Legal & Regulatory

The key facts about patents & trademarks in Saudi Arabia. Prepared in association with STA, an international law firm, this is an extract from The Pharma Legal Handbook: Saudi Arabia, available to purchase here for GBP 99.   1. What are the basic requirements to obtain patent and trademark protection? Trademarks, copyright works, patents, industrial designs and domain names are all capable of being protected in Saudi Arabia and there is an established legal framework that supports the registration and…

The key facts about product liability in Saudi Arabia. Prepared in association with STA, an international law firm, this is an extract from The Pharma Legal Handbook: Saudi Arabia, available to purchase here for GBP 99.   1. What types of liability are recognized in your jurisdiction? Product liability is the area of law in which manufacturers, distributors, suppliers and retailers are held responsible for any injuries products cause. Generally, there are three liabilities: Civil liability, punitive liability and disciplinary…

The ins and outs of traditional medicines and OTC products in Saudi Arabia. Prepared in association with STA, an international law firm, this is an extract from The Pharma Legal Handbook: Saudi Arabia, available to purchase here for GBP 99.   1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? This presentation comprised a briefing on the current situation of the practice of traditional medicine (TRM) and complementary and alternative medicine (CAM), the availability…

The key facts about marketing, manufacturing, packaging & labeling, advertising in Saudi Arabia. Prepared in association with STA, an international law firm, this is an extract from The Pharma Legal Handbook: Saudi Arabia, 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 MAA of the pharmaceutical product will be subjected to the followings processes:  Submit the application form and…

All legal aspects surrounding preclinical and clinical trial requirements in Saudi Arabia. Prepared in association with STA, an international law firm, this is an extract from The Pharma Legal Handbook: Saudi Arabia, 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? It is mandatory to inform SFDA immediately about any Suspected Unexpected Serious Adverse Reactions (SUSAR) as soon as possible, no later than…

An insight into regulatory, pricing and reimbursement overview in Saudi Arabia. Prepared in association with STA, an international law firm, this is an extract from The Pharma Legal Handbook: Saudi Arabia, 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 Saudi Food & Drug Authority (SFDA) is the government agency that regulates drugs and medical devices in Saudi Arabia. It is also in…

An intro to the legal situation for orphan drugs and rare diseases 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 GBP 99.   1. What is the definition of Rare Diseases in your country? Art. 3 of the Law of Ukraine “Fundamentals of the Legislation of Ukraine on Healthcare” (“Legislature on healthcare”)1 defines rare (orphan) disease as a disease that threatens human life…

Cannabinoid drugs, medicinal cannabis and opioid drugs in Ukraine – a comprehensive legal overview.. 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 GBP 99.   Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? Ukrainian legislation1, 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’ (hereinafter –…

An insight into regulatory reforms in Ukrainian pharma. 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 GBP 99.   1. Are there proposals for reform or significant change to the healthcare system? N/A   2. When are they likely to come into force? N/A  

The low-down on the situation regarding patents and trademarks in Ukrainian pharma. 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 GBP 99.   1. What are the basic requirements to obtain patent and trademark protection? In order to obtain an invention/utility model/design patent or trademark protection for an object in the field of medicine, it is required to file a trademark or…

All about product liability in Ukrainian pharma. 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 GBP 99.   1. What types of liability are recognized in your jurisdiction? A breach of laws and regulations on medicines may result in disciplinary, administrative, civil and criminal liability. Liability claims in general are regulated by laws and not by court precedents.    2. How do…

A brief overview of the situation regarding traditional medicines and OTC products 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 GBP 99.   1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? Ukkrainian legislation distinguishes between traditional and herbal medicines; furthermore, homeopathic preparations are as well recognized as medicines in Ukraine. There is no…

Key info on marketing, manufacturing, packaging and labeling and advertising in Ukrainian pharma. 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 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? With respect to the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and…

All legal aspects surrounding precinical and clinical trials 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 GBP 99.   1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? For the purpose of obtaining marketing approval, at least part of clinical trials should be conducted in Ukraine. Notably, in relation to medical products…

An intro to the legal situation for regulatory, pricing and reimbursement 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 GDP 99.   1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? the Ministry of Health of Ukraine (“Ministry”) the State Service of Ukraine on Medicines and Drugs Control (“SSM”) the National…

The key facts about biosimilars and biologics in Indonesia. Prepared in association with ABNR, a leading global law firm, this is an extract from The Pharma Legal Handbook: Indonesia, available to purchase here for GBP 99. 1. Are biosimilar medicines considered the same as generic medicines in your country? No. Head of BPOM Regulation No. 17 of 2015 on Guidelines for Assessment of Biosimilar Products (“BPOM Reg 17/2015”) defines Biosimilar Product or Similar Biotherapeutic Product as a biological product with similar…

The low-down on the situation regarding cannabinoid drugs, medical cannabis and opioids in Indonesia. Prepared in association with ABNR, a leading global law firm, this is an extract from The Pharma Legal Handbook: Indonesia, available to purchase here for GBP 99.   Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? There is no definition of “Cannabinoid” under the Indonesian law. In general, under Law No. 35 of 2009 on Narcotics, as amended by Omnibus Law (“Narcotics Law”), all substances which…

