Legal & Regulatory

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 119. 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 119. 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 119. 1. What is the definition of Rare Diseases in your country? There is no legal definition of Rare Diseases in Poland. In accordance with Regulation (EC) no. 141/2000 of European Parliament and of the Council of 16…

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 119. 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 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 119. 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 119.   1. What types of liability are recognized in your jurisdiction? Under Polish law, the following types of liability are recognized: criminal liability; administrative liability; civil liability for breach of contract or torts. The injured party may seek compensation for damage before a…

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 119.   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 119.   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 119.   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 119.   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…

Biosimilars and biologics in Canada: A legal guide. Prepared in association with Fasken, a leading global law firm, this is an extract from The Pharma Legal Handbook: Canada, available to purchase here for GBP 119.   1. Are biosimilar medicines considered the same as generic medicines in your country? A biosimilar is not a generic biologic product since it is not identical to its reference product; its authorization does not constitute evidence of pharmaceutical equivalence, bioequivalence or clinical equivalence.[1] A biosimilar is…

Want to know more about the localization in Canada? Read on! Prepared in association with Fasken, a leading global law firm, this is an extract from The Pharma Legal Handbook: Canada, available to purchase here for GBP 119.   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 of November, 2021, drugs intended for the Canadian market that could cause or exacerbate a shortage are…

All legal aspects surrounding orphan drugs and rare diseases in Canadian Pharma. Prepared in association with Fasken, a leading global law firm, this is an extract from The Pharma Legal Handbook: Canada, available to purchase here for GBP 119.   1. What is the definition of Rare Diseases in your country? In Canada, “Rare Diseases” are defined as “life-threatening, debilitating or serious, and chronic conditions affecting a small number of patients, many of which predominantly affect children, as these diseases are often…

The legal framework for cannabinoid drugs, medical cannabis and opioids in Canada. Prepared in association with Fasken, a leading global law firm, this is an extract from The Pharma Legal Handbook: Canada, available to purchase here for GBP 119.   Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? Yes. Cannabinoids can be the active ingredient of a drug product in Canada, provided that such product meets applicable safety, effectiveness and quality requirements under the Food and Drugs Act and its regulations.…

An insight into upcoming regulatory reforms affecting Canadian pharma. Prepared in association with Fasken, a leading global law firm, this is an extract from The Pharma Legal Handbook: Canada, available to purchase here for USD 99.   1. Are there proposals for reform or significant change to the healthcare system? There are three significant changes which may affect or impact healthcare in Canada. NATIONAL PHARMACARE Currently, Canada is the only member country of the Organization for Economic Co-operation and Development with universal public health…

The low-down on the situation regarding patents and trademarks in Canadian pharma. Prepared in association with Fasken, a leading global law firm, this is an extract from The Pharma Legal Handbook: Canada, available to purchase here for GBP 119.   1. What are the basic requirements to obtain patent and trademark protection? In order to obtain patent or trademark protection, one must submit an application to the Canadian Intellectual Property Office (“CIPO”) and comply with the formalities of the application process set…

All about product liability in Canadian pharma. Prepared in association with Fasken, a leading global law firm, this is an extract from The Pharma Legal Handbook: Canada, available to purchase here for GBP 119.   1. What types of liability are recognized in your jurisdiction? In general terms, product liability arises from claims in contract or civil wrongs under the common law or civil code, depending on the province. Plaintiffs can hold manufacturers concurrently liable in either contract or civil wrongs. Contractual Liability…

An intro to the legal situation for traditional products and OTC medicines in Canada. Prepared in association with Fasken, a leading global law firm, this is an extract from The Pharma Legal Handbook: Canada, available to purchase here for GBP 119.   1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? In Canada, traditional, herbal, complementary or alternative medicines are included under the previously defined term “NHPs.” NHPs are governed by the Food and Drugs Act and the…

The ins and outs of the marketing, manufacturing, packaging & labeling, and advertising in Canadian pharma. Prepared in association with Fasken, a leading global law firm, this is an extract from The Pharma Legal Handbook: Canada, available to purchase here for GBP 119.   1. What is the authorization process for the marketing of new drugs, biologics, medical devices, non-prescription medications, and other medicinal products? The authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other…

Preclinical and clinical trial requirements for pharma in Canada – a comprehensive legal overview. Prepared in association with Fasken, a leading global law firm, this is an extract from The Pharma Legal Handbook: Canada, available to purchase here for GBP 119.   1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? There is no requirement to conduct local trials of a new drug to receive marketing approval. Rather, in order to obtain…

A brief overview of the situation regarding regulation, pricing and reimbursement of drugs in Canada. Prepared in association with Fasken, a leading global law firm, this is an extract from The Pharma Legal Handbook: Canada, available to purchase here for GBP 119.   1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? Health Canada is the federal authority responsible for regulating pharmaceutical drugs, biologicals, and medical devices for human use. Health Canada’s…

