In Israel, pharmaceuticals and medical devices are regulated by various legislative acts and regulatory bodies. What follows is a summary of the main legislation and regulatory bodies.

• The main legislations for pharmaceuticals are the Pharmacists Ordinance of 1981 and the Pharmacists Regulations (Preparations) of 1986.
• The Minister of Health and the Ministry of Health (MoH) are the main regulatory bodies. The MoH is the government agency responsible for public health policy and regulation in Israel. It oversees and regulates pharmaceuticals and medical devices, as well as healthcare (providing services through state, mental health and geriatric hospitals), and issues guidelines relating to the various matters for which it is responsible.
• The Pharmacy Department of the MoH oversees the regulation of pharmaceuticals. This includes registration and monitoring of pharmaceutical preparations or medicinal drugs, manufacturing plants, importation/exportation, advertisements, and clinical trials.
• The main pieces of legislation dealing with medical devices are the Medical Device Law of 2012 and the Medical Devices Regulations (Registration of Medical Equipment in the Register and its Renewal) of 2013. Although the Medical Device Law of 2012 has yet to formally enter into force, the relevant actors are conducting themselves in accordance with it.
• The MoH’s Medical Device Division (AMAR) oversees the regulation of medical devices, including registration and monitoring.
• In addition, Israel’s National Health Insurance Law of 1994 and those regulations and orders issued in accordance therewith ensure funding for a standardised healthcare package. This package encompasses a range of medical products and services and is regularly updated.
• All Israeli residents are covered by one of four statutorily organised Health Maintenance Organisations (HMOs), based on personal choice, which serve both as insurers and providers of these healthcare services. Some HMOs also manage public hospitals.
• Additional relevant legislation is the Public Health Ordinance of 1940, which relates to clinical trials, epidemics, and more.

Decisions made by Israeli regulatory bodies are subject to various legal and administrative challenges.

Although there is no process similar to the United States Food and Drug Administration (FDA) citizen petition procedure in Israel, the applicable law provides procedures to challenge decisions (administrative procedures) in certain instances. By way of example, a registered pharmaceutical preparation owner may object to the MoH’s decision not to renew the registration thereof before the MoH’s director (or others in the MoH who are authorised by the director to hear such claims). Another example is individuals seeking funding for treatments not covered by the standard healthcare package (eg, for off-label or compassionate use), who may apply to their HMO’s special committee. Decisions made by these committees can be appealed before the labour courts.

In addition, any Israeli citizen has the right to file an administrative appeal with the administrative courts against the decision of any authority, provided that the decision pertains to matters outlined in the Administrative Matters Courts Law of 2000. In the healthcare sector, decisions subject to challenge may include those entered under the Pharmacists Ordinance of 1981, the National Health Insurance Regulations of 2012, the Organ Transplantation Law of 2008, the Public Health Protection (Food) Law of 2015, and any authority’s decision concerning importation under any law, including specific decisions regarding importation licences.

Moreover, governmental decisions can be challenged before the Supreme Court. The Supreme Court also hears appeals and applications for leave to appeal lodged against decisions of the district courts serving as administrative matters courts.

In January 2025, the MoH published a draft bill titled the “Healthcare Services Quality Assurance Law 2025” for public opinions and comments. The bill aims to improve compliance, enhance the MoH’s regulatory role, and strengthen enforcement by introducing measures such as a broader authority to demand information, levying financial penalties, and the expansion of the MoH’s oversight of HMOs and medical institutions.

There are two main categories of pharmaceuticals and medical devices in Israel – namely, registered and non-registered. These can be divided into further categories, as described here.

Registered Pharmaceuticals

A “preparation” or “medicinal drug” should be registered in the Israeli Drug Registry according to the MoH’s requirements (see 3.1 Product Classification: Pharmaceuticals or Medical Devices). Registered preparations can be further categorised as follows.

