Legal & Regulatory > Europe

All about marketing, manufacturing, packaging & labeling, advertising in Ireland. Prepared in association with Mason Hayes & Curran, a leading law firm in Ireland, this is an extract from The Pharma Legal Handbook: Ireland, available to purchase here for GBP 99.   1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? See Question 1 of Regulatory, Pricing and Reimbursement Overview.   2. What is the authorization process for…

A brief overview of the situation regarding preclinical and clinical trial requirements in Ireland. Prepared in association with Mason Hayes & Curran, a leading law firm in Ireland, this is an extract from The Pharma Legal Handbook: Ireland, available to purchase here for GBP 99.   1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? Clinical trials do not have to be conducted locally in order to gain marketing approval in…

An intro to the legal situation for regulatory, pricing and reimbursement in Ireland. Prepared in association with Mason Hayes & Curran, a leading law firm in Ireland, this is an extract from The Pharma Legal Handbook: Ireland, available to purchase here for GBP 99.   1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? The regulatory authority with responsibility for drugs, biologicals and medical devices in Ireland is the Health Products Regulatory…

Cannabinoid drugs, medicinal cannabis and opioid drugs in Luxembourg – a comprehensive legal overview. Prepared in association with Emmanuelle Ragot, an independent firm anchored in Luxembourg, this is an extract from The Pharma Legal Handbook: Luxembourg, available to purchase here for GBP 99. *Major changes are expected in 2022 on the use of cannabis which should impact its use for pharmaceutical purposes.     Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? The use of recreational cannabis is prohibited…

The key facts about regulatory reform in Luxembourg. Prepared in association with Emmanuelle Ragot, an independent firm anchored in Luxembourg, this is an extract from The Pharma Legal Handbook: Luxembourg, available to purchase here for GBP 99. *Many laws (11) have been published in Luxembourg in 2020, but 100% of them are in relation to the management of COVID 19.     1. Are there proposals for reform or significant change to the healthcare system? Yes, the ongoing draft law n°7383…

Patents and trademarks of drugs in Luxembourg – an overview. Prepared in association with Emmanuelle Ragot, an independent firm anchored in Luxembourg, this is an extract from The Pharma Legal Handbook: Luxembourg, available to purchase here for GBP 99. *Many laws (11) have been published in Luxembourg in 2020, but 100% of them are in relation to the management of COVID 19.     1. What are the basic requirements to obtain patent and trademark protection? I. THE MAIN LEGISLATIONS FOR…

An insight into product liability in Luxembourg. Prepared in association with Emmanuelle Ragot, an independent firm anchored in Luxembourg, this is an extract from The Pharma Legal Handbook: Luxembourg, available to purchase here for GBP 99. *Many laws (11) have been published in Luxembourg in 2020, but 100% of them are in relation to the management of COVID 19.     1. What types of liability are recognized in your jurisdiction? There are four types of product liability recognized in Luxembourg:…

All about traditional medicines and OTC products in Luxembourg. Prepared in association with Emmanuelle Ragot, an independent firm anchored in Luxembourg, this is an extract from The Pharma Legal Handbook: Luxembourg, available to purchase here for GBP 99. *Many laws (11) have been published in Luxembourg in 2020, but 100% of them are in relation to the management of COVID 19.     1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? According to article…

An intro to the legal situation for marketing, manufacturing, packaging & labeling, and advertising in Luxembourg. Prepared in association with Emmanuelle Ragot, an independent firm anchored in Luxembourg, this is an extract from The Pharma Legal Handbook: Luxembourg, available to purchase here for GBP 99. *Many laws (11) have been published in Luxembourg in 2020, but 100% of them are in relation to the management of COVID 19.     1. What is the authorization process for the marketing of new…

Preclinical and clinical trial requirements in Luxembourg – a legal guide. Prepared in association with Emmanuelle Ragot, an independent firm anchored in Luxembourg, this is an extract from The Pharma Legal Handbook: Luxembourg, available to purchase here for GBP 99. *Many laws (11) have been published in Luxembourg in 2020, but 100% of them are in relation to the management of COVID 19.      1. Are clinical trials required to be conducted locally as a condition (stated or implicit)…

A brief overview of the situation regarding regulatory, pricing and reimbursement of drugs in Luxembourg. Prepared in association with Emmanuelle Ragot, an independent firm anchored in Luxembourg, this is an extract from The Pharma Legal Handbook: Luxembourg, available to purchase here for GBP 99. *Many laws (11) have been published in Luxembourg in 2020, but 100% of them are in relation to the management of COVID 19.     1. What are the regulatory authorities with jurisdiction over drugs, biologicals,…

Key legal info on biosimilars & biologics in Portugal. Prepared in association with Cuatrecasas, a leading Iberian law firm, this is an extract from The Pharma Legal Handbook: Portugal, available to purchase here for GBP 99.     1. Are biosimilar medicines considered the same as generic medicines in your country? Biosimilar medicines are defined by exclusion, i.e. a biosimilar medicine is a biological medicine which does not fulfil the conditions of the definition of a generic medicine (amongst other,…

Want to know more about localization in Portugal? Prepared in association with Cuatrecasas, a leading Iberian law firm, this is an extract from The Pharma Legal Handbook: Portugal, available to purchase here for GBP 99.     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? Generally, in the pharmaceutical sector, there are no rules and policies requiring localization in Portugal. However, it is…

An intro to the legal situation for orphan drugs and rare diseases in Portugal. Prepared in association with Cuatrecasas, a leading Iberian law firm, this is an extract from The Pharma Legal Handbook: Portugal, available to purchase here for GBP 99.     1. What is the definition of Rare Diseases in your country? There is no legal definition for Rare Disease within the national legislation. However, within the European Union, diseases that affect less than five in ten thousand…

All legal aspects surrounding cannabinoid drugs, medicinal cannabis and opioid drugs in Portugal. Prepared in association with Cuatrecasas, a leading Iberian law firm, this is an extract from The Pharma Legal Handbook: Portugal, available to purchase here for GBP 99.   Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? The placing in the Portuguese market of products or substances based on cannabinoid drugs for medicinal purposes is subject to a specific authorization from Infarmed – National Authority on…

Regulatory reforms to watch out for in Portuguese pharma. Prepared in association with Cuatrecasas, a leading law firm in Portugal, this is an extract from The Pharma Legal Handbook: Portugal, available to purchase here for GBP 99.     1. Are there proposals for reform or significant change to the healthcare system? As far as publicly made available by the Portuguese Government and Parliament, there is no proposals for reform or significant changes to the healthcare system. In any case, with respect…

Read all about the legal situation around patents and trademarks in Portuguese pharma. Prepared in association with Cuatrecasas, a leading law firm in Portugal, this is an extract from The Pharma Legal Handbook: Portugal, available to purchase here for GBP 99.     1. What are the basic requirements to obtain patent and trademark protection? The main Portuguese legal framework for industrial property rights is enshrined in the Industrial Property Code (CPI), as approved by Decree-Law 110/2018, of 10 December 2018 (as…

A brief overview of the situation regarding product liability in Portuguese pharma. Prepared in association with Cuatrecasas, a leading law firm in Portugal, this is an extract from The Pharma Legal Handbook: Portugal, available to purchase here for GBP 99.     1. What types of liability are recognized in your jurisdiction? The Portuguese legal system provides for two fundamental types of civil liability: liability arising from failure to comply with contractual obligations (contractual liability) and liability resulting from the infringement of…

Want to know more about traditional medicines and OTC products in Portugal? Read on! Prepared in association with Cuatrecasas, a leading law firm in Portugal, this is an extract from The Pharma Legal Handbook: Portugal, available to purchase here for GBP 99.     1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? Traditional, herbal, complementary, or alternative medicines are subject to a registration procedure before Infarmed. The registration procedure may be national, based on a…

All about marketing, manufacturing, packaging and labeling and advertising of drugs in Portugal. Prepared in association with Cuatrecasas, a leading law firm in Portugal, this is an extract from The Pharma Legal Handbook: Portugal, available to purchase here for GBP 99.     1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? (i) Medicinal products The marketing of any medicinal products, including new drugs, biologics and over-the counter medicinal products,…

