Tagged with EG

Saudi Arabia With over 40 years of history in Saudi Arabia, in 2021 Eli Lilly moved to establish a regional headquarters in the country, underscoring its dedication to the country and region. Now led by Brazilian national Felipe Borges dos Reis, Lilly aims to tackle the pressing health concerns of diabetes and…

Saudi Arabia Farrukh Rehan outlines how GSK Saudi Arabia is actively collaborating with the Saudi government to align its initiatives with Vision 2030 and support national healthcare goals. Through strategic partnerships and MoUs, the company ensures the seamless integration of its innovations into the healthcare system, contributing to improved patient access and…

Saudi Arabia Trad Alkhelaiwi lays out the scale of Johnson & Johnson’s transformation in Saudi Arabia, particularly the transition to a direct model in the medtech space, reflecting the company’s long-term commitment to the country’s healthcare sector. Alkhelaiwi also explains how Johnson & Johnson’s solutions in Saudi Arabia are tailored to address…

Pharma Legal Handbook  1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? The Ministry of Health and Care Services (Helse- og Omsorgsdepartementet, “HOD”) is the superior administrative authority in Norway, with jurisdiction over drugs, biologicals, and medical devices.   The Norwegian Medical Products Agency (Direktoratet…

Pharma Legal Handbook 16. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? Clinical trials are not required to be conducted in Norway as a condition for obtaining a marketing approval. As part of the application for a marketing approval, the applicant must submit clinical…

Pharma Legal Handbook 22. What is the authorization process for the marketing of new drugs, biologics, medical devices, over the counter medications and other medicinal products? See answer to Chapter 1, question 3.   23. What is the authorization process for the marketing of generic versions of these products? To obtain a marketing…

Pharma Legal Handbook 44. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? Traditional medicine: The main legal framework regarding traditional medicinal products, regardless of whether the product is a prescription-only or non-prescription (OTC) product, is set out in the Medicines Act (LOV-1992-12-04-132) and the Medicines Regulation (FOR-2009-12-18-1839).…

Pharma Legal Handbook  53. What types of liability are recognized in your jurisdiction? Liability under Norwegian law can be distinguished between civil and criminal liability. Criminal liability may be incurred by anyone who violates penal provisions, either in the penal code, or provisions in other acts of legislation which is sanctioned with criminal…

Pharma Legal Handbook 58. What are the basic requirements to obtain patent and trademark protection?   Patents: The most basic requirements follow from the Norwegian Act relating to patents of 15 December 1967 No. 9 (“the Patents Act”). The Patents Act § 2 stipulate that patent protection may be granted to anyone who…

Pharma Legal Handbook 1. Are there proposals for reform or significant change to the healthcare system? As a party to the EEA Agreement, Norway will, as a main rule, be affected by all EU reforms in the area.  The European Commission has inter alia proposed several amendments to Regulation (EU) 2017/746 on in…

Global 2023 was a breakthrough year for cell and gene therapies. The field saw a record number of FDA approvals, as other promising therapies in a broad range of therapeutic areas progressed through the pipeline. 2024 looks to be another important year with up to 17 new therapies poised for regulatory…

Egypt The latest news from Egyptian healthcare and life sciences, including progress towards the launch of a massive new oncology hospital, why local manufacturer EIPICO is expanding into Kazakhstan, increased governmental investment in education and health, and lessons from the country’s successful battle against Hepatitis C.   Egypt gears up for…