07/11/2018
Key legal info on regulatory reforms in Estonia. Prepared in association with TGS Baltic, a leading law firm in Estonia, this is an extract from The Pharma Legal Handbook: Baltics, available to purchase here for USD 99. 1. Are there proposals for reform or significant change to the healthcare system? According to the current plan and corresponding legislation, reform concerning owning pharmacies will be finalized in two years. The aim of the reform is to separate wholesale and retail sale…
A structured legal guide about Patents & Trademarks in Estonia. Prepared in association with TGS Baltic, a leading law firm in Estonia, this is an extract from The Pharma Legal Handbook: Baltics, available to purchase here for USD 99. 1. What are the basic requirements to obtain patent and trademark protection? A. PATENTS There are three ways to obtain patent protection in the Republic of Estonia: National route: by filing an application directly with the Estonian Patent Office (hereinafter the EPO)…
The ins and outs of product liability in Estonia. Prepared in association with TGS Baltic, a leading law firm in Estonia, this is an extract from The Pharma Legal Handbook: Baltics, available to purchase here for USD 99. 1. What types of liability are recognized in your jurisdiction? A. Civil liability (where a patient claims compensation for damage or injury) In Estonia, contractual liability and liability for unlawful damage (non-contractual liability, including liability of defective product) are recognised. The manufacturer…
Traditional medicines and OTC products in Estonia – a comprehensive legal overview. Prepared in association with TGS Baltic, a leading law firm in Estonia, this is an extract from The Pharma Legal Handbook: Baltics, available to purchase here for USD 99. 1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? Primary legislation for herbal medicines and traditional herbal medicines is the Medicinal Products Act and its regulations. Marketing of herbal medicines requires a marketing…
All legal aspects of marketing, manufacturing, packaging, labeling and advertising of drugs in Estonia. Prepared in association with TGS Baltic, a leading law firm in Estonia, this is an extract from The Pharma Legal Handbook: Baltics, 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? A. MEDICINES (new medicines, biologics, OTC medicines) There are the following ways to obtain marketing authorization for…
All legal aspects surrounding preclinical and clinical trials in Estonia. Prepared in association with TGS Baltic, a leading law firm in Estonia, this is an extract from The Pharma Legal Handbook: Baltics, 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? Clinical trials are not required to be conducted locally as a condition for marketing approval. Following the national procedure, clinical trials may be conducted…
All legal aspects surrounding regulatory, pricing and reimbursement in Estonia. Prepared in association with TGS Baltic, a leading law firm in Estonia, this is an extract from The Pharma Legal Handbook: Baltics, available to purchase here for USD 99. 1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? The authority with jurisdiction over medicines and biologicals is the State Agency of Medicines (SAM). The authority responsible for applying and enforcing the…
Traditional medicines and OTC products in Estonia – a comprehensive…
The ins and outs of product liability in Estonia. Prepared…
All legal aspects surrounding regulatory, pricing and reimbursement in Estonia.…
All legal aspects of marketing, manufacturing, packaging, labeling and advertising…
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