Patents and trademarks in Indonesia – a comprehensive legal overview. Prepared in association with ABNR, a leading global law firm, this is an extract from The Pharma Legal Handbook: Indonesia, available to purchase here for GBP 99.   1. What are the basic requirements to obtain patent and trademark protection? In order to obtain patent or trademark protection, the applicant must register them with the Directorate General of Intellectual Property (“DGIP”). Trademark registrations are valid for 10 years and may be extended…

Product liability of drugs in Indonesia – a legal guide. Prepared in association with ABNR, a leading global law firm, this is an extract from The Pharma Legal Handbook: Indonesia, available to purchase here for GBP 99.   1. What types of liability are recognized in your jurisdiction? In general, product liability in Indonesia is governed under the Indonesian Civil Code and Law No. 8 of 1999 on Customers Protection (“Customers Protection Law”). The liabilities of the business enactors can be divided…

The ins and outs of regulatory reform in Indonesia. Prepared in association with ABNR, a leading global law firm, this is an extract from The Pharma Legal Handbook: Indonesia, available to purchase here for GBP 99.   1. Are there proposals for reform or significant change to the healthcare systems? The following proposal for reform may affect the pharmaceutical industry in Indonesia: Bill on Drugs and Food Supervision Law The Bill has been submitted by the Indonesian government to the House of…

Key legal info on traditional medicines and OTC products in Indonesia. Prepared in association with ABNR, a leading global law firm, this is an extract from The Pharma Legal Handbook: Indonesia, available to purchase here for GBP 99.   1. What are the regulatory requirements for traditional, herbal, complementary, or alternative drugs and devices? Traditional drugs are mainly regulated under MOH Regulation No. 006 of 2016 on Traditional Drugs Industries and Business (“MOH Regulation 006”) and MOH Regulation No. 007…

The ins and outs of marketing, manufacturing, packaging & labeling, and advertising in Indonesia. Prepared in association with ABNR, a leading global law firm, this is an extract from The Pharma Legal Handbook: Indonesia, 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 Any marketing of drugs (including biologics and over the counter medications) within Indonesian territory require…

Preclinical and clinical trial requirements in Indonesia – an overview. Prepared in association with ABNR, a leading global law firm, this is an extract from The Pharma Legal Handbook: Indonesia, 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 for applying for MAs. The applicants must provide clinical trials results to prove the…

The key facts about regulatory, pricing, and reimbursement of drugs in Indonesia. Prepared in association with ABNR, a leading global law firm, this is an extract from The Pharma Legal Handbook: Indonesia, 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 specific jurisdiction over drugs, biologicals, and medical devices in Indonesia are: Ministry of Health of the Republic of Indonesia…

The key facts about localization in the Indonesian pharma market. Prepared in association with ABNR, a leading global law firm, this is an extract from The Pharma Legal Handbook: Indonesia, 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? In principle, MOH Regulation No. 1010/MENKES/PER/XI/2008, as amended by MOH Regulation No. 1020/MENKES/PER/XII/2008 on Drugs Registration, requires that the…

Key legal info on regulatory reform 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 there proposals for reform or significant change to the healthcare system? In 2020, the onset of the Covid-19 global pandemic wreaked havoc on healthcare systems worldwide. Ireland, like many other countries had to adapt quickly and provide safeguards…

Want to know more about patents & trademarks in Ireland? Read on! 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 basic requirements to obtain patent and trademark protection? Patents The requirements to obtain patent protection are outlined on the website of the Intellectual Property Office of Ireland (IPOI). Any person can make…

The low-down on the situation regarding product liability 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 types of liability are recognized in your jurisdiction? There are four main sources of product liability in Ireland: Statute The Liability for Defective Products Act 1991 transposed the EU Product Liability Directive 85/374/EC and is the…

An insight into traditional medicines and OTC products 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 requirements for traditional, herbal, complementary, or alternative medicines and devices? Traditional, herbal, complementary or alternative medicines and devices on the Irish market must be either authorised or registered with the HPRA. Applications to…

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,…

Cannabinoid drugs, medicinal cannabis and opioid drugs in Malaysia – a comprehensive legal overview. Prepared in association with Skrine, a leading law firm in Malaysia, this is an extract from The Pharma Legal Handbook: Malaysia, available to purchase here for GBP 99.   CANNABINOID DRUGS 1. Are Cannabinoid Drugs authorized in your country? The Malaysian regulatory authority does not authorise the use or sale of any specific drug per se, i.e. cannabinoid drugs, rather it regulates the registration of products which…

An insight into regulatory reforms in Malaysian Pharma. Prepared in association with Skrine, a leading law firm in Malaysia, this is an extract from The Pharma Legal Handbook: Malaysia, available to purchase here for GBP 99.   1. Are there proposals for reform or significant change to the healthcare system? The followings are some of the regulatory proposals and reforms in the pharmaceutical industry in Malaysia:  i) online registration system. In 2017, the NPRA, MOH officially launched the upgraded online registration…

The key facts about patents and trademarks in Malaysian Pharma. Prepared in association with Skrine, a leading law firm in Malaysia, this is an extract from The Pharma Legal Handbook: Malaysia, available to purchase here for GBP 99.   1. What are the basic requirements to obtain patent and trademark protection? Patent and trademark laws in Malaysia are mainly codified in statutes, but its jurisprudence is derived from the United Kingdom’s common law. Thus, there are similarities between the two jurisprudences,…

