Every registration holder or marketer of drugs, medical devices or non-registered drugs in Israel must set and have a drug/ medical device surveillance and pharmacovigilance system in place to monitor and report adverse events and new safety information.
The Qualified Person Pharmacovigilance has to be a Pharmacist (with minimum 2 years of experience), appointed by the registration holder and is responsible for all pharmacovigilance activities.
He/ She is appointed usually by the managing director of the company, who notifies the Ministry of Health for their nomination.
Regulation 7(b)(2) of the Pharmacist Regulations (preparations) 1986, obliges every registration holder to notify the Ministry of Health promptly via the Appointed Pharmacist, regarding any new information concerning their drugs.
Part C – Article 11 of Medical Device Law (2012) sets similar requirements on medical device companies.
As of August 2012 the Ministry of Health aligned with international regulatory authorities and formalized a requirement for a Qualified Person – Pharmacovigilance function.
This function should report new information to the Ministry of Health via the Appointed Pharmacist.
New reporting guidelines with immediate effect were set in February, as of May 1st 2013, and updated guidelines have been approved by the Knesset (Israeli parliament) labor, welfare and health committee on June 12, 2013.
The absence of a Pharmacovigilance surveillance system may lead to revokation of marketing license.
The obligation for reporting includes sick funds (HMO’s) and hospitals.
The Ministry of Health views Post Marketing Surveillance a critical responsibility and liability for registration owners and marketers of drugs.
Key responsibilities of the Qualified Person Pharmacovigilance:
• Report within 3 days of any banning, limitation or warning published by the manufacturer or competent authority in a recognized country to the Ministry of Health
• Report within 15 days regarding new safety information, suspected Serious Adverse Event or unusual prevalence of Adverse Event in Israel, lack of efficiency or excess of drug, including post approval of a formulation change
• Report new side effects not included in the approved prescribing information
• Submission based on international reporting of serious, unexpected and there is a reasonable possibility that the adverse event is related to the drug
• Reporting of changes in clinical information emerging in Israel and abroad
• Reporting of Post marketing Spontaneous reporting of individual case safety reports (ICSRs)
• Submission of Follow Up reports for reported SAE’s
• Submission of PSUR – Periodic Safety Updates Reports or PBRER in accordance with European Guidelines on good pharmacovigilance practices (GVP) Module VI, to the Israeli Ministry of Health department of Risk Management and Medical Information
There is an inherent requirement to train all employees of company and marketers personnel regarding safety reporting.
The Israeli Ministry of Health emphasizes the importance of keeping public safety and allows only safe, efficacious and high quality drugs reach the market.
Mind Pharma, managed by Shavit Fragman provides Appointed Pharmacist , Responsible Pharmacist – Qualified Person (QP) & batch release , Qualified Person Pharmacovigilance (QP-PV) and Medical Director services.
We also support establishing quality assurance system management, writing SOPs, audits, mock audits, quality and technical agreements.
Need more information? Contact us here.