Tagged with Legal Handbook

Pharma Legal Handbook 1. Are there proposals for reform or significant change to the healthcare system? The Romanian authorities announced their intention to implement certain changes in the pharmaceutical legislation, including in relation to: the new advertising norms for medical devices, which will bring significant changes in connection with the marketing and advertising…

Pharma Legal Handbook Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? According to the national catalogue of medicines in Romania published by NAMMD, currently there is one medicinal product authorized for marketing in the country having as active substance cannabidiolum. By law, certain narcotic or psychotropic substances extracted from cannabis, such…

Pharma Legal Handbook 1. What is the definition of Rare Diseases in your country? Regulation (EC) no. 141/2000 on orphan medicinal products (“Regulation no. 141/2000”), which is directly applicable in Romania, specifies that a medicinal product could be designated by the European Medicines Agency as an orphan medicine when: (i) it is intended…

Pharma Legal Handbook 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? Romania has a favourable tax regime for companies, which encourages many businesses to set up and to operate subsidiaries in Romania. However, there are no…

Pharma Legal Handbook 1. Are biosimilar medicines considered the same as generic medicines in your country? The biosimilar medicinal products are not considered the same as generic medicinal products, since the Romanian legislation regulates biosimilars and generics in a different manner. As per the local legislation, a biosimilar is a biologic medicinal product…

Pharma Legal Handbook 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 Health (MOH) in Egypt. The EDA comprises three independent organizations consisting of the…

Pharma Legal Handbook 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 of conducting such preclinical and clinical trials.   How are clinical trials…

Pharma Legal Handbook 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: An application for obtaining a marketing authorization for pharmaceuticals is submitted to CAPA. The Pharmacy Law…

Pharma Legal Handbook 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 Practices; – Good Laboratory Practice; – Good Pharmacovigilance Practice; – Good Agricultural and Collection…

Pharma Legal Handbook 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 preparation process of the medicinal product. Civil liability, in case…

Pharma Legal Handbook 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 for patents at the Patent office; the patent application shall be accompanied…

Pharma Legal Handbook Are there proposals for reform or significant change to the healthcare system? No, but the Comprehensive Health Insurance Scheme Law No. 2 of year 2018 and its Executive Regulations issued by virtue of the Prime Minister’s Decree No. 909 of the year 2018.   When are they likely to come…