• Prescription Only (Rx) – prescription-only preparations may be provided only to consumers with a prescription at pharmacies and by certified pharmacists.
• OTC Medicines – P (Pharmacist) ‒ a preparation whose provision does not require a prescription yet is provided only in pharmacies by certified pharmacists.
• OTC – General Sale List (GSL) – non-prescription preparations that may be provided to consumers not by pharmacists and outside pharmacies, according to the Pharmacists Regulations (sale of a preparation without a prescription not in a pharmacy or not by a pharmacist) of 2004 and the MoH guidelines of 2011. The regulation includes a list of the active pharmaceutical ingredients (APIs) that may be included in GSL preparations.

Non-Registered Pharmaceuticals

The general rule is that it is not possible to provide consumers with a preparation unless it is registered. This is also the case for off-label uses of registered preparations, as was determined by the Israeli Supreme Court in the Tibet case of 1984.

However, the MoH may allow specific preparations to be imported, manufactured or marketed without registration or in an off-label manner for uses such as research or essential treatments or for export purposes, provided the MoH determines it will not negatively impact public health. Such allowances may also be made in cases of non-commercial quantities for personal use, preparations made in Israel or imported for registration purposes, preparations intended for treating epidemics, and registered preparations for off-label use by medical institutions for their patients. The MoH’s guidelines provide more details on such cases (see also 3.5 Access to Pharmaceuticals and Medical Devices Without Marketing Authorisations).

Registered Medical Devices

Medical devices should be registered in AMAR’s Medical Device Registry.

Non-Registered Medical Devices

The Medical Device Law of 2012 allows the Minister of Health to issue regulations that exclude certain types of medical devices from the registration requirement for purposes such as R&D, export, emergency, and more. A draft of such regulations was published in August 2023 for public comments but has not yet been enacted.

The Public Health Ordinance of 1940 and the Public Health Regulations (Medical Experiments on Humans) of 1980, which apply the Declaration of Helsinki, are the main legal acts overseeing clinical trials in Israel. In addition, several MoH guidelines and circulars apply. For actors interested in conducting trials in Israel, the main guideline is Guideline 14 on Medical Experiments on Humans (2020), which governs the submission and approval of clinical trials.

The guidelines include the requirement that the principal investigator adhere to international Good Clinical Practice (GCP) guidelines and ISO 14155 (Clinical Investigation of Medical Devices for Human Subjects).

In addition, legislation relevant to the realm of the specific research may apply, such as the Physicians Ordinance of 1976, the Patients’ Rights Law of 1996, the Genetic Information Law of 2000, privacy laws, the Medical Device Law of 2012 and standards, the Prohibition of Genetic Intervention Law (Human Cloning and Genetic Modification of Reproductive Cells) of 1999, and the Dangerous Drugs Ordinance of 1973.

The procedure for securing authorisation to conduct clinical trials in Israel is outlined in the Public Health Regulations (Medical Experiments on Humans) of 1980 and MoH Guideline 14 on Medical Experiments on Humans (2020), as described in 2.1 Regulation of Clinical Trials. The approval process entails a dual scrutiny mechanism involving assessment by both the medical institution’s Helsinki Committee and the MoH. In many kinds of “specialised medical trials”, as defined in the Public Health Regulations (Medical Experiments on Humans) of 1980 (eg, trials on registered preparations and medical devices), approval by the institution’s director is sufficient.

Trials relating to human genetics, non-natural female fertilisation, and others determined by the MoH require the opinion of the Higher Helsinki Committee. This committee may also approve urgent medical cases where the informed consent of a trial participant cannot be given.

Trials on existing data or questionnaires also require approvals and have specific instructions in the guidelines.

Multi-centre trials are evaluated by a dedicated national committee, according to MoH Guideline 168 of 2023.

According to MoH Guideline 14 on Medical Experiments on Humans (2020), the initiation of a clinical trial is contingent upon its registration within the MoH’s MyTrial website. The information presented on the MyTrial website includes details of the disease/medical condition, the intervention being tested and how the trial is conducted, as well as criteria for inclusion and exclusion, a list of the centres where the trial is conducted, and contact details for obtaining further information.

Exemptions from registration on the MyTrial website can be requested from the Helsinki Committee. They can be based on reasons of IP in feasibility trials, as long as the trial was not registered on the USA’s National Institutes of Health (NIH) website.

