The Soviet Union collapsed more than 30 years ago and each country has started to build its own legal and regulatory system. Significant differences in political and economic situations in each state have led to appearance of absolutely different requirements to permission and sales of medical products.
In several countries the process of registration (marketing authorization) is simplified, e.g. due to the small number of national manufacturers, or aiming at the creation of a maximum effective price setting in the healthcare system. For example, Georgia conducts a simplified registration policy for products, which was approved by the countries with high regulatory requirements (the EU, the USA, and others), the parallel importing is permitted.
Other countries have chosen to create the Eurasian Economic Union (EAEU), which includes Armenia, Kazakhstan, and Kyrgyzia. Participation of a country in the Union influences a state’s regulatory policy implementing “centralized” registration.
Ukraine and Moldova have chosen integration with the European Union and conduct gradual harmonization with the European legislation. For example, Ukrainian legislation in the field of permission and marketing of medical products is based on European directives and stipulates simplified conditions for manufacturers from countries with high regulatory requirements.
Several countries have their own independent system of marketing authorization, quality, and safety control of medical products, with a large number of national characteristics and nuances.
Each country has its own state language and a large number of national legislative acts that directly or indirectly affect the registration process in each country.
Due to excellent knowledge of the legislation, extensive practical experience of various regulatory procedures performance, consideration for national peculiarities and individual approach to each project, our team effectively and professionally conducts registration of medical products in 11 countries of Eastern Europe and Central Asia:
- Azerbaijan;
- Armenia;
- Georgia;
- Kazakhstan;
- Kyrgyzstan;
- Moldova;
- Mongolia;
- Tajikistan;
- Turkmenistan;
- Uzbekistan;
- Ukraine.
We try to build a transparent and convenient system of cooperation for our partner, which is built on our experience and knowledge, proactive informing, and carrying out the necessary actions. “Cratia” has extensive experience in cooperation with both major international corporations and specialized manufacturers and products.
Cratia provides services of state registration of medicinal products and active pharmaceutical ingredients, medical devices and medical equipment in Azerbaijan, Armenia, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Mongolia, Tajikistan, Turkmenistan, Uzbekistan, and Ukraine. We do not work in Belarus or Russia, and we do not cooperate with manufacturers from these states.
We have the necessary scope of knowledge, experience, and skills to carry out all necessary work. We will undertake management and organization of the process; we will help carry out the procedure quickly. Depending upon your needs – we offer both a full range of works to fulfill all regulatory requirements, and any separate tool:
- regulatory planning and preliminary consulting;
- patent search;
- check of the registration dossier for compliance with legislative requirements;
- preliminary consulting with the competent authorities;
- confirmation of the status and/or type of the Application;
- translation of scientific, medical, technical and legal documentation;
- legal analysis and preparation of administrative documentation;
- preparation of specific national documents, including instructions for use (leaflet), labeling and mock-ups;
- preparation and execution of the registration dossier;
- submission of documentation, support;
- development and maintenance of the pharmacovigilance system;
- development and maintenance of a quality assurance system;
- management of all payments;
- examination process support, communication with competent authorities;
- analysis of remarks, preparation of recommendations for responding to remarks;
- obtaining permission to import samples and standards for intra-registration quality control;
- import (customs clearance) of samples and standards;
- deadlines control at all stages of the examination;
- verification of the registration certificate and its annexes drafts;