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 119.   1. What is the definition of Rare Diseases in your country? According to Act 1438/2011 Orphan diseases are chronically debilitating, serious, life-threatening diseases with a prevalence of less than 1 per 5,000 people, including rare, ultra-orphan and neglected…

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 119.   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…

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 119. 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 with…

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 119.   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 119.   1. What are the basic requirements to obtain patent and trademark protection? Colombia, as WTO Member, complies with the  Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). Therefore, in Colombia patent applications in all technical fields must satisfy the…

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 119.   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 119.   1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? Traditional medicines are ruled through Decree 2266/2004, Decree 4927/09, and Decree 1156/18 which establishes regulatory requirements for Phyto therapeutics.   The main requirements for traditional…

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 119.   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 119.   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 119.    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.…

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 119. 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 biosimilars and generics in a different manner. 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 119.   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 119.   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…

All about cannabinoid drugs, medicinal cannabis and opioid drugs in Romania. Prepared in association with Mușat & Asociații, a leading global law firm, this is an extract from The Pharma Legal Handbook: Romania, available to purchase here for GBP 119.   Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? According to the national catalogue of medicines in Romania published by NAMMD, currently there are no cannabinoid medicinal products authorized for marketing in the country. By law, certain psychotropic substances extracted…

A brief overview of the situation regarding patents and trademarks in Romanian Pharma. Prepared in association with Mușat & Asociații, a leading global law firm, this is an extract from The Pharma Legal Handbook: Romania, available to purchase here for GBP 119.   1. What are the basic requirements to obtain patent and trademark protection? As a rule, a patent or a trademark protection can only be obtained by registration with the State Office for Inventions and Trademarks (“OSIM”), based on…

The ins and outs of regulatory reforms in Romania. Prepared in association with Mușat & Asociații, a leading global law firm, this is an extract from The Pharma Legal Handbook: Romania, available to purchase here for GBP 119.   1. Are there proposals for reform or significant change to the healthcare system? The Romanian authorities announced their intention to implement certain reform or significant change to changes in the pharmaceutical legislation, including in relation to: healthcare system? the new advertising norms for…

Product liability in Romanian Pharma – a legal guide. Prepared in association with Mușat & Asociații, a leading global law firm, this is an extract from The Pharma Legal Handbook: Romania, available to purchase here for GBP 119.   1. What types of liability are recognized in your jurisdiction? The failure to comply with the Romanian pharma legislation can trigger disciplinary, civil, material, contraventional or criminal liability, depending on the case. Additionally, the competent authorities in various fields can apply fines and…

The key facts about traditional medicines and OTC products in Romania. Prepared in association with Mușat & Asociații, a leading global law firm, this is an extract from The Pharma Legal Handbook: Romania, available to purchase here for GBP 119.   1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? The Health Law transposed into the national legislation the provisions of Directive 2001/83/EC on the Community code relating to medicinal products for human use, and provides…

Marketing, manufacturing, packaging & labeling, advertising in Romanian Pharma – a comprehensive legal overview. Prepared in association with Mușat & Asociații, a leading global law firm, this is an extract from The Pharma Legal Handbook: Romania, available to purchase here for GBP 119.   1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over the-counter medications, and other medicinal products? In order to be placed on the Romanian market, a medicinal product needs a marketing authorization,…

An intro to the legal situation for preclinical and clinical trial requirements in Romanian Pharma. Prepared in association with Mușat & Asociații, a leading global law firm, this is an extract from The Pharma Legal Handbook: Romania, available to purchase here for GBP 119.   1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? The Romanian law does not expressly provide such limitation as to the performing of clinical trials solely in Romania…

The legal framework for regulatory, pricing and reimbursement in Romanian Pharma. Prepared in association with Mușat & Asociații, a leading global law firm, this is an extract from The Pharma Legal Handbook: Romania, available to purchase here for GBP 119.   1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? The regulatory authorities competent in these fields are: the Ministry of Health (http://www.ms.ro/); the National Agency for Medicines and Medical Devices (https://www.anm.ro/);…

The ins and outs of biosimilars & biologics in Peru. Prepared in association with Osterling Abogados, a leading global law firm, this is an extract from The Pharma Legal Handbook: Peru, available to purchase here for GBP 119.   1. Are biosimilar medicines considered the same as generic medicines in your country? No, they are different. On one side biosimilar products are biologically synthesized products which require a much more complex procedure to elaborate due to the fact that bigger…

Key legal info on orphan drugs & rare diseases in Peru. Prepared in association with Osterling Abogados, a leading global law firm, this is an extract from The Pharma Legal Handbook: Peru, available to purchase here for GBP 119.   1. What is the definition of Rare Diseases in your country? Rare Diseases are defined, by Supreme Decree No. 004-2019-SA, as those with danger of death or chronic disability, which have a frequency of less than 1 disease per 100,000…

Key legal info on cannabinoid drugs, medicinal cannabis and opioid drugs in Greece. Prepared in association with Osterling Abogados, a leading global law firm, this is an extract from The Pharma Legal Handbook: Peru, available to purchase here for GBP 75.   Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? In our country, Cannabinoid Drugs are only allowed in the form of Medical Cannabis, for informed use, research, production, import and trade for medicinal and therapeutic purposes, as it…

Regulatory reforms in Peru – an overview. Prepared in association with Osterling Abogados, a leading global law firm, this is an extract from The Pharma Legal Handbook: Peru, available to purchase here for GBP 119.   1. Are there proposals for reform or significant change to the healthcare system? There are no proposals that imply a significant change to the healthcare system.   2. When are they likely to come into force? N/A.  

