Pharmacovigilance
Pharmacovigilance (PV) is the pharmacological science relating to the detection, assessment, understanding and prevention of adverse effects, particularly long term and short term side effects of medicines. Generally speaking, pharmacovigilance is the science of collecting, monitoring, researching, assessing and evaluating information from healthcare providers and patients on the adverse effects of medications, biological products, herbals and traditional medicines with a view to:
- identifying new information about hazards associated with medicines,
- preventing harm to patients.
In Ukraine the procedure of pharmacovigilance is regulated by the Order of MOH of Ukraine #898 (27.12.2006) “About Approval of Procedure for Surveillance over Adverse Reactions to Medicinal Products Permitted for Medical Use”.
Our specialists would help you to get the most extensive information about terms of use and adverse reactions of your product. The reports for distributor or producer must be given in accordance of following time-periods:
- Once in 6 months during first two years after registration of product.
- Once a year during three following years.
- Further once in a five years (usually at the same time of re-registration).
According to order #898 responsibilities of the producer are following:
<...>8. Pharmacovigilance system at the manufacturer / applicant (or his representative)
8.1. The applicant must establish, ensure and guarantee the proper functioning of the pharmacovigilance system in Ukraine, which is a prerequisite for drugs’ circulation in the territory of Ukraine:
8.1.1. Employ qualified person responsible for pharmacovigilance, the appropriate qualifications, with higher medical and/or pharmaceutical education. If this person has the higher pharmaceutical education, it should be able to apply to a person with higher medical education, if necessary. An authorized person responsible for pharmacovigilance, is responsible for:
• create and maintain an adequate system for collecting, evaluating and reporting adverse reactions / lack of efficacy of drugs, according to a certain order;
• preparation and submission of regular reports on drug safety, allowed for medical use in Ukraine, according to a certain order;
• guarantee that all requests will be given the additional information needed to assess the risk / benefit ratio when using the drug to be urgently provided with full reports, including information about sales of the drug or the number of doctor formulations to certain drugs, in accordance with a certain order;
• ensuring delivery of any data needed to assess the risks and benefits for medical use of drugs, including information on research in security in the post-registration period in accordance with a certain order;
• Ensure the provision of data and taking appropriate action in case of detection of previously unknown hazardous properties of the drug, which led or may lead to severe consequences for human health and safety or the changing of risk / benefit ratio in the direction of risk.
8.1.2. Structured system of pharmacovigilance.
8.1.3. Documentation of all treatment processes.
8.1.4. Establishing and maintain appropriate databases.
8.1.5. In case of necessity involve the implementation of pharmacovigilance other individuals and organizations through contractual arrangements.
8.1.6. Provide training for company personnel to carry out activities related to pharmacovigilance.
8.1.7. Create a quality management system of pharmacovigilance.
8.1.7.1. Ensure introduction of appropriate changes and additions to information on Safety of Medicines, as reflected in its general characteristics.
8.1.7.2. Create a risk management system which is proportional to the detected and the potential risks and needs for data security.
8.1.7.3. Have a risk management plan estimated risk / benefit ratio of drugs. <...>
What activities are included in pharmacovigilance?
- Permanent monitoring and reporting in each case of adverse reactions, absence of positive reactions, deaths or serious harm of the health.
- Forming a list of variations for dossier (for example application instructions).
- Communication with State Pharmacological Center including physiologists reporting.
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