28/05/2020
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 USD 99. 1. Are there proposals for reform or significant change to the healthcare system? The most relevant changes to the Norwegian healthcare system expected to enter into force in the near future are the following: – the new EU…
Patents & trademarks in Norwegian Pharma – a comprehensive legal overview. 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 USD 99. 1. What are the basic requirements to obtain patent and trademark protection? a) Patents The requirements for obtaining patents and the protection thereof is regulated by the Norwegian Patent Act ( LOV-1967-12-15-9). The basic requirements for obtaining a patent…
27/05/2020
The low-down on the situation regarding product liability in Norwegian Pharma. 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 USD 99. 1. What types of liability are recognized in your jurisdiction? Norwegian law recognizes the following types of liability Criminal liability, for violation of the Norwegian Penal Code or where criminal liability is stipulated by law (such as the Medicines…
Key legal info on traditional medicines and OTC products in Norwegian Pharma. 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 USD 99. 1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? The Medicines Act (LOV-1992-12-04-132) provides for any procedure for the MA of traditional medicines, including herbal and homeopathic medicines, whilst the Medical Devices…
All about marketing, manufacturing, packaging & labeling, advertising in Norwegian Pharma. 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 USD 99. 1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? See Regulatory, Pricing and Reimbursement Overview, question 3. 2. What is the authorization process for the marketing…
A brief overview of the situation regarding preclinical and clinical trial requirements in Norwegian Pharma. 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 USD 99. 1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? See [Regulatory, Pricing and Reimbursement Overview, Section 3 b)]; new medical products must undergo an evaluation of…
An insight into regulatory, pricing and reimbursement overview in Norwegian Pharma. 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 USD 99. 1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? The Ministry of Health and Care Services (nw. Helse-og omsorgsdepartementet, “HOD”) is the legislative authority. The Norwegian Medicines Agency (nw. Statens legemiddelverk…
Keen to learn more about regulatory reforms in Norwegian Pharma?…
All about marketing, manufacturing, packaging & labeling, advertising in Norwegian…
Key legal info on traditional medicines and OTC products in…
The low-down on the situation regarding product liability in Norwegian…
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