Regulatory services in Israel

Local entity and regulatory representation support in Israel

Medicalix helps international companies assess and arrange a local entity solution for pharmaceutical and medical device activities in Israel. The starting point is the role the entity needs to perform, the product involved and the responsibilities that must sit with each party.

Discuss this service

Who this service is for

For companies entering Israel without their own affiliate, companies considering an independent local structure, and manufacturers reviewing their existing representation arrangements. The assessment connects the regulatory plan with the commercial operating model.

Deliverables we can agree with you

  • A comparison of an existing Avner-owned entity, your own Israeli entity or a suitable third-party arrangement.
  • A map of the proposed entity's role, required authorizations and interfaces with other providers.
  • A responsibility framework covering product records, communication, documentation access and transitions.
  • An implementation plan identifying regulatory, operational and specialist legal or corporate workstreams.

How the work progresses

  1. Define the activities

    Clarify what you plan to register, import or support, who owns the product rights and which parties are already involved.

  2. Compare operating options

    Consider the available entity models against responsibilities, continuity, document access and your longer-term business plans.

  3. Agree the arrangements

    Define the scope, authorizations and division of responsibilities before implementation with the relevant specialists.

What to prepare for an initial conversation

Share the product category, existing approvals, intended Israeli activities, expected counterparties and your preferred commercial model. Identify whether you need an ongoing local structure or a solution for a particular project.

Service scope

An existing entity is not automatically authorized for every pharmaceutical or device activity. Availability, suitability, formal roles and required permissions are assessed for each engagement. Corporate, tax and legal matters need the appropriate specialist input.

Common questions

Do we have to establish our own Israeli company?

The appropriate structure depends on the product and intended activities. Medicalix can help compare your own entity with an existing entity or a suitable partner arrangement before deciding how to proceed.

Does local entity support include every regulated role?

No. The entity's role and the responsibilities of the Appointed Pharmacist, QP, QPPV, importer and other parties must be defined separately where relevant. A single engagement should not be assumed to cover them all.

Can the model support a later change of partner?

Transition arrangements can be considered from the start, including access to records, document ownership and handover responsibilities. Any formal transfer must follow the applicable requirements.

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