All legal aspects surrounding product liability in Malaysian Pharma. Prepared in association with Skrine, a leading law firm in Malaysia, this is an extract from The Pharma Legal Handbook: Malaysia, available to purchase here for GBP 99.   1. What types of liability are recognized in your jurisdiction? Product liability for medicines can arise through several grounds of action. These include liability arising from the tort of negligence or strict liability or from breach of contract. Since 1999, the Consumer Protection…

A brief overview of the situation regarding traditional medicines and OTC products in Malaysian Pharma. Prepared in association with Skrine, a leading law firm in Malaysia, this is an extract from The Pharma Legal Handbook: Malaysia, available to purchase here for GBP 99.   1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? Alternative medicine is regulated by the Traditional and Complementary Medicine Council (“TCM Council”) established under the Traditional and Complementary Medicine Act 2016…

All about marketing, manufacturing, packaging & labeling, advertising in Malaysian Pharma. Prepared in association with Skrine, a leading law firm in Malaysia, this is an extract from The Pharma Legal Handbook: Malaysia, 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? Although it is common for the marketing authorisation of medicines and devices to vest in the PRH, this is not…

The low-down on the situation regarding preclinical & clinical trial requirements in Malaysian pharma. Prepared in association with Skrine, a leading law firm in Malaysia, this is an extract from The Pharma Legal Handbook: Malaysia, 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? Malaysia is actively developing its capability in all phases of clinical trials and there is currently no mandatory condition for…

An intro to the legal situation for regulatory, pricing and reimbursement in Malaysia. Prepared in association with Skrine, a leading law firm in Malaysia, this is an extract from The Pharma Legal Handbook: Malaysia, available to purchase here for GDP 99.   1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? The Ministry of Health (MOH) is the primary governmental body responsible for the health of the people and the overall healthcare…

The key facts about biosimilars and biologics in Colombia. Prepared in association with Cavelier Abogados, a leading global law firm, this is an extract from The Pharma Legal Handbook: Colombia, available to purchase here for GBP 99.   1. Are biosimilar medicines considered the same as generic medicines in your country? No, generic medicines are understood as medicines with the same structure of the active substance as the reference medicine. And biosimilar medicines are those biotech molecules that can have a…

An intro to the legal situation for orphan drugs and rare diseases in Colombia. Prepared in association with Cavelier Abogados, a leading global law firm, this is an extract from The Pharma Legal Handbook: Colombia, available to purchase here for GBP 99.   1. What is the definition of Rare Diseases in your country? According to the ministry of health and social protection, which is the head of the health sector, rare diseases are those that affect a small number of…

All legal aspects surrounding cannabinoid drugs, medicinal cannabis and opioid drugs in Colombia. Prepared in association with Cavelier Abogados, a leading law firm in Colombia, this is an extract from The Pharma Legal Handbook: Colombia, available to purchase here for GBP 99. Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? Yes, cannabinoid drugs are authorized in Colombia. However, they are subject to government control and to a specific regulatory framework.     2. What are the regulatory authorities…

Regulatory reforms in Colombia – a legal guide. Prepared in association with Cavelier Abogados, a leading global law firm, this is an extract from The Pharma Legal Handbook: Colombia, available to purchase here for GBP 99.   1. Are there proposals for reform or significant change to the healthcare system? Yes, Currently is in course a modification for the Decree 677 which is the principal regulatory framework for drugs, cosmetics, pharmaceutical preparations based on natural resources, cleaning and hygiene products and…

Read more to find out about patents and trademarks in Colombian pharma. Prepared in association with Cavelier Abogados, a leading global law firm, this is an extract from The Pharma Legal Handbook: Colombia, available to purchase here for GBP 99.   1. What are the basic requirements to obtain patent and trademark protection? Colombia is an Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) standard jurisdiction with a pre-grant opposition, absolute novelty patent system where all technical fields are eventually…

Find out about product liability in Colombian pharma. Prepared in association with Cavelier Abogados, a leading global law firm, this is an extract from The Pharma Legal Handbook: Colombia, available to purchase here for GBP 99.   1. What types of liability are recognized in your jurisdiction? Contractual and extracontractual responsibility under the general principle that anyone causing damages to a given person is liable for those damages.   2. How do these types of liabilities apply to the manufacturers of…

Get the lowdown on traditional medicines and OTC products in Colombian pharma. Prepared in association with Cavelier Abogados, a leading global law firm, this is an extract from The Pharma Legal Handbook: Colombia, 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 ruled through Decree 2266/04 which establishes regulatory requirements for phytotherapeutics. These are some of their main requirements: Pharmaceutical forms: tisanes or any…

A structured legal guide to marketing, manufacturing, packaging & labelling and advertising in Colombian pharma. Prepared in association with Cavelier Abogados, a leading global law firm, this is an extract from The Pharma Legal Handbook: Colombia, 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? Please refer to Chapter 1: Regulatory, Pricing, and Reimbursement Overview.   2. What is the authorization…

The key requirements for conducting preclinical and clinical trials in Colombia. Prepared in association with Cavelier Abogados, a leading global law firm, this is an extract from The Pharma Legal Handbook: Colombia, 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. INVIMA accepts clinical trials conducted abroad, if they sufficiently demonstrate safety and efficacy of the drug product.   2. How are clinical…

