Legal & Regulatory > Lithuania

With the end of the Lithuanian Parliament’s Spring Session, a period of neverending discussions and misunderstandings has ended too, as the Parliament and the Ministry of Health have finally adopted a new medicines reimbursement system, writes Ruta Pumputienė.   Lithuanian Ministry of Health deserves compliments for getting involved in the dialogue around the new reimbursement system itself, as well as involving all stakeholders. They have also taken into account the comments of doctors, patients, and industry’s representatives. Finally, they have…

Ruta Pumputiene examines recent regulatory reform in Lithuania, as the Baltic nation attempts to introduce a holistic HTA mechanism for the evaluation of what to include on the country’s reimbursable medicines list.   It is not yet clear whether the new procedure will complicate and damage Lithuanian patients’ access to the newest and most effective medicines The Spring Session Agenda of Seimas [the Lithuanian parliament – Ed.] includes long-promised changes, namely amendments to the Pharmaceutical Law, which will legitimize the…

Regulatory reform in Lithuania – a comprehensive legal overview. Prepared in association with TGS Baltic, a leading law firm in Lithuania, 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? Yes, there are proposals for reforms in the healthcare system. At this moment, the following initiatives are being considered: allowing the sale of prescription medicinal products online; allowing the sale…

All about patents and  trademarks in Lithuanian pharma. Prepared in association with TGS Baltic, a leading law firm in Lithuania, 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 Lithuania: National route: by filing an application directly with the State Patent Bureau (hereinafter, the SPB) (under the Patent…

Want to know more about product liability in Lithuanian pharma? Read on! Prepared in association with TGS Baltic, a leading law firm in Lithuania, 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? There are three types of liability recognized in the Republic of Lithuania: civil; criminal; administrative CIVIL LIABILITY There are two types of civil liability in the Republic of Lithuania: non-contractual…

The ins and out of traditional medicines and OTC products in Lithuania. Prepared in association with TGS Baltic, a leading law firm in Lithuania, 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 Law of the Republic of Lithuania on Pharmacy and its regulations. Traditional herbal medicinal products may receive…

Introducing the legal situation around marketing, manufacturing, packaging & labelling and advertising of pharmaceuticals in Lithuania. Prepared in association with TGS Baltic, a leading law firm in Lithuania, 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? Possible authorization procedures for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and…

All legal aspects surrounding preclinical and clinical trials in Lithuania answered in this structured guide. Prepared in association with TGS Baltic, a leading law firm in Lithuania, 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 Lithuania as a condition for marketing…

All about regulation, pricing and reimbursement of drugs in Lithuania. Prepared in association with TGS Baltic, a leading law firm in Lithuania, 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 responsible for applying and enforcing the regulatory framework and performing control functions in relation to drugs and biologicals is the State Medicine…