Tagged with B

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…

Spain Brazilian national Maria Fernanda Prado, who began her career in pharma more than 20 years ago, has been at Janssen/Johnson & Johnson for more than half of that time. She has taken on the leadership of a diverse set of geographies —­ from Turkey to Central Europe and Benelux —…

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…

Global Having been quietly working away on its mRNA platform for years, Moderna stepped into the limelight during the COVID-19 pandemic and became a commercial-stage outfit almost overnight with its vaccine. After generating sales of USD 18.4 billion in 2022, demand for the company’s Spikevax shot, still its only commercialized product…

Switzerland While the Swiss biotech sector is inevitably facing many of the same funding challenges as the global industry and is still struggling to make a meaningful comeback from its 2022 slump, the latest report from the Swiss Biotech Association and EY shows the sector’s resilience with the record revenues of…

Global First established in 1985 at the height of the AIDS pandemic, IAPAC is the world’s oldest medical association dedicated to HIV. Today, the organisation brings together over 30,000 professional and paraprofessionals delivering services to people living with and affected by the disease. In an exclusive and wide-ranging interview, IAPAC President…