The Appointed Pharmacist

The Appointed Pharmacist has an important role in the pharmaceutical company.

An Appointed Pharmacist is a must legally in order to submit applications for registration and other regulatory submissions with the Ministry of Health.

He/ She is appointed usually by the managing director of the company, who applies to the Ministry of Health for their approval and nomination.

The Appointed Pharmacist is legally responsible vis a vis the Ministry of Health on any professional matters and issues, relating to the pharmaceutical preparations he/ she is in charge of according to his nomination.

All in accordance with Pharmacists Ordinance (new version) – 1981, the Pharmacists Regulation (preparations) – 1986 and guidelines published periodically by the Ministry of Health.

The Ministry of Health  views the Appointed Pharmacist a central point of contact responsible and accountable for all matters related with the preparations he is in charge of.

Key responsibilities of the Appointed Pharmacist:

• Submissions of new/ renewal/ variations/ cancellation applications of a pharmaceutical product to the Pharmaceutical Administration and Standards Institute of the Ministry of Health
• Ongoing supervision on marketing in accordance with license terms
• Handle applications of variations and changes in the registration/ marketing authorization license
• Submission of updates to label (physician / patient inserts) and assure implementation in marketed product
• Pharmacovigilance surveillance and Serious  Adverse Events  reporting
• Reporting of changes in clinical information emerging in Israel and abroad
• Report manufacturing deviations and malfunctions as required by the Ministry of Health
• Submission for inclusion or removal from National Health Basket list (reimbursement)
• Submission of requests for advertising of OTC and Rx drugs and assure advertising compliance
• For a local manufacturer – update the responsible pharmacist (Qualified Person, QP) and quality assurance managers regarding Ministry of Health  guidelines and update on approvals to variations and changes relating to manufacturing, including source of API’s

The Appointed Pharmacist is considered accountable for his products until he sends a notice in writing to the Ministry of Health regarding the end of his role and or to the appointing party (company). When an Appointed Pharmacist terminates its role, a replacing Appointed Pharmacist must be nominated immediately. Otherwise, the Ministry of Health will cancel the marketing authorization licenses of the registration owner.

The Appointed Pharmacist must be well acquainted and have vast experience and knowledge of all the laws, regulations, guidelines, circulars and current requirements of the Israeli Ministry of Health.

He/ She must also be proficient and have vast body of knowledge regarding the quality, safety, control and efficacy related to his products.

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.