Lex Analitik takes part in the first Kazakhstani Pharmaceutical Forum

The Forum took place in the Conference room of the Foundation of the First President of the Republic of Kazakhstan on May 16-17, 2011. The event was supported by the Committee for control over pharmaceutical practice for the Ministry of Health of the Republic of Kazakhstan, the Almaty Board of Health, Association of Representative Offices of Foreign Pharmaceutical Companies in the Republic of Kazakhstan, Association of Representative Offices of International Pharmaceutical Companies in Belarus, Pharmacological Committee of the Kyrgyz Republic, Diabetes Association of the Republic of Kazakhstan, and the Association for the Support and Development of Pharmaceutical Practice in Kazakhstan.

Olga Somova, Managing Partner of Lex Analitik, spoke about the ‘Legal aspects of the regulation of the safety and quality of medicines in Kazakhstan’ during the Forum’s session dedicated to the ‘Safety, efficacy and quality of medicines’.

In her speech, Olga emphasised the importance of strong national systems on which the global safety of pharmaceutical products depends. In her opinion, a comprehensive legal framework, uniform quality standards for pharmaceuticals, close control over each phase of the circulation and administration of drugs, and competent controlling authorities are key to a strong national system. She also pointed out that a comprehensive legal framework is vital as the rest of the components depend on it and cannot operate effectively without it.

‘If we look at the development of the national legislation regulating the pharmaceutical market in the Republic of Kazakhstan, we will see that the local legal framework is gradually coming in line with international standards.  No doubt, this will affect the quality and safety standards of pharmaceutical products manufactured in the Republic of Kazakhstan, as well as those imported for use in this country’- said Ms Somova.

During her presentation Ms Somova examined in detail the state procedures and mechanisms for the quality control of medicines, paying particular attention to the relevant legislation.

The issues relating to the quality and safety of medicines within the Customs Union were of particular interest to the Forum’s participants.

The participants were given an opportunity to put to Ms. Somova any queries and concerns they had relating to the adopted and implemented Good Pharmacy Practices and the newly introduced changes affecting the licensing, registration and import of medicines to the Republic of Kazakhstan under Custom Union’s laws.