The use of digital means in the process of obtaining informed consent is regulated under MoH Guideline 169/01. The guideline refers to the use of digital means in presenting the information to the participants and verifying their understanding, as well as the use of such means in obtaining informed consent and documenting the process. The use of such digital means requires the approval of the Helsinki Committee as part of the approval of the trial.

In addition, restrictions under additional laws and regulations exist, such as those outlined in 2.5 Use of Data Resulting From Clinical Trials.

The informed consent forms provided in MoH Guideline 14 on Medical Experiments on Humans (2020) state that the consent to participate in the trial also includes consent for medical and personal information collected during the trial to be transferred to an external party for data processing. The information is to be transferred in an encoded form, free of identifying details, with the link between the code and the identifying details being kept securely by the Principal Investigator in Israel. Changes in these forms require the approval of the Helsinki Committee.

In addition, to the extent that the resulting data from the trials amounts to a database containing identifying information about an individual (eg, their health status), it should be considered a database of “sensitive data” according to the Protection of Privacy Law of 1981. The use of such a database is subject to the provisions outlined in the law and regulations ‒ examples of which include the following.

• If an external service provider needs access to the database in order to provide a service, the agreement with such service provider must include provisions set forth in the Protection of Privacy Regulations (Data Security) of 2017 (such as provisions referring to the data security implementation, confidentiality, and annual reports).
• Transfer of data from such a database to a third party outside Israel is governed by the Protection of Privacy Regulations (Transfer of Data to Databases Outside the State Borders) of 2001. These regulations set out conditions for transferring data abroad ‒ for example, the transferee must undertake to comply with the conditions for data retention and use applying to a database located in Israel, or the transferee must be a corporation under the control of a database owner that has assured the protection of privacy after the transfer.

Two MoH circulars from 2018 relate to secondary uses of health data and collaborations based on such data. The circulars include various measures to protect the data, such as de-identification, requirements for approvals, and security measures.

If the data in the database is identifying, then the database should be subject to the provisions of the Protection of Privacy Law of 1981 and its regulations, including those described in 2.5 Use of Data Resulting From Clinical Trials. This may require registration of the database if sensitive information such as health conditions are included, more than 10,000 persons are included in the database, or for other reasons defined in the law. Such inclusion may also require the implementation of adequate security measures stipulated in the Protection of Privacy Regulations (Data Security) of 2017. Amendment No 14 of the Privacy Protection Law of 1981 – currently under legislative procedure ‒ seeks to revise the definition of “sensitive data” to encompass, inter alia, medical data as defined in the Patients’ Rights Law of 1996 and genetic data as defined in the Genetics Information Law of 2000.

According to the Pharmacists Ordinance of 1981, “preparation” or “medicinal drug” is any form of substance that has properties for curing or preventing a disease or for the treatment of a disease ‒ or that is presented as having such features that cause (or is given for the purpose of causing, restoring, replacing, repairing or changing) a physiological action in the body through pharmacological, immunological or metabolic action ‒ and is given (or can be given) for medical diagnosis.

The Medical Device Law of 2012 excludes preparations (see 1.3 Different Categories of Pharmaceuticals and Medical Devices) from the definition of “medical device” but includes any of the following:

• a device used for medical treatment, as well as a device or computer software required for operating such a device ‒ for this purpose, “device” includes an accessory, chemical substance, biological product, or biotechnological product;
• contact lenses; and
• an electrical device that emits ionising or non-ionising radiation used for cosmetic treatment.

Additionally, in 2002 (a decade before the Medical Device Law of 2912 was enacted), the MoH issued a guideline classifying medical products that combine preparations and medical devices or whose classification is unclear/disputed (MoH Guideline 47). The guideline includes rules on how to classify the product, as well as the classifications of specific products (such as bandages containing medical material, biological glue, ultrasound gels, condoms, and more).

Requests for early designation may be filed with the medical assistant at the Preparations Registration Department or AMAR in the MoH. Appeals are made to the deputy general director of the MoH.

In general, registration of original biologic medicinal products (which makes it possible to market those products – see 3.4 Procedure for Obtaining a Marketing Authorisation for Pharmaceuticals and Medical Devices) requires that a quality certificate be obtained from the MoH for that product.