Need to know about regulation, pricing and reimbursement in Colombian pharma? Read on! Prepared in association with Cavelier Abogados, a leading global law firm, this is an extract from The Pharma Legal Handbook: Colombia, 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 at the Colombian National Food & Drug Surveillance Institute, better known as INVIMA.…

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 China. Prepared in association with Fangda Partners, one of China’s most prestigious and well-regarded law firms. This is an extract from The Pharma Legal Handbook: China, which can be purchased here for GBP 99.   1. Are biosimilar medicines considered the same as generic medicines in your country? The basic principles of research and evaluation of biosimilar medicines are similar to that of generic medicines, but the regulation in practice is different. Biosimilar medicines are…

Want to know more about localization in China? Prepared in association with Fangda Partners, one of China’s most prestigious and well-regarded law firms. This is an extract from The Pharma Legal Handbook: China, which can be purchased 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? Yes. The key regulations are the Pharmaceutical Administration Law (药品管理法) and the Regulations for the Implementation…

An intro to the legal situation for orphan drugs and rare diseases in China. Prepared in association with Fangda Partners, one of China’s most prestigious and well-regarded law firms. This is an extract from The Pharma Legal Handbook: China, which can be purchased here for GBP 99.   1. What is the definition of Rare Diseases in your country? As of now, there is no definition of Rare Diseases in China. The List of Rare Diseases (罕见病目录) promulgated by the National Health…

Cannabinoid drugs, medicinal cannabis & opioid drugs in India – a comprehensive legal overview. Prepared in association with Fangda Partners, one of China’s most prestigious and well-regarded law firms. This is an extract from The Pharma Legal Handbook: China, which can be purchased here for GBP 99.   CANNABINOID DRUGS 1. Are Cannabinoid Drugs authorized in your country? Cannabinoid Drugs are not authorized in China.   2. What are the regulatory authorities with jurisdiction over Cannabinoid Drugs? N/A   3. Is there a…

The key facts about regulatory reforms in Chinese pharma. Prepared in association with Fangda Partners, one of China’s most prestigious and well-regarded law firms. This is an extract from The Pharma Legal Handbook: China, which can be purchased here for GBP 99.   1. Are there proposals for reform or significant change to the healthcare system? Reform of Medical Insurance Payments To improve the cost-effectiveness of the current healthcare system, pilot policies of Diagnosis-Related Groups (“DRG”) payments have been implemented…

An outline of the legal situation around patents and trademarks for pharmaceuticals in China. Prepared in association with Fangda Partners, one of China’s most prestigious and well-regarded law firms. This is an extract from The Pharma Legal Handbook: China, which can be purchased here for GBP 99.   1. What are the basic requirements to obtain patent and trademark protection? Please refer to Question 3 below.   2. What agencies or bodies regulate patents and trademarks? In China, patents are regulated by…

A comprehensive guide to the legal implications around product liability in China. Prepared in association with Fangda Partners, one of China’s most prestigious and well-regarded law firms. This is an extract from The Pharma Legal Handbook: China, which can be purchased here for GBP 99.   1. What types of liability are recognized in your jurisdiction? Violation of laws and regulations may result in civil liabilities, administrative penalties and criminal liabilities. Civil liability can include: Desistance from infringement; Removal of obstacles;…

A legal intro to traditional medicines and OTC products in China. Prepared in association with Fangda Partners, one of China’s most prestigious and well-regarded law firms. This is an extract from The Pharma Legal Handbook: China, which can be purchased here for GBP 99.   1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? Traditional Chinese Medicine (“TCM”) is a system for diagnosis, prevention and treatment that has existed for thousands of years and is…

A brief overview of the situation regarding marketing, manufacturing, packaging & labeling and advertising within Chinese pharma. Prepared in association with Fangda Partners, one of China’s most prestigious and well-regarded law firms. This is an extract from The Pharma Legal Handbook: China, which can be purchased 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? Please refer to Questions 3 & 6 of the…

The essential requirements for conducting preclinical and clinical trials in China. Prepared in association with Fangda Partners, one of China’s most prestigious and well-regarded law firms. This is an extract from The Pharma Legal Handbook: China, which can be purchased here for GBP 99.   1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? No. According to the Technical Guidelines Governing Acceptance of Drug Clinical Data from Foreign Studies issued by the…

An intro to the regulatory, pricing and reimbursement scenario for pharmaceuticals in China. Prepared in association with Fangda Partners, one of China’s most prestigious and well-regarded law firms. This is an extract from The Pharma Legal Handbook: China, which can be purchased here for GBP 99.   1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? Several governmental agencies are responsible for the administration of drugs (including biologicals) and medical devices, including…

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…

There is no doubt that COVID-19 has impacted almost every aspect of our lives. Due to the ongoing health crisis, among other efforts, governments have implemented measures expecting to break high rates of infection while trying to adapt the regulatory landscape to respond to the new virus and continuing to attend other illnesses. Moreover, the vaccination process has increased discussions over human rights, from right to health to patent rights.   An equitable and global distribution of the vaccine will…

The cannabis and hemp industry is an emerging new industry in Ecuador with the Reform of the Criminal Law, enacted on June 21st, 2020.   Included among the reforms is the decriminalization of possession of drugs containing cannabis or derivatives as their active ingredient for therapeutic, palliative, or medicinal use, or for the practice of alternative medicine. In addition, the Law of Control and Prevention of the use of Drugs has been amended, excluding non-psychoactive or hemp cannabis from control,…

