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 USD 99.   1. Are there proposals for reform or significant change to the healthcare system? The revised Therapeutic Products Act (TPH) 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 USD 99.   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) as well…

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 USD 99.   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 USD 99.   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 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? 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 USD 99.   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 USD 99.   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…