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…
Mexico The latest stories from Mexican pharma and healthcare, including Sanfer’s purchase of Colombia-based manufacturer Vitalis; Organon Mexico’s new business; the FDA’s warning to Glicerinas Industriales, and a look at the issues, including health, the new Mexican president will have to face. Mexico’s Health Ministry issues measles alert (Mexico News) Mexico’s…
Italy A roundup of some of the biggest stories from Italian pharma and healthcare, including Italfarmaco’s FDA approval for its DMD treatment; Alfasigma’s acquisition of Galapagos’s Jyseleca, the antibiotics deal between Venatorx Pharmaceuticals and Menarini, and the country’s drop in healthcare spending. Stevanato Group Announces Public Offering of Ordinary Shares…
Global Latin America will be the world’s fastest growing region for pharmaceuticals up to 2027, with a stunning expected compound annual growth rate of 22 percent, according to recent reporting from IQVIA. The Indian subcontinent can also expect sizeable growth over the next three years, although the US, Europe, and East…
LatAm A roundup of some of the latest stories coming out of Latin American pharma and healthcare, including Merck’s new distribution centre in Brazil; the region’s record dengue surge; Roemmers Laboratory’s acquisition of 30% of Argentina’s Tuteur, and Urufarma’s new manufacturing facility in Uruguay. Merck to open new distribution centre…
Pharma Legal Handbook An intro to the legal situation for regulatory, pricing and reimbursement in Russia. Prepared in association with Lidings, a leading global law firm, this is an extract from The Pharma Legal Handbook: Russia, available to purchase here for GBP 99. 1. What are the regulatory authorities with jurisdiction…
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