Legal & Regulatory > Bulgaria

All legal aspects surrounding localization in Bulgaria. Prepared in association with Kinstellar and PharmDedict, this is an extract from The Pharma Legal Handbook: Bulgaria, available to purchase here for GBP 75. 1. Are biosimilar medicines considered the same as generic medicines in your country? In order to be considered generic biosimilar medicines shall fulfill the requirements for categorizing a product as generic, namely: Generic medicinal product shall be a medicinal product of the same qualitative and quantitative composition in terms…

All legal aspects surrounding localization in Bulgaria. Prepared in association with Kinstellar and PharmDedict, this is an extract from The Pharma Legal Handbook: Bulgaria, 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? Under the general regulation for encouraging investment initiatives in Bulgaria and provision of support thereof contained in the Investment Promotion Act (“the IPA”), subject…

Keen to learn more about orphan drugs & rare diseases in Bulgaria? Read on! Prepared in association with Kinstellar and PharmDedict, this is an extract from The Pharma Legal Handbook: Bulgaria, available to purchase here for GBP 75. 1. What is the definition of Rare Diseases in your country? Under the Medicinal Products in Human Medicine Act (“MPHMA”), a “rare diseases” is defined as a disease characterized by an incidence not higher than 5 per 10,000 individuals.   2. Does…

The key facts about the cannabinoids drugs in Bulgaria. Prepared in association with Kinstellar and PharmDedict, this is an extract from The Pharma Legal Handbook: Bulgaria, available to purchase here for GBP 75.   Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? Pursuant to the Narcotic Substances and Their Precursors Act and secondary legislation for its implementation, Cannabis, as well as Cannabinoid Drugs, are classified in Bulgaria as plants constituting high risk to public health due to the…

The low-down on the situation regarding regulatory reforms in Bulgaria. Prepared in association with Kinstellar and PharmDedict, this is an extract from The Pharma Legal Handbook: Bulgaria, available to purchase here for GBP 75.   1. Are there proposals for reform or significant change to the healthcare system? The topic of changing the existing healthcare system has been thoroughly debated in Bulgaria. In the final quarter of 2018, the Bulgarian minister of healthcare proposed two alternative models (“Model A” and…

A brief overview of the situation regarding patents and trademarks in Bulgaria. Prepared in association with Kinstellar and PharmDedict, this is an extract from The Pharma Legal Handbook: Bulgaria, available to purchase here for GBP 75.   1. What are the basic requirements to obtain patent and trademark protection? A) Patents In Bulgaria, the legislative framework regulating legal relations arising in connection with the creation, protection and use of patentable inventions comprises of the Patents and Utility Models Registration Act…

All legal aspects surrounding product liability in Bulgaria. Prepared in association with Kinstellar and PharmDedict, this is an extract from The Pharma Legal Handbook: Bulgaria, available to purchase here for GBP 75.   1. What types of liability are recognized in your jurisdiction? There are three types of liability recognised in Bulgaria, as follows: civil liability; administrative liability; and criminal liability. (A) Civil Liability There are two types of civil liability under Bulgarian law: contractual liability, which results from non-performance…

The key facts about traditional medicines and OTC products in Bulgarian Pharma. Prepared in association with Kinstellar and PharmDedict, this is an extract from The Pharma Legal Handbook: Bulgaria, available to purchase here for GBP 75.   1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? Bulgarian law regulates medicinal products and medical devices differently. Medicinal products are grouped in three categories: (i) conventional medicinal products; (ii) traditional herbal medicinal products; and (iii) homeopathic…

Marketing, manufacturing, packaging & labeling, advertising in Bulgaria – a comprehensive legal overview. Prepared in association with Kinstellar and PharmDedict, this is an extract from The Pharma Legal Handbook: Bulgaria, available to purchase here for GBP 75.   1. What is the authorisation process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? Homeopathic and traditional herbal medicinal products may be placed on the market in Bulgaria based on а registration certificate. All other medicinal products may be placed…

The ins and outs of preclinical & clinical trial requirements: Bulgaria. Prepared in association with Kinstellar and PharmDedict, this is an extract from The Pharma Legal Handbook: Bulgaria, 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? There is no requirement for clinical trials to be conducted locally as a condition for obtaining market authorisation. However, if the clinical trials have been conducted…

Key legal info on regulatory, pricing and reimbursement in Bulgaria. Prepared in association with Kinstellar and PharmDedict, this is an extract from The Pharma Legal Handbook: Bulgaria, available to purchase here for GBP 75.   1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? The following authorities are responsible for applying and enforcing the regulatory framework pertaining to drugs (including biologicals) and medical devices in Bulgaria: The Bulgarian Drug Agency (BDA) is a specialized State regulatory…