Where a biosimilar – namely, a pharmaceutical comprising a biological active ingredient that is similar to the active ingredient of an already-registered original biologic pharmaceutical – is concerned, MoH Guideline PRA-127/03 is applied. The guideline adopts the European Medicines Agency (EMA)’s policy regarding registration ‒ with changes ‒ and registration is usually dependent on showing actual registration for the biosimilar (or a positive opinion regarding it) from one of several foreign countries, as well as on the provision of data proving that there is no significant difference in aspects of quality, safety and efficacy between the biosimilar and the original biologic medicinal product.

The basic requirement for marketing pharmaceuticals and medical devices is their registration. The initial period of validity for such registration is typically no more than five years and is subject to renewals. In certain circumstances, the MoH may prohibit the marketing of a preparation or medical device, revoke its registration, and take any action required to ensure public health.

Pharmaceuticals

In general, retail marketing of preparations can only be done by pharmacists in pharmacies. Wholesale marketing of preparations can be carried out only by “pharmaceutical trading houses”, which store, distribute, and transport preparations or raw materials.

According to the Pharmacists Regulations (Preparations) of 1986, the first registration of a preparation must not exceed five years. A renewal may be limited or unlimited in time, depending on quality, efficiency, or safety reasons.

A registered preparation marketed for the first time must receive marketing authorisation from the MoH for the first batch. Marketing of any further batches requires the authorisation of a responsible pharmacist in a business that has received authorisation from the MoH to act as such.

A preparation whose registration has not been renewed, or has been cancelled, may continue to be marketed for a period not exceeding one year from the expiration of the registration.

Medical Devices

The general rule for the first registration of a medical device is the same as for preparations ‒ ie, it shall not exceed five years. This is according to the Medical Devices Regulations (Registration of Medical Equipment in the Register and its Renewal) of 2013. The registration may be renewed.

According to the Medical Device Law of 2012, a medical device whose registration has not been renewed or has been deleted or cancelled may continue to be marketed for a period not exceeding two years from the expiration of the registration.

Pharmaceuticals

The basic requirement for marketing pharmaceuticals and medical devices is their registration, as noted in 3.3 Period of Validity for Marketing Authorisation for Pharmaceuticals or Medical Devices.

To register a preparation, apart from adhering to the Pharmacists Ordinance of 1981 and the Pharmacists Regulations (Preparations) of 1986, applicants must submit an application to the Preparations Registration Department of the MoH. This application is exclusively available to Israeli residents or registered Israeli corporations and should be filed by a pharmacist approved by the MoH for such a purpose.

The procedure adheres to MoH Circular No 08_2012 (“Application Submission Guideline for the Registration of Medical Preparations (Including Changes and Renewals)”) (last updated in 2015). The circular classifies pharmaceutical preparations into six groups, including new APIs, generics, and biosimilars ‒ each with specific requirements.

Any change in a registered preparation should be brought to the attention of the MoH and the circular includes procedures for changing the registration (such as changes in indication, dosage, and manufacturing plant). Another circular, No EX-009/04, relates to changes from a quality perspective and is based on the EC guidelines (mainly EC 1234/2008).

MoH Guideline No 36 delineates the procedure for changing the registration holder. This process necessitates the manufacturer’s declaration regarding the new registration holder, including their unrestricted access to all confidential information contained within the product file.

Medical Devices

To register a medical device, applicants must complete an application, which is to be submitted to AMAR according to the relevant guidelines. This application must include valid regulatory approvals, encompassing safety and efficiency certifications issued by recognised certifying bodies abroad (eg, FDA, Conformité Européenne (CE), and International Organization for Standardization (ISO) approvals), or documentation corresponding to the device’s class.

In 2024, the MoH published guidelines for fast track registration of medical devices (see 4.1 Fast Track Registration Routes). This is part of a reform in the registration procedure for medical devices that was published in August 2023 and is aimed at shortening the registration times of medical devices in Classes I and II.

Requests to transfer registration to another holder must be submitted along with, inter alia, a letter of consent from the current registration holder, declarations from the manufacturer and the importer, and other requirements detailed in the MoH’s guidelines.

Preparations and medical devices that are not registered may be supplied in specific circumstances, as detailed here.

