Russia moved narcotics licensing from FSKN to the MIA in 2016. The paperwork behind it multiplied
Companies often search the Roszdravnadzor registry for a single license and find no mention of the Ministry of Internal Affairs (MIA) anywhere in it. That creates confusion: it looks as if the police agency simply signs off on paperwork somewhere behind the scenes. In reality, the MIA issues two separate clearances, and without them Roszdravnadzor will not even accept the application for review.
The term «double licensing» appears in no regulatory legal act. It is professional jargon that grew out of practice. Legally, a single license is issued. Its issuance is preceded by two documents from the MIA, each governed by its own rules: one for the premises, the other for specific employees. Confusing these documents or getting the order of obtaining them wrong is a common reason applications get rejected.
How the Control System Looked Before 2016
Until April 2016, the function of controlling the circulation of narcotic drugs and psychotropic substances (hereinafter, ND and PS) belonged to the Federal Drug Control Service of the Russian Federation (FSKN). Presidential Decree No. 156 of April 5, 2016 abolished the FSKN. Its staff and authority were transferred to the Ministry of Internal Affairs. Inside the MIA, a Main Directorate for Drug Control was created, inheriting the FSKN’s former territorial units.
The rules on licensing, storage, and personnel clearance were not rewritten immediately after the transfer. Companies kept working under acts adopted back under the FSKN: Government Decree No. 1085 of December 22, 2011 on licensing, Decree No. 1148 of December 31, 2009 on storage, and Ministry of Health Order No. 484n of July 24, 2015 on special requirements for storing narcotic and psychotropic dosage forms. The MIA’s administrative regulation for issuing facility-compliance clearances appeared separately from the wider reform, back in 2017, and replaced the FSKN’s earlier regulation.
The main package of acts was updated only during the so-called «regulatory guillotine» of 2021-2022. The government replaced five documents with new editions. The MIA’s facility regulation was untouched: MIA Order No. 495 of July 21, 2017 remains in force because it rests on the statutory requirement for an internal affairs clearance set out in Article 8 of Federal Law No. 3-FZ of January 8, 1998, «On Narcotic Drugs and Psychotropic Substances» (hereinafter, FL No. 3-FZ). The reform never touched that underlying provision, so the old regulation stayed active even after every decree connected to it was replaced.
Which Acts Are in Force Now
| Area of regulation | In force before the reform | In force now |
|---|---|---|
| Circulation licensing | RF Government Decree No. 1085 of Dec 22, 2011 | RF Government Decree No. 1007 of Jun 2, 2022 |
| Storage of ND and PS | RF Government Decree No. 1148 of Dec 31, 2009 | RF Government Decree No. 809 of Apr 30, 2022 |
| Personnel clearance | RF Government Decree No. 892 | RF Government Decree No. 911 of May 20, 2022 |
| Special drug storage requirements | Ministry of Health Order No. 484n of Jul 24, 2015 | Ministry of Health Order No. 1103n of Nov 26, 2021 |
| Narcological status certificate | Ministry of Health Order No. 988n of Dec 22, 2016 | Ministry of Health Order No. 303n of May 4, 2022 |
| MIA facility clearance | MIA Order No. 495 of Jul 21, 2017 | Same order, not replaced |
Government Decree No. 1007 of June 2, 2022, «On Licensing Activities for the Circulation of Narcotic Drugs, Psychotropic Substances and Their Precursors, and the Cultivation of Narcotic-Containing Plants,» is in force from September 1, 2022 through September 1, 2028. The licensing authority for wholesale trade organizations, federal pharmacy organizations, and circulation of Schedule I precursors is Roszdravnadzor. For most medical organizations, licenses are issued by the executive authorities of Russia’s constituent regions, which hold the delegated power.
Among the licensing requirements in Paragraph 5 of the Regulation approved by Decree No. 1007 is a direct reference to the procedure for clearing individuals to work with ND and PS, established by the government under Article 8 of FL No. 3-FZ. That procedure is set out in a separate act, Government Decree No. 911 of May 20, 2022, «On Clearing Individuals to Work with Narcotic Drugs and Psychotropic Substances.» Without meeting the requirements of Decree No. 911, filing a license application is technically impossible: the corresponding fields of the electronic application on the Gosuslugi portal simply stay blank.
The application specifies not only the types of work but also the specific names of ND, PS, and precursors for a number of items in the list of works and services in the annex to the Regulation (Paragraphs 2, 3, 15, 16, 27, 28, 43, and 44). If a company plans to add substances to that list after the license is already issued, it files an application to amend the license register. A new license is not required for that.
Changing the address of operations triggers almost the same procedure as obtaining a license for the first time: a simple notice to the regulator is not enough. The licensee files an application to amend the license register, stating the new address. Because this involves a new facility, a new MIA clearance confirming the premises meet engineering and technical requirements is required: the old clearance covers the previous address and does not extend to the new site. The list of cleared employees usually carries over without re-verification, provided the staff composition has not changed.
