The Soviet Union collapsed more than 25 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 small quantity of national manufacturers, or aiming at creation of maximum effective price setting in the healthcare system. For example, Georgia conducts 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 the way of creating of the Eurasian economic union (EAEU), which includes Armenia, Belarus, Kazakhstan, Kyrgyzia and Russia. Participation of a country in the Customs Union influences regulatory policy of a state and so far allows realizing both national and “centralized” registration.
Ukraine and Moldova have chosen integration with the European Union and conduct gradual harmonization with the European legislation. For example, the Ukrainian legislation in the field of permission and marketing of the medical products is based on the 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 only in some of them Russian language has the status of the second state language. There is 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 the former Soviet Union and Mongolia:
In addition to the abovementioned, we can provide access to the market of the Russian Federation through the registration of products in EAEU member countries (Belarus, Armenia, Kazakhstan and Kyrgyzstan).
We try to build the most simple, 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.
Company “Cratia” offers carrying out of state registration of medicinal products and active pharmaceutical ingredients, medical devices and medical equipment, biologically active supplements and cosmetic products in Azerbaijan, Armenia, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Mongolia, Tajikistan, Turkmenistan, Uzbekistan, Ukraine. We have the necessary scope of knowledge, experience and skills to carry out all necessary works. We will undertake management and organization of the process; we will help to carry out the procedure in a short time. 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;