The process of pharmaceutical drug products registration in Israel
The main regulatory body in the pharmaceutical administration in Israel is the Registration Department of the Israeli Ministry of Health (IMOH). The department’s action is based on the Pharmacist’s Regulations from 1986 that are being updated periodically.
According to the Pharmacist’s regulations, all medicinal products must be registered in the National Drugs Registry after its efficacy, quality and safety has been proven. The IMOH registration department is responsible for the content of the drug product registry and for updating it.
The main goal of this registration is obviously to protect public health and acts as a barricade to the marketing of poor quality and dangerous/unsafe/adulterated medicines, but it also enables physicians to prescribe medicine to patients with a high degree of confidence.
In the Israeli Registration Department, policies and procedures are set regarding the registration of preparations of a medicine containing new substances (innovative products) as well as generic ones, rules regarding limitations to the marketing of a medicine, information to the public, to patients and physicians by means of leaflets, labels, policy regarding approval of advertising of medicines, and more.
Pharmaceutical products registration requirements in Israel
Before and during the product registration process in the IMOH, you need to ensure the efficacy, safety and quality of the medicines. Strict regulatory requirements were determined for the registration holder. Among others, one must comply with the following:
- Every pharmaceutical product need to have a registration file.
- The registration holder via an authorized pharmacist will be allowed to register the pharmaceutical product in Israel.
- The registration holder has to be an official Israeli representative of the drug product manufacturer/rights owner.
- Appointing a QP pharmacist/local consultancy firm who will be responsible for all medicine registration actions with the Israeli Health Ministry.
- Submit a registration file and samples analysis (if necessary) for marketing a new medicine.
- Reporting and monitoring of possible variations in the registration condition of a medicine.
- Updating the information about the registrations conditions when required and being aware of changes in the country.
- To guarantee efficacy, one should perform marketing activities for the right audience.
- If the medicine is manufactured outside of Israel, you will need an annual import approval.
Pharmaceutical/medicinal products registration process in Israel
- Filling application forms and submission of the relevant documents based on pharmaceutical product type
- The documents will be reviewed by the Israeli registration department in the pharmacy department of the IMOH in parallel to the institute of control & certifications of pharmaceutical material in order to generate a quality certification.
- The application will be forwarded to the relevant committee discussion.
- After quality certification approval, the process will be continued in the registration department.
- In case no discrepancies were found, the drug product will be registered.