Preclinical and clinical trials in Portugal – a legal guide. Prepared in association with Cuatrecasas, a leading law firm in Portugal, this is an extract from The Pharma Legal Handbook: Portugal, available to purchase here for GBP 99.     1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? No, clinical trials may be conducted abroad. In those cases, and whenever clinical trials are conducted outside the European Union, the applicant of the…

The key legal info around regulation, pricing and reimbursement in Portuguese pharma. Prepared in association with Cuatrecasas, a leading law firm in Portugal, this is an extract from The Pharma Legal Handbook: Portugal, available to purchase here for GBP 99.     1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? Jurisdiction over drugs, biologicals and medical devices is centralized in Infarmed, the Portuguese Medicine Regulatory Authority (Autoridade Nacional do Medicamento e…

Key legal info on biosimilars & biologics in Czech Republic. Prepared in association with PRK Partners, a leading law firm in Czech Republic, this is an extract from The Pharma Legal Handbook: Czech Republic, available to purchase here for GBP 99.   1. Are biosimilar medicines considered the same as generic medicines in your country? No, biosimilars are not regarded as generics of biological medicines. Czech legislation implements EU directives, and directly applicable EU regulations on biosimilars and biologics apply. EU…

Want to know more about localization in Czech Republic? Prepared in association with PRK Partners, a leading law firm in Czech Republic, this is an extract from The Pharma Legal Handbook: Czech Republic, available to purchase here for GBP 99.   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? As a general rule, there are no localization requirements relating to medicinal products in the…

An intro to the legal situation for orphan drugs and rare diseases in Czech Republic. Prepared in association with PRK Partners, a leading law firm in Czech Republic, this is an extract from The Pharma Legal Handbook: Czech Republic, available to purchase here for GBP 99.   1. What is the definition of Rare Diseases in your country? The relevant Czech regulation defines rare diseases as those with a very low incidence in the population, within the meaning of the relevant…

Cannabinoid drugs, medicinal cannabis and opioid drugs in Czech Republic – a legal guide. Prepared in association with PRK Partners, a leading law firm in Czech Republic, this is an extract from The Pharma Legal Handbook: Czech Republic, available to purchase here for GBP 99.   CANNABINOID DRUGS 1. Are Cannabinoid Drugs authorized in your country? Cannabinoid Drugs, i.e. drugs containing active compounds of cannabis, such as tetrahydrocannabinol (THC) or cannabidiol (CBD), can be authorized in the Czech Republic under the…

A brief overview of the situation regarding regulatory reforms in Czech Republic. Prepared in association with PRK Partners, a leading law firm in Czech Republic, this is an extract from The Pharma Legal Handbook: Czech Republic, available to purchase here for GBP 99.   1. Are there proposals for reform or significant change to the healthcare system? Digitalization With respect to Czech legislation, the main topic of proposed regulatory changes is the ongoing process of digitalization. The Ministry of Health is…

The legal framework for patents and trademarks in Czech Republic Pharma. Prepared in association with PRK Partners, a leading law firm in Czech Republic, this is an extract from The Pharma Legal Handbook: Czech Republic, available to purchase here for GBP 99.   1. What are the basic requirements to obtain patent and trademark protection? One can file for patent protection for any invention, in all fields of technology, provided the invention is new, involves an inventive step, and is capable…

Want to know more about product liability in Czech Republic? Read on! Prepared in association with PRK Partners, a leading law firm in Czech Republic, this is an extract from The Pharma Legal Handbook: Czech Republic, available to purchase here for GBP 99.   1. What types of liability are recognized in your jurisdiction? Two types of liability are recognized in the Czech Republic: contractual liability, arising from the failure to comply with one’s contractual obligations; non-contractual (civil) liability, arising as…

Key legal info on marketing, manufacturing, packaging & labeling, advertising in Czech Republic. Prepared in association with PRK Partners, a leading law firm in Czech Republic, this is an extract from The Pharma Legal Handbook: Czech Republic, available to purchase here for GBP 99.   1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? DRUGS The following authorization procedures are available in the Czech Republic for obtaining market authorization…

The ins and outs of traditional medicines and OTC products in Czech Republic. Prepared in association with PRK Partners, a leading law firm in Czech Republic, this is an extract from The Pharma Legal Handbook: Czech Republic, available to purchase here for GBP 99.   1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? Traditional herbal medicinal products and homeopathic medicinal products are subject to specific regulation set out in the Act on Drugs. Traditional…

Preclinical & clinical trial requirements in Czech Republic – an overview. Prepared in association with PRK Partners, a leading law firm in Czech Republic, this is an extract from The Pharma Legal Handbook: Czech Republic, available to purchase here for GBP 99.   1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? No, clinical trials may be also conducted abroad. If a clinical trial was conducted in a country outside of…

An insight into regulatory, pricing and reimbursement overview in Czech Republic. Prepared in association with PRK Partners, a leading law firm in Czech Republic, this is an extract from The Pharma Legal Handbook: Czech Republic, available to purchase here for GBP 99.   1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? The main authorities with jurisdiction over drugs, biologicals, and medical devices in the Czech Republic are the Ministry of Health…

Key legal info on biosimilars & biologics in Swiss Pharma. Prepared in association with Wenger Plattner, a leading law firm in Switzerland, this is an extract from The Pharma Legal Handbook: Switzerland, available to purchase here for GBP 99. 1. Are biosimilar medicines considered the same as generic medicines in your country? No, compared to generics with chemically synthesized active ingredients, the production of biosimilars is much more complex, and further requirements must be met for their approval.    …

Key legal info on localization in Swiss Pharma. Prepared in association with Wenger Plattner, a leading law firm in Switzerland, this is an extract from The Pharma Legal Handbook: Switzerland, available to purchase here for GBP 99. 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? No, there are none. Since Switzerland is one of the most important pharmaceutical research hubs in the world…

Key legal info on orphan drugs & rare diseases in Swiss Pharma. Prepared in association with Wenger Plattner, a leading law firm in Switzerland, this is an extract from The Pharma Legal Handbook: Switzerland, available to purchase here for GBP 99. 1. What is the definition of Rare Diseases in your country? A disease is deemed to be rare if it affects no more than five out of every 10,000 people. 2. Does the designation of ‘Orphan Drug’ exist in…

Key legal info on cannabinoids in Swiss Pharma. Prepared in association with Wenger Plattner, a leading law firm in Switzerland, this is an extract from The Pharma Legal Handbook: Switzerland, available to purchase here for GBP 99.   Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? In principle, the cultivation, introduction, production and placing on the market of narcotics containing an effective concentration of Cannabinoid Drugs are not permitted (art. 8 para. 1 lit. d of the Narcotics…

Key legal info on biosimilars & biologics in Russia. Prepared in association with Lidings, a leading global law firm, this is an extract from The Pharma Legal Handbook: Russia, available to purchase here for GBP 99.     1. Are biosimilar medicines considered the same as generic medicines in your country? Biosimilar drugs are not the same as generic drugs in Russia. A biosimilar drug cannot be a copy of the original biological drug, as in respect of a biosimilar drug…

Want to know more about localization in Russia? Prepared in association with Lidings, a leading global law firm, this is an extract from The Pharma Legal Handbook: Russia, available to purchase here for GBP 99.     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? The Strategy of the pharmaceutical industry development until 2020 (“Pharma-2020”) defined localization as one of the main tendencies of…

An intro to the legal situation for orphan drugs and rare diseases in Russia. Prepared in association with Lidings, a leading global law firm, this is an extract from The Pharma Legal Handbook: Russia, available to purchase here for GBP 99.     1. What is the definition of Rare Diseases in your country? The definition of rare diseases is stipulated by Art. 44 of the Federal law dd 21.11.2011 No. 323-FZ “On fundamental healthcare principles in the Russian Federation” (the…

All legal aspects surrounding cannabinoid drugs, medicinal cannabis and opioid drugs in Russia. Prepared in association with Lidings, a leading global law firm, this is an extract from The Pharma Legal Handbook: Russia, available to purchase here for GBP 99.     Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? Cannabinoid Drugs are regarded as narcotic drugs of ‘List I’ which circulation within the Russian Federation is prohibited. Cannabinoid Drugs might be imported for scientific and expertise purposes only.…

