Tagged with Norway

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 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  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  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 Keen to learn more about regulatory reforms in Norwegian Pharma? Read on! Prepared in association with DLA Piper, a leading law firm in Norway, this is an extract from The Pharma Legal Handbook: Norway, available to purchase here for GBP 99.   1. Are there proposals for reform or significant…

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).…

Norway Norway has been a global frontrunner in collecting health data and building unique registries for decades but has struggled to utilise and benefit from them. Karita Bekkemellem, CEO of the Association of the Pharmaceutical Industry in Norway (LMI), examines how a new health data sharing platform can change that— to…

Global The global push to vaccinate populations against COVID-19 has played out differently in different geographies, with a yawning gap still existing between vaccination rates in developed and developing economies and vaccine hesitancy and scepticism rife in certain countries. Here, three country managers from Pfizer – which is aiming to manufacture…

Norway Equality has long been a deeply held ideal in Norway, where the concept of allemannsretten – the legal right to roam – permeates all aspects of society. Notably, surplus wealth produced by Norway’s sizeable petroleum industry is deposited into the Government Pension Fund Global, today the world’s largest sovereign wealth…

Europe While 2020 may have seemed like the year the world stood still for many, the pharma industry went into overdrive, working around the clock to ensure security of supply as well as develop diagnostics, treatments, and vaccines for COVID-19. Recruitment also continued apace; here four recent country manager appointees share…

Norway Sissel Lønning Andresen explains how Pfizer Norway has been a pioneer of digital communication channels for years, what other Pfizer affiliates can learn from Norway in this field, and how it helped in terms of working through the COVID-19 pandemic. Andresen also highlights her market access priorities, with the gene…