Istanbul’s First Instance IP Court recently dismissed a negative declaratory action (the “Case”) against our client citing the plaintiff’s lack of standing because the pharmaceutical at issue was unlicensed as of the when the action was started. The ruling is noteworthy because it appears to confirm the precedential force of similar Court of Appeal decisions.   For pharmaceuticals in particular, negative declaratory relief is considered as an effective market-clearing tool. Anyone with an interest in a pharmaceutical product sufficient to…

Key facts about biosimilars and biologics in Mexico. Prepared in association with Olivares, a leading global law firm, this is an extract from The Pharma Legal Handbook: Mexico, available to purchase here for GBP 99. 1. Are biosimilar medicines considered the same as generic medicines in your country? No, biosimilars are not considered the same as generic medicines. Biosimilars are regulated by specific provisions within the sanitary legislation. The Mexican General Health Law defines a “biologic product” as any substance…

Key facts about Localization in Mexico. Prepared in association with Olivares, a leading global law firm, this is an extract from The Pharma Legal Handbook: Mexico, 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? Largely, there are no specific rules or regulations requiring and/or encouraging localization in Mexico. Thus, there is no legal framework defining localization…

Important legal info for orphan drugs and rare diseases in Mexican pharma. Prepared in association with Olivares, a leading global law firm, this is an extract from The Pharma Legal Handbook: Mexico, available to purchase here for GBP 99.   1. What is the definition of Rare Diseases in your country? In accordance with the General health law, rare diseases are those that have a prevalence of not more than 5 people for every 10,000 inhabitants.   2. Does the…

The COVID-19 pandemic has caused economic and social disruption and affected the behaviour of both consumers and producers in Argentina, with an important impact on Argentine currency (ARS) devaluation and inflation, among others. We are not yet able to measure the real impact of the uncertainty the world is currently facing and its impact on the country.   In December 2019, President Macri ended his term and Alberto Fernandez took office with Cristina Kirchner as vice president, after having promised…

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…

The key facts about biosimilars and biologics in Japan. Prepared in association with Nishimura & Asahi, a leading law firm in Japan, this is an extract from The Pharma Legal Handbook: Japan, available to purchase here for GBP 75.   1. Are biosimilar medicines considered the same as generic medicines in your country? A biosimilar medicine is differentiated from a generic medicine in the point that final biosimilar products possibly differ from the original product, depending on the manufacturing process. This…

The key facts about localization in Japan. Prepared in association with Nishimura & Asahi, a leading law firm in Japan, this is an extract from The Pharma Legal Handbook: Japan, 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 and/or encouraging localization in Japan. This means that the decision…

The key facts about regulatory reforms in the UAE. Prepared in association with STA, a leading law firm in the UAE, this is an extract from The Pharma Legal Handbook: UAE, available to purchase here for GBP 75.   1. Are there proposals for reform or significant change to the healthcare system? On 19 December 2019, the UAE government adopted a new federal law which was to overhaul Law No. 4 of 1983 on the Pharmacy Professional and Pharmaceutical Establishments…

The key facts about patents & trademarks in the UAE. Prepared in association with STA, a leading law firm in the UAE, this is an extract from The Pharma Legal Handbook: UAE, available to purchase here for GBP 75.   1. What are the basic requirements to obtain patent and trademark protection? In the United Arab Emirates, patents are granted if the applications meet the criteria of Novelty, Inventive Concept (also known as Non-obviousness) and Industrial applicability.   2. What…

The key facts about product liability in the UAE. Prepared in association with STA, a leading law firm in the UAE, this is an extract from The Pharma Legal Handbook: UAE, available to purchase here for GBP 75.   1. What types of liability are recognized in your jurisdiction? In the UAE, Federal Law No. 24 of 2006 on Consumer Protection (Consumer Protection Law), as amended by Federal Law No. 7 of 2011, is the main piece of legislation relating…

The ins and outs of traditional medicines and OTC products in the UAE. Prepared in association with STA, a leading law firm in the UAE, this is an extract from The Pharma Legal Handbook: UAE, available to purchase here for GBP 75.   1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? As per Article 1 of the Pharmacy Law of 1983, medicines are defined as “any medicine that contains one or more element…

The key facts about marketing, manufacturing, packaging & labeling, advertising in the UAE. Prepared in association with STA, an international law firm, this is an extract from The Pharma Legal Handbook: UAE, 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? Under the Pharmaceutical Law, all applications for marketing authorization must be made through the Ministry of Health (MOH). The authorization…

All legal aspects surrounding preclinical and clinical trial requirements in the UAE. Prepared in association with STA, an international law firm, this is an extract from The Pharma Legal Handbook: UAE, 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? It is not an established requirement to conduct the clinical trials for products locally. As previously established, clinical trials are only required when the…

An insight into regulatory, pricing and reimbursement in the UAE. Prepared in association with STA, an international law firm, this is an extract from The Pharma Legal Handbook: UAE, 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 UAE Ministry of Health (MOH) is the primary authority responsible for oversight of all the regulatory functions concerning pharmaceuticals in the UAE. The Ministry of…