Upcoming reforms in Russia’s pharma environment. Prepared in association with Lidings, a leading global law firm, this is an extract from The Pharma Legal Handbook: Russia, available to purchase here for GBP 99.     1. Are there proposals for reform or significant change to the healthcare system? Functioning of the EAEU common market for drugs and the EAEU common market for medical devices. The authorization of distance selling of OTC drugs subject to the following requirements: The following types of drugs…

All about patents and trademarks in Russia. Prepared in association with Lidings, a leading global law firm, this is an extract from The Pharma Legal Handbook: Russia, available to purchase here for GBP 99.     1. What are the basic requirements to obtain patent and trademark protection? PATENTS The Russian law provides protection for registered inventions, utility models and industrial designs. Pharmaceutical substance is generally protected as an invention. An invention is a technical solution in any field related to a…

The lowdown on the situation regarding the product liability in Russian Pharma. Prepared in association with Lidings, a leading global law firm, this is an extract from The Pharma Legal Handbook: Russia, available to purchase here for GBP 99.     1. What types of liability are recognized in your jurisdiction? There are several types of liability recognized by the Russian Federation, namely: disciplinary liability (for disciplinary offenses); civil liability (for civil offenses); administrative liability (for administrative offenses); criminal liability (for…

A brief overview of the situation regarding traditional medicines and OTC products in Russia. Prepared in association with Lidings, a leading global law firm, this is an extract from The Pharma Legal Handbook: Russia, available to purchase here for GBP 99.     1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? Traditional medicines are treated as nutrition products (dietary products or health supplements, as the case may be) under Russian law. Thus, the basic…

Learn more about marketing, manufacturing, packaging & labeling, and advertising in Russian pharma. Prepared in association with Lidings, a leading global law firm, this is an extract from The Pharma Legal Handbook: Russia, available to purchase here for GBP 99.     1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? The authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications has been already covered by…

All about preclinical and clinical trial requirements in Russia. Prepared in association with Lidings, a leading global law firm, this is an extract from The Pharma Legal Handbook: Russia, available to purchase here for GBP 99.     1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? Under the EAEU regulations, clinical trials are to be conducted in the EAEU in compliance with the Good Clinical Practice of the EAEU (approved by the…

An intro to the legal situation for regulatory, pricing and reimbursement in Russia. Prepared in association with Lidings, a leading global law firm, this is an extract from The Pharma Legal Handbook: Russia, available to purchase here for GBP 99.     1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? The authorities responsible for applying and enforcing the regulatory framework shall be: concerning drugs and biologicals – the Ministry of Healthcare…

Key legal info on litigation in Croatia. Prepared in association with Danijel Pribanić, a leading global law firm, this is an extract from The Pharma Legal Handbook: Croatia, available to purchase here for GBP 99.   1.Who has the burden of proof in litigation for drug side effects? The burden of proof is on the plaintiff, there is no automatism. The parties are obliged to state all the facts on which their claims are based in the lawsuit and the…

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…

All legal aspects surrounding biosimilars and biologics in the Polish pharma market. Prepared in association with DLA Piper, a leading law firm in Poland, this is an extract from The Pharma Legal Handbook: Poland, available to purchase here for GBP 75. 1. Are biosimilar medicines considered the same as generic medicines in your country? Under the Pharmaceutical Law, a product is deemed as generic with respect to the reference product if it has the same qualitative and quantitative composition of…

All legal aspects surrounding localization in the Polish pharma market. Prepared in association with DLA Piper, a leading law firm in Poland, this is an extract from The Pharma Legal Handbook: Poland, 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? No, there are no rules or regulations requiring or encouraging localisation in Poland. However, certain activities…

All legal aspects surrounding orphan drugs and rare diseases in the Polish pharma market. Prepared in association with DLA Piper, a leading law firm in Poland, this is an extract from The Pharma Legal Handbook: Poland, available to purchase here for GBP 75. 1. What is the definition of Rare Diseases in your country? There is no legal definition of Rare Diseases in Poland. On official websites the government uses the definition recommended by the EU, i.e. a rare disease…

All legal aspects surrounding cannabinoid drugs, medicinal cannabis and opioid drugs in Poland. Prepared in association with DLA Piper, a leading law firm in Poland, this is an extract from The Pharma Legal Handbook: Poland, available to purchase here for GBP 75. Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? In general, hemp herb other than fibre, containing more than 0.20% of the sum of delta-9-Tetrahydrocannabinol (THC) and Tetrahydrocannabinoleic acid (delta-9-THC-carboxylic acid) is not authorised in Poland. However,…

All legal aspects surrounding the regulatory reforms in the Polish pharma market. Prepared in association with DLA Piper, a leading law firm in Poland, this is an extract from The Pharma Legal Handbook: Poland, available to purchase here for GBP 75. 1. Are there proposals for reform or significant change to the healthcare system? Proposed legislation on medical devices At the beginning of 2020, a new act on medical devices was published on the website of the Polish Government Legislation…

All legal aspects surrounding patents & trademarks in Poland. Prepared in association with DLA Piper, a leading law firm in Poland, this is an extract from The Pharma Legal Handbook: Poland, available to purchase here for GBP 75. 1. What are the basic requirements to obtain patent and trademark protection? 1.1. Patents An invention (which is patentable) is a new (on a global scale) solution of a technical nature, characterized by a degree of inventiveness (not obvious in prior art),…

The legal framework for product liability in Poland. Prepared in association with DLA Piper, a leading law firm in Poland, this is an extract from The Pharma Legal Handbook: Poland, available to purchase here for GBP 75.   1. What types of liability are recognized in your jurisdiction? Under Polish law, the following types of liability are recognized: criminal liability; civil liability for breach of contract or torts. The injured party may seek compensation for damage before a civil law…

The legal framework for traditional medicines and OTC products in Polish Pharma. Prepared in association with DLA Piper, a leading law firm in Poland, this is an extract from The Pharma Legal Handbook: Poland, available to purchase here for GBP 75.   1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? Pharmaceutical Law provides for a simplified procedure for the marketing authorization of herbal medicinal products, provided that they meet criteria for traditional herbal…

All about marketing, manufacturing, packaging & labeling, advertising in Polish Pharma. Prepared in association with DLA Piper, a leading law firm in Poland, this is an extract from The Pharma Legal Handbook: Poland, 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? a) Medicinal products Chapter 2 of the Pharmaceutical Law sets forth the rules relating to the marketing of…

All legal aspects surrounding preclinical and clinical trial requirements in Polish Pharma. Prepared in association with DLA Piper, a leading law firm in Poland, this is an extract from The Pharma Legal Handbook: Poland, 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, there is no requirement to conduct clinical trials locally to receive marketing approval.   2. How are clinical trials…

An insight into regulatory, pricing and reimbursement overview in Polish Pharma. Prepared in association with DLA Piper, a leading law firm in Poland, this is an extract from The Pharma Legal Handbook: Poland, 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 President of the Office for the Registration of Medicinal Products, Medical Devices and Biocidal Products (Prezes Urzędu Rejestracji Produktów Leczniczych, Wyrobów…

The ins and outs of biosimilars and biologics in Romania. Prepared in association with Mușat & Asociații, a leading global law firm, this is an extract from The Pharma Legal Handbook: Romania, available to purchase here for GBP 75. 1. Are biosimilar medicines considered the same as generic medicines in your country? The biosimilar medicinal products are not considered the same as generic medicinal products, since the Romanian legislation regulates in a different manner biosimilars and generics. As per the local…

The ins and outs of localization in Romanian pharma. Prepared in association with Mușat & Asociații, a leading global law firm, this is an extract from The Pharma Legal Handbook: Romania, 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? Romania has a favourable tax regime for companies, which encourages many businesses to set up and to…

All legal aspects surrounding the orphan drugs and rare diseases in Romania. Prepared in association with Mușat & Asociații, a leading global law firm, this is an extract from The Pharma Legal Handbook: Romania, available to purchase here for GBP 75.   1. What is the definition of Rare Diseases in your country? Regulation (EC) no. 141/2000 on orphan medicinal products (“Regulation no. 141/2000”), which is directly applicable in Romania, specifies that a medicinal product could be designated by the European…

