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Pharmacovigilance Requirements in Kazakhstan

How to report?

1) Information about the PPC should be posted online on the portal using the login and password assigned to your organization.

2) If it is not possible to send messages on-line, the completed message card (paper version) should be sent to the pharmacovigilance and monitoring department of the PDLS of the NCELS, or by e-mail.

Address

Republic of Kazakhstan, Almaty, Abylai Khan ave., 63, Republican State Enterprise on REM “National Center for Expertise of Medicines, Medical Products and Medical Equipment” of the Ministry of Health and Social Development of the Republic of Kazakhstan.

by phone: 8 (727) 2 73 45 00;

by fax: 8 (727) 2 73 45 00;

by email: pdlc@dari.kz

The responsibilities of the Pharmacovigilance Officer (QPPV) include:

Ensuring the functioning of the pharmacovigilance system of the owner of the registration certificate in the territory of the Republic of Kazakhstan and the provision of all required documents on pharmacovigilance to the RSE "NTsELS, medical devices and MT" in accordance with the current legislation;

submission of information on identified adverse reactions, other information on safety and periodically updated reports on the safety of medicines in the RSE "NTsELS, medical devices and MT" in accordance with the requirements of the legislation of the Republic of Kazakhstan;

availability of an updated assessment of the safety profile for each of the medicinal products and complete information for each case of detection of adverse reactions/events;

submission of information in response to inquiries of the RSE "NTsELS, medical devices and MT" regarding the safety profile of drugs, assessment of the benefit-risk ratio;

implementation of the introduced risk minimization measures;

participation in the revision of the protocols of post-registration studies to study the safety of a medicinal product;

participation in the development of risk management plans;

ensuring the required quality, including the reliability and completeness, of the data on the safety of the medicinal product provided to the RSE "NTsELS, medical devices and MT";

ensuring 24x7 Availability

 

Comprehensive Side Effects Monitoring Plan

 

As part of the implementation of the "Comprehensive plan for monitoring side effects, lack (low) effectiveness, overdose, abuse, use not in accordance with the approved instructions for the medical use of drugs and incidents during the operation of medical devices and medical equipment", approved by the Ministry of Health of the Republic of Kazakhstan On July 27, 2017, to ensure the uniformity of primary documents and information provided to the consumer, the following have been developed and submitted:
1.comprehensive plan for monitoring side effects, lack of (low) efficacy, overdose, abuse, use not in accordance with the approved instructions for the medical use of drugs and incidents during the operation of medical devices and medical equipment
2. questionnaires for active monitoring of drug side effects in primary health care organizations and inpatient medical care organizations (departments of nephrology, dialysis, urology, therapy) for questioning patients with kidney disease and renal failure (p. 3, p. 4 ) in Kazakh and Russian languages;
3.a model of the stand with information on monitoring side effects of drugs and incidents during the operation of medical devices and medical equipment for primary health care organizations, inpatient medical care and pharmaceutical organizations, for feedback patient-doctor-message-doctor-patient ( p.14, p.18) in Kazakh and Russian languages.
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BLACK TRIANGLE DRUGS

If a drug is marked with a black triangle, it means it is under more control than other drugs. This is usually because this drug has less information available than another drug, for example, it is new on the market or there is limited data on its long-term use.

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1)  Additional monitoring

2) Additional monitoring for January 2018

PSMF

One of the prerequisites for finding medicines in circulation on the territory of the Republic of Kazakhstan is the presence of a PSMF with the owner of the registration certificate.

The owner of the marketing authorization must ensure and guarantee the proper functioning of the pharmacovigilance system in the Republic of Kazakhstan.

The PSMF of the MAH must include

  • presence in the staff of a person in charge of pharmacovigilance;
  • collection of information on detected adverse reactions to medicinal products;
  • analysis and assessment of information on adverse reactions and data related to the assessment of the safety profile, the benefit-risk ratio of manufactured medicines;
  • availability of a database necessary for the proper performance of pharmacovigilance functions;
  • compliance with the requirements of the legislation of the Republic of Kazakhstan on the submission of information on the identified adverse reactions, information on the safety profile and the benefit-risk ratio of drugs in the RSE "NTSELS, medical devices and MT";
  • timely informing the RSE "NTsELS, medical devices and MT" about all changes in the assessment of the benefit-risk ratio of manufactured medicines;
  • identification of signals about a possible change in the benefit-risk ratio based on the collected information on adverse reactions and taking immediate measures to ensure the safe use of manufactured medicines with a positive benefit-risk ratio;
  • availability of documented procedures / standard operating procedures for all functions performed by the marketing authorization holder within the pharmacovigilance system;
  • periodic training of personnel involved in performing the functions of the owner of a registration certificate for pharmacovigilance;
  • functioning of the quality assurance system of the pharmacovigilance system of the owner of the marketing authorization;
  • coordination of amendments to the instructions for medical use related to changes in the safety profile of manufactured medicines and assessment of the benefit-risk ratio, within 1 month from the date of the decision by the authorized body;
  • providing, by decision of the authorized body, a risk management plan and a risk minimization plan.

The marketing authorization holder must provide the responsible person for pharmacovigilance with the resources, conditions, including access to all sources of information, and communication mechanisms necessary to fulfill his responsibilities and effectively solve tasks in the field of pharmacovigilance.

The RSE "NTsELS, IMN and MT" provides the contact information of the person in charge for pharmacovigilance of the owner of the marketing authorization.

In the event of a temporary absence of the person in charge for pharmacovigilance, it is required to ensure the proper performance of all his duties by another specialist in the field of pharmacovigilance.

The owner of the registration certificate notifies the RSE "NTsELS, IMN and MT" about the change in contact information or the change of the responsible person for pharmacovigilance.

The person in charge of pharmacovigilance must have a higher medical or pharmaceutical education;

The responsibilities of the Pharmacovigilance Officer include:

  • ensuring the functioning of the pharmacovigilance system of the owner of the registration certificate on the territory of the Republic of Kazakhstan and providing all the required documents on pharmacovigilance to the RSE "NTsELS, medical devices and MT" in accordance with the current legislation;
  • submission of information on identified adverse reactions / actions, other information on safety and periodically updated reports on the safety of drugs in the RSE "NTsELS, medical devices and MT" in accordance with the requirements of the legislation of the Republic of Kazakhstan;
  • availability of an updated assessment of the safety profile for each drug and complete information for each case of detection of adverse reactions / effects;
  • submission of information in response to inquiries of the RSE "NTsELS, medical devices and MT" regarding the safety profile of medicinal products, assessment of the benefit-risk ratio;
  • implementation of the introduced risk minimization measures;
  • participation in the revision of the protocols of post-registration studies to study the safety of a medicinal product;
  • participation in the development of risk management plans;
  • ensuring the required quality, including the reliability and completeness, of the data on the safety of the medicinal product provided to the RSE "NTsELS, IMN and MT";
  • ensuring the possibility of contact with the RSE "NTsELS, IMN and MT" within 24 hours a day.
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