The State Expert Center of the Ministry of Health of Ukraine issued Ukraine's first positive conclusion under the parallel import procedure for the medicinal product IMIPENEM/CILASTATIN.
The expert evaluation was carried out upon referral from the State Service of Ukraine on Medicines and Drugs Control for the importation of the product from one of the European Union countries.
During the assessment, the Center verified:
- the composition and pharmaceutical form of the product
- the indications for use
- the availability of a marketing authorisation in the exporting country (EU country)
- the documentation on labelling, packaging and storage conditions.
Based on the results of the expert evaluation, the Center issued a positive conclusion on the possibility of importing the product under the parallel import procedure – the document is advisory in nature.
After receiving the Center's conclusion, the State Service on Medicines and Drugs Control decides on issuing a permit for parallel import, which grants a business entity with the relevant licence the right to import the product.
The permit is granted for a period of five years, and the corresponding entry is made in the State Register of Medicinal Products Imported in Parallel into the Territory of Ukraine.
Parallel import is one of the tools for improving the availability of medicinal products. It provides for the importation into Ukraine of products that are already lawfully in circulation in EU countries.
The introduction of this mechanism will help expand the sources of supply of medicinal products, reduce the risks of shortages and strengthen the resilience of Ukraine's healthcare system.
Background information. Imipenem/Cilastatin is a combined broad-spectrum antibacterial product from the carbapenem group, used to treat severe bacterial infections, in particular of the respiratory tract, abdominal organs, urinary tract, skin and soft tissues, as well as to treat septic conditions. For many patients, timely access to such products is critically important.
