Legal & Regulatory > Egypt

Biosimilars & biologics in Egypt – a legal guide. Prepared in association with Youssry Saleh Law Firm, a leading global law firm, this is an extract from The Pharma Legal Handbook: Egypt, available to purchase here for GBP 75.   1. Are biosimilar medicines considered the same as generic medicines in your country? In Egypt, Biosimilars are considered different from Generic Medicines but similar to biological products, where the “Biosimilar” definition according to the Guidelines for Registration of biosimilar products…

The key facts about the localization in Egypt. Prepared in association with Youssry Saleh Law Firm, a leading global law firm, this is an extract from The Pharma Legal Handbook: Egypt, available to purchase here for GBP 75.   1. Are there any rules or regulations requiring and/or encouraging localization in your country? What is the legal framework defining these localization rules and policies? Yes, the legal framework of localization is regulated through Ministerial Decree No. 425 of the year…

All legal aspects surrounding orphan drugs & rare diseases in Egypt. Prepared in association with Youssry Saleh Law Firm, a leading global law firm, this is an extract from The Pharma Legal Handbook: Egypt, available to purchase here for GBP 75.   1. What is the definition of Rare Diseases in your country? In Egypt, there is no definition of the “Rare Diseases” however, in accordance with the conclusion of medicine professors’ researches and studies a disease is considered a…

Cannabinoid drugs, medicinal cannabis and opioid drugs in Egypt – an overview. Prepared in association with Youssry Saleh Law Firm, a leading global law firm, this is an extract from The Pharma Legal Handbook: Egypt, available to purchase here for GBP 75.   Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? No, Cannabinoid Drugs are not authorized in Egypt, however, they are regulated by Law No. 182 of the year 1960 concerning combating drugs and regulating their use…

An intro to the legal situation for regulatory reforms in Egypt. Prepared in association with Youssry Saleh Law Firm, a leading global law firm, this is an extract from The Pharma Legal Handbook: Egypt, available to purchase here for GBP 75.   1. Are there proposals for reform or significant change to the healthcare system? No, but the Comprehensive Health Insurance Scheme Law No. 2 of the year 2018 was issued on 11th of January 2018 and its Executive Regulations…

Patents and trademarks in Egypt – a comprehensive legal overview. Prepared in association with Youssry Saleh Law Firm, a leading global law firm, this is an extract from The Pharma Legal Handbook: Egypt, available to purchase here for GBP 75.   1. What are the basic requirements to obtain patent and trademark protection? In accordance to the Executive Regulations provided in the Decree No. 1366 of the year 2003, the requirements to obtain patents are as follows: Fill the application…

The key facts about product liability in Egypt. Prepared in association with Youssry Saleh Law Firm, a leading global law firm, this is an extract from The Pharma Legal Handbook: Egypt, available to purchase here for GBP 75.   1. What types of liability are recognized in your jurisdiction? There are two types of liabilities in Egypt, Criminal Liability, in case the product caused any injury, permanent disability injury or wrongful death due to negligence or mistake occurred in the…

A brief overview of the situation regarding traditional medicines and OTC products in Egypt. Prepared in association with Youssry Saleh Law Firm, a leading global law firm, this is an extract from The Pharma Legal Handbook: Egypt, available to purchase here for GBP 75.   1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? The regulatory requirements for traditional and herbal products shall follow the regulations and standards: WHO requirements and guidelines; Good Manufacturing…

All legal aspects surrounding marketing, manufacturing, packaging & labeling, and advertising in Egypt. Prepared in association with Youssry Saleh Law Firm, a leading global law firm, this is an extract from The Pharma Legal Handbook: Egypt, available to purchase here for GBP 75.   1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over the-counter medications, and other medicinal products? The authorization process of marketing new drugs and any medicinal products are as follows:…

Preclinical and clinical trial requirements in Egypt – an overview. Prepared in association with Youssry Saleh Law Firm, a leading global law firm, this is an extract from The Pharma Legal Handbook: Egypt, available to purchase here for GBP 75.   1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? Yes, as there is an Authority “Central Directorate for Research and Health Development”, which is responsible for the registration and approvals…

An insight into regulatory, pricing, and reimbursement of drugs in Egypt. Prepared in association with Youssry Saleh Law Firm, a leading global law firm, this is an extract from The Pharma Legal Handbook: Egypt, available to purchase here for GBP 75.   1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? The pharmaceutical regulatory body in Egypt is the Egyptian Drug Authority (EDA) operating and working under supervision of the Ministry of…