License to import medicinal products in Ukraine

In Ukraine, the import of medicinal products is regulated to provide the population with high-quality, effective, and safe medicinal products.

To carry out import activities in this area, it is necessary to obtain a special license issued by the Ministry of Health of Ukraine and other authorized bodies.

In this article, we will consider the main requirements and conditions for obtaining a license and a list of necessary documents.

Requirements for economic entities

To obtain a license to import medicinal products, a business entity must meet the following requirements:

• Be a legal entity or an individual entrepreneur duly registered in Ukraine.
• Have available or leased storage facilities that meet the established norms for the storage of medicinal products, including proper conditions of temperature, humidity, lighting, etc.
• Have qualified personnel, in particular, specialists in the field of pharmacy, who are responsible for quality control of imported medicines.
• To comply with the requirements of the current legislation of Ukraine in the field of circulation of medicinal products, in particular, the rules of good distribution practice (GDP).

Conditions for obtaining a license

Obtaining a license to import medicinal products requires compliance with certain conditions and the following procedure:

• Submission of application and documents. First, you need to apply for a license State Service of Ukraine for Medicinal Products and Drug Control (hereinafter – the State Medical Service), together with a set of necessary documents, namely statutory registration documents of legal entities or individual entrepreneurs.
• Verification of documents and compliance with requirements. After the application is submitted, the submitted documents are checked and the business entity’s compliance with the established requirements is evaluated.
• Inspection visit. Authorized bodies (Derzhliksluzhba) may conduct an inspection visit to the subject’s warehouses to check their compliance with storage regulations.
• Issuance of a license. In the case of successful completion of all stages of verification and inspection, the business entity is issued a license to import medicinal products.

A list of documents is required

To obtain a license for the import of medicinal products, the following documents must be submitted:

• Application for the issuance of a license.
• Copies of founding documents of a legal entity or documents of an individual entrepreneur.
• A document confirming the right to use storage facilities (ownership, lease agreement, etc.).
• Certificate of no criminal record for managers and specialists responsible for imports.
• Documents confirming personnel qualifications (diplomas, certificates, etc.).
• Declaration on compliance of warehouse premises with GDP requirements.
• Proof of payment of the state duty for the issuance of a license, which is 2481 UAH.

Obtaining a license to import medicinal products is an important step to ensure the quality and safety of medicinal products entering the market of Ukraine.

Business entities that fulfill the established requirements and go through the necessary procedure for obtaining a license make a significant contribution to the health of the nation and become important players in the modern market.

The legal company “Prikhodko and Partners” guarantees reliable support in the process of obtaining a license to import medicines, providing a professional approach and individual solutions for your business.

Our team of experts will help you prepare and submit the necessary documents, advise you on the compliance of warehouse premises with the requirements, and also provide support at all stages of the process of obtaining a license.

By choosing the law firm “Prikhodko and Partners”, you are choosing flawlessness, transparency of procedures, and a guarantee of a successful result, which will allow your business to effectively expand and prosper in the field of importing medicines in Ukraine.

We undertake the collection and preparation of the entire set of documentation, in particular, we assist in the preparation of a declaration on the compliance of warehouse premises with the requirements of good distribution practices, we provide legal support during inspections, and we also represent the interests of the client in the relevant state bodies.

Our team of specialists provides advice on all aspects of drug import regulation, including the regulatory framework, allowing clients to avoid potential risks and errors in this complex process.

By turning to Prikhodko and Partners, you get not only legal expertise but also the confidence that your business is moving forward with all the necessary permits for successful work on the market of medicinal products in Ukraine.