Publication date: 15.05.2024
I am studying in the third year of the State University of Economics and Technology.I specialize in contractual, economic and corporate law, in particular, I provide consultations and write articles.
A business license is an official document issued to a company or individual for the right to carry out a certain commercial or professional activity. Licensing may include a process of verifying the quality of the products or services provided by the business. This ensures that consumers receive safe and reliable goods and services. Many industries, such as medicine, pharmaceuticals, finance and the food industry, are subject to strict regulatory requirements. A license allows businesses to comply with these requirements and avoid fines or other legal consequences.
Features of obtaining a license to import medicinal products:
The following requirements are usually established for carrying out business activities involving the import of medicinal products (except for active pharmaceutical ingredients) in Ukraine:
Business registration: The company must be legally registered in accordance with the legislation of Ukraine. This may include registration as a business entity, obtaining a taxpayer identification number, etc.
Obtaining a license: In order to carry out the import of medicinal products, it is necessary to obtain a license from the State Service of Ukraine for Medicinal Products and Drug Control (State Service of Ukraine). This includes submitting an application and supporting documentation.
Compliance with quality standards: The company must have a quality control system that meets established standards to ensure the quality and safety of medicinal products.
Registration of medicinal products: Each imported medicinal product must be registered in Ukraine in accordance with the procedures established by the State Medical Service.
Compliance with regulatory requirements: The company must comply with all regulatory requirements that apply to the import of medicinal products, such as packaging, labeling, storage and transportation requirements.
Availability of qualified personnel: The company must have sufficient qualified personnel who understand the processes and requirements related to the import of medicinal products. In particular, in the state, it is necessary to have an authorized person for issuing a permit for the release of a series of medicinal products.
Adequate facilities: the licensee, i.e. the person or company granted a license to import medicinal products, is obliged to ensure proper storage conditions for these products in warehouses. Each medicinal product may have its own requirements for storage conditions, indicated on the package or in the instructions for use. The licensee must comply with these requirements.
Certificate of quality of the product series: medicinal products imported into the territory of Ukraine must be accompanied by a quality certificate of the product series issued by the manufacturer. This is an important part of the procedure for importing medical products and ensures that the product meets the established quality and safety standards. The licensee must keep such quality certificates of the manufacturer. In addition, documents confirming the purchase and sale of medicinal products and containing all necessary information are required to be kept for 3 years.
The procedure for obtaining a license:
Preparation of documents: Before applying for a license, you must prepare a set of necessary documents. This may include the statutory documents of the company, documents confirming financial stability, as well as other documents determined by the State Accounting Service. At this stage, the legal services are highly desirable
Application submission: After preparing the documents, the application for obtaining a license is submitted to the State Medical Service. The application must be submitted in writing and must contain all the necessary information about the applicant and his activities.
Review of the application: The State Public Accounts Service checks the submitted application and documents. This stage may include checking documents for compliance with established requirements and assessing the applicant's business reputation and financial stability.
Issuance of a license: If the application is accepted, the State Medical Service issues a license for the import of medicinal products. This allows the applicant to legally import medicinal products into the territory of Ukraine.
Compliance with requirements: After obtaining a license, the licensee must comply with all requirements established by the State Medical Service and other regulatory bodies. This includes keeping records, meeting quality and safety standards, and operating within license restrictions.
Lawyer services in obtaining a license:
The lawyer advice in the licensing procedure are of exceptional importance, because all steps to obtain a license are clearly regulated by legislation and must comply with it. The lawyer help will analyze the licensing requirements, collect a package of necessary documents, conduct a legal analysis of the situation, and submit the collected information to the licensing authority. Therefore, the lawyer consultation is a reliable tool for achieving desired results and business success.