Two MIA Clearances Instead of One
The first clearance concerns the facility. Article 8 of FL No. 3-FZ requires a clearance from internal affairs authorities confirming that the premises meet the established requirements for engineering and technical security equipment. The procedure for obtaining it is set out in the administrative regulation under MIA Order No. 495 of July 21, 2017. The applicant files an application with the drug-control unit of the MIA’s territorial body at the facility’s location: in person, by mail, or through the Gosuslugi portal.
The service takes no more than 21 business days from the date the application is registered. Of that, up to 17 business days go to the on-site inspection of the premises and drafting the inspection report, and a few more days go to preparing and signing the clearance itself. The final document is sent to the applicant within 3 business days of signing. The application is processed free of charge; no state fee applies.
The MIA notifies the organization of the date, place, and time of the on-site inspection no later than 3 business days in advance. That is usually not enough time to install an alarm system or replace a safe, so the facility is prepared well before the application is filed. The MIA’s regulation provides only for an in-person inspection with officers visiting the site; it offers no remote option.
The second clearance concerns personnel. The employer draws up a list of employees who need access to ND and PS for their job duties and sends a request to the MIA’s territorial body. An employee cannot apply for this clearance directly; the procedure runs only through the employer. The MIA checks each employee for an outstanding or unexpunged criminal record for a crime of medium gravity, a grave crime, or an especially grave crime, or for any crime related to illegal drug trafficking, including crimes committed outside Russia. That wording is taken verbatim from Article 8 of FL No. 3-FZ and applies without any time-based exception for the individual.
Alongside the criminal-record check, a certificate is required from a state or municipal healthcare organization confirming the employee has no drug addiction, substance abuse, or chronic alcoholism. The procedure for issuing that certificate is set by Ministry of Health Order No. 303n of May 4, 2022, which replaced the earlier Order No. 988n of December 22, 2016. The two checks run independently of each other, and both are mandatory: the narcologist’s certificate does not substitute for the MIA clearance, and vice versa. When an employee leaves or a new person is hired for a position with access to ND and PS, both procedures are repeated from scratch for that specific worker.
Five Categories of Storage Premises
Government Decree No. 809 of April 30, 2022 divides all ND and PS storage premises into five categories. Safe and security requirements depend on the category, so getting the category wrong at the design stage leads either to unnecessary expense or to a denied MIA clearance.
| Category | Who it covers | Stock limit | Safe requirement | Security |
|---|---|---|---|---|
| 1 | Manufacturers, producers, wholesale trade, processing, emergency and mobilization reserves | Not capped | Lockable safe or metal cabinet | Rosgvardia or departmental security |
| 2 | Pharmacy organizations, veterinary pharmacies | 3 months (6 months for rural and remote pharmacies) | Lockable safe or metal cabinet | Rosgvardia or departmental security; a private security organization is allowed only where these are unavailable locally |
| 3 | Medical and veterinary organizations, retail dispensing to individuals, scientific and educational organizations | 15 days for Schedule II, one month for Schedule III | Safe rated at least burglary-resistance class 3 | Rosgvardia, departmental security, or a private security organization |
| 4 | Medical and veterinary organizations, ND surrendered by relatives of the deceased | 3 days | Safe rated at least burglary-resistance class 3 | Rosgvardia, departmental security, or a private security organization |
| 5 | Standalone subdivisions of medical organizations with retail dispensing to individuals | One month | Safe rated at least burglary-resistance class 3 | Mandatory security is not required |
Actual practice diverges from common assumptions in three places here. Safe requirements run counter to intuition: Categories 1 and 2, which hold the largest volumes, get by with an ordinary lockable safe or metal cabinet with no burglary-resistance class specified. They are guarded by Rosgvardia or departmental security: the law allows a private security organization (hereinafter, PSO) only as an exception for Category 2, and only where a locality has neither a Rosgvardia unit nor departmental security. Category 1 has no such exception at all.
Stricter safe requirements apply to Categories 3, 4, and 5: they must use a safe rated at least burglary-resistance class 3. A safe weighing under 1,000 kilograms must also be anchored to the floor or wall with bolts.
The decree gives Category 4 a three-day stock limit. In practice it is often confused with a daily limit, though the daily limit belongs to a separate concept: temporary storage points. These are nursing stations, prescription-department pharmacist workstations, and similar spots, where the decision to set one up is made by the head of the organization through an internal order, already in the course of daily work. Safe requirements for temporary storage points are lower than for Category 4: a safe rated at least burglary-resistance class 1, or a metal container, is enough.