An outline of the situation regarding patents and trademarks in Peruvian pharma. Prepared in association with Osterling Abogados, a leading global law firm, this is an extract from The Pharma Legal Handbook: Peru, available to purchase here for GBP 119.   1. What are the basic requirements to obtain patent and trademark protection? A patent application must comply with 3 basic requirements, meaning that a patent must have: Novelty Inventive Level Industrial Application A trademark application must both be distinctive and must…

Get to know the legal situation around product liability in Peru. Prepared in association with Osterling Abogados, a leading global law firm, this is an extract from The Pharma Legal Handbook: Peru, available to purchase here for GBP 119.   1. What types of liability are recognized in your jurisdiction? Regarding the quality of the pharmaceutical products and medical devices the responsibility will lie with the manufacturing company when these are made in the country, with the importer holding the Sanitary Registration…

The ins and outs of the legal requirements for traditional medicines and OTC medicines in Peru. Prepared in association with Osterling Abogados, a leading global law firm, this is an extract from The Pharma Legal Handbook: Peru, available to purchase here for GBP 119.   1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? Storage, Commercialization, importation, distribution require, with the exception of alternative medicine, a Sanitary Registration for each product.   2. Can these traditional,…

The key info on marketing, manufacturing, packaging & labelling and advertising pharmaceuticals in Peru. Prepared in association with Osterling Abogados, a leading global law firm, this is an extract from The Pharma Legal Handbook: Peru, available to purchase here for GBP 119.   1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? Any new drug, biologic, medical device, over the counter medication and in general medicinal product require a…

Want to know about preclinical and clinical trial requirements in Peru? Read on! Prepared in association with Osterling Abogados, a leading global law firm, this is an extract from The Pharma Legal Handbook: Peru, available to purchase here for GBP 119.   1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? Peruvian law only regulates clinical trials conducted locally.   2. How are clinical trials funded? Clinical trials are funded by…

An intro to the regulatory, pricing and reimbursement scenario for pharmaceuticals in Peru. Prepared in association with Osterling Abogados, a leading global law firm, this is an extract from The Pharma Legal Handbook: Peru, available to purchase here for GBP 119.   1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? Drugs, biological and medical devices are regulated by the Directorate General of Medicines, Supplies and Drugs – (known in Spanish as…

Key legal info on biosimilars & biologics in Denmark. Prepared in association with Gorrissen Federspiel, a leading law firm in Denmark, this is an extract from The Pharma Legal Handbook: Denmark, available to purchase here for GBP 119.   1. Are biosimilar medicines considered the same as generic medicines in your country? No. A biosimilar medicinal product is a new version of an existing biological medicinal product (i.e. a medicinal product is derived from a biological source). Biosimilar products are…

Keen to learn more about localization in Denmark? Read on! Prepared in association with Gorrissen Federspiel, a leading law firm in Denmark, this is an extract from The Pharma Legal Handbook: Denmark, available to purchase here for GBP 119.   1. Are there any rules or regulations requiring and/or encouraging localization in your country? What is the legal framework defining these localization rules and policies? No, as a starting point there are no rules or regulations formally requiring localization in…

An insight into orphan drugs and rare diseases in Denmark. Prepared in association with Gorrissen Federspiel, a leading law firm in Denmark, this is an extract from The Pharma Legal Handbook: Denmark, available to purchase here for GBP 119.   1. What is the definition of Rare Diseases in your country? Pursuant to Regulation (EC) no. 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products (“Orphan Drug Regulation”), a medicinal product may be designated…

An intro to the legal situation for cannabinoid drugs, medicinal cannabis and opioid drugs in Denmark. Prepared in association with Gorrissen Federspiel, a leading law firm in Denmark, this is an extract from The Pharma Legal Handbook: Denmark, available to purchase here for GBP 119.   Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? Cannabinoid drugs, i.e. medicinal products where the active substance is cannabinoids, can be authorised in Denmark in accordance with the general rules on development, manufacture and…

The ins and outs of regulatory reforms in Denmark. Prepared in association with Gorrissen Federspiel, a leading law firm in Denmark, this is an extract from The Pharma Legal Handbook: Denmark, available to purchase here for GBP 119.   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.   Click the following links to read more legal articles from Denmark: Regulatory Pricing and Reimbursement Overview Preclinical…

The low-down on the situation regarding patents and trademarks in Denmark. Prepared in association with Gorrissen Federspiel, a leading law firm in Denmark, this is an extract from The Pharma Legal Handbook: Denmark, available to purchase here for GBP 119.   1. What are the basic requirements to obtain patent and trademark protection? Patents In Denmark, a patent can be obtained by i) filing of a patent application with the Danish Patent and Trademark Office (“DKPTO”), ii) filing a patent application according…

