Legal & Regulatory > Germany

Want to know more about cannabinoid drugs, medicinal cannabis and opioid drugs in Germany? Read on! Prepared in association with Heuking Kühn Lüer Wojtek, a leading global law firm, this is an extract from The Pharma Legal Handbook: Germany, available to purchase here for USD 99.   Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? There is no uniform answer to this question. In Germany, some Cannabinoid Drugs are subject to restrictions under the Narcotic Drugs Act (“BtMG”)…

Dentons Germany’s Peter Homberg outlines the key requirements that companies need to fulfil in order to import medical cannabis into Germany and how attitudes and legislation on the topic are shifting across Europe.   In order to import medicinal cannabis from another country to Germany, like many other countries, the essential factor is that such medicinal cannabis has to be cultivated in a country compliant with Art. 23 and 28 para. 1 of the 1961 Single Convention on Narcotic Drugs…

All legal aspects surrounding regulatory reform in Germany. Prepared in association with Heuking Kühn Lüer Wojtek, a leading global law firm, this is an extract from The Pharma Legal Handbook: Germany, available to purchase here for USD 99.   1. Are there proposals for reform or significant change to the healthcare system? Two reforms came into law on January 1, 2019. The first one concerns the reduction of health insurance premiums for employees. It is named the “GKV-Versichertenentlastungsgesetz” (GKV-VEG) which…

The legal framework for patents and trademarks in Germany. Prepared in association with Heuking Kühn Lüer Wojtek, a leading global law firm, this is an extract from The Pharma Legal Handbook: Germany, available to purchase here for USD 99.   1. What are the basic requirements to obtain patent and trademark protection? 1. In Germany, the Patent Act (Patentgesetz, PatG of 16 December 1980, as last amended on 8 October 2017 forms the legal basis for patents, while the Trade…

An insight into product liability in Germany. Prepared in association with Heuking Kühn Lüer Wojtek, a leading global law firm, this is an extract from The Pharma Legal Handbook: Germany, available to purchase here for USD 99.   1. What types of liability are recognized in your jurisdiction? Under German law, liability can result from a culpable failure to comply with contractual or quasi-contractual obligations (contractual/quasi-contractual liability), or from a failure to comply with legal obligations which are not at…

The low-down on the situation regarding traditional medicines and OTC products in Germany. Prepared in association with Heuking Kühn Lüer Wojtek, a leading global law firm, this is an extract from The Pharma Legal Handbook: Germany, available to purchase here for USD 99.   1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? The Medicinal Products Act contains special regulations governing Traditional Herbal Medicines and Homoeopathic Medicinal Products: 1. As per secc. 39a et…

All about marketing, manufacturing, packaging & labeling, and advertising in Germany. Prepared in association with Heuking Kühn Lüer Wojtek, a leading global law firm, this is an extract from The Pharma Legal Handbook: Germany, 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? 1. The Third Chapter of the Medicinal Products Act sets forth the rules relating to the manufacture…

A brief overview of the situation regarding preclinical and clinical trial requirements in Germany. Prepared in association with Heuking Kühn Lüer Wojtek, a leading global law firm, this is an extract from The Pharma Legal Handbook: Germany, 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? 1. In principle, pre-clinical and clinical studies and trials can be obtained from regulated and approved providers…

An intro to the legal situation for regulatory, pricing, and reimbursement of drugs in Germany. Prepared in association with Heuking Kühn Lüer Wojtek, a leading global law firm, this is an extract from The Pharma Legal Handbook: Germany, available to purchase here for USD 99.   1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? Federal Ministry for Health (Bundesministerium für Gesundheit (BMG), Berlin and Bonn). https://www.bundesgesundheitsministerium.de/ Drafting legislation, regulations and ordinances…

Peter Homberg of Dentons Germany examines the regulatory status quo around the free sale of products containing cannabidiol (CBD) across Europe. Although deregulation efforts are underway, Homberg argues that the trade in these products is not as free and unregulated as it may initially seem.   CBD products that are marketed in Gemany as pharmaceutical products must comply with the strict provisions of the Medicinal Products Act of Germany (Arzneimittelgesetz), as a CBD pharmaceutical product is categorized as a prescription…