Riad & Riad

Introduction Regulatory Authorities Licensing Pharmaceutical Entities Warehousing Selling Pharmaceutical Factory Drug Registration Drug Marketing & Advertisement Drug Pricing Scientific Offices Drug Manufacturing Drug Distribution Drug Importation Drug Exportation INTRODUCTION Having an effective and enforceable legal structure for the pharmaceutical sector is an essential element in achieving the country's goals of accessibility, quality, and rational use of medicine. This report aims to review the current pharmaceutical sector-related legal provisions in Egypt. The pharmaceutical sector in Egypt is mainly regulated by law No. 127 of 1955 on the Pharmacy Profession (“Pharmacy Law”) and other decrees and internal circulars issued by MoH and its affiliated bodies. One of the constitutional rights under the Egyptian Constitution, as amended in 2014, is the healthcare right. Part of the healthcare right is the accessibility of medicines in an equal manner and at affordable prices. The Constitution mandates on the Government to spend at least 3% of the GDP on healthcare. Such percentage is supposed to gradually increase to reach the international standards.

The Egyptian Financial Regulatory Authority (“FRA”) announced the launch of the Egypt's first central movable collateral registry. Egypt had its first Movable Collaterals Law on 15 November 2015 (Movable Collaterals Law no. 115/2015), and the Ministry of Investment passed the Executive Regulations On 15 December 2016. The law introduced an overarching system for taking non-possessory security over diversified movable assets. It aims at facilitating access to credit through a well-defined legal regime that is in line with the international standards, such as those established by the United Nations Commission on International Trade Law (UNCITRAL) and by the World Bank.

On 19 February 2018, a new law no. 11/2018 was issued regulating the restructuring, preventive reconciliation and bankruptcy in Egypt (the" Bankruptcy Law"). The law entered into force as of 22 March 2018. The law introduces for the first time an out-of-court restructuring system which helps troubled companies reorganize their business. In the meant time, courts are given the authority to enforce a restructuring plan if a consensual solution is not reached. Also a new court supervised mediation system is introduced.

A new labor union organizations law was issued last December under Law No. 213/2017 (the “Law”) replacing previous labor union organizations law No. 35/1976. The Law explicitly provides for the prohibition of establishing labor unions based on religious or political grounds or incorporating discriminative rules in the articles of association of such organizations.

A new law is issued in Egypt to amend the Joint Stock Companies, Partnerships Limited by Shares and Limited liability Companies, known as the Companies Act no. 159 of 1981 (the "Law"). The amendments are effective as of 17 January 2018. This report will summarize the main amendments introduced.