All legal aspects surrounding product liability. Prepared in association with Gorrissen Federspiel, a leading law firm in Denmark, this is an extract from The Pharma Legal Handbook: Denmark, available to purchase here for GBP 119.   1. What types of liability are recognized in your jurisdiction? Generally, a person or company may incur liability by way of (i) contractual liability or (ii) civil liability due to violations of statutory law and/or culpable behaviour. Depending on the wording of the contractual terms giving rise…

Key legal info on traditional medicines and OTC products in Denmark. Prepared in association with Gorrissen Federspiel, a leading law firm in Denmark, this is an extract from The Pharma Legal Handbook: Denmark, available to purchase here for GBP 119.   1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? Natural medicinal products, traditional herbal medicinal products, homeopathic medicinal products, and strong vitamin and mineral products are all special categories of medicinal products and are as…

A brief overview of the situation regarding marketing, manufacturing, packaging & labeling, advertising in Denmark. Prepared in association with Gorrissen Federspiel, a leading law firm in Denmark, this is an extract from The Pharma Legal Handbook: Denmark, available to purchase here for GBP 119.   1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? Please see Question 3 of Regulatory, Pricing and Reimbursement Overview.   2. What is the authorization…

Preclinical and clinical trial requirements in Denmark – an overview. Prepared in association with Gorrissen Federspiel, a leading law firm in Denmark, this is an extract from The Pharma Legal Handbook: Denmark, available to purchase here for GBP 119.   1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? No, clinical trials are not required to be conducted locally as a condition for a marketing authorization. As a starting point, an application for…

The legal framework for regulatory, pricing and reimbursement of drugs in Denmark. Prepared in association with Gorrissen Federspiel, a leading law firm in Denmark, this is an extract from The Pharma Legal Handbook: Denmark, available to purchase here for GBP 119.   1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? The Danish Ministry of Health is responsible for defining the overall framework for the national healthcare system. As a governmental body…

Cannabinoid drugs, medicinal cannabis and opioid drugs in Spain – a legal guide. Prepared in association with Faus Moliner Abogados, a leading law firm in Spain, this is an extract from The Pharma Legal Handbook: Spain, available to purchase here for GBP 119.   Cannabinoid Drugs For the purposes of this Chapter 8: Cannabinoid Drugs, Cannabinoid Drugs shall mean any industrially produced medicinal product which contains cannabinoids.   1. Are Cannabinoid Drugs authorized in your country? Cannabinoid Drugs may be authorized in…

Want to know more about regulatory reforms in Spain? Read on! Prepared in association with Faus Moliner Abogados, a leading law firm in Spain, this is an extract from The Pharma Legal Handbook: Spain, available to purchase here for GBP 119.   1. Are there proposals for reform or significant change to the healthcare system? In July 2022, the Ministry of Health opened a public consultation on the first draft of the law that will amend the current Spanish Law on Medicinal…

The legal framework for patents and trademarks in Spain. Prepared in association with Faus Moliner Abogados, a leading law firm in Spain, this is an extract from The Pharma Legal Handbook: Spain, available to purchase here for GBP 119.   1. What are the basic requirements to obtain patent and trademark protection? Pursuant to Law 24/2015 on patents, the basic legal requirements to obtain a patent are: (i) to have a new invention in any field of technology; (ii) that such invention…

The low-down on the situation regarding product liability in Spain. Prepared in association with Faus Moliner Abogados, a leading law firm in Spain, this is an extract from The Pharma Legal Handbook: Spain, available to purchase here for GBP 119.   1. What types of liability are recognized in your jurisdiction? The Spanish regime for product liability is a strict liability regime.  Such regime imposes strict liability to the “producer” of a defective product. The producer will be liable for personal injury…

A brief overview of the situation regarding traditional medicines and OTC products in Spain. Prepared in association with Faus Moliner Abogados, a leading law firm in Spain, this is an extract from The Pharma Legal Handbook: Spain, available to purchase here for GBP 119.   1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? Plants traditionally used in Spain for medicinal purposes can be sold to the public without the need for a marketing authorization issued…

All about marketing, manufacturing, packaging & labeling, advertising in Spain. Prepared in association with Faus Moliner Abogados, a leading law firm in Spain, this is an extract from The Pharma Legal Handbook: Spain, available to purchase here for GBP 119.   1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? The AEMPS is the authority in charge of granting marketing authorizations in Spain, whether they result from a…

Preclinical & clinical trial requirements in Spain – a comprehensive legal overview. Prepared in association with Faus Moliner Abogados, a leading law firm in Spain, this is an extract from The Pharma Legal Handbook: Spain, available to purchase here for GBP 119.   1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? No, clinical trial may be conducted abroad. For those cases whenever clinical trials are conducted outside the European Union,…

