08/11/2018
The latest regulatory reforms in Latvian pharma. Prepared in association with TGS Baltic, a leading law firm in Latvia, 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? Procedure on Medicine Advertising The rules provide that marketing authorization holder will have to submit data about organized and sponsored events – concerning remuneration of lecturers and consultants, technical equipment, catering, etc.…
The legal lowdown on patents and trademarks in Latvian pharma. Prepared in association with TGS Baltic, a leading law firm in Latvia, 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? PATENTS There are three ways to obtain patent protection in the Republic of Latvia: National route: by filing an application directly with the Patent Board (hereinafter the PB) (under the…
All you need to know about product liability in Latvian pharma. Prepared in association with TGS Baltic, a leading law firm in Latvia, 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? Liability regarding damage to persons or property following from supply of defective or faulty products can be claimed on the basis of tort or contract. Tort law-based claims can be brought…
All you need to know about traditional medicines and OTC products in Latvian pharma. Prepared in association with TGS Baltic, a leading law firm in Latvia, 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? Traditional herbal medicinal products are regulated by the PL and its regulations. Traditional herbal medicinal products may receive a marketing authorization following a…
Tackling the big issues around marketing, manufacturing, packaging & labelling, and advertising in Latvian pharma. Prepared in association with TGS Baltic, a leading law firm in Latvia, 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? Please refer to Question 3 in Regulatory, Pricing and Reimbursement overview. 2. What is the…
Important legal info on preclinical and clinical trial requirements in Latvia. Prepared in association with TGS Baltic, a leading law firm in Latvia, 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? No, there is no requirement for clinical trials to be conducted in Latvia as a condition for marketing approval. Following the national procedure,…
A brief overview of the situation regarding regulatory, pricing and reimbursement in Latvia. Prepared in association with TGS Baltic, a leading law firm in Latvia, 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? There are several authorities responsible for applying and enforcing the regulatory framework in relation to drugs, biologicals, and medical devices:…
