Legal & Regulatory > Switzerland

Key legal info on biosimilars & biologics in Swiss Pharma. Prepared in association with Wenger Plattner, a leading law firm in Switzerland, this is an extract from The Pharma Legal Handbook: Switzerland, available to purchase here for GBP 119. 1. Are biosimilar medicines considered the same as generic medicines in your country? No, compared to generics with chemically synthesized active ingredients, the production of biosimilars is much more complex, and further requirements must be met for their approval.    …

Key legal info on localization in Swiss Pharma. Prepared in association with Wenger Plattner, a leading law firm in Switzerland, this is an extract from The Pharma Legal Handbook: Switzerland, available to purchase here for GBP 119. 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, there are none. Since Switzerland is one of the most important pharmaceutical research hubs in the world…

Key legal info on orphan drugs & rare diseases in Swiss Pharma. Prepared in association with Wenger Plattner, a leading law firm in Switzerland, this is an extract from The Pharma Legal Handbook: Switzerland, available to purchase here for GBP 119. 1. What is the definition of Rare Diseases in your country? A disease is deemed to be rare if it affects no more than five out of every 10,000 people. 2. Does the designation of ‘Orphan Drug’ exist in…

Key legal info on cannabinoids in Swiss Pharma. Prepared in association with Wenger Plattner, a leading law firm in Switzerland, this is an extract from The Pharma Legal Handbook: Switzerland, available to purchase here for GBP 119.   Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? In principle, the cultivation, introduction, production and placing on the market of narcotics containing an effective concentration of Cannabinoid Drugs are not permitted (art. 8 para. 1 lit. d of the Narcotics…

Key legal info on regulatory reforms in Swiss Pharma. Prepared in association with Wenger Plattner, a leading law firm in Switzerland, this is an extract from The Pharma Legal Handbook: Switzerland, available to purchase here for GBP 119.   1. Are there proposals for reform or significant change to the healthcare system? The revised Therapeutic Products Act (TPA) entered into force on 1 January 2019. Current therapeutic products legislation projects are listed on the website of the Federal Office of…

The low-down on the situation regarding patents & trademarks in Swiss Pharma. Prepared in association with Wenger Plattner, a leading law firm in Switzerland, this is an extract from The Pharma Legal Handbook: Switzerland, available to purchase here for GBP 119.   1. What are the basic requirements to obtain patent and trademark protection? The general principals of patents and trademarks are regulated in the Federal Act on the Protection of Trade Marks and Indications of Source (TmPA; SR 232.11)…

Want to know more about product liability in Swiss Pharma? Read on! Prepared in association with Wenger Plattner, a leading law firm in Switzerland, this is an extract from The Pharma Legal Handbook: Switzerland, available to purchase here for GBP 119.   1. What types of liability are recognized in your jurisdiction? Swiss law generally distinguishes between two types of liability: contractual and non-contractual. Contractual liability is governed by the section about breach of contract in the Swiss Code of…

An intro to the legal situation for traditional medicines and OTC products in Swiss Pharma. Prepared in association with Wenger Plattner, a leading law firm in Switzerland, this is an extract from The Pharma Legal Handbook: Switzerland, available to purchase here for GBP 119.   1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? The distribution of alternative medicinal products such as traditional, herbal or complementary medicines requires a marketing authorisation. Such authorisation is…

Marketing, manufacturing, packaging & labeling, advertising in Swiss Pharma – an overview. Prepared in association with Wenger Plattner, a leading law firm in Switzerland, this is an extract from The Pharma Legal Handbook: Switzerland, available to purchase here for GBP 119.   1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? Medicinal products According to the Federal Act on Medicinal Products and Medical Devices (Therapeutic Products Act; TPA)…

Key legal info on preclinical and clinical trial requirements in Swiss Pharma. Prepared in association with Wenger Plattner, a leading law firm in Switzerland, this is an extract from The Pharma Legal Handbook: Switzerland, available to purchase here for GBP 119.   1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? No, clinical trials do not have to be conducted locally as a condition for marketing approval.   2. How are…

An insight into regulatory, pricing and reimbursement overview in Swiss Pharma. Prepared in association with Wenger Plattner, a leading law firm in Switzerland, this is an extract from The Pharma Legal Handbook: Switzerland, available to purchase here for GBP 119.   1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? Swiss Agency for Therapeutic Products (Schweizerisches Heilmittelinstitut [Swissmedic]): The Swiss Agency for Therapeutic Products (hereinafter: Swissmedic) is the competent authority for various…