When coming to a pharmacy, Ukrainian ordinary citizen is unlikely to ever think about how the drugs reach the shelves of pharmaceutical institutions.
In fact, after being produced by the pharmaceutical factory and before reaching the pharmacy shelves, the drugs are still registered, checked for quality and safety. This is a whole separate business sector, which has representation in at least all countries of the former Soviet Union.
For example, when a foreign drug manufacturer wants to “enter” the Ukrainian market, it must register this procedure in accordance with the regulated procedure. Such registration is performed by the Ministry of Health of Ukraine, and the examination of the documents is performed by the State Expert Center of the Ministry of Health of Ukraine.
Changes in legislation, the growing scope of state regulation of the industry and new approaches to the provision of medical services, as well as pharmaceutical development trends require a foreign manufacturer to look for a legal intermediary in Ukraine.
Еhe differences in the pharmaceutical legislation of Ukraine and the EU is just a separate issue. Since 2005, when Euro-integration processes were first launched, Ukraine became to adapt its pharmaceutical legislation to the European one, which, in turn, is constantly changing.
Solving legal issues in this segment requires not only knowledge of the intricacies of legal regulation of the industry, but also the features of the Ukrainian business climate, the principles of work of state bodies.
So, the manufacturer needs to collect a large number of documents, the registration dossier. The documentation is divided into five parts (modules), it consists of more than 130 sections, which spell out all aspects of production, labeling, quality management, experiments and evidence of safety and effectiveness of the finished product.
Such a dossier is submitted to the State Expert Center, it might have more than 50,000 pages. 210 working days (11 calendar months) are required to work with documentation, and this does not include time for a dialogue between experts and the manufacturer. After this drug, a registration certificate is issued, the instructions for use, methods for controlling the quality of the drug, information for labeling the package are approved. And the drug enters the State Register of Medicines of Ukraine.
Obviously, a foreign manufacturer needs a certain intermediary between him and the Ministry of Health for processing and control all the above stages. Ukraine has special profile companies, the services of which can be addressed by a foreign manufacturer.
Such companies are similar to lawyers and scholars. Because in addition to working with the registration dossier, they also monitor the quality and safety of medicines. Each drug that is imported into Ukraine undergoes quality control. Medications can be sent for laboratory examination, which will become the basis for the appearance of several thousand more sheets of documentation and will add work for lawyers. In fact, the share of imports among pharmaceuticals in Ukraine is not so large. 80% of the drugs we have are our own production. And their quality, as experts assure us, is more than acceptable.
In 2009, the Ministry of Health updated a number of manuals on ensuring the quality of medicines, including the Good Manufacturing Practice (GMP). After that, in 2011, Ukraine joined the International Organization for the Cooperation of Pharmaceutical Inspections (PIC / S). As a result, the pharmaceutical market has changed significantly: manufacturers from developing countries did not meet the standards and were forced to leave the market, which led to the growth of national companies.
Therefore, the quality of Ukrainian medicines is closely monitored. Since the company is commercial, it is not connected with the state apparatus, and therefore the possibility of corruption is minimized. So, at least in the pharmaceutical sector, we are all more than good, which, in turn, brings us closer to full accession to the European Union.