Key legal info on regulatory, pricing and reimbursement in Spain. Prepared in association with Faus Moliner Abogados, a leading law firm in Spain, this is an extract from The Pharma Legal Handbook: Spain.   The guide is available to purchase here for GBP 119.   1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? The main regulatory authorities in Spain are: The Spanish Ministry of Health (‘Spanish Ministry of Health’), which is…

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 119. 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 119. 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 119. 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 119.   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 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 GBP 119.   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 119.   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 119.   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 119.   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 119.   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 119.   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 119.   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…

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 119.   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 119.   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 119.   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 119.   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…

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 119.   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…

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 119.   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…

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 119.   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 119.   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…

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 119.   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 119.   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…

Keen to learn more about orphan drugs & rare diseases in Vietnam? 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 GBP 119.   1. What is the definition of Rare Diseases in your country? There are no legal documents in Vietnam providing a definition of “rare diseases.”   2. Does the designation of ‘Orphan Drug’ exist in your…

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 119.   1. Are there proposals for reform or significant change to the healthcare system? Law on Medical Examination and Treatment The draft version of an amended Law on Medical Examination and Treatment was submitted to the National Assembly in May 2022…

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 GBP 119.   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 119.   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 GBP 119.   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 119.   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 119.   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 drug MA must conform to…

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 119-   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 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 119.   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…

The key facts about regulatory reforms in Italy. Prepared in association with Baker Mckenzie, a leading law firm in Italy, this is an extract from The Pharma Legal Handbook: Italy, available to purchase here for GB 119.   Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? In Italy, the use of recreational cannabis is prohibited under Presidential Decree no. 309/1990 (the “Presidential Decree”).  However, it is possible to use cannabis for medical purposes.  Indeed, the Decree of the Ministry…

The key facts about regulatory reforms in Italy. Prepared in association with Baker Mckenzie, a leading law firm in Italy, this is an extract from The Pharma Legal Handbook: Italy, available to purchase here for GB 119.   1. Are there proposals for reform or significant change to the healthcare system? The most recent changes in legislation relate to the clinical trial sector, where Legislative Decree No. 52/2019 and the Decree of the MoH dated November 30, 2021, which was published…

All legal aspects surrounding patents & trademarks in Italian Pharma. Prepared in association with Baker Mckenzie, a leading law firm in Italy, this is an extract from The Pharma Legal Handbook: Italy, available to purchase here for GB 119.   1. What are the basic requirements to obtain patent and trademark protection? The regulation of Italian patents and trademarks is mainly contained in the Industrial Property Code (Legislative Decree No. 30/2005, hereinafter “I.P.C.”). Some provisions on patents and trademarks are also…

 The low-down on the situation regarding product liability in Italy. Prepared in association with Baker Mckenzie, a leading law firm in Italy, this is an extract from The Pharma Legal Handbook: Italy, available to purchase here for GB 119.   1. What types of liability are recognized in your jurisdiction? The Italian regulatory framework, with reference to the liability for defective products, consists of:    • Contractual liability, governed by article 1218 of the Italian Civil Code;  • Liability for defective…

The ins and outs of traditional medicines and OTC products in Italy. Prepared in association with DLA Piper, a leading law firm in Italy, this is an extract from The Pharma Legal Handbook: Italy, available to purchase here for USD 99.   1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? a. Medicinal products To obtain a marketing authorization for medicinal products through a national, mutual recognition or decentralized procedure, the applicant is always required to submit…

All about marketing, manufacturing, packaging & labeling, advertising in Italy. Prepared in association with Baker Mckenzie, a leading law firm in Italy, this is an extract from The Pharma Legal Handbook: Italy, available to purchase here for GB 119.   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 the answer to Question 2 in Chapter 1.   2. What is the authorization process for the…

Key legal info on preclinical and clinical trial requirements in Italy. Prepared in association with Baker Mckenzie, a leading law firm in Italy, this is an extract from The Pharma Legal Handbook: Italy, available to purchase here for GB 119.   1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? No. Under Legislative Decree No. 211/2003 on the application of good clinical practice in the conduct of clinical trials of medicines,…

Regulatory, pricing and reimbursement overview in Italy – a legal guide. Prepared in association with Baker Mckenzie, a leading law firm in Italy, this is an extract from The Pharma Legal Handbook: Italy, available to purchase here for GB 119.   1. What are the regulatory authorities with jurisdiction over drugs, biological, and medical devices in your country? In Italy, the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices are: • the Ministry of Health (“MoH”), which generally…

Biosimilar uptake initiatives are gaining traction across Canada and have already been implemented in several provinces. Dara Jospé and Lina Bensaidane of Fasken examine the impact of these policies on patients, prescribers, and pharmacists thus far, and the implications should non-medical biosimilar switching become a nationwide norm.   In the last few years, several provinces in Canada have decided to introduce a biosimilar policy, through which only the biosimilar version of a given biologic drug is reimbursed by the public…

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 119.   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 119.   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 119.   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…

