoholism, an MVD background check, and a formal clearance order signed by the head of the organization.
Storage premises requirements depend on the facility category. Storage rules are set by Government Decree of 30.04.2022 No. 809 (effective until 01.09.2028) and define five categories.
| Category | Applies to | Security | Safe Requirements |
|---|---|---|---|
| 1st | Manufacturers, wholesalers, emergency and mobilization reserve warehouses | Rosgvardia (National Guard) or departmental security | Metal cabinet or racking in transport packaging |
| 2nd | Pharmacies with a 3-month (6-month for rural) stock; veterinary pharmacies with a 3-month stock | Rosgvardia or departmental security (where unavailable — licensed PSC) | Lockable safe or metal cabinet |
| 3rd | Medical and veterinary organizations with a 15-day stock (Schedule II) and 1-month stock (Schedule III); research organizations | Private Security Company (PSC) or Rosgvardia | Safe of at least burglary resistance grade 3; if under 1,000 kg — anchor-bolted to floor or wall |
| 4th | Medical and veterinary organizations with a 3-day stock; storage of unclaimed N/PS from relatives of deceased patients | PSC or Rosgvardia | Safe of at least grade 3; if under 1,000 kg — anchor-bolted |
| 5th | Separate subdivisions of medical organizations (feldsher-midwife stations — FAPs, outpatient clinics) dispensing narcotic medicines to the public; stock up to 1 month | Not required | Safe of at least grade 3 |
The review period for the application is no more than 15 business days after the MVD conclusion is received. The license is indefinite.
N/PS circulation is subject to PCC under Law No. 99-FZ (paragraph 18, part 1, article 12). Compliance confirmation runs every three years at the initiative of the licensee.
Comparative Table
| Parameter | Production of Medicines | Pharmaceutical Activity | N/PS Circulation |
|---|---|---|---|
| Primary regulation | Decree No. 686 (as amended 25.12.2025) | Decree No. 547 (as amended 06.11.2024) | Decree No. 1007 (as amended 13.06.2024) |
| Regulation valid until | Indefinite | 01.09.2028 | 01.09.2028 |
| Regulator (human medicines) | Minpromtorg | Roszdravnadzor / regional body | Roszdravnadzor / regional body |
| Regulator (veterinary medicines) | Rosselkhoznadzor | Rosselkhoznadzor | Rosselkhoznadzor |
| Standard license issuance period | 27 b.d. (human) / 30 b.d. (veterinary) | 15 b.d. | 15 b.d. after MVD conclusion |
| Expedited period | 12 b.d. (certain work types) | 10 b.d. (amendments) | — |
| License validity | Indefinite | Indefinite | Indefinite |
| Periodic compliance confirmation (PCC) | Every 3 years, mandatory | Not required | Every 3 years, mandatory |
| MVD requirement | No | No | Mandatory conclusion |
| Requirements for management | Authorized Person in EAEU registry | Professional degree required for employees only | Specialist with additional N/PS training |
| Scheduled inspections | Abolished; replaced by preventive visits and remote monitoring | Federal supervision in medicine circulation | N/PS circulation control |
| Primary standard | EAEU GMP (human) / RF GMP (veterinary) | EAEU GDP, Good Pharmacy Practice | Decree No. 809 (storage and security) |
| Storage outsourcing | Not permitted | Permitted for wholesalers (contract ≥ 12 months) | Not applicable |
What to Do
Identify which license you need. Manufacturing medicines — apply to Minpromtorg under Decree No. 686. Selling or dispensing finished drugs — apply for a pharmaceutical license under Decree No. 547. Working with morphine, ketamine, promedol, or other N/PS — obtain a license under Decree No. 1007 in parallel.
Set a PCC reminder in your calendar. Medicine manufacturers and N/PS license holders must independently initiate the procedure via Gosuslugi every three years. The regulator sends no reminders. Missing the deadline means suspension of operations.
Verify your staffing before submitting the application. Manufacturing requires a certified Authorized Person registered in the EAEU registry. For pharmaceutical activity, qualified employees on staff are sufficient — a manager without a pharmacy degree is formally acceptable. For N/PS, the management must include a specialist with additional training in drug circulation, and every employee with N/PS access must hold a formally documented clearance.
Request the MVD conclusion well in advance if you plan to work with N/PS. Background checks take time, and the 15-day review period only begins once the conclusion reaches the licensing authority.
Confirm the storage premises category for N/PS work. The required safe grade, security type, and the obligation to place premises under guard at the end of each working day all follow from the category. Category 5 premises (FAPs and equivalent separate subdivisions) require no security guard, but a grade 3 safe is still mandatory.
Pharmaceutical licensing in Russia has become digital, indefinite, and for most entities noticeably more accessible. One dividing line remains: whether you work with substances from the N/PS schedules. If you do, any inaccuracy in personnel records or storage security is treated as a serious violation — with potential criminal consequences.
Regulatory Framework:
1. Decision of the Council of the Eurasian Economic Commission of 03.11.2016 No. 77 «On Approval of the Good Manufacturing Practice Rules of the Eurasian Economic Union»
2. Decree of the Government of the Russian Federation of 06.07.2012 No. 686 «On Approval of the Regulations on Licensing of Medicines Production» (as amended 25.12.2025, amended by Decree No. 2143)
3. Decree of the Government of the Russian Federation of 31.03.2022 No. 547 «On Approval of the Regulations on Licensing of Pharmaceutical Activity» (as amended 06.11.2024)
4. Decree of the Government of the Russian Federation of 02.06.2022 No. 1007 «On Licensing of Activities Related to the Circulation of Narcotic Drugs, Psychotropic Substances and Their Precursors, and the Cultivation of Narcotic-Containing Plants» (as amended 13.06.2024)
5. Decree of the Government of the Russian Federation of 30.04.2022 No. 809 «On the Storage of Narcotic Drugs, Psychotropic Substances and Their Precursors» (effective until 01.09.2028)
6. Federal Law of 04.05.2011 No. 99-FZ «On Licensing of Certain Activities»
7. Federal Law of 12.04.2010 No. 61-FZ «On the Circulation of Medicines»
8. Federal Law of 08.01.1998 No. 3-FZ «On Narcotic Drugs and Psychotropic Substances»