The registration procedure contains many specific nuances and features that must be taken into account by the applicant. This is partly due to the fact that the Ministry of Health of Ukraine continues to work on improving the procedures for state registration of medicines.
Constant monitoring of regulatory requirements, proper preparation of materials for registration / re-registration / introduction of changes and appropriate support of the process guarantees timely fulfillment of the planned tasks.
Marketing authorization of medicines
The procedure, which is conducted in accordance with the requirements of the current legislation with the purpose of granting or extending a permit for the medical use of medicines.
Drugs are allowed to be used in Ukraine after their state registration.
The state registration of medicinal products is made on the basis of an application submitted to the central executive authority that implements the state policy in the field of health care.
The state registration of medicinal products is carried out by the Ministry of Health of Ukraine on the basis of the results of examination of registration materials (registration dossier) on medicines and quality control conducted by the State Expert Center of the Ministry of Health of Ukraine.
We offer the following services:
- Registration of medicines
- Formation of the registration dossier
- Submission of the dossier to the registration authorities of Ukraine
- Accompanying the registration dossier in the registration process
- Obtaining a registration certificate
- Marketing Authorisation Variations