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…

Key legal info on regulatory reforms in Swiss Pharma. Prepared in association with Wenger Plattner, a leading law firm in Switzerland, this is an extract from The Pharma Legal Handbook: Switzerland, available to purchase here for USD 99.   1. Are there proposals for reform or significant change to the healthcare system? The revised Therapeutic Products Act (TPA) entered into force on 1 January 2019. Current therapeutic products legislation projects are listed on the website of the Federal Office of…

The low-down on the situation regarding patents & trademarks in Swiss Pharma. Prepared in association with Wenger Plattner, a leading law firm in Switzerland, this is an extract from The Pharma Legal Handbook: Switzerland, available to purchase here for GBP 99.   1. What are the basic requirements to obtain patent and trademark protection? The general principals of patents and trademarks are regulated in the Federal Act on the Protection of Trade Marks and Indications of Source (TmPA; SR 232.11)…

Want to know more about product liability in Swiss Pharma? Read on! Prepared in association with Wenger Plattner, a leading law firm in Switzerland, this is an extract from The Pharma Legal Handbook: Switzerland, available to purchase here for GBP 99.   1. What types of liability are recognized in your jurisdiction? Swiss law generally distinguishes between two types of liability: contractual and non-contractual. Contractual liability is governed by the section about breach of contract in the Swiss Code of…

An intro to the legal situation for traditional medicines and OTC products in Swiss Pharma. Prepared in association with Wenger Plattner, a leading law firm in Switzerland, this is an extract from The Pharma Legal Handbook: Switzerland, available to purchase here for GBP 99.   1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? The distribution of alternative medicinal products such as traditional, herbal or complementary medicines requires a marketing authorisation. Such authorisation is…

Marketing, manufacturing, packaging & labeling, advertising in Swiss Pharma – an overview. Prepared in association with Wenger Plattner, a leading law firm in Switzerland, this is an extract from The Pharma Legal Handbook: Switzerland, available to purchase here for GBP 99.   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 According to the Federal Act on Medicinal Products and Medical Devices (Therapeutic Products Act; TPA)…

Key legal info on preclinical and clinical trial requirements in Swiss Pharma. Prepared in association with Wenger Plattner, a leading law firm in Switzerland, this is an extract from The Pharma Legal Handbook: Switzerland, available to purchase here for GBP 99.   1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? No, clinical trials do not have to be conducted locally as a condition for marketing approval.   2. How are…

An insight into regulatory, pricing and reimbursement overview in Swiss Pharma. Prepared in association with Wenger Plattner, a leading law firm in Switzerland, this is an extract from The Pharma Legal Handbook: Switzerland, available to purchase here for GBP 99.   1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? Swiss Agency for Therapeutic Products (Schweizerisches Heilmittelinstitut [Swissmedic]): The Swiss Agency for Therapeutic Products (hereinafter: Swissmedic) is the competent authority for various…

Keen to learn more about regulatory reforms in Norwegian Pharma? Read on! Prepared in association with DLA Piper, a leading law firm in Norway, this is an extract from The Pharma Legal Handbook: Norway, available to purchase here for USD 99.   1. Are there proposals for reform or significant change to the healthcare system? The most relevant changes to the Norwegian healthcare system expected to enter into force in the near future are the following: –  the new EU…

Patents & trademarks in Norwegian Pharma – a comprehensive legal overview. Prepared in association with DLA Piper, a leading law firm in Norway, this is an extract from The Pharma Legal Handbook: Norway, available to purchase here for USD 99.   1. What are the basic requirements to obtain patent and trademark protection? a) Patents The requirements for obtaining patents and the protection thereof is regulated by the Norwegian Patent Act ( LOV-1967-12-15-9). The basic requirements for obtaining a patent…

The low-down on the situation regarding product liability in Norwegian Pharma. Prepared in association with DLA Piper, a leading law firm in Norway, this is an extract from The Pharma Legal Handbook: Norway, available to purchase here for USD 99.   1. What types of liability are recognized in your jurisdiction? Norwegian law recognizes the following types of liability Criminal liability, for violation of the Norwegian Penal Code or where criminal liability is stipulated by law (such as the Medicines…

Key legal info on traditional medicines and OTC products in Norwegian Pharma. Prepared in association with DLA Piper, a leading law firm in Norway, this is an extract from The Pharma Legal Handbook: Norway, available to purchase here for USD 99.   1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? The Medicines Act (LOV-1992-12-04-132) provides for any procedure for the MA of traditional medicines, including herbal and homeopathic medicines, whilst the Medical Devices…

All about marketing, manufacturing, packaging & labeling, advertising in Norwegian Pharma. Prepared in association with DLA Piper, a leading law firm in Norway, this is an extract from The Pharma Legal Handbook: Norway, 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? See Regulatory, Pricing and Reimbursement Overview, question 3.   2. What is the authorization process for the marketing…

A brief overview of the situation regarding preclinical and clinical trial requirements in Norwegian Pharma. Prepared in association with DLA Piper, a leading law firm in Norway, this is an extract from The Pharma Legal Handbook: Norway, 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? See [Regulatory, Pricing and Reimbursement Overview, Section 3 b)]; new medical products must undergo an evaluation of…

An insight into regulatory, pricing and reimbursement overview in Norwegian Pharma. Prepared in association with DLA Piper, a leading law firm in Norway, this is an extract from The Pharma Legal Handbook: Norway, 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 Ministry of Health and Care Services (nw. Helse-og omsorgsdepartementet, “HOD”) is the legislative authority. The Norwegian Medicines Agency (nw. Statens legemiddelverk…

On 16 April 2020, a new Act was adopted by the Belgian parliament to increase the transparency of managed entry agreements (‘MEA’) concluded between pharmaceutical companies and the National Institute for Health and Disability Insurance (‘NIHDI’). MEAs stipulate confidential compensation mechanisms for the Belgian government regarding the publicly-listed price and reimbursement basis of the medicine(s) concerned. The Act provides that if the Belgian parliament’s Chamber of Representatives orders a management audit, then the Court of Audit is granted full access to…

On 8 April 2020, the Belgian federal agency for medicines and health products (‘FAMHP’) adopted a consolidated version of its decision (the ‘Decision’) taking the following urgent measures for certain listed medicines (and raw materials) to avoid medicine shortages during the SARS-CoV-2 pandemic:   Wholesalers, full-line wholesalers and manufacturers are obliged to limit their sales to full-line wholesalers and pharmacies for the products concerned to amounts that correspond to the sales for the same period of the previous year increased by a…

With national governments scrambling to take measures in order to counter the Covid-19 pandemic, we are again confronted with the fact that a EU common policy in the healthcare field is quasi inexistent. This is equally so in respect of the pricing and reimbursement of medicines.   While the so-called Transparency Directive 89/105/EEC provides for a limited harmonization of pricing & reimbursement procedures, one however cannot deny a growing tendency of national governments to look beyond their national borders and…

In its ruling of 30 January 2020, the Court of Justice of the European Union (‘CJEU’) has clarified for the first time the criteria governing whether a reverse payment settlement agreement concerning a dispute between the holder of a pharmaceutical patent (‘originator’) and a manufacturer of generic medicines (‘generic’) is contrary to EU competition law. In particular, the Court has provided further guidance on whether and when: (i) originators and generics should be considered as ‘potential competitors’, (ii) a patent…

Key legal info on biosimilars & biologics in Croatia. Prepared in association with Danijel Pribanić, a leading global law firm, this is an extract from The Pharma Legal Handbook: Croatia, available to purchase here for GBP 99.   1. Are biosimilar medicines considered the same as generic medicines in your country? Biosimilar medicines are not the same as generic drugs (a drug that contains the same molecule as an existing non-biological medicine, such as aspirin). Namely, biological medicine, unlike non-biological…

Want to know more about localization in Croatia? Read on! Prepared in association with Danijel Pribanić, a leading global law firm, this is an extract from The Pharma Legal Handbook: Croatia, available to purchase here for GBP 99.   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 not any specific rules or regulations regarding localization in Croatia. There are only general…

