{"id":161,"date":"2019-10-09T17:55:23","date_gmt":"2019-10-09T14:55:23","guid":{"rendered":"http:\/\/cratia.com\/?p=161"},"modified":"2020-11-18T16:16:58","modified_gmt":"2020-11-18T14:16:58","slug":"farmakonadzor","status":"publish","type":"post","link":"https:\/\/cratia.com\/en\/uslugi\/lekarstvennye-sredstva\/farmakonadzor\/","title":{"rendered":"Pharmacovigilance"},"content":{"rendered":"

Cratia provides professional pharmacovigilance and medicines registration services in 12 countries and the Eurasian Economic Union (EAEU)<\/a>:<\/span><\/p>\n\n\n\n\n\n
Azerbaijan<\/span><\/a><\/td>\nGeorgia<\/span><\/strong><\/a><\/td>\nMoldova<\/span><\/a><\/td>\nTurkmenistan<\/span><\/a><\/td>\n<\/tr>\n
Armenia<\/span><\/a><\/td>\nKazakhstan<\/span><\/a><\/td>\nMongolia<\/span><\/a><\/td>\nUzbekistan<\/span><\/a><\/td>\n<\/tr>\n
Belarus<\/span><\/a><\/td>\nKyrgyzstan<\/span><\/a><\/td>\nTajikistan<\/span><\/a><\/td>\nUkraine<\/span><\/a><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

For some countries, the establishment and maintenance of a local pharmacovigilance system is an obligatory requirement for establishment and maintenance of the medicinal product registration. Some other countries have not yet included such requirements in national legislation, and the local pharmacovigilance system can operate voluntarily.<\/span><\/p>\n

In those countries where pharmacovigilance is a mandatory part of the regulatory system, we have our own internally trained local employees with high professional skills, experience, knowledge of the national legislation and language. All activities are coordinated by our Head office, whose specialists control the quality and timescales of work.<\/span><\/p>\n

The Head office is located in Ukraine, the country with the most developed and high regulatory requirements. Since 2005 Ukrainian drug regulatory legislation has been actively harmonized with European legislation, and since 2006 national pharmacovigilance legislation has been based on Directive 2001\/83\/EC of the European Parliament and Council, EU Council Regulation 2309\/93 and Guidelines of Good Pharmacovigilance Practice (GVP). We have successfully applied the many years of experience and knowledge gained on the national market to scale services in other countries. Our experts have deep knowledge of the national legislation of each country, specific requirements for registration materials and approval procedures, use professional terminology and monitor all changes.<\/span><\/p>\n

In addition to coordinating the work, the Head office specialists develop documentation in the pharmacovigilance system, such as the Risk Management Plan (RMP), the Addendum to the Clinical Overview (ACO), the Periodic Safety Update Report (PSUR), the Pharmacovigilance System Master File, SOPs, etc.<\/span><\/p>\n

Establishment and maintenance of the local pharmacovigilance system includes:<\/span><\/p>\n