Key legal info on cannabinoid drugs, medicinal cannabis and opioid drugs 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 119.   Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? The usage of Cannabinoid Drugs in Argentina is  authorized for medicinal purposes (medicinal cannabis). Please see Questions 12 to 14 of this Chapter for further information about medicinal…

An insight into upcoming regulatory reforms affecting Argentinian pharma. 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 119.   1. Are there proposals for reform or significant change to the healthcare system? There are no proposals for reform or significant change of the healthcare system in the short term. Nonetheless, due to the COVID-19 pandemic, several new regulations and laws have…

A legal briefing on patents and trademarks 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 119.   1. What are the basic requirements to obtain patent and trademark protection? Patents To obtain patent protection in Argentina, it is necessary to file a patent application with the National Institute of Industrial Property (the “INPI” after its acronym in Spanish). The…

Intro to product liability in Argentinian pharma. 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 119.   1. What types of liability are recognized in your jurisdiction? In general terms, liability arises from provisions in the Argentine Constitution, the Civil and Commercial National Code, the Criminal Code, and other laws that apply to specific cases such as the Corporate Criminal Liability…

The environment surrounding traditional and OTC products 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 119.   1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? Herbal and vegetable medicines are regulated by ANMAT. They are defined as medicine that contains as an active ingredient one or more plant medicines, or one or…

Preclinical and clinical trial requirements in Argentina – a legal guide. 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 119.   1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? No. It is not a condition for marketing approval to conduct a clinical trial in Argentina (the approval of pharmaceutical…

A brief overview of the situation regarding regulation, pricing and reimbursement of drugs 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 119.   1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? The National Ministry of Health (“MoH”) is the main health authority in Argentina. Nonetheless, in the year…

Outlining the legal situation for marketing, manufacturing, packaging & labelling in Argentinian pharma. 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 119.   1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? See answers to Questions 2 and 3 in Regulatory, Reimbursement and Pricing Overview.   2. What is…

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 GB 119.   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…

Preclinical and Clinical Trial Requirements in Croatia – an overview. Prepared in association with Danijel Pribanić, a leading global law firm, this is an extract from The Pharma Legal Handbook: Croatia, available to purchase here for GB 119.   1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? Clinical trials are not required to be conducted locally as a condition for marketing approval.   2. How are clinical trials funded? Clinical…

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 GB 119.   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…

An insight into upcoming regulatory reforms affecting Croatia pharma. Prepared in association with Danijel Pribanić, a leading global law firm, this is an extract from The Pharma Legal Handbook: Croatia, available to purchase here for GB 119.   1. Are there proposals for reform or significant change to the healthcare system? Bill of Ordinance on benchmarks for the classification of medicinal products on basic and additional list of medicinal products of the Croatian Health Insurance Fund and on benchmarks on…

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 GB 119.   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…

All about traditional medicines and OTC products in Croatia. Prepared in association with Danijel Pribanić, a leading global law firm, this is an extract from The Pharma Legal Handbook: Croatia, available to purchase here for GB 119.   1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? Regulatory requirements for traditional herbal or homeopathic medicinal products are regulated by the provisions of Medicinal Products Act and traditional herbal medicinal products are also regulated by…

Localization in Thailand – a legal guide. Prepared in association with Tilleke & Gibbins, a leading law firm in Thailand, this is an extract from The Pharma Legal Handbook: Thailand, available to purchase here for GBP 119.   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. Pursuant to Section 12 of the Drug Act 1967, as amended, any domestic manufacturing, importing or ordering…

Biosimilars and biologics in Thailand – a legal guide. Prepared in association with Tilleke & Gibbins, a leading law firm in Thailand, this is an extract from The Pharma Legal Handbook: Thailand, available to purchase here for GBP 119.   1. Are biosimilar medicines considered the same as generic medicines in your country? No. At present, a “biosimilar” is not the same as a generic drug. Previously, some biological marketing authorization licenses were obtained by using the same registration pathway of generic…

An intro to the legal situation for orphan drugs and rare diseases in Thailand. Prepared in association with Tilleke & Gibbins, a leading law firm in Thailand, this is an extract from The Pharma Legal Handbook: Thailand, available to purchase here for GBP 119.   1. What is the definition of Rare Diseases in your country? Neither the Ministry of Public Health in Thailand (MoPH) nor the Thai Food and Drug Administration (Thai FDA) has prescribed a definition for “rare diseases.” However,…

The low-down on the situation regarding cannabinoid drugs, medicinal cannabis and opioid drugs in Thailand. Prepared in association with Tilleke & Gibbins, a leading law firm in Thailand, this is an extract from The Pharma Legal Handbook: Thailand, available to purchase here for GBP 119.   Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? For the purpose of this chapter, cannabinoid drugs are drugs containing a cannabinoid, which may be extracted and purified from a cannabis plant or synthesized by…

Keen to learn more about regulatory reforms in Thailand? Read on! Prepared in association with Tilleke & Gibbins, a leading law firm in Thailand, this is an extract from The Pharma Legal Handbook: Thailand, available to purchase here for GBP 119.   1. Are there proposals for reform or significant change to the healthcare system? The Patent Act The Patent Act is currently under review and final revision by the Department of Intellectual Property, and is expected to be passed soon. The…

