Tagged with legal

Pharma Legal Handbook 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 119.   1. What is the authorization process for…

Pharma Legal Handbook 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 119.   1. What are the regulatory requirements for traditional, herbal, complementary, or…

Pharma Legal Handbook 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 119.   1. What are the basic requirements to obtain patent and trademark…

Pharma Legal Handbook 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 119.   1. Are there proposals for reform or significant change to the healthcare system?…

Pharma Legal Handbook 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 119.   Cannabinoid Drugs 1. Are Cannabinoid Drugs…

Pharma Legal Handbook 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 119.   1. Are there any rules or regulations requiring and/or encouraging…

Pharma Legal Handbook 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 119.   1. What is the definition of Rare Diseases in your country? Pursuant…

Pharma Legal Handbook 1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? The key regulatory authority with jurisdiction over drugs, biological and medical devices in Singapore is the Health Sciences Authority (HSA). It was established on 1 April 2001 as a statutory board of the…

Pharma Legal Handbook 1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? No, there is no such express statutory requirement under Singapore legislation.   2. How are clinical trials funded? Clinical trials may be funded by pharmaceutical companies, hospitals, medical technology companies, biotechnology companies…

Pharma Legal Handbook 1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? THERAPEUTIC PRODUCTS For therapeutic products, marketing approval may be obtained by making an application to the Health Sciences Authority (HSA) for product registration. The applicant (or product registrant) must…

Pharma Legal Handbook 1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? Chinese proprietary medicines, traditional (Indian and Malay) medicines, homeopathic medicines and medicated oils and balms are regulated under the Medicines Act 1975, the Medicines (Advertisement and Sale) Act 1955, the Sale of Drugs Act 1914and…

Pharma Legal Handbook 1. What types of liability are recognized in your jurisdiction? In Singapore, product liability in relation to medicines can arise under an action in tort, contract and/or breach of relevant statutory provisions.   2. How do these types of liabilities apply to the manufacturers of medicines and devices? An action…