Attorney
Medical lawyer. Specializes in protecting the rights of doctors and patients, handling medical malpractice and liability cases, supporting disability determination and appeals procedures, and providing legal analysis of medical documentation.
License for import of medicinal products
Importing medicines is a complex and strictly regulated process that requires compliance with numerous requirements. A license for importing medicines is a permit that gives business entities the right to import medicines from abroad and sell them on the territory of Ukraine. Obtaining a license is mandatory in accordance with the legislation of Ukraine in the field of healthcare.
Who can obtain a license to import medicines?
A license can be obtained by legal entities and individual entrepreneurs (FOPs) who meet the requirements of the legislation on the import of medicines – Licensing conditions for conducting economic activities in the production of medicines, wholesale and retail trade in medicines, import of medicines (except active pharmaceutical ingredients).
The main conditions are:
- Availability of a material and technical base that meets the requirements.
- Compliance with the requirements for storage, transportation and quality control of medicines.
- Appointment of a person responsible for quality who has the necessary pharmaceutical education and experience in the field of circulation of medicines.
- Absence of ties with the aggressor country.
What are the licensing conditions for such activities?
The importer must ensure several key points for carrying out the activity, in particular,
- Storage of quality certificates: Business entities are required to store the manufacturer’s quality certificates (in paper or electronic form) for sold or free-of-charge batches of medicinal products for one year after the expiration date of the batch or for at least five years, whichever is longer
- Qualification of personnel: Persons directly engaged in the production or retail trade of medicinal products must have a higher education of at least the initial level in the specialty “Pharmacy, industrial pharmacy”. Specialists with a master’s degree must have an appropriate certificate or certificate of qualification category. Dispensing of medicinal products may be carried out by pharmacists and pharmacist assistants with appropriate education.
- Material and technical base: Business entities must ensure that the material and technical base, personnel qualifications, and conditions for quality control of medicinal products comply with the requirements of regulatory documents regarding the import, quality control, or production of medicinal products.
What documents are required to obtain a license?
To obtain a license to import medicines, the following package of documents must be submitted to the State Service of Ukraine for Medicines and Drug Control (State Service):
- Application of the established form.
- Letter of no influence on the economic activities of the enterprise from the aggressor country.
- Importer’s dossier.
- Description of documents.
Additionally, if necessary, a power of attorney of the representative is attached, if the documents are submitted through a representative.
Documents can be submitted in electronic or paper form.
License obtaining procedure
The license obtaining procedure includes several stages:
- After receiving the application and documents provided above in full, the State Health Service checks such documents, in particular the importer’s dossier, for the person’s compliance with the licensing conditions for conducting this type of activity.
- If the documents are drawn up correctly, all documents are submitted in full and the applicant meets the requirements, the State Health Service makes a decision to issue a license.
- If there are errors in the documents or not all the necessary documents are submitted, a refusal may be issued even if there is compliance with the conditions for conducting the activity.
- If the person does not meet the conditions for conducting the activity – the State Health Service refuses to issue a license.
The total term for considering the application is about 10 working days, but if additional checks are necessary, this period may be extended.
Liability for Violation of Licensing Conditions
Violation of licensing conditions may lead to temporary suspension of the license until the violations are eliminated or even complete cancellation of the license in case of serious violations.
The State Medical Service monitors compliance with licensing conditions by conducting scheduled and unscheduled inspections.
Obtaining a license to import medicines is a mandatory condition for conducting activities in this area. The licensing process requires careful compliance with legislative norms, proper logistics organization and ensuring high quality standards of medicines. However, even when these conditions are met, obtaining a license requires careful preparation of documents and a clear understanding of the requirements for filling them out. Successful completion of the procedure allows enterprises to legally import medicines, providing consumers with high-quality and safe products.
In turn, the company Prikhodko and partners can provide you with high-quality preparation of documents for the licensing procedure and support in obtaining a license, as well as the procedure for conducting inspections for compliance with licensing conditions.
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Are you located in Kyiv or Kyiv region?
Is a subscriber form of service possible to quickly resolve issues as they arise?
Yes, of course, we take companies for permanent support.
The subscription form of service allows you to receive a full range of legal services on an ongoing basis for a fixed monthly fee.
Our lawyers will accompany all economic legal relations of your company: from drawing up contracts and solving corporate issues to representing interests during inspections by regulatory bodies and in court disputes.
We have very flexible pricing, so contact us and we will discuss your specific case.
Do you work only in Kyiv?
Fortunately, modern technologies allow us to effectively solve almost any legal issue online regardless of your location. In cases where personal presence is necessary, our lawyers are ready to travel to any point in Ukraine. Moreover, thanks to our network of reliable partners abroad, we can provide legal support even in international cases. Our goal is to provide you with quality legal assistance wherever you are.
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