Licensing of the production of medicinal products in Ukraine

Licensing of the production of medicinal products is the process of obtaining a permit from the state for a business entity to carry out activities related to the production of medicinal products. Such activities are high-risk and require strict control both from the state and internal supervision of compliance with product quality and safety standards.

In Ukraine, the production of medicinal products is regulated by a number of regulatory legal acts, the main of which is the Law of Ukraine “On Licensing of Types of Economic Activities”. This Law provides that pharmaceutical production is an activity subject to mandatory licensing.

Legislative regulation of licensing

The main regulatory legal acts that regulate the licensing of the production of medicinal products are:

• The Law of Ukraine “On Medicinal Products”;
• The Law of Ukraine “On Licensing Types of Economic Activities”;
• Licensing conditions for conducting economic activities in the production of medicinal products (approved by Resolution of the Cabinet of Ministers of Ukraine No. 929 of 30.11.2016);
• Orders of the Ministry of Health of Ukraine regulating specifications for production requirements.

In addition, compliance with the principles of good manufacturing practice (GMP – Good Manufacturing Practice), which are implemented in Ukraine in accordance with European standards, is mandatory.

Who has the right to obtain a license?

Both legal entities and individual entrepreneurs who have:

1. appropriate material and technical base for the production of medicinal products;
2. staff of qualified employees (responsible persons with appropriate education and experience);
3. documents confirming compliance of premises and equipment with GMP requirements;
4. product quality control system;
5. internal documentation confirming compliance with technological processes.

License obtaining procedure

• Document preparation

The package of documents for obtaining a license includes:

1. application for a license;
2. production site dossier;
3. power of attorney (in case of submission of documents not by the head of a legal entity);
4. confirmation of the absence of control over the activities of the business entity by the aggressor state.

• Submission of documents

Documents are submitted to the relevant licensing authority – the State Service of Ukraine for Medicines and Drug Control. Submission can be made both in paper and electronic form.

• Verification and decision-making

The licensing authority considers the documents within 10 working days. If necessary, an on-site inspection of production facilities may be carried out. If everything meets the requirements, a decision is made to issue a license. Otherwise, a reasoned refusal is sent to the applicant.

• Obtaining a license

After a positive decision is made, the business entity receives a license in electronic form, which is valid indefinitely, provided that the license conditions are met.

How much does it cost to obtain a license to manufacture medicines?

The application for a license itself is free of charge. However, the business entity should take into account a number of costs that accompany the licensing process:

Implementation of GMP (Good Manufacturing Practice) is one of the most costly parts, which includes the reconstruction or construction of premises, the purchase of specialized equipment, and the automation of production processes. The total amount of investment depends on the scale of production, but can range from 500,000 to several million hryvnias.

• Consulting and legal services are support from specialists for the development of documentation, passing inspections, and training personnel. The cost of such services is from 50,000 to 150,000 UAH and more.
• Personnel training and certification – including training of a responsible person in good manufacturing practices. Training courses and certificates cost an average of 10,000 to 30,000 UAH.
• Preparation of documents and internal policies – costs for preparing SOPs (standard operating procedures), forms, instructions, protocols.
• Rent or purchase of premises, their repair and modernization in accordance with the requirements.

Thus, the total costs for preparing and obtaining a license from scratch can be from 800,000 to 5,000,000 UAH and more, depending on production volumes, existing base and scale of the project.

GMP requirements – the key to successful licensing

One of the most important conditions for obtaining a license is compliance with Good Manufacturing Practice (GMP) standards. These are internationally recognized requirements that relate to:

• location and organization of production facilities;
• cleaning and disinfection of equipment;
• storage of raw materials and finished products;
• control at each stage of production;
• documentation;
• personnel (training, qualification, medical control).

A GMP certificate is issued after an inspection by an authorized body. Without it, it is impossible to obtain a license to manufacture medicinal products.

Control and responsibility

The licensing authority has the right to conduct scheduled and unscheduled inspections of production for compliance with license conditions. In case of violation of license conditions, it is possible to:

1. issue an order to eliminate violations;
2. suspend the license;
3. cancel the license;
4. bring to administrative or even criminal liability (in case of serious violations that may harm the health of citizens).

Features for foreign companies

Foreign companies wishing to manufacture medicines in Ukraine must comply with the same requirements as Ukrainian ones. If production will be carried out on the territory of Ukraine, a license must be obtained in accordance with Ukrainian legislation. If it is a question of importing products, then the medicine must be registered and certified in Ukraine.

The process of licensing the production of medicines in Ukraine is a complex, costly, but necessary step to ensure the quality and safety of pharmaceutical products. Successful completion of this procedure opens up new opportunities for business, including entering international markets and participating in government funding programs.

To effectively complete the procedure, it is recommended to seek help from lawyers at Prіkhodko & Partners, who specialize in pharmaceutical law, as well as to involve specialists in the implementation of GMP.