Orphan drugs & rare diseases in Croatia – a legal guide. Prepared in association with Danijel Pribanić, a leading global law firm, this is an extract from The Pharma Legal Handbook: Croatia, available to purchase here for GBP 99.   1. What is the definition of Rare Diseases in your country? Simply put, an orphan drug is indicated for the treatment of a very rare disease. Such diseases are often caused by genetic defects and therefore children and newborns are…

On 3 February 2020 the Act of 20 December 2019 amending various legal provisions concerning shortages of medicinal products was published in the Official Gazette. Except for Articles 2 and 4, which entered into force on 31 January 2020, the act’s provisions entered into force on 13 February 2020. In our view, the new legislation does not prevent pharmaceutical companies from applying quotas, provided that they do not affect the public service obligation of wholesaler-distributors (also known as full-line wholesalers. In addition, we…

The year 2019, which continued the trend of rapid and numerous changes in healthcare regulations in Russia, was rich with expectations, events and legislative proposals aiming to reform the Russian pharmaceutical industry: medical drugs labeling, reform of price determination, new procedure of entry into drugs civil circulation, amendments to regulatory framework of the Eurasian Economic Union, etc. This trend is likely to continue in 2020 as well.   Some of the major developments that are yet to be shaped into…

Want to know more about cannabinoid drugs, medicinal cannabis and opioid drugs in Germany? Read on! Prepared in association with Heuking Kühn Lüer Wojtek, a leading global law firm, this is an extract from The Pharma Legal Handbook: Germany, available to purchase here for USD 99.   Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? There is no uniform answer to this question. In Germany, some Cannabinoid Drugs are subject to restrictions under the Narcotic Drugs Act (“BtMG”)…

Key legal info on biosimilars & biologics in Denmark. Prepared in association with Gorrissen Federspiel, a leading law firm in Denmark, this is an extract from The Pharma Legal Handbook: Denmark, available to purchase here for GBP 75.   1. Are biosimilar medicines considered the same as generic medicines in your country? No. A biosimilar medicinal product is a new version of an existing biological medicinal product (i.e. a medicinal product is derived from a biological source). Biosimilar products are…

Keen to learn more about localization in Denmark? Read on! Prepared in association with Gorrissen Federspiel, a leading law firm in Denmark, this is an extract from The Pharma Legal Handbook: Denmark, 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? No, as a starting point there are no rules or regulations requiring and/or encouraging localization…

The key facts about regulatory reforms in Italy. Prepared in association with DLA Piper, a leading law firm in Italy, this is an extract from The Pharma Legal Handbook: Italy, available to purchase here for USD 99.   1. Are there proposals for reform or significant change to the healthcare system? The most relevant reforms to the Italian healthcare system expected to enter into force in the near future are the following: the new EU regulations on medical devices, namely Regulation (EU) 745/2017…

All legal aspects surrounding patents & trademarks in Italian Pharma. Prepared in association with DLA Piper, a leading law firm in Italy, this is an extract from The Pharma Legal Handbook: Italy, available to purchase here for USD 99.   1. What are the basic requirements to obtain patent and trademark protection? Italian legislative decree 30/2005 (Italian Industrial Property Code or “IIPC”) sets out the requirements to obtain patent and trademark protection. a. Patents According to Articles 45 and ff. of the IIPC,…

 The low-down on the situation regarding product liability in Italy. Prepared in association with DLA Piper, a leading law firm in Italy, this is an extract from The Pharma Legal Handbook: Italy, available to purchase here for USD 99.   1. What types of liability are recognized in your jurisdiction? The Italian system recognizes the following types of liability: criminal liability for violation of the Italian Criminal Code; liability for breach of contract according to Article 1218 of the Italian Civil Code; liability…

The ins and outs of traditional medicines and OTC products in Italy. Prepared in association with DLA Piper, a leading law firm in Italy, this is an extract from The Pharma Legal Handbook: Italy, available to purchase here for USD 99.   1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? a. Herbal Medicinal Products The Italian Medicines Code provides for an abridged procedure for the marketing authorization of herbal medicinal products, provided that: they are intended…

All about marketing, manufacturing, packaging & labeling, advertising in Italy. Prepared in association with DLA Piper, a leading law firm in Italy, this is an extract from The Pharma Legal Handbook: Italy, 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. Medicinal Products As a general rule, medicinal products may only be placed on the market once authorization has been granted…

Key legal info on preclinical and clinical trial requirements in Italy. Prepared in association with DLA Piper, a leading law firm in Italy, this is an extract from The Pharma Legal Handbook: Italy, 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. However, having conducted part of the medicinal product development (including clinical trials) in Italy may place the marketing authorization holder in a stronger…

Regulatory, pricing and reimbursement overview in Italy – a legal guide. Prepared in association with DLA Piper, a leading law firm in Italy, this is an extract from The Pharma Legal Handbook: Italy, available to purchase here for USD 99.   1. What are the regulatory authorities with jurisdiction over drugs, biological, and medical devices in your country? The Italian Medicines Agency (Agenzia Italiana del Farmaco – “AIFA”) is the national authority vested with jurisdiction over medicinal products (including biologics).…

The key facts about regulatory reforms in Belgium. Prepared in association with ALTIUS, a leading law firm in Belgium, this is an extract from The Pharma Legal Handbook: Belgium, available to purchase here for USD 99.   1. Are there proposals for reform or significant change to the healthcare system? As of recently, attempts have been made to remedy the unavailability of medicines on the Belgian market. The Act of 7 April 2019 on the unavailability of medicines introduced two measures in this…

Keen to learn more about patents & trademarks in Belgium? Read on! Prepared in association with ALTIUS, a leading law firm in Belgium, this is an extract from The Pharma Legal Handbook: Belgium, available to purchase here for USD 99.   1. What are the basic requirements to obtain patent and trademark protection? The Belgian legal framework governing patents and trademarks is enshrined in Book XI of the Code of Economic Law (CEL). A specific framework for Benelux trademarks is provided by the…

The low-down on the situation regarding product liability in Belgium. Prepared in association with ALTIUS, a leading law firm in Belgium, this is an extract from The Pharma Legal Handbook: Belgium, available to purchase here for USD 99.   1. What types of liability are recognized in your jurisdiction? Belgian law distinguishes two types of civil liability: contractual liability and tort liability. Where the first arises from a failure to execute, respect or comply with contractual obligations, the latter arises when certain acts…

A brief overview of the situation regarding traditional medicines and OTC products in Belgium. Prepared in association with ALTIUS, a leading law firm in Belgium, this is an extract from The Pharma Legal Handbook: Belgium, available to purchase here for USD 99.   1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? The Law of 25 March 1964 on the medicines distinguishes between homeopathic medicines, traditional herbal medicines and herbal medicines. All three categories are subject to…

All about marketing, manufacturing, packaging & labeling, advertising in Belgium. Prepared in association with ALTIUS, a leading law firm in Belgium, this is an extract from The Pharma Legal Handbook: Belgium, 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? First of all, the medicines must be the subject of clinical trials. These clinical trials must be submitted to the FAMHP and an…

All legal aspects surrounding preclinical and clinical trial requirements in Belgium. Prepared in association with ALTIUS, a leading law firm in Belgium, this is an extract from The Pharma Legal Handbook: Belgium, 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, clinical trials are not required to be conducted locally to receive marketing approval in Belgium. In order to obtain marketing approval, for new drugs,…

An intro to the legal situation for regulatory, pricing and reimbursement in Belgium. Prepared in association with ALTIUS, a leading law firm in Belgium, this is an extract from The Pharma Legal Handbook: Belgium, 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 Federal Agency for Medicines and Health Products (‘FAMHP’) is the competent authority for drugs, biologicals and medical devices in Belgium.…

Nadezhda Fedotova and Andrey Zelenin of Lidings law firm gives an update on recent amendments to the labeling legislation for medicines in Russia, their potential impact on the Russian pharmaceutical industry, and the numerous uncertainties still remaining.   Despite the time moving up to January 1, 2020, it seems impossible to say whether the drugs labeling system will or will not be launched in time completely Under the Decree of the Government of the Russian Federation No. 1556 dated December…