Pharmaceuticals

The Pharmacists Regulations (Preparations) of 1986 delineates certain exceptions to the regular requirements for preparations (such as registration and batch approvals), subject to MoH approval/requirements. These exceptions include materials used without any process or change, preparations in non-commercial and small quantities, personal use of such, use for research, local manufacture for export purposes, use for epidemic purposes, and registered preparation for off-label use.

The MoH published several guidelines concerning the exceptions, which include various requirements, forms and approvals.

Medical Devices

The Medical Device Law of 2012 grants authority to the Minister of Health to establish regulations governing exceptions to the registration requirement under specific circumstances outlined in said law. Such regulations have not yet been enacted. However, in August 2023, the MoH released draft regulations, which proposed allowing the use of unregistered medical devices in the following cases:

• essential medical treatment and urgent care in the absence of a registered, marketed and available alternative;
• compassionate treatments;
• research, development and production of medical equipment not intended for marketing purposes;
• emergency preparedness;
• export-only purposes;
• conducting clinical evaluations of a limited number of patients; and
• personal use of customised medical equipment by a therapist.

“Pharmacovigilence” is defined here as the pharmacological science relating to the detection, assessment, understanding and prevention of adverse effects – in particular, the long-term and short-term side effects of medicines.

“Technovigilance” is defined here as the science relating to the detection, assessment, understanding and prevention of adverse incidents – in particular, the long-term and short-term side effects of medical devices.       

Pharmaceuticals

The preparation registration owner must maintain a drug monitoring system – for which, a physician/pharmacist with at least two years’ experience will be responsible.

The preparation registration owner must notify the MoH of any change in the registration file. MoH Guideline No 6 (“Reporting Adverse Events and New Safety Information”) details which information should be provided and additional relevant requirements. Among other things, the MoH’s guidelines require creating a system for monitoring side effects and new safety information for the registered preparation (pharmacovigilance system), providing Periodic Benefit-Risk Evaluation Reports (PBRER) or Periodic Safety Update Reports (PSUR), post-marketing spontaneous reporting of individual case safety reports, and follow-up on serious side effects.

The MoH may impose additional conditions on registration or renewal of the preparation, such as requiring regular and ongoing supply of the preparation.

Medical Devices

Section 7 of the Medical Device Law of 2012 outlines the parameters that the MoH may impose during the registration phase of medical devices. These include requirements for transportation and storage, the regular supply of the medical device in question, and others. Renewals may also require the filing of information regarding ongoing obligations.

The Medical Device Law of 2012 also authorises the Minister of Health to establish quality control regulations. However, these regulations have not yet been issued.

Pending applications for marketing authorisations for pharmaceuticals and medical devices remain confidential until registration. Basic information only (such as name, active ingredients, indications, dosage forms, and other details) becomes accessible to third parties upon completion of the registration process. The Israeli Drug Registry is available on the MoH’s website, which also features additional information such as information on preparations that are no longer marketed in Israel and notices regarding certain defects and side effects.

The MoH may use data to authorise generics only after the market exclusivity period ends.

Medical Devices

Registered Israeli medical devices are public and available on the MoH’s website. At this stage, the information available online is not complete.

Israel’s regulatory framework offers fast track registration routes both for medicines and medical devices, as detailed here.

Medicines

In February 2024, the MoH published a temporary framework for the approval of generic or biosimilar drug imports under Regulation 29 of the Pharmacists Regulations (Preparations) of 1986. This framework introduces expedited regulatory pathways by allowing conditional import approval for up to ten pharmaceuticals that meet the predefined criteria.

The approval process requires, inter alia, that:

• the pharmaceutical must be generic or biosimilar;
• the pharmaceutical must be registered in recognised regulatory markets (such as the USA, the EU and the UK);
• the original pharmaceutical must be already registered in Israel; and
• there must be two or fewer registered pharmaceuticals for the same active ingredient in Israel.

Applications to import such drugs can only be submitted by HMOs, with a permit being granted automatically after 45 working days, unless the MoH decides otherwise. Once issued, the permit is valid for up to one year, and extendable based on compliance with registration requirements. The framework aims to facilitate patient access to essential medications while ensuring regulatory oversight and cost-effectiveness, with the savings being used to improve healthcare in Israel.

