Side Effects and New Safety Information
Adverse event (side effect) is an undesirable and unintentional effect resulting from use of a medicinal product or medical equipment (medical device).Regulation 7(b)(2) of the pharmacists’ regulations (preparations) 1986 (hereinafter referred to as “the regulations”), requires any Marketing Authorization Holder (MAH) to immediately notify the Ministry of Health, via the Qualified Person responsible for Pharmacovigilance (QPPV), of any new information regarding a registered medicinal product.
Drugs’ manufacturers and importers are required to monitor daily any safety information, adverse reactions or drug inefficiency brought to their knowledge, which occurred in or outside Israel (in recognized countries) and are related to their registered medicines or medicines used for clinical research (clinical supplies).
Drug safety monitoring field, called Pharmacovigilance, is of critical importance to the caregiving staff, to the end user (the patient) and to the public.
The legislation in Israel is based on the European regulation guidelines on Good Pharmacovigilance Practices (GVP).
It is important to remember that the Ministry of Health is able to impose sanctions on registration holders who breach the requirements of the law and relevant procedures in the field of side effects reporting – Pharmacovigilance (PV).
Since its establishment ten years ago,Blau Pharmaceutical Services has been involved in the field of the adverse reactions and new safety information reporting, and is in close and direct contact with all the relevant parties: The Ministry of Health, the MAH, the manufacturer, medical staff (doctors, pharmacists, nurses), medical and academic institutions.
Our extensive knowledge of PV, together with our aspirations for excellence and desire to meet your standards, leads us to a complete control of this complex field, which has lately undergone significant changes.
We wish to assist you in this field, whether concerning prescription medicine, OTC, GSL, medical equipment, human and veterinary medications, or whether concerning medications or medical devices that are registered/marketed or during clinical trials.
BLAU Pharmaceutical Services’ team of experts is at your service at any time to provide a comprehensive answer to the regulatory requirements in the field of Pharmacovigilance in a focused professional manner and in accordance with the defined schedule.
Requirements in the Field of Side Effects and New Safety Information Reporting
Procedure 6 issued by the Ministry of Health, “Reporting of Side Effects and New Safety Information” necessitates importers/ manufacturers (MAHs) to establish and manage a side effects and new information tracking system for medicinal products registered in the Israeli drug registry.MAHs are required to report to the Risk Management and Drug Information Department at the Ministry of Health in many cases regarding, among others:
A side effect with abnormal incidence
A side effect or lack of efficacy observed after drug’s formulation change
Any serious or non-serious side effect that occurred in Israel
Any information that has possible implications on product safety
A restriction, alert or prohibition related to a safety problem (existing or potential) determined by a health authority of a recognized country regarding use of the medicine
Notice to the healthcare professionals or to the public issued outside of Israel regarding the safety/ efficacy and/or use of the medicine
New information published in the local and international medical literature related to drug’s safety.
MAHs are also required to submit periodic safety reports to the Ministry of Health:
PSUR (periodic safety update report) or PBRER (periodic benefit-risk evaluation report)
DSUR (development safety update report)
Monthly signal report
The Ministry of Health has strict requirements regarding the reporting method, timelines and contents of the report. The MAH is obligated to submit follow up reports for reported serious adverse events as well as for any additional reports upon request.
Regarding medical devices, there is an obligation to report:
An action taken by a health authority in the world or a notice from the overseas manufacturer, the MAH or a health authority in the world
Harm caused to the physical or mental health of a patient, or fear that such harm was caused by use of the medical equipment (in Israel or overseas)
Serious malfunction of the medical equipment (in Israel or overseas)
Our Services in the Field of Side Effects and New Safety Information Reporting
Blau Pharmaceutical Services understands the importance of complying with your requirements, the requirements of the holder of the international rights and the requirements of the Israeli law, and works every day, allowing you to focus on other tasks that are important to your organization.Our PV services includeLong or short-term fulfillment of the role of Qualified Person responsible for Pharmacovigilance (QPPV)
In addition, services are provided for specific projects, such as:
Receipt, processing, evaluating and distributing of safety cases
Review of periodic PSUR/PBRER and annual DSUR safety reports prior to submission to the Ministry of Health.
Professional literature review, specific for recognition of safety reports
Preparation of a local Pharmacovigilance master file
Assessment of your organization’s Pharmacovigilance system (audit)
Training and qualification for the QPPV position
World-wide tracking for safety signals
Risk management due to use of medicines, risk/benefit assessment
The knowledge, expertise and, above all, the experience of Blau Pharmaceutical Services in the field of side effects and new safety information reporting, from the clinical trials stage and throughout the marketing period of medicines and medical equipment, are the tools for your success!