Israel Pharmaceutical Licensing

This guide covers retail pharmacy operations for human medicines, wholesale / storage / distribution by pharmaceutical trading enterprises, and manufacturing or import businesses. Nationwide pharmacists’ regulations, GMP rules and Ministry of Health procedures apply alongside local business licensing. A product registration certificate alone, or an individual practice certificate alone, does not authorise all activities.

The new drug registration service allows an overseas holder of medicinal product rights or its representative in Israel to apply for product registration. However, the materials accessed in this review did not provide a uniform answer on foreign ownership percentages, company forms or minimum capital applicable to all pharmacies, trading enterprises and manufacturers. Before investing or acquiring a business, verify the requirements for the proposed location and scope of business with the competent authority in writing.

— An applicant for product registration may be the Israeli representative of a medicinal product manufacturer or an overseas rights holder, but the application must be submitted by a licensed pharmacist authorised by the Ministry of Health.

— For local business licensing, “change of ownership” includes adding or removing registered licence holders and a transfer of company control; this is not a rule for the automatic transfer of a Ministry of Health pharmaceutical authorisation.

The Ministry of Health Pharmaceutical Division provides services for medicinal product registration, renewal, registration changes, import licences and the medicinal product register. Its district pharmacists have regional responsibilities closely connected with the professional management of pharmacies and pharmaceutical trading enterprises. The GMP supervisory unit of the Institute for Standardization and Control of Pharmaceuticals is responsible for MIAs, GMP / GDP certificates and the corresponding inspections.

The GMP supervisory unit states that its inspection authority is based on the 2008 Pharmacists Regulations (Good Manufacturing Practices for Medicinal Products) and the 1981 Pharmacists Ordinance. The district pharmacist supervises GDP for independent distribution.

— Medicinal Product Registration Department: product marketing registration, changes and renewal.

— Medicinal Product Import and Controlled Drugs Department: import approvals and import/export of controlled substances.

— Local business licensing authority: pharmacy business licences, premises and licence changes.

The officially hosted text of the Pharmacists Ordinance provides that retail sales of medical products, prescription products and medical poisons must be conducted by a pharmacist and in a pharmacy. Statutory exceptions for non-prescription medicines must comply with conditions established by the Minister under the law. A pharmacy owner must entrust professional management to a responsible pharmacist approved by the competent authority.

Pharmacy operations are also subject to the business licensing system. A business licence application must include an environmental plan, an existing-conditions plan and an operating plan, signed by a qualified professional. The uniform specifications are not a licence and do not waive requirements under other laws or Ministry of Health rules.

— Confirm the pharmacy business licence, planning / fire-safety requirements and any additional local conditions with the local licensing authority.

— Apply to the district pharmacist for the area where the premises are located for approval of the responsible pharmacist’s professional management.

— Establish internal pharmacy procedures, staff registers, recall records and prescription records before commencing operations.

A pharmaceutical trading enterprise is an enterprise approved by the competent authority, managed by a responsible pharmacist, and used for the wholesale sale / distribution and storage of medicines or pharmaceutical raw materials. Official procedures define “distribution” to include activities such as procurement, storage, transport and supply, and expressly exclude retail distribution.

The person responsible for a wholesale enterprise must ensure that the law, GDP and Ministry of Health procedures are implemented, including requirements for storage and transport conditions, quality complaints, recalls, defect reporting, controlled drug management, documentation and training. An enterprise may not operate without an approved responsible person.

— Establish supplier / customer qualification, a quality system, deviation and corrective and preventive action processes, internal audits and risk management in accordance with GDP.

— Retain records of batches, procurement, supply, recalls, complaints, environmental excursions, destruction and the movement of controlled products.

— Confirm that independent distribution is supervised by the district pharmacist; if distribution is an activity covered by an MIA, also liaise with the GMP supervisory unit.

The principal authorisation for companies manufacturing or importing medicinal products is the MIA. The Ministry of Health’s GMP Supervision Unit states that it issues manufacturer/importer approvals and oversees compliance through quality-system, infrastructure, and activity inspections; the MIA describes the activities that are actually authorised for the business.