All legal aspects surrounding traditional medicines and OTC products in Thailand. Prepared in association with Tilleke & Gibbins, a leading law firm in Thailand, this is an extract from The Pharma Legal Handbook: Thailand, available to purchase here for GBP 119.   1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? In April 2019, the Thai FDA published and implemented the Herbal Product Act. This is now the main act regulating herbal or traditional medicine in…

The key facts about marketing, manufacturing, packaging & labeling, advertising in Thailand. Prepared in association with Tilleke & Gibbins, a leading law firm in Thailand, this is an extract from The Pharma Legal Handbook: Thailand, available to purchase here for GBP 119.   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 The authorization processes for the marketing of new drugs, biologics, over-the-counter medications, and other medicinal products…

Regulatory, pricing and reimbursement overview in Thailand – a comprehensive legal overview. Prepared in association with Tilleke & Gibbins, a leading law firm in Thailand, this is an extract from The Pharma Legal Handbook: Thailand, available to purchase here for GBP 119.   1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? In Thailand, drugs, biologics, and medical devices are regulated by the Thai Food and Drug Administration (Thai FDA), under 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.   1. Are biosimilar medicines considered the same as generic medicines in your country? A biosimilar medicine is differentiated from a generic medicine to the extent that final biosimilar products may differ from the original product, depending on the manufacturing process. This is because the…

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 149.   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…

Keen to learn more about cannabinoid drugs, medicinal cannabis and opioid drugs in Japan? Read on! 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 149.   Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? No. In Japan, the utilisation of cannabis (all kinds) is severely restricted by two acts.  The first is the Cannabis Control Act, under which…

The ins and outs of orphan drugs & rare diseases 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 149.   1. What is the definition of Rare Diseases in your country? In Japan, there is no fixed definition for Rare Diseases, although the concept is included in the definition of Orphan Drugs (refer to Q104). It should be…

The key facts about regulatory reforms in Japanese Pharma. 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 149.   1. Are there proposals for reform or significant change to the healthcare system? No proposal is pending for significant reform or change to the healthcare system in Japan. However, there are small changes every year. For example, there have been changes…

The legal framework for patents and trademarks in Japanese Pharma. 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 149.   1. What are the basic requirements to obtain patent and trademark protection? The Patent Act states that an invention must be novel, non-obvious, and have industrial applicability. The Trademark Act allows registration of any trademark unless the mark is the…

All legal aspects surrounding product liability in Japanese Pharma. 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 149.   1. What types of liability are recognized in your jurisdiction? Contract liability and tort liability are the two basic forms of civil liability. In principle, tort liability requires intent or negligence. However, Japan has the Product Liability Law under which liability…

A brief overview of the situation regarding traditional medicines and OTC products 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 149.   1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? Traditional, herbal, complementary, and/or alternative medicines and devices are subject to the PMD Act.   2. Can these traditional, herbal, complementary,…

Marketing, manufacturing, packaging & labeling, advertising in Japanese Pharma – a comprehensive legal overview. 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 149.   1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? To obtain marketing authorization for new drugs, biologics, and medical devices, submission of an application to…

The low-down on the situation regarding preclinical & clinical trial requirements in Japanese Pharma. 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 149.   1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? Generally, under the PMD Act, clinical trials relating to applications for marketing authorization approval must be conducted locally.…

An intro to the legal situation for regulatory, pricing and reimbursement 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 149.   1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? The Ministry of Health, Labour and Welfare (the “MHLW”) and the Pharmaceuticals and Medical Devices Agency (the “PMDA”).  …

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 119.   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…

All legal aspects surrounding cannabinoid drugs, medical cannabis and opioids in Croatia. Prepared in association with Danijel Pribanić, a leading global law firm, this is an extract from The Pharma Legal Handbook: Croatia, available to purchase here for GB 119.   Cannabinoid Drugs   1. Are Cannabinoid Drugs authorized in your country? Cannabinoid Drugs are authorized only in the form of Medicinal Cannabis.   2. What are the regulatory authorities with jurisdiction over Cannabinoid Drugs? Office for Suppression of Drug…

Patents and trademarks in Croatia – a comprehensive legal overview. Prepared in association with Danijel Pribanić, a leading global law firm, this is an extract from The Pharma Legal Handbook: Croatia, available to purchase here for GB 119.   1. What are the basic requirements to obtain patent and trademark protection? In the territory of Croatia the State Intellectual Property Office (hereinafter: the Office) carries out patent and trademark granting procedure in compliance with the Patent Act (Official Gazette No.…

Key legal info on product liability in Croatia. Prepared in association with Danijel Pribanić, a leading global law firm, this is an extract from The Pharma Legal Handbook: Croatia, available to purchase here for GB 119.   1. What types of liability are recognized in your jurisdiction? Types of liability recognized in Croatian jurisdiction are civil liability as contractual liability and non- contractual (liability as a result of fault, liability for another person, liability for damage caused by dangerous thing…