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…

An insight into digital health in Indian Pharma. Prepared in association with Nishith Desai & Associates, a leading law firm in India, this is an extract from The Pharma Legal Handbook: India, available to purchase here for GBP 75. 151. Is the term ‘digital health’ defined in your jurisdiction? If no, how is the term generally understood? The term digital health is not specifically defined in India. It is generally understood to include tools and services that use information and…

An insight into medical devices in India. Prepared in association with Nishith Desai & Associates, a leading law firm in India, this is an extract from The Pharma Legal Handbook: India, available to purchase here for GBP 75.   1. Who are the regulatory authorities governing medical devices in your jurisdiction? The following regulatory authorities have jurisdiction over medical devices in India. The Drugs Controller General of India (“DCGI”) The Central Drugs Standard Control Organisation (“CDSCO”) State drug licensing authorities…

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…

The shockwaves from the UK’s exit from the European Union have resounded across the continent, including in Turkey, where the country’s pharmaceutical and medical devices regulator has had to adjust its guidance on CE-mark certified devices. Leading lawyers from top Turkish law firm and PharmaBoardroom legal partner Moroğlu Arseven explain the current situation.   CE Certificate Requirement in Turkey The Regulation on CE Marking, published in the Official Gazette on, and effective as of, 23 February 2012 (the “Regulation”) governs…

Fasken Canada’s Dara Jospe and Denis Douville examine Canada’s COVID-19 vaccine strategy, from the steps the country has taken to expedite the approval process to its funding of R&D projects and the preparations needed for ensuring the necessary supply and distribution infrastructure is in place.   Vaccination is a historically successful strategy to prevent the spread of infectious diseases. The immunization of a large enough proportion of a population will reduce the percentage of vulnerable hosts to a level below…

The key facts about biosimilars and biologics in Chile. Prepared in association with Carey, a leading global law firm, this is an extract from The Pharma Legal Handbook: Chile, available to purchase here for GBP 99.   1. Are biosimilar medicines considered the same as generic medicines in your country? No. According to Technical Guideline No. 170, issued by the Ministry of Health on August 21, 2014 and approved by decree No. 945 of 2014 -and its amendments-, which contain…

Want to know more about orphan drugs and rare diseases in Chile? Read on! Prepared in association with Carey, a leading global law firm, this is an extract from The Pharma Legal Handbook: Chile, available to purchase here for GBP 99.   1. What is the definition of Rare Diseases in your country? Currently, we don’t have a legal or regulatory definition for rare diseases in Chile. Indeed, neither our Sanitary Code nor Supreme Decree No. 03/2010 (S.D. No. 3/10), which…

Drugs, biologicals and medical devices authorization fees are fixed as part of Finance Law in Algeria. Fees are payable by the person who makes the application or submits variations, in local currency for locally-manufactured products, and in convertible foreign currencies for imported ones.   The supplementary Finance Law for 2020 has just been published in the Official Gazette. Its Article 61 has modified authorization fee due for a new application related to imported and non-essential drugs and biologics.   As…

In Algeria, the supplementary Finance Law for 2020 has just been published in the Official Gazette. This law materializes the authorities’ will to significantly ease the control of foreign investments in order to boost Foreign Direct Investment (FDI) and to accelerate the diversification of the national economy.   Despite several competitive advantages, including low cost of energy, skilled and inexpensive workforce, and geographic location at the crossroads of Europe, Africa, and the Middle East, FDI flows into Algeria have remained…

The legal framework for regulatory reforms in Vietnamese Pharma. Prepared in association with Tilleke & Gibbins, a leading law firm in Vietnam, this is an extract from The Pharma Legal Handbook: Vietnam, available to purchase here for GBP 75.   1. Are there proposals for reform or significant change to the healthcare system? The MOH published a draft version of an amended Law on Medical Examination and Treatment dated 12 October 2019 to collect public opinions. Once adopted, the new…

All about patents & trademarks in Viatnamese Pharma. Prepared in association with Tilleke & Gibbins, a leading law firm in Vietnam, this is an extract from The Pharma Legal Handbook: Vietnam, available to purchase here for USD 99.   1. What are the basic requirements to obtain patent and trademark protection? PATENT To qualify for patent protection, an invention must meet the following basic conditions: Be globally novel; Involve an inventive step; and Have its subject matter capable of industrial…

The low-down on the situation regarding product liability in Vietnamese Pharma. Prepared in association with Tilleke & Gibbins, a leading law firm in Vietnam, this is an extract from The Pharma Legal Handbook: Vietnam, available to purchase here for GBP 75.   1. What types of liability are recognized in your jurisdiction? The following types of liability are recognized under Vietnamese laws: disciplinary liability, administrative liability, civil liability and criminal liability.   2. How do these types of liabilities apply…

Want to know more about traditional medicines and OTC products in Vietnamese Pharma? Read on! Prepared in association with Tilleke & Gibbins, a leading law firm in Vietnam, this is an extract from The Pharma Legal Handbook: Vietnam, available to purchase here for USD 99.   1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? The Law on Pharmacy and its implementing regulations are equally applicable to modern drugs and traditional and herbal drugs.…

The key facts about marketing, manufacturing, packaging & labeling, advertising in Vietnamese Pharma. Prepared in association with Tilleke & Gibbins, a leading law firm in Vietnam, this is an extract from The Pharma Legal Handbook: Vietnam, 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? PHARMACEUTICAL PRODUCTS Under Vietnamese law, pharmaceutical products or drugs are defined to cover all modern…

