Pharmaceutical and drug product registration and submissions in Israel

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Pharmaceutical and drug product registration and submissions in Israel

2020-08-30T11:01:38+00:00March 18th, 2019|

The process of pharmaceutical and drug product registration in Israel

The main regulatory body for pharmaceutical administration in Israel is the Registration Department of the Ministry of Health of the State of Israel (IMOH). The department activities are based on the Pharmacy Regulations of 1986. The regulations are periodically updated.

According to the pharmacy regulations, a medicinal product must be registered in the National Drugs Registry after its quality, safety and efficacy have been proven. The IMOH registration department is responsible for the content of the drug product registry and for updating it.

The main goal of registration is, obviously, to protect public health and it acts as a barrier to the marketing of poor quality and dangerous/unsafe/adulterated medicines. It also enables physicians to prescribe, with a high degree of confidence, safe and effective medicines to patients.

The IMOH registration department sets policies and procedures for the registration of medicinal preparations containing new substances (innovative products) as well as generic medicines, makes rules regarding limitations to marketing of medicines, and provides information to the public, patients and physicians by publishing leaflets, labels, policies on approval of medicine advertising and promotional materials, and more.

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Pharmaceutical (drug) product registration requirements in Israel

Before and during the IMOH product registration process, you need to ensure the quality, safety and efficacy of the medicinal product.
The registration holder must adhere to strict regulatory requirements, including the following :

  • Every pharmaceutical product must have a registration file.
  • The registration holder, via an authorized (licensed) pharmacist, may register a pharmaceutical product in Israel.
  • The registration holder must be an official, Israeli representative of the drug product manufacturer/rights owner.
  • Appointing a QP pharmacist/local consulting firm who will be responsible for all medicine registration activities and interactions with the IMOH.
  • Submission of a registration file and sample analyses (if necessary) for marketing a new medicine.
  • Reporting and monitoring of possible variations in the registration conditions of medicine.
  • Updating the information about the registration condition, when required, and being aware of regulatory changes in the country.
  • To guarantee efficacy, perform marketing activities for the appropriate audience.
  • If the medicine is manufactured outside of Israel, obtain an annual import license/approval.

The pharmaceutical/medicinal/drug product registration process in Israel

  • Completion of application forms and submission of relevant documents based on pharmaceutical product type.
  • The documents will be reviewed by the IMOH registration department. Documentation will also be reviewed by the Institute of Control and Certification of Pharmaceutical Materials in order for them to issue quality certification for the product.
  • The application will be forwarded to the relevant committee discussion.
  • After quality certification approval, the process will be continued at the registration department.
  • If no deficiencies are found, the drug product will be registered.

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Contact us for medicinal/pharmaceutical/drug product registration advice.
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