Legal & Regulatory > Denmark

Key legal info on biosimilars & biologics in Denmark. Prepared in association with Gorrissen Federspiel, a leading law firm in Denmark, this is an extract from The Pharma Legal Handbook: Denmark, available to purchase here for GBP 75.   1. Are biosimilar medicines considered the same as generic medicines in your country? No. A biosimilar medicinal product is a new version of an existing biological medicinal product (i.e. a medicinal product is derived from a biological source). Biosimilar products are…

Keen to learn more about localization in Denmark? Read on! Prepared in association with Gorrissen Federspiel, a leading law firm in Denmark, this is an extract from The Pharma Legal Handbook: Denmark, available to purchase here for GBP 75.   1. Are there any rules or regulations requiring and/or encouraging localization in your country? What is the legal framework defining these localization rules and policies? No, as a starting point there are no rules or regulations requiring and/or encouraging localization…

An insight into orphan drugs and rare diseases in Denmark. Prepared in association with Gorrissen Federspiel, a leading law firm in Denmark, this is an extract from The Pharma Legal Handbook: Denmark, available to purchase here for GBP 75.   1. What is the definition of Rare Diseases in your country? Pursuant to Regulation (EC) no. 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products (“Orphan Drug Regulation”), a medicinal product may be designated…

An intro to the legal situation for cannabinoid drugs, medicinal cannabis and opioid drugs in Denmark. Prepared in association with Gorrissen Federspiel, a leading law firm in Denmark, this is an extract from The Pharma Legal Handbook: Denmark, available to purchase here for GBP 75.   Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? Cannabinoid drugs, i.e. medicinal products where the active substance is cannabinoids, can be authorised in Denmark in accordance with the rules on development, manufacture and marketing…

The ins and outs of regulatory reforms in Denmark. Prepared in association with Gorrissen Federspiel, a leading law firm in Denmark, this is an extract from The Pharma Legal Handbook: Denmark, available to purchase here for GBP 75.   1. Are there proposals for reform or significant change to the healthcare system? Clinical Trial Regulation The aim of the Clinical Trial Regulation is to ensure greater harmonisation of the rules on clinical trials throughout the EU. To this end, it will introduce,…

The low-down on the situation regarding patents and trademarks in Denmark. Prepared in association with Gorrissen Federspiel, a leading law firm in Denmark, this is an extract from The Pharma Legal Handbook: Denmark, available to purchase here for GBP 75.   1. What are the basic requirements to obtain patent and trademark protection? Patents In Denmark, a patent can be obtained by i) filing of a patent application with the Danish Patent and Trademark Office (“DKPTO”), ii) filing a patent application according…

All legal aspects surrounding product liability. Prepared in association with Gorrissen Federspiel, a leading law firm in Denmark, this is an extract from The Pharma Legal Handbook: Denmark, available to purchase here for GBP 75.   1. What types of liability are recognized in your jurisdiction? Generally, a person or company may incur liability by way of (i) contractual liability or (ii) civil liability due to violations of statutory law and/or culpable behaviour. Depending on the wording of the contractual terms giving…

Key legal info on traditional medicines and OTC products in Denmark. Prepared in association with Gorrissen Federspiel, a leading law firm in Denmark, this is an extract from The Pharma Legal Handbook: Denmark, available to purchase here for GBP 75.   1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? Natural medicinal products, traditional herbal medicinal products, homeopathic medicinal products, and strong vitamin and mineral products are all special categories of medicinal products and are as…

A brief overview of the situation regarding marketing, manufacturing, packaging & labeling, advertising in Denmark. Prepared in association with Gorrissen Federspiel, a leading law firm in Denmark, this is an extract from The Pharma Legal Handbook: Denmark, available to purchase here for GBP 75.   1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? Please see Question 3 of Regulatory, Pricing and Reimbursement Overview.   2. What is the authorization…

Preclinical and clinical trial requirements in Denmark – an overview. Prepared in association with Gorrissen Federspiel, a leading law firm in Denmark, this is an extract from The Pharma Legal Handbook: Denmark, available to purchase here for GBP 75.   1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? No, clinical trials are not required to be conducted locally as a condition for a marketing authorization. As a starting point, an application for…

The legal framework for regulatory, pricing and reimbursement of drugs in Denmark. Prepared in association with Gorrissen Federspiel, a leading law firm in Denmark, this is an extract from The Pharma Legal Handbook: Denmark, available to purchase here for GBP 75.   1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? The Danish Ministry of Health is responsible for defining the overall framework for the national healthcare system. As a governmental body…