A brief overview of the situation regarding preclinical and clinical trial requirements in Vietnamese Pharma. Prepared in association with Tilleke & Gibbins, a leading law firm in Vietnam, this is an extract from The Pharma Legal Handbook: Vietnam, 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? By law, clinical research documentation for the purpose of obtaining the MA must conform to the…

An intro to the legal situation for regulatory, pricing and reimbursement in Vietnamese Pharma. Prepared in association with Tilleke & Gibbins, a leading law firm in Vietnam, this is an extract from The Pharma Legal Handbook: Vietnam, 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 Vietnam, pharmaceutical products (including drugs and biologicals) and medical devices are under the overall management of the…

The legal framework for cannabinoid drugs, medicinal cannabis and opioid drugs in Venezuelan Pharma. Prepared in association with Hoet Pelaez Castillo & Duque (HPCD), a leading law firm in Venezuela, this is an extract from The Pharma Legal Handbook:Venezuela, available to purchase here for USD 99.   Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? No.   2. What are the regulatory authorities with jurisdiction over Cannabinoid Drugs? The National Unique Registry of Chemicals Operators. Meanwhile, they are…

Keen to learn more about regulatory reforms in Venezuelan Pharma? Read on! Prepared in association with Hoet Pelaez Castillo & Duque (HPCD), a leading law firm in Venezuela, this is an extract from The Pharma Legal Handbook:Venezuela, available to purchase here for USD 99.   1. Are there proposals for reform or significant change to the healthcare system? We are not aware of any reform or proposed change within the health system.   2. When are they likely to come…

An insight into patents & trademarks in Venezuelan Pharma. Prepared in association with Hoet Pelaez Castillo & Duque (HPCD), a leading law firm in Venezuela, this is an extract from The Pharma Legal Handbook:Venezuela, available to purchase here for USD 99.   1. What are the basic requirements to obtain patent and trademark protection? The basic requirements for a patent application consist of: (Art. 59 Industrial Property Law) A. Submit the application and a copy of it to the Autonomous…

The ins and outs of product liability in Venezuelan Pharma. Prepared in association with Hoet Pelaez Castillo & Duque (HPCD), a leading law firm in Venezuela, this is an extract from The Pharma Legal Handbook:Venezuela, available to purchase here for USD 99.   1. What types of liability are recognized in your jurisdiction? Civil, criminal and administrative liability.   2. How do these types of liabilities apply to the manufacturers of medicines and devices? The 3 types of responsibilities apply.…

Traditional medicines and OTC products in Venezuelan Pharma – a comprehensive legal overview. Prepared in association with Hoet Pelaez Castillo & Duque (HPCD), a leading law firm in Venezuela, this is an extract from The Pharma Legal Handbook:Venezuela, available to purchase here for USD 99.   1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? The Constitution of Venezuela recognizes the practice of traditional medicine in indigenous peoples and communities. Alternative medicine is not…

Key legal info on marketing, manufacturing, packaging & labeling, advertising in Venezuelan Pharma. Prepared in association with Hoet Pelaez Castillo & Duque (HPCD), a leading law firm in Venezuela, this is an extract from The Pharma Legal Handbook:Venezuela, 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? To request the authorization of a clinical protocol of a Pharmaceutical Specialty, the…

The key facts about preclinical and clinical trial requirements in Venezuelan Pharma. Prepared in association with Hoet Pelaez Castillo & Duque (HPCD), a leading law firm in Venezuela, this is an extract from The Pharma Legal Handbook:Venezuela, 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? Yes.   2. How are clinical trials funded? Clinical trials are funded by those interested in obtaining…

All legal aspects surrounding regulatory, pricing and reimbursement in Venezuelan Pharma. Prepared in association with Hoet Pelaez Castillo & Duque (HPCD), a leading law firm in Venezuela, this is an extract from The Pharma Legal Handbook:Venezuela, 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 Regulatory authority is the National Institute of Hygiene.   2. What is the regulatory framework for the authorization,…

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…

A brief overview of the situation regarding biosimilars & biologics in Singaporean Pharma. Prepared in association with Drew & Napier LLC, this is an extract from The Pharma Legal Handbook: Singapore, available to purchase here for USD 99.   1. Are biosimilar medicines considered the same as generic medicines in your country? Biosimilar medicines are not considered the same as generic medicines. According to the Health Sciences Authority of Singapore (“HSA”), biologics are medicinal products with large complex molecules produced by living…

The ins and outs of orphan drugs & rare diseases in Singaporean Pharma. Prepared in association with Drew & Napier LLC, this is an extract from The Pharma Legal Handbook: Singapore, available to purchase here for USD 99.   1. What is the definition of Rare Diseases in your country? As at the date hereof, there is no legal definition of rare diseases in Singapore. In a press release dated 2 July 2019, the Ministry of Health of Singapore (“MOH”) defined a…

Cannabinoid drugs, medicinal cannabis and opioid drugs in Singaporean Pharma – a legal guide. Prepared in association with Drew & Napier LLC, this is an extract from The Pharma Legal Handbook: Singapore, available to purchase here for USD 99.   Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? In general, Cannabinoid Drugs are not authorised in Singapore. The Misuse of Drugs Act (Chapter 185) of Singapore (“MDA”) prescribes that it shall be an offence to traffic, manufacture, import or export,…

