Who this service is for
For manufacturers, rights holders, Israeli affiliates and importers planning a new registration or assessing whether an existing dossier is ready for Israel. Each product needs an assessment of its own evidence, approval history and intended local use.
Deliverables we can agree with you
- A dossier gap assessment identifying missing information, dependencies and questions for the manufacturer.
- A submission plan with responsibilities and required local documentation.
- Coordination of dossier components, proposed product information and administrative materials within the agreed scope.
- A tracker for authority questions, responses and outstanding items through the submission process.
How the work progresses
Assess the product and dossier
Review the medicine, overseas approval status, available quality and clinical documentation, and the intended application.
Prepare the local submission
Coordinate the necessary materials with the authorized parties and check consistency across documents and product information.
Manage follow-up
Organize responses to Ministry of Health questions and connect approval-related work to lifecycle planning.
What to prepare for an initial conversation
Useful starting information includes the active substance, dosage form, strengths, indications, manufacturer, existing approvals and a dossier contents list. The Ministry of Health's service guidance states that a new-drug application must be submitted by an authorized licensed pharmacist.
Service scope
Submission planning is product specific. Overseas approval does not by itself replace the Israeli assessment, and a consultancy cannot promise a Ministry of Health decision or a fixed approval date.
Common questions
Does Medicalix support generic and biological medicines?
Yes. The scope includes human medicines such as generics and biologics. The proposed application and supporting dossier are assessed before the work plan is agreed.
How long does drug registration in Israel take?
There is no single reliable timetable for every application. Product type, dossier completeness, the applicable pathway and authority questions all affect the schedule. A planning estimate should follow a product-specific review.
What happens after registration?
The product needs ongoing regulatory maintenance. Medicalix can support renewals, variations, leaflet and labeling updates and coordination with the manufacturer under a separate or continuing scope.
Official sources
Consulted when preparing this page on 14 October 2026. Check the applicable current guidance before acting.