The pharmacovigilance system in the Republic of Kazakhstan is established according to Article 85 of the Code of the Republic of Kazakhstan “On the public health and the healthcare system”, drug side effect monitoring was introduced in 2005.

The main legislative acts regulating the pharmacovigilance system in Kazakhstan are:

• Order of the Ministry of Health and Social Development of the Republic of Kazakhstan No. 421 “On approval of Rules for carrying out pharmacovigilance and monitoring of side effects of medicinal products, medical devices and medical equipment” dated May 29, 2015.
• Order of the Ministry of Health and Social Development of the Republic of Kazakhstan No. 392 “On approval of Good Pharmacy Practice”, Appendix 6 “Good pharmacovigilance practices (GVP) standard” dated May 27, 2015.
• Order of the Ministry of Health and Social Development of the Republic of Kazakhstan No. 735 “On approval of Rules for state registration, re-registration and amendments to the registration dossier of the medicinal product, medical device and medical equipment” dated November 18, 2009.

The competent authority for drug safety monitoring is the National Center for expert evaluation of medicinal products, medical devices and medical equipment, on the basis of which the Center for pharmacovigilance and monitoring of side effects of medicinal products and medical devices was organized in June 2016.

Participants of the pharmacovigilance system are healthcare professionals (doctors, healthcare institutions), entities involved in the circulation of medicinal products and medical devices (importers, distributors, pharmacies), as well as holders of registration certificates for medicinal products.

A spontaneous method of collecting information on drug side effects by filling the adverse drug reaction report form, also known as the “yellow card” is well-known everywhere in Kazakhstan.

Establishment and maintenance of pharmacovigilance in Kazakhstan

According to the Order of the Minister of Health of the Republic of Kazakhstan No. 735 dated November 18, 2009, MAH (Marketing Authorization Holder) must submit information regarding pharmacovigilance system in Kazakhstan as a part of the Application: 

• Description of the pharmacological safety control system and risk management system (corresponds to section 1.8.1. “Summary of the pharmacovigilance system”); 
• Confirmation of the presence of a local contact person responsible for pharmacovigilance in Kazakhstan (CV of the LCP). 

The responsibilities of the MAH are described in the Order of the Ministry of Health and Social Development of the Republic of Kazakhstan No. 421 dated May 29, 2015, and include:

• The presence of a qualified person responsible for pharmacovigilance (QPPV) and a local contact person for pharmacovigilance (LCP) in the Republic of Kazakhstan; 
• Maintaining of the pharmacovigilance system Master File up to date; 
• Maintaining a database for identified side effects (adverse events) of the drug use in the territory of the Republic of Kazakhstan; 
• Annual submission to the competent authority of information on any restrictions of use taken in other countries regarding the medicinal product registered in the Republic of Kazakhstan, as well as data for evaluation of the benefit-risk ratio; 
• Submission of relevant notification in case of planned deregistration or temporary stop of the circulation of the product in Kazakhstan.  

The competent authority has the right to inspect the pharmacovigilance system of the MAH, both locally and globally. The inspection is carried out for compliance with the requirements of Good Pharmacovigilance Practice of the Republic of Kazakhstan.

The MAH timelines for submission of information on adverse drug reactions:

• serious adverse reaction in the territory of the Republic of Kazakhstan: within 15 calendar days from the receipt of information;
• adverse reaction in the territory of the Republic of Kazakhstan: within 15 calendar days from the moment of the occurrence of the event;
• serious unexpected adverse reaction to the investigational medicinal product in the Republic of Kazakhstan, identified in clinical trials, if it caused death or life-threatening condition: within 7 calendar days from the date of receipt of information;
• for other cases of a serious unexpected adverse reaction to the investigational medicinal product in the territory of the Republic of Kazakhstan: up to 15 calendar days from the date of receipt of information;
• serious unexpected adverse reaction that occurred outside the Republic of Kazakhstan and was fatal and (or) life-threatening: within 15 calendar days from the date of receipt of the information.

Cratia provides professional services of establishment and maintenance of pharmacovigilance system in Kazakhstan. We have an excellent knowledge of national legislation, necessary experience and resources. 

To start cooperation or get advice, please contact us by phone: +38 068 064-78-31, +38 044 223-61-67, by e-mail: info@cratia.ua, or visit our office.