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Pharmacovigilance services

Pharmacovigilance - is "the science and activities relating to the detection, assessment, understanding and prevention of adverse reactions or any other problems associated with medicines "
(WHO)

"Pharmacovigilance of medicinal products - a system of monitoring, analyzing and evaluating of information on the safety of registered medicines "

Code of RK "On people's health and the health care system"

 

Pharmacovigilance in Kazakhstan

Since 2006, the National Center for Expertise of Medicines of the Republic of Kazakhstan was an observer of the WHO International Program on monitoring drug side-effects, on July 16, 2008, Kazakhstan became the 85th full-fledged official participant of the WHO International Program on Monitoring Drug Side-effects (https://www.who-umc.org/global-pharmacovigilance/members/) WHO is implementing a special information product "VigiFlow" in the member countries of this program, through which they send an on-line message to the center in Uppsala on the revealed side effects of medications every month. Kazakhstan has had this opportunity since 2008. According to the Order No. 63 of the Ministry of Health of the Republic of Kazakhstan dated May 6, 2005, the NCFE is an authorized organization in the collection, analysis and evaluation of the safety of drugs.

Pharmacovigilance services  of LLP "Adalan"

"Adalan" LLP – is a young and ambitious company, which was founded in 2010 and is one of the leading companies providing services in the field of registration of medicines, medical devices and MT, promotion of these products on the markets of Kazakhstan in Central Asia, as well as in the field of pharmacovigilance as the contact person for our partners.

Pharmacovigilance system is designed to fulfill the tasks and responsibilities for pharmacovigilance to control the safety of medicines, the timely detection of any changes in the assessment of the benefit-risk of medicines, the development and implementation of measures to ensure the use of drugs in excess of benefit over risk.

TOO "Adalan" create and maintain a system that ensures the collection of information about all suspected adverse reactions (as reported the staff of the company and / or medical representatives), and the timely transmission of received information to all interested parties, as well as providing feedback, both from holders of registration certificates, as well as from authorized agency.

Only individual reports on adverse reactions that have positive results of validation are subject to urgent reporting. As a result, all reports of adverse drug reactions before their submission to the regulatory authorities should be subject to validation of the existence of the minimum required information.
The minimum required information includes:
a) identifiable reporter (
original source) -
the reporter is considered identifiable if the following data are available:
- Name / initials, address or qualification (doctors, pharmacists, other health professionals and patient / consumer, patient / consumer representative);
- contact data providing the ability to confirm the message or perform follow-up if necessary;;
b) identifiable patient -
the patient may be identified by the presence of the following data:
- Name / initials of the patient;
- Patient identification number;
- Date of Birth;
- Age or age group;
- Sex;
c) one suspect drug (at a minimum);
g) one suspected adverse reaction (at least).

On our site you can download a copy of the message card, which you can multiply and fill it is desirable together with the doctor.
Completed cards is necessary send to the address of "Adalan" LLP,  and we will submit them to the RGE "NCFE".

Pharmacovigilance services at the territory of: Kazakhstan, Azerbaijan, Kyrgyzstan, Uzbekistan, Tajikistan, Mongolia and Turkmenistan

  • Collection, processing and submission of information on adverse events in the medical application of the company's product (ICSR) to the partner's head office and Regulators;
  • Monitoring of side effects of medicines, medical products and medical equipment.
  • Preparation and submission to the Regulators of periodic reports on the safety of drugs (PSUR)
  • Preparation and submission to the Regulators of reports of serious adverse events (CIOMS), coding spontaneous calls of consumer, entering information in the pharmacovigilance database;
  • Screening of literature, preparing literary reviews on drug safety, searching of information on websites;
  • Tracking changes in legislation and much more ...

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