Medical Devices

In 2024, the MoH published two guidelines for fast track registration of medical devices, introducing simplified procedures for Class I and Class II devices. The first guideline, published in January 2024, established an expedited route for low-risk devices (Class I and IVD Class A), allowing them to be registered based solely on a declaration from the registration holder or the importer. This route applies only to devices that are already registered and marketed in recognised countries (including the USA, Canada, Australia and the UK, as well as EU member states such as France and Germany). Applications must include a completed form, a signed declaration, regulatory certificates, and supporting documents. No fees are required. Additionally, annual renewal declarations must be submitted by October 1 of each year to maintain registration.

In June 2024, a second guideline was introduced to enable fast track registration for Class II and in vitro diagnostic (IVD) medium-risk devices. This procedure applies to Class II, IIa, IIb, and IVD B/C devices that are already registered in recognised countries. The registration process under the guideline is simplified, requiring proof of marketing history (four to six months), regulatory certificates, and a declaration from the registration holder. Processing times vary, as new registrations for Class IIb and IVD C devices may take up to 60 days, whereas renewals may take up to ten days. There are no fees required. These two guidelines aim to streamline the registration process in Israel, ensuring that pre-approved medical devices can enter the market efficiently while regulatory oversight is maintained.

Israel has embraced the concept of regulatory reliance, both for pharmaceuticals as well as for medical devices.

Where pharmaceuticals are concerned, the registration of a new pharmaceutical for the purposes of obtaining a market approval may only begin after it has been registered in other recognised countries. The same is true for biosimilars and generics as well.

Additionally, according to the Medical Device Law of 2012, the MoH may register a medical device even if the conditions outlined in the law are not fully met, provided that the device is registered in a recognised country or authorised for marketing and actively marketed in that recognised country.

Moreover, the Medical Devices Regulations (Registration of Medical Equipment in the Register and its Renewal) of 2013 set forth that – during the registration process – medical devices that are already registered or marketed in a recognised country do not require additional documentation such as risk analysis, clinical evaluation, clinical trial summaries, and expert opinions. If a device is equivalent to a device that is already registered in Israel or in a recognised country, it can follow the same simplified registration process.

Manufacturing of Pharmaceuticals

The manufacturing of pharmaceuticals is regulated by the Pharmacists Ordinance of 1981 and the Pharmacists Regulations (Preparations) of 1986, as well as by specific regulations relating to production conditions for preparation and by the MoH’s guidelines. Among other things:

• the plant should be operated by skilled professionals, including a quality assurance manager, a lead pharmacist, and a business manager;
• the preparations should be manufactured according to good manufacturing practices (GMP) and the principles of EU Directive 2003/94/EC for human preparations;
• the APIs used in manufacturing the preparation should be manufactured according to GMP and the principles of EU Directive EC/2001/83;
• the MoH must audit the business according to the EMA’s “Compilation of Community Procedures on Inspections and Exchange of Information”; and
• the plant must have a business licence pursuant to the Business Licensing Law.

Manufacturing of Medical Devices

The manufacturing of medical devices is regulated by the Medical Devices Law of 2012, the Medical Devices Regulations (Registration of Medical Equipment in the Register and its Renewal) of 2013 and the MoH’s guidelines.

The manufacturing plant’s GMP should meet the requirements of ISO 13485, as well as have a business licence pursuant to the Business Licensing Law of 1968.

Transportation conditions must meet the requirements of ISO9001. Businesses also require an appropriate business licence for the storage and transportation of medical devices pursuant to the Business Licensing Law of 1968.

Pharmaceuticals

Wholesale marketing of preparations can be done only by “pharmaceutical trading houses” that store, distribute and transport preparations or raw materials (as noted in 3.3 Period of Validity for Marketing Authorisation for Pharmaceuticals or Medical Devices and 3.8 Rules Against Illegal Medicines and/or Medical Devices). The pharmaceutical trading houses should be managed by a pharmacist approved by the MoH according to MoH Guideline 139.