The principal MIA application procedure requires the business to be inspected and comply with GMP, to hold a business licence where required, and to appoint suitably qualified personnel for the relevant duties, including a QP, Quality Assurance Manager, Head of Production, or other key personnel.

— The application should specify the product/API categories and authorised activities for manufacturing, import, or export.

— Submit information such as site and engineering layouts, facility suitability, process/personnel/material flows, and CVs and declarations for key personnel.

— Before adding an outsourced site or outsourcing manufacturing, obtain any required prior approval under the procedure and verify that the relevant quality documents are valid.

Individuals practising as pharmacists must hold a licence from the Ministry of Health. The Ministry’s page on individual practice lists general requirements, including pharmacy studies at a recognised institution and practical training, and explains that overseas qualifications are subject to separate recognition and review of training/experience. This is an individual professional qualification, not a business authorisation.

Appointment of a Responsible Pharmacist is approved by the District Pharmacist. Procedure 16 generally requires a valid Israeli pharmacist’s licence, at least 2 years of practical experience after obtaining the licence, and familiarity with pharmacy legislation and Ministry of Health procedures; the work arrangements for a pharmacy, pharmaceutical trading company, or other applicable setting must be described in the application. A QP under an MIA is separately included in the MIA under EX-017/01.

— The Responsible Pharmacist application includes an application from the candidate and owner, a copy of the licence, CV/qualifications, work arrangements, resource commitment, and a copy of the applicable business licence.

— A QP application under an MIA also includes the site/business category, the candidate’s education and experience, a copy of the company’s business licence, and a statutory declaration.

— Departure, extended absence, or a change in a key position should trigger timely notification, appointment of a replacement, or an update application.

A pharmacy business licence application should include an environmental plan, an existing-state plan, and an operating plan; the Responsible Pharmacist procedure and pharmacy documentation procedure also require retention of a pharmacy plan signed by the District Pharmacist. Confirm the specific planning, fire-safety, premises, and local additional requirements with the licensing authority for the proposed location.

Wholesale GDP requires premises appropriate to the products, segregation by status, temperature/humidity monitoring and mapping, controlled access, equipment maintenance, and transport controls. An MIA manufacturing application requires engineering plans, the use and dimensions of each room, and applicable information such as air handling and pressure differentials, as well as verification of facility suitability.

— Clearly segregate products for sale, quarantined products, returns, recalls, products awaiting destruction, and controlled products by status.

— Establish records for temperature and humidity, equipment calibration, alarms, access control, cleaning, pest control, and transport.

— Before renovation, relocation, or a change in area or structure, initiate an assessment of business-licence and Ministry of Health MIA/Responsible Pharmacist amendments.

A retail pharmacy usually needs to progress the local business licence and the District Pharmacist’s approval of the Responsible Pharmacist in parallel. A trading company should first put a Responsible Pharmacist and GDP system in place and be subject to the applicable district/GMP oversight according to its actual activities. For manufacturing or import, the Quality Assurance Manager applies for the MIA to the GMP Supervision Unit; the competent authority decides on the basis of document review, inspection, and compliance results.

The MIA application requirements include the product/API scope, engineering and business information, key personnel, business licences for outsourced sites, and fee receipts. Do not assume that incomplete documentation has been accepted or that any activity is authorised.

— Determine the legal entity, proposed address, business scope, product types, storage and transport model, and whether controlled substances are involved.

— Prepare tiered documentation, including business-licence drawings, Responsible Pharmacist/QP appointment documents, the quality system, premises, and outsourcing agreements.

— After submission, retain version-controlled evidence of receipt, requests for additional information, inspections, approved scope, and conditions.

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The Ministry of Health’s fee services list fee categories for manufacturer/importer approvals, GMP compliance audits, copies of GMP confirmations, and major/other changes, but this review does not treat the payment page as a uniform current fee schedule. New medicinal product registration and renewals also have separate fees; refer to the government fee system and the competent authority’s notices at the time of submission.