Category 5 is the only one where the law explicitly exempts the organization from having to contract with a security provider. Formally, this covers any standalone subdivision with retail dispensing to individuals and a one-month stock. In practice, rural feldsher-obstetric posts most often fall into this category, since they sit far from private-security patrol routes.
Engineering and technical requirements for the premises themselves, the walls, doors, and alarm systems, are set by a separate act, Government Decree No. 1035 of December 17, 2010, which Decree No. 809 merely references. The document was adopted well before the 2022 reform and continues to apply unchanged, so project documentation should cite it directly.
What Most Often Goes Wrong
The application for an MIA facility clearance is often filed before the premises are actually ready: the alarm is not installed, the security contract is not signed, or the safe does not match the burglary-resistance class required for the chosen category. The inspection outcome in that case is predictable, and refiling restarts the 21-business-day clock.
A second common scenario: a company obtains the MIA facility clearance and forgets that the list of cleared employees needs its own paperwork, updated with every staff change. A facility clearance does not cover a new employee hired six months after the warehouse opens.
A third mistake involves the wrong licensing authority. Wholesale trade organizations and federal pharmacy organizations file with Roszdravnadzor, while most medical organizations deal with their regional executive authority. Filing with the wrong authority does not save time. The application is returned, and the clock only starts once it is filed with the right one.
A fourth mistake shows up when a warehouse or pharmacy point relocates. Companies often assume that notifying the licensing authority of the new address is enough, and carry the existing MIA clearance over to the new site without an inspection. A clearance is tied to a specific premises and its engineering setup, so a new address needs a fresh inspection and a new clearance from scratch, even for a move across town.
Action Plan
Determine the premises category before design work starts. Check the organization’s actual activity profile and planned drug stock against Paragraphs 5-9 of the Storage Rules approved by Decree No. 809. The safe choice and security setup depend on this, and retrofitting later costs significantly more.
File the MIA facility-clearance application early. The service takes up to 21 business days, 17 of which go to the on-site inspection. Plan for this at least a month before the intended date of the license application.
Run the personnel check at the same time as the facility clearance. The MIA request for a criminal-record check and the narcologist’s certificate request to a state or municipal healthcare organization can both be sent right away, without waiting for the facility result first.
Gather both results before filing with Roszdravnadzor or the regional authority. The application is filed through the Gosuslugi portal using an enhanced qualified electronic signature. The license decision takes 8 business days, rising to 20 business days for activity within a closed administrative-territorial formation.
Set up the specialized operations logs right after getting the license. The procedure for keeping these logs, including in electronic form with an enhanced qualified electronic signature, is set by Government Decree No. 2117 of November 30, 2021. Not having a log at the time of the first inspection counts as a serious violation of licensing requirements.
A violation of ND and PS handling rules that results in their loss constitutes an offense under Article 228.2 of the Criminal Code of the Russian Federation. Liability falls on the head of the organization or an official designated by internal order as responsible for storage. Both MIA clearances are best understood as part of an ongoing control system that determines who gets access to controlled substances and under what conditions, and that keeps working for as long as the license remains valid.
Regulatory Framework
1. Article 228.2 of the Criminal Code of the Russian Federation
2. Federal Law No. 3-FZ of January 8, 1998, «On Narcotic Drugs and Psychotropic Substances»
3. Government Decree No. 1007 of June 2, 2022, «On Licensing Activities for the Circulation of Narcotic Drugs, Psychotropic Substances and Their Precursors, and the Cultivation of Narcotic-Containing Plants»
4. Government Decree No. 809 of April 30, 2022, «On the Storage of Narcotic Drugs, Psychotropic Substances and Their Precursors»
5. Government Decree No. 911 of May 20, 2022, «On Clearing Individuals to Work with Narcotic Drugs and Psychotropic Substances»
6. Government Decree No. 1035 of December 17, 2010, «On the Procedure for Establishing Requirements for Equipping Facilities and Premises with Engineering and Technical Security Equipment»
7. Government Decree No. 2117 of November 30, 2021, «On the Procedure for Submitting Information on Activities Related to the Circulation of Narcotic Drugs and Psychotropic Substances»
8. MIA Order No. 495 of July 21, 2017, «On Approving the Administrative Regulation … for Issuing Facility and Premises Compliance Clearances»
9. Ministry of Health Order No. 303n of May 4, 2022, «On Approving the Procedure for Issuing Certificates of the Absence of Drug Addiction, Substance Abuse, or Chronic Alcoholism in Employees»
10. Ministry of Health Order No. 1103n of November 26, 2021, «On Approving Special Requirements for the Storage Conditions of Narcotic and Psychotropic Medicines»
11. Presidential Decree No. 156 of April 5, 2016, «On Improving Public Administration in the Area of Control Over the Circulation of Narcotic Drugs, Psychotropic Substances and Their Precursors, and in the Area of Migration»