Want to know more about regulatory reforms in United Kingdom? Read on! Prepared in association with Clyde & Co, a leading law firm in United Kingdom, this is an extract from The Pharma Legal Handbook: United Kingdom, available to purchase here for USD 99.   1. Are there proposals for reform or significant change to the healthcare system? The UK is currently due to leave the EU on 31 October 2019. There is much uncertainty as to the effect that this will have…

The ins and outs of patents & trademarks in United Kingdom. Prepared in association with Clyde & Co, a leading law firm in United Kingdom, this is an extract from The Pharma Legal Handbook: United Kingdom, available to purchase here for USD 99.   1. What are the basic requirements to obtain patent and trademark protection? (i) Patents There are 2 types of UK patents: a national patent applied for at (and granted by) the UK Intellectual Property Office (UKIPO) and a European…

An intro to the legal situation for product liability in United Kingdom. Prepared in association with Clyde & Co, a leading law firm in United Kingdom, this is an extract from The Pharma Legal Handbook: United Kingdom, available to purchase here for USD 99.   1. What types of liability are recognized in your jurisdiction? The majority of product liability claims for medical products in the United Kingdom are brought under the Consumer Protection Act 1987 (CPA) and / or in negligence. Claimants…

The legal framework for traditional medicines and OTC products in United Kingdom. Prepared in association with Clyde & Co, a leading law firm in United Kingdom, this is an extract from The Pharma Legal Handbook: United Kingdom, available to purchase here for USD 99.   1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? No specific definition of complementary and alternative medicines (CAMs) is used in the UK, though “complementary” would typically refer to a CAM when…

An insight into marketing, manufacturing, packaging & labeling, advertising in United Kingdom. Prepared in association with Clyde & Co, a leading law firm in United Kingdom, this is an extract from The Pharma Legal Handbook: United Kingdom, 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? The authorisation process is discussed in the answer to Questions 2 and 3 in Regulatory, Pricing and…

A brief overview of the situation regarding preclinical and clinical trial requirements in United Kingdom. Prepared in association with Clyde & Co, a leading law firm in United Kingdom, this is an extract from The Pharma Legal Handbook: United Kingdom, 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? There is no requirement to conduct clinical trials locally to receive marketing approval. The steps that have…

All about regulatory, pricing and reimbursement overview in United Kingdom. Prepared in association with Clyde & Co, a leading law firm in United Kingdom, this is an extract from The Pharma Legal Handbook: United Kingdom, available to purchase here for USD 99.   1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? Although the United Kingdom (UK) is negotiating its withdrawal from the European Union (EU), as of now, the UK remains…

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…

Dentons Germany’s Peter Homberg outlines the key requirements that companies need to fulfil in order to import medical cannabis into Germany and how attitudes and legislation on the topic are shifting across Europe.   In order to import medicinal cannabis from another country to Germany, like many other countries, the essential factor is that such medicinal cannabis has to be cultivated in a country compliant with Art. 23 and 28 para. 1 of the 1961 Single Convention on Narcotic Drugs…

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…

Cannabinoid drugs, medicinal cannabis and opioid drugs in Spain – a legal guide. Prepared in association with Faus & Moliner Abogados, a leading law firm in Spain, this is an extract from The Pharma Legal Handbook: Spain, available to purchase here for USD 99.   Cannabinoid Drugs For the purposes of this topic shall mean any industrially produced medicinal product which contains cannabinoids.   1. Are Cannabinoid Drugs authorized in your country? Cannabinoid Drugs may be authorized in Spain on the basis of…

Want to know more about regulatory reforms in Spain? Read on! Prepared in association with Faus & Moliner Abogados, a leading law firm in Spain, this is an extract from The Pharma Legal Handbook: Spain, available to purchase here for USD 99.   1. Are there proposals for reform or significant change to the healthcare system? At present, the main proposals for regulatory reform are referred to the Spanish regulations on: price and reimbursement of medicinal products and medical devices, advertising of medicinal…

The legal framework for patents and trademarks in Spain. Prepared in association with Faus & Moliner Abogados, a leading law firm in Spain, this is an extract from The Pharma Legal Handbook: Spain, available to purchase here for USD 99.   1. What are the basic requirements to obtain patent and trademark protection? The legal condition to obtain a patent or a trademark in Spain is to validly register it before the Spanish Patent and Trade Mark Office. In order to do so,…

The low-down on the situation regarding product liability in Spain. Prepared in association with Faus & Moliner Abogados, a leading law firm in Spain, this is an extract from The Pharma Legal Handbook: Spain, available to purchase here for USD 99.   1. What types of liability are recognized in your jurisdiction? The regime for product liability established in Spain is of a strict nature. It imposes strict liability upon the “producer” of a defective product. The producer will be liable for personal…

A brief overview of the situation regarding traditional medicines and OTC products in Spain. Prepared in association with Faus & Moliner Abogados, a leading law firm in Spain, this is an extract from The Pharma Legal Handbook: Spain, available to purchase here for USD 99.   1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? Plants traditionally used in Spain for medicinal purposes can be sold to the public without the need for a marketing authorization issued…

All about marketing, manufacturing, packaging & labeling, advertising in Spain. Prepared in association with Faus & Moliner Abogados, a leading law firm in Spain, this is an extract from The Pharma Legal Handbook: Spain, 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? The AEMPS is the authority in charge of granting marketing authorizations in Spain, whether they result from…

Preclinical & clinical trial requirements in Spain – a comprehensive legal overview. Prepared in association with Faus & Moliner Abogados, a leading law firm in Spain, this is an extract from The Pharma Legal Handbook: Spain, 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, clinical trial may be conducted abroad. For those cases whenever clinical trials are conducted outside the European…

Key legal info on regulatory, pricing and reimbursement in Spain. Prepared in association with Faus & Moliner Abogados, a leading law firm in Spain, this is an extract from The Pharma Legal Handbook: Spain, 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 main regulatory authorities in Spain are: The Spanish Ministry of Health, Consumption and Welfare (‘Spanish Ministry of Health’), which is…

An insight into orphan drugs and rare diseases in Denmark. Prepared in association with Gorrissen Federspiel, a leading law firm in Denmark, this is an extract from The Pharma Legal Handbook: Denmark, available to purchase here for GBP 75.   1. What is the definition of Rare Diseases in your country? Pursuant to Regulation (EC) no. 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products (“Orphan Drug Regulation”), a medicinal product may be designated…

An intro to the legal situation for cannabinoid drugs, medicinal cannabis and opioid drugs in Denmark. Prepared in association with Gorrissen Federspiel, a leading law firm in Denmark, this is an extract from The Pharma Legal Handbook: Denmark, available to purchase here for GBP 75.   Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? Cannabinoid drugs, i.e. medicinal products where the active substance is cannabinoids, can be authorised in Denmark in accordance with the rules on development, manufacture and marketing…

The ins and outs of regulatory reforms in Denmark. Prepared in association with Gorrissen Federspiel, a leading law firm in Denmark, this is an extract from The Pharma Legal Handbook: Denmark, available to purchase here for GBP 75.   1. Are there proposals for reform or significant change to the healthcare system? Clinical Trial Regulation The aim of the Clinical Trial Regulation is to ensure greater harmonisation of the rules on clinical trials throughout the EU. To this end, it will introduce,…

The low-down on the situation regarding patents and trademarks in Denmark. Prepared in association with Gorrissen Federspiel, a leading law firm in Denmark, this is an extract from The Pharma Legal Handbook: Denmark, available to purchase here for GBP 75.   1. What are the basic requirements to obtain patent and trademark protection? Patents In Denmark, a patent can be obtained by i) filing of a patent application with the Danish Patent and Trademark Office (“DKPTO”), ii) filing a patent application according…

All legal aspects surrounding product liability. Prepared in association with Gorrissen Federspiel, a leading law firm in Denmark, this is an extract from The Pharma Legal Handbook: Denmark, available to purchase here for GBP 75.   1. What types of liability are recognized in your jurisdiction? Generally, a person or company may incur liability by way of (i) contractual liability or (ii) civil liability due to violations of statutory law and/or culpable behaviour. Depending on the wording of the contractual terms giving…