On February 19, 2019, by amending the Narcotics Act B.E. 2522, Thailand caught the cannabis industry by surprise and became the first Asia-Pacific country to legalize medicinal cannabis. While hemp had been approved for use in industry since 2018 (see here), the amendment of the Narcotics Act B.E. 2522, providing for a Thai FDA registration pathway for medicinal cannabis, was largely unexpected.     While the amendments create the foundation for a cannabis industry in Thailand, the true viability and future…

The ongoing reform of pharmaceutical regulations in Algeria has been marked on January 2020 by publication in the Official Gazette of the long-awaited Decree No 19-379 dated of 31st December 2019. This Decree has laid down procedures for specific administrative, technical and safety control of substances and drugs with psychotropic properties (i.e. including Cannabinoids).   The Decree No 19-379 was initially planned to enter into force by 5th of April 2020 according to its Article 41, but considering COVID-19 pandemic…

On March 30, 2020, the State Administration for Market Regulation (SAMR) enacted the Amended Drug Registration Regulation (DRR) as part of its efforts to strengthen and streamline its regulation of the pharmaceutical industry. The DRR seeks, on the one hand, to further confirm a series of changes made in drug evaluation and approval in recent years, and, on the other, to implement in full a series of processes proposed in the Drug Administration Law (DAL), including who is authorized to…

For more than 20 years, Ordinance No. 802/1998 (“Ordinance No. 802/1998”), issued by the Brazilian Ministry of Health, used to regulate the distribution of pharmaceutical products in Brazil. Needless to say that such rule, although very extensive, became outdated and stopped reflecting the dynamics and needs of those involved in the drugs supply chain.   For this reason and for a period of more than two years, the update of Ordinance No. 802/1998 was discussed by the Brazilian National Health…

Dealing with the COVID-19 pandemic has taken top priority for almost every country in the world. In Thailand, even though the strength of the country’s health security measures has been ranked sixth-best globally, COVID-19 has hit hard, and the number of confirmed cases is steadily increasing each day.   In the early stages of the outbreak in January 2020, only passengers who had visited mainland China were subject to close monitoring by communicable disease control officers. By late February, South…

The COVID-19 pandemic continues to spread rapidly across the globe amid critical supply shortages of medical devices and medicines. The rapid spread of the virus, on the one hand, threatens supply chains and causes shortages, on the other hand, it also strengthens global solidarity.   Brands from different sectors make an effort towards helping in the fight against the pandemic. Fashion brands are manufacturing masks, luxury cosmetic brands are supporting disinfectant manufactures, the entrepreneur ecosystem swept into seeking alternative ways to…

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…

All legal aspects surrounding biosimilars & biologics in Argentina. Prepared in association with Marval, O’Farrell & Mairal, a leading global law firm, this is an extract from The Pharma Legal Handbook: Argentina, available to purchase here for GBP 99.   1. Are biosimilar medicines considered the same as generic medicines in your country? No, biosimilar medicines have their own legal regime. ANMAT does not use any specific term such as “biosimilar” or “biocomparable”, but defines this type of biological medicines as: “medicinal…

The low-down on the situation regarding localization in Argentina. Prepared in association with Marval, O’Farrell & Mairal, a leading global law firm, this is an extract from The Pharma Legal Handbook: Argentina, 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 preliminary comment, please note that to carry out activities in Argentina on a permanent basis,…

Keen to learn more about orphan drugs & rare diseases in Argentina? Read on! Prepared in association with Marval, O’Farrell & Mairal, a leading global law firm, this is an extract from The Pharma Legal Handbook: Argentina, available to purchase here for GBP 99.   1. What is the definition of Rare Diseases in your country? According to Law No. 26,689 on Rare Diseases, rare diseases are considered to be those whose prevalence in the population is equal to or less than…

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…

Keen to learn more about regulatory reform in Zimbabwe? Read on! Prepared in association with Honey & Blanckenberg, a leading law firm in Zimbabwe, this is an extract from The Pharma Legal Handbook: Zimbabwe, available to purchase here for USD 99.   1. Are there proposals for reform or significant change to the healthcare system? Currently, there is no proposal for reform in the form of proposed or draft legislation. The last major proposal for reform was the Public Health…

A brief overview of the situation regarding patents & trademarks in Zimbabwe. Prepared in association with Honey & Blanckenberg, a leading law firm in Zimbabwe, this is an extract from The Pharma Legal Handbook: Zimbabwe, available to purchase here for USD 99.   1. What are the basic requirements to obtain patent and trademark protection? Patent Protection The Patents Act [Chapter 26:03], provides that in order to qualify for patent protection, an invention must consist of patentable subject matter and…

An intro to the legal situation for product liability in Zimbabwe. Prepared in association with Honey & Blanckenberg, a leading law firm in Zimbabwe, this is an extract from The Pharma Legal Handbook: Zimbabwe, available to purchase here for USD 99.   1. What types of liability are recognized in your jurisdiction? Zimbabwe has recently passed a Consumer Protection Act [Chapter 14:14] (“the CPA”), which was gazetted on 10 December 2019. In addition, the common law concept of delict law…