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Registration of medicines in Ukraine

дог. грн дог.

Registration of medicines in Ukraine

Registration of medicines in Ukraine

In Ukraine, for the legal import of medicines, their manufacture in the country and further implementation, it is necessary to conduct state registration of medicines with a state licensee - State Enterprise "State Expert Center of the Ministry of Health of Ukraine.

Today in Ukraine are not subject to registration only those drugs that are manufactured according to official formulas (have a permanent composition prescribed by the pharmacopoeia, prepare them in the factory) to order treatment and prevention facilities and pharmacies according to the main formulas, do not have a permanent composition, are made according to doctors' prescriptions).

The legislation of Ukraine on the registration and circulation of medicines has been harmonized with the legislation of the European Union since 2005. Based on this, it can be seen that the general requirements for documentation, the process of examination of funds are quite close to the directives, but in the meantime there are significant national specifics that affect regulatory processes.

That is why in order to register medicines in Ukraine reliably, safely and as quickly as possible, it is better to seek professional help.

Olson Law Firm provides professional legal services for the registration of medicines in Ukraine. Our qualified specialists have considerable, successful experience of legal work in the field of medicine, namely in registration of licenses of any kinds, permits, registration of medicines and other.

By contacting us, each client can be guaranteed to count on an individual approach to each issue, comprehensive comprehensive consultations and, of course, comprehensive support and legal assistance in the registration of medicines in Ukraine.

The process of registration of medicines has a clear sequence and consists of certain stages that must be followed.

Today, in order to register medicines in Ukraine, it is necessary to take the following steps:

  • draw up and submit an application to the Ministry of Health of Ukraine for registration of a medicinal product. The application must be accompanied by a dossier on the product, which must contain information about the drug, dosage form, components, efficacy, contraindications, pharmacological studies, etc .;
  • The Ministry of Health reviews the application and then submits it to the State Expert Center with a referral for examination of the drug;
  • the examination is carried out on the basis of concluding an agreement with the State Expert Center, payment of duties and the cost of the examination itself. It is also necessary to provide a complete registration dossier for the drug;
  • specialists of the State Expert Center conduct an examination, after which they make a conclusion about the quality, safety, effectiveness of the drug;
  • the conclusion is forwarded to the Ministry of Health of Ukraine. In cases when the conclusion is positive, a decision is made on the registration of the medicinal product, a certificate is issued for it and the information of the State Register of Medicinal Products is entered.

The period of validity of registration for a medicinal product is 5 years, after which the drug must be re-registered.

Olson Law Firm is ready to provide full assistance in the registration of medicines in Ukraine. Our specialists not only have a deep knowledge of the legal framework, but also know how to quickly and efficiently navigate the issue.

We will provide consultations, prepare a package of necessary documents, in this case a dossier for the drug, submit documents to the licensing authorities, provide full legal support at each step of the registration procedure and receive a certificate, which will be handed over in person.

By cooperating with us, you will be able to enlist the help of experienced, competent professionals and the procedure for registering a drug will be clear, distinct and solved!

Frequently Asked Questions

• In which cities do we provide the service?

Lutsk, Ivano-Frankivsk, Rivne, Ternopil, Khmelnytskyi, Chernivtsi, Uzhhorod, Mukachevo, Drohobych, Sambir, Stryi, Zolochiv, Mykolaiv, Truskavets, Yavoriv, Kovel, Kalush and others.