Key legal info on traditional medicines and OTC products in Denmark. Prepared in association with Gorrissen Federspiel, a leading law firm in Denmark, this is an extract from The Pharma Legal Handbook: Denmark, available to purchase here for GBP 75.   1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? Natural medicinal products, traditional herbal medicinal products, homeopathic medicinal products, and strong vitamin and mineral products are all special categories of medicinal products and are as…

A brief overview of the situation regarding marketing, manufacturing, packaging & labeling, advertising in Denmark. Prepared in association with Gorrissen Federspiel, a leading law firm in Denmark, this is an extract from The Pharma Legal Handbook: Denmark, 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? Please see Question 3 of Regulatory, Pricing and Reimbursement Overview.   2. What is the authorization…

Preclinical and clinical trial requirements in Denmark – an overview. Prepared in association with Gorrissen Federspiel, a leading law firm in Denmark, this is an extract from The Pharma Legal Handbook: Denmark, 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 are not required to be conducted locally as a condition for a marketing authorization. As a starting point, an application for…

The legal framework for regulatory, pricing and reimbursement of drugs in Denmark. Prepared in association with Gorrissen Federspiel, a leading law firm in Denmark, this is an extract from The Pharma Legal Handbook: Denmark, 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 Danish Ministry of Health is responsible for defining the overall framework for the national healthcare system. As a governmental body…

The legal framework for cannabinoid drugs, medicinal cannabis and opioid drugs in Ukraine. Prepared in association with Sayenko Kharenko, a leading law firm in Ukraine, this is an extract from The Pharma Legal Handbook: Ukraine, available to purchase here for USD 99.   Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? Ukrainian legislation, namely Resolution No.770 of the Cabinet of Ministers of Ukraine (the ‘CMU’) dated 6 May 2000, establishes the ‘List of Narcotic Drugs, Psychotropic Substances and Precursors’…

Regulatory reforms in Greece – a comprehensive legal overview. Prepared in association with Calavros Law Firm, a leading global law firm, this is an extract from The Pharma Legal Handbook: Greece, available to purchase here for USD 99.   1. Are there proposals for reform or significant change to the healthcare system? A. The recently enacted Law 4578/2018 on the “Reduction of social security contributions and other provisions” establishes under its paragraph 12 the new percentages of imposed reduction (namely “rebate”) on the…

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…

All about cannabinoid drugs, medicinal cannabis and opioid drugs in Romania. Prepared in association with Mușat & Asociații, a leading global law firm, this is an extract from The Pharma Legal Handbook: Romania, available to purchase here for GBP 99.   Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? According to the national catalogue of medicines in Romania published by NAMMD, currently there are no cannabinoid medicinal products authorized for marketing in the country. By law, certain psychotropic substances extracted…

The ins and outs of regulatory reforms in Romania. Prepared in association with Mușat & Asociații, a leading global law firm, this is an extract from The Pharma Legal Handbook: Romania, available to purchase here for GBP 75.   1. Are there proposals for reform or significant change to the healthcare system? The Romanian authorities announced their intention to implement certain reform or significant change to changes in the pharmaceutical legislation, including in relation to: healthcare system? improving the legal framework for…

A brief overview of the situation regarding patents and trademarks in Romanian Pharma. Prepared in association with Mușat & Asociații, a leading global law firm, this is an extract from The Pharma Legal Handbook: Romania, available to purchase here for GBP 75.   1. What are the basic requirements to obtain patent and trademark protection? As a rule, a patent or a trademark protection can only be obtained by registration with the State Office for Inventions and Trademarks (“OSIM”), based on…

Product liability in Romanian Pharma – a legal guide. Prepared in association with Mușat & Asociații, a leading global law firm, this is an extract from The Pharma Legal Handbook: Romania, available to purchase here for GBP 75.   1. What types of liability are recognized in your jurisdiction? The failure to comply with the Romanian pharma legislation can trigger disciplinary, civil, material, contraventional or criminal liability, depending on the case. Additionally, the competent authorities in various fields can apply fines and…

The key facts about traditional medicines and OTC products in Romania. Prepared in association with Mușat & Asociații, a leading global law firm, this is an extract from The Pharma Legal Handbook: Romania, available to purchase here for GBP 75.   1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? The Health Law transposed into the national legislation the provisions of Directive 2001/83/EC on the Community code relating to medicinal products for human use, and provides…

Marketing, manufacturing, packaging & labeling, advertising in Romanian Pharma – a comprehensive legal overview. Prepared in association with Mușat & Asociații, a leading global law firm, this is an extract from The Pharma Legal Handbook: Romania, 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? In order to be placed on the Romanian market, a medicinal product needs a marketing authorization,…

An intro to the legal situation for preclinical and clinical trial requirements in Romanian Pharma. Prepared in association with Mușat & Asociații, a leading global law firm, this is an extract from The Pharma Legal Handbook: Romania, 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? The Romanian law does not expressly provide such limitation as to the performing of clinical trials solely in Romania…

The legal framework for regulatory, pricing and reimbursement in Romanian Pharma. Prepared in association with Mușat & Asociații, a leading global law firm, this is an extract from The Pharma Legal Handbook: Romania, 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 regulatory authorities competent in these fields are: the Ministry of Health (http://www.ms.ro/); the National Agency for Medicines and Medical Devices (https://www.anm.ro/);…

All legal aspects surrounding regulatory reform in Germany. Prepared in association with Heuking Kühn Lüer Wojtek, a leading global law firm, this is an extract from The Pharma Legal Handbook: Germany, available to purchase here for USD 99.   1. Are there proposals for reform or significant change to the healthcare system? Two reforms came into law on January 1, 2019. The first one concerns the reduction of health insurance premiums for employees. It is named the “GKV-Versichertenentlastungsgesetz” (GKV-VEG) which…

The legal framework for patents and trademarks in Germany. Prepared in association with Heuking Kühn Lüer Wojtek, a leading global law firm, this is an extract from The Pharma Legal Handbook: Germany, available to purchase here for USD 99.   1. What are the basic requirements to obtain patent and trademark protection? 1. In Germany, the Patent Act (Patentgesetz, PatG of 16 December 1980, as last amended on 8 October 2017 forms the legal basis for patents, while the Trade…

An insight into product liability in Germany. Prepared in association with Heuking Kühn Lüer Wojtek, a leading global law firm, this is an extract from The Pharma Legal Handbook: Germany, available to purchase here for USD 99.   1. What types of liability are recognized in your jurisdiction? Under German law, liability can result from a culpable failure to comply with contractual or quasi-contractual obligations (contractual/quasi-contractual liability), or from a failure to comply with legal obligations which are not at…

The low-down on the situation regarding traditional medicines and OTC products in Germany. Prepared in association with Heuking Kühn Lüer Wojtek, a leading global law firm, this is an extract from The Pharma Legal Handbook: Germany, available to purchase here for USD 99.   1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? The Medicinal Products Act contains special regulations governing Traditional Herbal Medicines and Homoeopathic Medicinal Products: 1. As per secc. 39a et…

All about marketing, manufacturing, packaging & labeling, and advertising in Germany. Prepared in association with Heuking Kühn Lüer Wojtek, a leading global law firm, this is an extract from The Pharma Legal Handbook: Germany, 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? 1. The Third Chapter of the Medicinal Products Act sets forth the rules relating to the manufacture…

A brief overview of the situation regarding preclinical and clinical trial requirements in Germany. Prepared in association with Heuking Kühn Lüer Wojtek, a leading global law firm, this is an extract from The Pharma Legal Handbook: Germany, 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? 1. In principle, pre-clinical and clinical studies and trials can be obtained from regulated and approved providers…

An intro to the legal situation for regulatory, pricing, and reimbursement of drugs in Germany. Prepared in association with Heuking Kühn Lüer Wojtek, a leading global law firm, this is an extract from The Pharma Legal Handbook: Germany, available to purchase here for USD 99.   1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? Federal Ministry for Health (Bundesministerium für Gesundheit (BMG), Berlin and Bonn). https://www.bundesgesundheitsministerium.de/ Drafting legislation, regulations and ordinances…