Procedure 16 states that a complete Responsible Pharmacist application is generally decided within 14 working days, that approval is generally valid for up to 5 years, and that renewal should be submitted at least 60 days before expiry. MIA renewal should be submitted at least 120 days before expiry; EX-015/02 states that an application/renewal decision is generally made within 90 days, that requests for additional information may add up to 30 days, and that the MIA is valid for 5 years. These provisions apply only to the specific procedures cited.

— The controlled-drug import/export page lists separate applications for each substance and states a processing time of 21 working days.

— The general medicinal product import service page also lists 21 working days, but requests for additional information, conditional approval, product category, and other approvals affect actual completion.

— The initial marketing authorisation under a medicinal product registration certificate is for 5 years; the renewal page states that it may be extended for 10 years after renewal. This is a product-registration period, not a premises or MIA validity period.

Ongoing pharmacy obligations include retaining legislation and internal procedures, lists of registered products, employee registers, training, recalls, quarterly reports, internal audits, and plans signed by the District Pharmacist; Procedure 195 also sets different retention periods for prescriptions, controlled drugs, recalls, and audit records.

Wholesale companies must continuously maintain a GDP quality system, environmental and transport controls, traceability records, and procedures for handling complaints/deviations/recalls. MIA holders must maintain GMP, undergo periodic or for-cause inspections, and track MIA expiry and changes to the QP/key personnel, buildings, outsourced parties, and actual activities.

— Retain recall, controlled-drug, and prescription-related records in accordance with pharmacy procedures and ensure they are available for inspection.

— Maintain records under GDP for suppliers/customers, transport, temperature-control deviations, returns, destruction, and training.

— Arrange MIA renewal before expiry under the applicable procedure and keep the quality system, business licence, and key positions continuously valid.

The unified pharmacy business-licence specifications define the addition or removal of a licence holder and the transfer of company control as a “change of ownership.” If the business category, structure, area, ownership, location, or activities change from those recorded or attached, the business licence or temporary licence may become invalid; changes that may affect compliance with the licence must be reported to the approving authority at least 3 months in advance and handled as directed.

MIA holders must update information on key positions, buildings/premises, outsourced parties, and other matters stated in the authorisation. Major business changes and changes to key personnel, production lines, product/API categories, technology, or outsourcing require an update application; outsourced manufacturing also requires prior approval. A Responsible Pharmacist ceasing work should generally be reported at least 14 days in advance; an approved replacement must be arranged for an absence exceeding 14 days.

— Shareholding or control transaction: first check whether the pharmacy business-licence records and all Ministry of Health approvals require reapplication, updating, or inspection.

— Relocation/renovation/change of area: do not merely update company details; trigger review of premises plans, business licence, GDP, or MIA amendments.

— Responsible Pharmacist/QP change: submit departure, candidate, replacement, and MIA/Responsible Pharmacist update documentation under the applicable procedure.

Product marketing registration is separate from business authorisation. The Ministry of Health’s new drug registration page states that a medicinal product must be registered in the Register of Medicinal Products before it is manufactured, imported, or marketed in Israel, and that registration is granted only after efficacy and appropriate manufacturing have been confirmed. Registration applications, searches of the Register of Medicinal Products, and renewals are handled by the Pharmaceutical Division. The renewal page states that a product registration certificate is initially granted for 5 years and must be renewed under the procedure for marketing to continue.

Import is also a separate licensing step. An application to import a registered medicinal product must be submitted online by the registration holder or Responsible Pharmacist and include, among other things, product registration, manufacturer/importer authorisation, a letter of authorisation, and a declaration by the Responsible Pharmacist. The general import page states that registration is usually required first, although unregistered medicinal products may be imported in the special circumstances specified in Regulation 29. Controlled drugs, psychotropic substances, or precursors require separate import/export permits for each substance, and a document signed by the District Pharmacist must first be obtained.

— First check whether the product is in Israel’s Register of Medicinal Products, then apply for an import permit according to the product and importing entity.

— Import/export of controlled substances: apply separately for each substance; permit holders must also submit annual reports as required by the page.

— A specific service for consignment-by-consignment export of non-controlled finished medicinal products was not located in the public materials reviewed; do not mechanically apply controlled-drug export permits or import permits to ordinary exports.