Wholesale is also allowed by institutions that have been acknowledged by the Minister of Health. The Minister of Health is also authorised to allow wholesale in other cases for necessary treatment, research or registration, provided such actions do not pose any detriment to public health.

Distribution and storage should be according to MoH Guideline 126 and MoH Guideline 130.

Non-prescription medicines may be sold subject to approval by the district pharmacist according to the Pharmacists Regulations (sale of medicine without a prescription not in a pharmacy or not by a pharmacist) of 2004 and under MoH Guideline 56.

Medical Devices

The sale of medical devices necessitates registering the equipment in the registry – although exceptions may exist (see 3.4 Procedure for Obtaining a Marketing Authorisation for Pharmaceuticals and Medical Devices and 3.5 Access to Pharmaceuticals and Medical Devices Without Marketing Authorisations).

In Israel, there are two main categories of pharmaceuticals. The first is registered pharmaceuticals and the second is non-registered pharmaceuticals. For a detailed explanation, please see 1.3 Different Categories of Pharmaceuticals and Medical Devices.

The importation and exportation of products are mainly governed by the Import and Export Ordinance of 1979, the Customs Ordinance of 2014, and the Free Import Order of 2014. In addition, specific regulations and MoH guidelines exist for the importation and exportation of pharmaceuticals and medical devices; these make it necessary to obtain approvals from the Import of Pharmaceuticals and Drugs Department or AMAR. MoH Guideline 33 governs the submission and handling of applications for import approval. MoH Guideline EX-015/02 outlines the procedures for granting, renewing, updating, suspending and revoking approvals for importers of pharmaceuticals.

At the point of entry, the customs authorities are responsible for enforcing import regulations. Following entry into the country, ongoing enforcement and oversight are maintained by various entities within the MoH, such as the Pharmaceutical Administration and AMAR.

A proposal for an amendment to the Patents Law of 1967 is currently pending. According to Amendment No 14 (Increasing Competitiveness in the Israeli Economy), 5781-2021, third parties shall be allowed to manufacture an otherwise infringing medical device or pharmaceutical during the period of a patent term extension (PTE) order – provided that the exploitation of the invention is made for export purposes or made for stockpiling and marketing in Israel during the final six months of the period of the PTE.

There is no official definition of “importer of record” in Israel.

Importers of pharmaceuticals and medical devices are generally required to obtain prior authorisations from the MoH, as mentioned in 7.1 Governing Law for the Importation and Exportation of Pharmaceuticals and Medical Devices and Relevant Enforcement Bodies. The Pharmacists Ordinance of 1981 defines “marketing” as including importation; therefore, any approval required for marketing is also applicable for importation (see 3.3 Period of Validity for Marketing Authorisation for Pharmaceuticals or Medical Devices and 6.1 Wholesale of Pharmaceuticals and Medical Devices).

Exemptions exist, according to Regulation 29 of the Pharmacists Regulations (Preparations) of 1986 (see 1.3 Different Categories of Pharmaceuticals and Medical Devices). In addition, in view of the war in Gaza, the MoH published a donation outline for medical devices that allows the importation of specific medical devices without MoH import authorisation under certain conditions.

The Pharmacists Ordinance of 1981 permits the parallel import of a product equivalent to a registered preparation by entities other than the registration holder, provided it is identical to the registered item and meets regulatory storage and delivery conditions. Except for the requirement of registration itself, all rules applicable to the registered preparation also apply to the imported equivalent on a comparable basis.

As of January 2025, and according to Amendment to the Pharmacists Ordinance (Amendment No 37) of 2024, Israel’s “What is Good for Europe is Good for Israel” reform allows importers (registered as “proper importers”) to bring in cosmetic products legally marketed in EU member states, Switzerland or the UK through a streamlined process. The reform aims to facilitate imports, increase competition, and reduce consumer prices while maintaining product safety standards.

From an IP perspective, importing a product protected by a local patent for purposes such as production, use, sale, or offering for sale is regarded as exploitation of the invention. Therefore, if a medical device or pharmaceutical has a related registered patent/s in Israel, the importer is obligated to obtain consent from the patentee prior to importing the product.

The Import and Export Ordinance of 1979, the Customs Ordinance of 2014, and the Free Import Order of 2014 include various non-tariff regulations and restrictions imposed upon importation.

