Medicinal Products
End-to-end support from experienced Regulatory experts.

Medicinal Products Regulatory Support in Israel – Overview

Israel’s pharmaceutical market is highly advanced, influenced by its strong biotech ecosystem, innovative R&D infrastructure, and stringent Regulatory framework aligned with global standards. The Ministry of Health (MoH) ensures all medicinal products undergo rigorous evaluation for quality, safety, and efficacy before marketing.

To obtain Marketing Authorization, companies must submit a CTD-format dossier, present valid GMP certification, comply with local pricing frameworks, and meet Hebrew labeling requirements.

Freyr supports pharmaceutical manufacturers and importers throughout the entire Regulatory process — ensuring accurate dossier compilation, compliance with MoH guidelines, and timely approvals.

Medicinal Product Classification in Israel

Under the Israel Pharmacists Ordinance, MoH regulations, and updated pharmaceutical directives, products are classified as follows:

• Prescription Medicines (Rx): Dispensed only with a physician’s prescription.
• OTC Medicines: Approved for self-use with proven safety profiles.
• Biologicals & Biosimilars: Require extensive analytical comparability, nonclinical and clinical data.
• Controlled Substances: Regulated under narcotic and psychotropic substance laws; require additional licensing.
• Herbal & Natural Products: May fall under CAM (Complementary & Alternative Medicine) or pharmaceutical category depending on claims and ingredients.

All products must be registered with the MoH before marketing or distribution. Unregistered product sales are prohibited.

Medicinal Product Registration & Approval Process in Israel

Regulatory Authority: Ministry of Health (MoH) – Pharmaceutical Division & MTI
Legislation: Pharmacists Ordinance, MoH Directives for Medicinal Products, Medical Devices & Clinical Trials

Key Steps:

1. Licensing

• Foreign manufacturers must appoint a local Registration Holder (MAH).
• Manufacturing sites must hold valid GMP certification recognized by the MoH.

2. Dossier Submission

• Submitted in CTD format (Modules 1–5).
• Requires CPP, GMP certificates, quality data, stability studies, and Hebrew labeling content.

3. Technical Evaluation

• MoH conducts administrative and scientific review.
• Evaluation includes quality, safety, efficacy, and reference country approvals.

4. Pricing Approval

• Prices regulated under the Uniform Price List for Prescription Medicines.
• Pricing Committee approval is required prior to commercialization.

5. Marketing Authorization (MA) Grant

• MA issued upon successful review; validity aligned with MoH regulations.

Post-Authorization Requirements

• Hebrew/Arabic labeling compliance.
• Import permits for each shipment.
• Local pharmacovigilance system under a Qualified Person (QPPV).

Specific Requirements by Product Type 

• Generics: Require bioequivalence studies or justification per MoH guidance.
• Biologics/Biosimilars: Must comply with EMA/ICH/WHO comparability guidelines, plus MoH-specific evaluation.
• Vaccines: Require batch release and oversight from the MoH Central Laboratories.
• OTC Products: May follow a simplified pathway but must meet strict safety and labeling criteria.

Post-Approval & Pharmacovigilance

Registered products undergo continuous oversight by the MoH:

• Renewals: Required periodically with updated safety and quality documentation.
• Variations: Any changes in formulation, manufacturing, labeling, or site must be pre-approved.
• Pharmacovigilance: MAH must operate a local QPPV and manage ADR reporting per Israeli PV standards.
• Market Surveillance: Includes inspections, sampling, recalls, and safety updates.

Freyr provides comprehensive lifecycle support to maintain compliance and product quality across Israel.