Legal & Regulatory > Slovakia

The legal framework for orphan drugs and rare diseases in the Slovakian Pharma. Prepared in association with PRK Partners, a leading global law firm, this is an extract from The Pharma Legal Handbook: Slovakia, available to purchase here for GBP 75. 1. What is the definition of Rare Diseases in your country? The Slovak legislation does not have a specific legal definition for Rare Diseases. The Slovak Act on Medicinal Products rather refers to the Regulation (EC) No. 141/2000 with respect…

The legal framework for biosimilars and biologics in Slovakian Pharma. Prepared in association with PRK Partners, a leading global law firm, this is an extract from The Pharma Legal Handbook: Slovakia, available to purchase here for GBP 75.   1. Are biosimilar medicines considered the same as generic medicines in your country? Biosimilar medicines are not considered the same as generic medicines in Slovakia. A similar biological medicinal product, also known as “biosimilar”, is a product which is similar (not identical)…

The legal framework for localization in Slovakian Pharma. Prepared in association with PRK Partners, a leading global law firm, this is an extract from The Pharma Legal Handbook: Slovakia, available to purchase here for GBP 75.   1. Are there any rules or regulations requiring and/or encouraging localization in your country? What is the legal framework defining these localization rules and policies? There are generally not such rules. However, the handling with medicinal products (as defined by the Act on Medicinal…

All legal aspects surrounding cannabinoid drugs, medicinal cannabis and opioid drugs in Slovakia. Prepared in association with PRK Partners, a leading global law firm, this is an extract from The Pharma Legal Handbook: Slovakia, available to purchase here for GBP 75.   Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? Yes. In our understanding, Cannabinoid Drugs are medicinal drugs containing active compounds of cannabis (such as THC and CBD) as opposed to psychoactive cannabis per se intended for recreational use.…

The legal framework for regulatory reform in Slovakian Pharma. Prepared in association with PRK Partners, a leading global law firm, this is an extract from The Pharma Legal Handbook: Slovakia, available to purchase here for GBP 75.   1. Are there proposals for reform or significant change to the healthcare system? E-Health With effect as of 1 January 2018, mandatory e-Health system has been introduced in the Slovak Republic. This reform included the introduction of an electronic health book of a patient,…

An insight into patents & trademarks in Slovakian Pharma. Prepared in association with PRK Partners, a leading global law firm, this is an extract from The Pharma Legal Handbook: Slovakia, available to purchase here for GBP 75.   1. What are the basic requirements to obtain patent and trademark protection? PATENTS One can file for patent protection for any invention, in all fields of technology, provided it is new, involves an inventive step, and is capable of industrial application and the…

All about product liability in Slovakian Pharma. Prepared in association with PRK Partners, a leading global law firm, this is an extract from The Pharma Legal Handbook: Slovakia, available to purchase here for GBP 75.   1. What types of liability are recognized in your jurisdiction? The Slovak legal order recognizes three types of liability: civil, criminal, and administrative. Civil liability may be further divided into contractual liability, which results from a failure to comply with contractual obligations (e.g. failure to perform…

The low-down on the situation regarding traditional medicines and OTC products in Slovakia. Prepared in association with PRK Partners, a leading global law firm, this is an extract from The Pharma Legal Handbook: Slovakia, available to purchase here for GBP 75.   1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? Traditional herbal medicinal products and homeopathic medicinal products are regulated by the Act on Medicinal Products and its regulations. Traditional herbal medicinal products may receive…

A brief overview of the situation regarding marketing, manufacturing, packaging & labeling, advertising in Slovakia. Prepared in association with PRK Partners, a leading global law firm, this is an extract from The Pharma Legal Handbook: Slovakia, available to purchase here for GBP 75.   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 In the Slovak Republic, the following authorization procedures are available in order to obtain the…

Preclinical and clinical trial requirements in Slovakian Pharma – a legal guide. Prepared in association with PRK Partners, a leading global law firm, this is an extract from The Pharma Legal Handbook: Slovakia, available to purchase here for GBP 75.   1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? No, clinical trials can also be conducted abroad. If the clinical trial is performed outside the EEA, the applicant for the…

An intro to the legal situation for regulatory, pricing and reimbursement in Slovakian Pharma. Prepared in association with PRK Partners, a leading global law firm, this is an extract from The Pharma Legal Handbook: Slovakia, available to purchase here for GBP 75.   1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? In the Slovak Republic, the main regulatory authorities over medicinal products, biologicals, and medical devices are the State Institute for Drug Control…