Israel has signed many free trade agreements and trade pacts with multiple countries and economic blocs, including the USA, the EU (including the Agreement on Conformity Assessment and Acceptance of Industrial Products (ACAA)), the European Free Trade Association (EFTA), the UK, South Korea, China, the Eurasian Economic Union, India, Mercosur (a South American trade bloc comprising Argentina, Brazil, Paraguay and Uruguay), and neighbouring/regional countries such as Jordan, Egypt, Turkey, and UAE.

Although the prices of medical devices are not controlled, the prices of pharmaceuticals are. Specifically, the Supervision of Prices of Commodities and Services (Maximum Prices for Prescription Preparations) Order of 2001 determines maximum prices for prescription preparations, as elaborated on in 8.2 Price Levels of Pharmaceuticals or Medical Devices.

As for preparations sold without prescriptions, the Supervision of Prices of Commodities and Services (Application of the Law on Preparations) Order of 2001 provides that the prices of such preparations may not be raised without their sellers first obtaining governmental approval.

When it comes to GSL preparations, the same order provides that the registrants of such are to provide a biannual report to the MoH in which they are to detail the prices of all preparations they are selling, as well as provide an annual report regarding their profitability from the sales thereof.

The prices of medical devices are not controlled. As regards pharmaceuticals, the Supervision of Prices of Commodities and Services (Maximum Prices for Prescription Preparations) Order of 2001 noted in 8.1 Price Control for Pharmaceuticals and Medical Devices provides that the maximum price of prescription preparations is to be determined as an average of the lowest three prices for that preparation in the following countries: Belgium, the Netherlands, Hungary, Spain, France, the UK, and Germany.

The order further provides that where that prescription preparation is not sold in three of the above-mentioned seven countries, the price of a given preparation would be set as the average of the prices thereof in the two countries in which it is being sold. Finally, where the preparation is sold in only one of the seven countries referenced by the order, that price alone would be used to set the maximum price for that preparation in Israel.

As mentioned in 1.1 Legislation and Regulation for Pharmaceuticals and Medical Devices, Israel nationalised its healthcare system in 1994 when it enacted the National Health Insurance Law of 1994. This law provides a lengthy list of all the healthcare services to which all residents of Israel are entitled, which is formally known as the “Health Service Basket” or ‒ more commonly ‒ the “Health Basket”.

Once a given medical device or pharmaceutical has been introduced into the Health Basket, it is subsidised by the State of Israel and provided by HMOs. In particular cases, patients may request reimbursement for pharmaceuticals or medical devices that are not included in the Health Basket. Such requests are evaluated on a case-by-case basis by healthcare providers, who consider factors such as medical necessity, lack of alternative treatments, and clinical justification.

The Health Basket is updated on a yearly basis, according to the recommendations of a public committee, which are then assessed by the government before a decision is made. Given that the annual budget for this purpose is always limited, a cost-benefit analysis is always carried out. Specifically, the public committee must consider the benefits offered by a given preparation or device against the costs thereof ‒ both at the individual and the national level – and rank these prospective additions accordingly. In certain cases, negotiations are carried out between the State of Israel and the companies to secure hedges, which would place a cap on the total cost incurred as a result of a company’s product being included in the Health Basket.

A cost-benefit analysis is also carried out in a way whereby the maximum prices for prescription preparations are concerned. As noted in 8.1 Price Control for Pharmaceuticals and Medical Devices, it is permissible to set a higher price than that which would have otherwise been set if setting a lower price might cause the preparation not to be marketed in Israel.

The Physicians Regulations (Provision of Prescription) of 1981 lists the details to be included in a prescription and allows such to be issued digitally. When it comes to dispensing prescriptions, the Pharmacists Ordinance of 1981 provides that – unless the physician clearly states that the preparation is not to be switched – the pharmacist may provide a generic product thereof and must advise the patient which additional generics for that preparation are available at the dispensing pharmacy.

In practice, HMOs instruct their physicians – when possible – to not include such clear statements in their prescriptions so that pharmacists dispense generic preparations rather than reference preparations, thus curbing spending.