All legal aspects surrounding cannabinoid drugs, medical cannabis and opioids in Croatia. Prepared in association with Danijel Pribanić, a leading global law firm, this is an extract from The Pharma Legal Handbook: Croatia, available to purchase here for GBP 99.   Cannabinoid Drugs   1. Are Cannabinoid Drugs authorized in your country? Cannabinoid Drugs are authorized only in the form of Medicinal Cannabis.   2. What are the regulatory authorities with jurisdiction over Cannabinoid Drugs? Office for Suppression of Drug…

An insight into upcoming regulatory reforms affecting Croatia pharma. Prepared in association with Danijel Pribanić, a leading global law firm, this is an extract from The Pharma Legal Handbook: Croatia, available to purchase here for GBP 99.   1. Are there proposals for reform or significant change to the healthcare system? Bill of Ordinance on benchmarks for the classification of medicinal products on basic and additional list of medicinal products of the Croatian Health Insurance Fund and on benchmarks on…

Patents and trademarks in Croatia – a comprehensive legal overview. Prepared in association with Danijel Pribanić, a leading global law firm, this is an extract from The Pharma Legal Handbook: Croatia, available to purchase here for GBP 99.   1. What are the basic requirements to obtain patent and trademark protection? In the territory of Croatia the State Intellectual Property Office (hereinafter: the Office) carries out patent and trademark granting procedure in compliance with the Patent Act (Official Gazette Nos.…

Key legal info on product liability in Croatia. Prepared in association with Danijel Pribanić, a leading global law firm, this is an extract from The Pharma Legal Handbook: Croatia, available to purchase here for GBP 99.   1. What types of liability are recognized in your jurisdiction? Types of liability recognized in Croatian jurisdiction are civil liability as contractual liability and non- contractual (liability as a result of fault, liability for another person, liability for damage caused by dangerous thing…

All about traditional medicines and OTC products in Croatia. Prepared in association with Danijel Pribanić, a leading global law firm, this is an extract from The Pharma Legal Handbook: Croatia, available to purchase here for GBP 99.   1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? Regulatory requirements for traditional herbal or homeopathic medicinal products are regulated by the provisions of Medicinal Products Act and traditional herbal medicinal products are also regulated by…

An insight into marketing, manufacturing, packaging & labeling, and advertising in Croatia. Prepared in association with Danijel Pribanić, a leading global law firm, this is an extract from The Pharma Legal Handbook: Croatia, available to purchase here for GBP 99.   1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? B) MEDICINAL PRODUCTS Only those medicinal products having a marketing authorisation granted by the Agency for Medicinal Products…

Preclinical and Clinical Trial Requirements in Croatia – an overview. Prepared in association with Danijel Pribanić, a leading global law firm, this is an extract from The Pharma Legal Handbook: Croatia, available to purchase here for GBP 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.   2. How are clinical trials funded? Clinical…

An intro to the legal situation for regulatory, pricing and reimbursement of drugs in Croatia. Prepared in association with Danijel Pribanić, a leading global law firm, this is an extract from The Pharma Legal Handbook: Croatia, available to purchase here for GBP 99.   1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? The regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in Croatia is the Agency for Medicinal products…

Lawyer Ira Perić Ostojić highlights recent regulatory updates in Croatia, where the legal status of cultivating and producing cannabis for medical purposes has been liberalised.   On 25 April 2019 the Amendments to the Act on Combating Drugs Abuse entered into force in Croatia, which liberalizes the cultivation and production of low THC cannabis for medicinal purposes. With the new law going into effect, companies which have a manufacturing authorization for drugs or active substances from the Croatian Agency for…

Lawyer Ira Perić Ostojić outlines two major new regulatory updates regarding pricing and reimbursement for drugs in Croatia.   Bylaw regulating the maximum permitted wholesale price of the prescription medicinal products The bylaw regulates the detailed criteria for determining the maximum permitted wholesale price of prescription medicinal products in Croatia and the calculation of such prices by the Croatian Agency for Medicinal Products and Medical Devices (HALMED). Generally, the calculation by HALMED is mandatory and is carried out: (i) when the…

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…

Joana Silveira Botelho of Cuatrecasas argues for the need for an EU-wide regulatory update on the advertising of pharmaceutical products online, given current rules do not take into account the spread and influence of social media today.   Today’s internet is so much more than a company’s website It is undeniable that the internet has changed the world. It is also undeniable how little laws have changed to accommodate the internet and the new reality that emerged from its foundation.…

Peter Homberg of Dentons Germany examines the regulatory status quo around the free sale of products containing cannabidiol (CBD) across Europe. Although deregulation efforts are underway, Homberg argues that the trade in these products is not as free and unregulated as it may initially seem.   CBD products that are marketed in Gemany as pharmaceutical products must comply with the strict provisions of the Medicinal Products Act of Germany (Arzneimittelgesetz), as a CBD pharmaceutical product is categorized as a prescription…

All legal aspects surrounding cannabinoid drugs, medicinal cannabis & opioid drugs in Greece. Prepared in association with Calavros Law Firm, a leading global law firm, this is an extract from The Pharma Legal Handbook: Greece, available to purchase here for USD 99.   Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? By virtue of article 1 of recent Law 4523/2018, article 2A has been introduced to Law 4139/2013 on Narcotics, providing for the possibility to obtain exceptional authorization for the production,…

Key information on patents and trademarks in Greek pharma. Prepared in association with Calavros Law Firm, a leading global law firm, this is an extract from The Pharma Legal Handbook: Greece, available to purchase here for USD 99.   1. What are the basic requirements to obtain patent and trademark protection? Patents Currently, inventions of pharmaceutical products can be protected in Greece either by national patents, granted by Hellenic Industrial Property Organization (Greek acronym OBI) in line with Law 1733/1987 (as amended and in force)…

Need the lowdown on product liability in Greek pharma? Read on! Prepared in association with Calavros Law Firm, a leading global law firm, this is an extract from The Pharma Legal Handbook: Greece, available to purchase here for USD 99.   1. What types of liability are recognized in your jurisdiction? Several types of liability, namely civil, administrative, criminal and disciplinary liability may be established under the national legislation in force in the event of breach of pharmaceutical laws and regulations, depending both…

The ins and outs of traditional medicines and OTC products in Greek pharma. Prepared in association with Calavros Law Firm, a leading global law firm, this is an extract from The Pharma Legal Handbook: Greece, available to purchase here for USD 99.   1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? Legal provisions pertaining to the regulatory requirements of the various types of medicinal products and medical devices may be found in various Interministerial Decisions and…

All about marketing, manufacturing, packaging & labeling and advertising in Greek pharma. Prepared in association with Calavros Law Firm, a leading global law firm, this is an extract from The Pharma Legal Handbook: Greece, 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? Medicinal Products In line with EU legislation, four different procedures may alternatively be followed in view of obtaining marketing authorization…

The key requirements for conducting pre-clinical and clinical trials in Greece. Prepared in association with Calavros Law Firm, a leading global law firm, this is an extract from The Pharma Legal Handbook: Greece, 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. Article 9 par. 3 of Ministerial Decision Δ.ΥΓ3α/Γ.Π. 32221/Government Gazette B 1049/2013, issued in application of Directive 2001/83/EC of the European Parliament and…

A legal intro to the situation regarding regulation, pricing and reimbursement in Greek pharma. Prepared in association with Calavros Law Firm, a leading global law firm, this is an extract from The Pharma Legal Handbook: Greece, 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 National Organization for Medicines (hereinafter referred to as E.O.F.) which was established in 1983 as a public entity…

Managing partner of the law firm Herbert Smith Freehills in Italy, Laura Orlando is one of Italy’s leading life sciences specialists, with a focus on IP and regulatory matters.  Together with Sara Balice, one of the firm’s senior associates they examine the Court of Justice of the European Union’s (CJEU) ruling on the Reimbursement of off-label medicinal products.   It is the responsibility of EU Member States to control off-label use of medicinal products.   Under EU Legislation (Directive 2001/83/EC, the “Directive”),…

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…

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:…