Staff Clearance for Handling Precursors: Requirements and Liability

The circulation of precursors in Ukraine is a licensed activity subject to strict state control. For pharmaceutical companies, chemical manufacturers, and other business entities, compliance with licensing conditions depends directly on properly organized personnel operations.

HR matters, including the appointment of responsible persons, staff clearance for handling narcotics and precursors, maintenance of accounting records, and internal controls, are among the key areas reviewed during inspections by the State Service of Ukraine on Medicines and Drugs Control.

The legal framework is governed, in particular, by Law of Ukraine No. 60/95-VR “On Narcotic Drugs, Psychotropic Substances and Precursors” and the Licensing Conditions approved by Resolution of the Cabinet of Ministers of Ukraine No. 282 of 2016.

How to Obtain Staff Clearance to Work with Precursors

Who determines which responsible persons are authorized to work with controlled substances? The appointment of responsible persons and the authorization of employees to work with precursors are carried out exclusively by the head of the business entity. These decisions must be formalized through the company’s internal organizational and administrative documents, primarily an Order Authorizing Employees to Work with Precursors.

A sample Order Authorizing Employees to Work with Precursors can be downloaded here.

These documents define the specific employees authorized to maintain precursor records and perform operations involving them, from receiving and storing the substances to their direct use in the production process or disposal.

Please note! Generalized descriptions, such as “pharmaceutical personnel,” are not sufficient. The order must identify specific employees by stating their positions and full names. For example: chemist, [full name]; warehouse manager, [full name].

If the company expands its staff or there is a change in the responsible employee, the order must be updated or a new one must be issued before the new employee begins working with precursors. Allowing an employee to work with precursors during a “probationary period” without a formal authorization order may, during an inspection, be treated as unauthorized access by an unauthorized person to controlled substances.

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Personnel Requirements: Education and Qualifications

Employees authorized to work with precursors must meet the applicable qualification requirements and comply with the company’s internal procedures. In addition to understanding the rules for storage and record-keeping, the general requirements include:

• Relevant professional education. Depending on the nature of the activity, employees may be required to have a pharmaceutical, medical, chemical, or biological education. The diploma must be officially recognized, and foreign qualifications must undergo the recognition procedure in Ukraine where required.
• Completion of internal training and safety instruction. Employees must receive training on occupational safety, the handling of chemically active and controlled substances, and emergency response procedures.
• Acknowledgment of job descriptions and internal orders. Each employee should sign an acknowledgment confirming that they understand their duties and the scope of their responsibilities.
• No unexpunged or outstanding criminal conviction for offenses related to the illicit trafficking of narcotic drugs, psychotropic substances, or precursors, as well as a valid medical certificate in Form No. 100-2/o confirming completion of the psychiatric examination required by Ukrainian law.

Specific staffing requirements apply to precursor manufacturing activities (List No. 2, Table IV of the Schedule):

• At least 25% of the personnel must have a higher education degree (bachelor’s or master’s level).
• Employees’ educational backgrounds must correspond to the company’s technological profile, for example, Chemical Technologies and Engineering, Pharmacy and Industrial Pharmacy, Chemistry, Biology.
• Requirements must also be determined with regard to the applicable production regulations.

These requirements help ensure proper control over the handling and circulation of precursors within the company.

Job Responsibilities and Functions of the Person Responsible for Precursor Record Keeping

The responsible person is a key element of the internal control system for precursor handling and is appointed by an order issued by the head of the company.

Key Functions of the Responsible Person

Under the applicable licensing conditions, the responsible person is assigned the following functions:

• maintaining and monitoring record-keeping documentation;
• organizing internal control procedures;
• participating in inventory checks;
• coordinating the work of personnel;
• liaising with regulatory authorities.

During an inspection by the State Service of Ukraine on Medicines and Drugs Control, the responsible person provides access to the documentation, explains the record-keeping procedures, and, together with the head of the company, confirms compliance with the licensing conditions.

Documents Required for Staff Clearance to Work with Controlled Substances

As mentioned above, employees may be authorized to work with narcotic drugs and precursors only based on an order issued by the head of the company. However, significant preparatory work must be completed before such an order is issued.

Including an employee in the order without proper supporting documentation creates a risk of violating the licensing conditions. Information about the order authorizing employees to work with precursors is also included in the documents submitted when applying for a license.

The mandatory document package for authorizing an employee includes:

1. Certificate confirming completion of a psychiatric examination (Form No. 100-2/o). The employee must have a valid document confirming completion of the mandatory psychiatric examination in accordance with applicable legislation.
2. Criminal record certificate. Official confirmation issued by the National Police of Ukraine in the form of an extract from the information and analytical system “Records of Information on Criminal Prosecution of a Person and Criminal Convictions,” confirming that the employee has no unexpunged or outstanding conviction for offenses related to the illegal trafficking of narcotic drugs, psychotropic substances, or precursors.
3. Education document. A copy of the diploma confirming the qualifications required to perform the relevant type of work.
4. Job description. A document clearly defining the employee’s rights, duties, and functions related to the handling of precursors, signed by the employee.

Before starting work, the employee must undergo mandatory instruction covering record-keeping, substance storage, and internal control procedures. All training and instruction must be recorded in a designated log and confirmed by the signatures of both the employee and the person who conducted the instruction.

Please note! Proper preparation of internal orders is critical during inspections, particularly when confirming that employees have lawful access to controlled substances. To avoid common mistakes in preparing internal documentation, we recommend obtaining professional legal assistance.

Specifics of Personnel Responsibilities: Record Keeping, Storage, and Internal Control

Working with precursors requires an established system of record-keeping, storage, and internal control. See more details in the table below:

Risks and Liability for Violating Licensing Conditions

Violations of legal requirements governing the handling of precursors can have serious consequences for a company, ranging from financial losses to the complete loss of its ability to operate in the market. The State Service of Ukraine on Medicines and Drugs Control pays particular attention to personnel-related compliance, as the human factor is often the main source of precursor diversion into illegal circulation.

Typical violations involving documentation and personnel include:

• failure to issue or improper preparation of such orders;
• improper maintenance of record-keeping logs;
• actual access granted to unauthorized persons (not included in the list approved by the order);
• violations of precursor storage requirements;
• failure to establish an internal control system.

Possible consequences for the company and its management include:

• orders or instructions issued by regulatory authorities;
• administrative fines;
• suspension of the license;
• revocation of the license.

Please note! When applying for a license, the order authorizing employees to work with precursors must be specified, together with its details, in the prescribed licensing information. It is therefore important to ensure that the order reflects the employees’ actual duties and activities. Any discrepancy between the information submitted to the State Service of Ukraine on Medicines and Drugs Control when obtaining the license and what an inspector finds at the company during an inspection may be considered the submission of inaccurate information.

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Legal Assistance with Obtaining a License for Precursors and Narcotic Drugs

Obtaining and maintaining a license for precursors requires comprehensive preparation of the company. Preparing orders, job descriptions, and internal control procedures independently often leads to errors that inspectors may identify during the first inspection. Our company provides full-cycle support to prepare your business to operate in compliance with legal requirements.

We assist businesses with:

• preparing the document package for obtaining a license;
• minimizing the risk of violations;
• responding to requirements issued by regulatory authorities.

Do you need professional assistance with obtaining a license for precursors and preparing the required supporting documentation? Choose the cooperation format that suits you, from a consultation to full legal support, and we will help ensure compliance with all licensing requirements.

Learn more about obtaining a license for precursors with our assistance here.