An insight into marketing, manufacturing, packaging & labeling, and advertising in Croatia. Prepared in association with Danijel Pribanić, a leading global law firm, this is an extract from The Pharma Legal Handbook: Croatia, available to purchase here for GB 119.   1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? B) MEDICINAL PRODUCTS Only those medicinal products having a marketing authorisation granted by the Agency for Medicinal Products…

An intro to the legal situation for regulatory, pricing and reimbursement of drugs in Croatia. Prepared in association with Danijel Pribanić, a leading global law firm, this is an extract from The Pharma Legal Handbook: Croatia, available to purchase here for GB 119.   1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? The regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in Croatia is the Agency for Medicinal products…

The COVID-19 pandemic has caused economic and social disruption and has affected the behavior 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,  the National Government implemented agreements with key sectors, such as that with the local pharma association, and enacted…

The key facts about biosimilars & biologics in Panamanian Pharma. Prepared in association with AFRA, a leading global law firm, this is an extract from The Pharma Legal Handbook: Panama, available to purchase here for GBP 99.   BIOSIMILARS AND BIOLOGICS in Panama are regulated by Law 1 January 10, 2001, Executive Decree No. 95 of May 14, 2019.   1. Are biosimilar medicines considered the same as generic medicines in your country? No. Generic medicines are defined as medicines…

Keen to learn more about orphan drugs & rare diseases in Panama? Read on! Prepared in association with AFRA, a leading global law firm, this is an extract from The Pharma Legal Handbook: Panama, available to purchase here for GBP 99.   Orphan Drugs in Panama are regulated by Law 1 January 10, 2001, Executive Decree No. 95 of May 14, 2019 and Executive Decree 1217 of December 7, 2015; Rare Diseases are regulated by Law 28 of October 28,…

The low-down on the situation regarding cannabinoid drugs, medicinal cannabis and opioid drugs in Panama. Prepared in association with AFRA, a leading global law firm, this is an extract from The Pharma Legal Handbook: Panama, available to purchase here for GBP 99.   Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? Cannabinoids are substances subject to national control for therapeutic, medical, veterinary, scientific and research use.    2. What are the regulatory authorities with jurisdiction over Cannabinoid Drugs? The regulatory…

All legal aspects surrounding regulatory reforms in Panama. Prepared in association with AFRA, a leading global law firm, this is an extract from The Pharma Legal Handbook: Panama, available to purchase here for GBP 99.   1. Are there proposals for reform or significant change to the healthcare system? Currently enforced new healthcare related regulations are due to Covid19 preventions, extraordinary and temporary measures enacted until the state of emergency is declared by the Panamanian Government.    2. When are they likely…

All about patent and trademarks in Panamanian Pharma. Prepared in association with AFRA, a leading global law firm, this is an extract from The Pharma Legal Handbook: Panama, available to purchase here for GBP 99.   1. What are the basic requirements to obtain patent and trademark protection? The basic requirements for obtaining a patent are the following:  Power of attorney granted by the applicant; no legalization nor notarization required Assignment Document legalized by Panamanian Consulate or Apostille Specifications, claims, abstract and…

A brief overview of the situation regarding traditional medicines and OTC products in Panama. Prepared in association with AFRA, a leading global law firm, this is an extract from The Pharma Legal Handbook: Panama, available to purchase here for GBP 99.   1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? The requirements for traditional, herbal, complementary, or alternative medicines and devices that have therapeutically property are the same as for drugs. Please see Question 1…

An insight into marketing, manufacturing, packaging & labeling, advertising in Panama. Prepared in association with AFRA, a leading global law firm, this is an extract from The Pharma Legal Handbook: Panama, 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? To obtain authorization to develop and market a product, each product must obtain a sanitary registration before the Ministry of Health. …

Preclinical and clinical trial requirements in Panamanian Pharma – an overview. Prepared in association with AFRA, a leading global law firm, this is an extract from The Pharma Legal Handbook: Panama, available to purchase here for GBP 99.   Preclinical & Clinical Trial in Panama are regulated on Law 1 January 10, 2001; Law 78 November 20, 2003; Law 84 of May 14, 2019; Executive Decree 1110 June 6, 2012; Resolution No. 512 of June 28, 2019; Executive Decree 1843 December 16,…

The legal framework for product liability in Panama. Prepared in association with AFRA, a leading global law firm, this is an extract from The Pharma Legal Handbook: Panama, available to purchase here for GBP 99.   1. What types of liability are recognized in your jurisdiction? Contractual and extracontractual responsibility. These can be administrative, civil, or criminal sanctions.   2. How do these types of liabilities apply to the manufacturers of medicines and devices? In general terms, manufacturers, promoters, sellers, and all…

An intro to the legal situation for regulatory, pricing and reimbursement in Panamanian Pharma. Prepared in association with AFRA, a leading global law firm, this is an extract from The Pharma Legal Handbook: Panama, 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 Authority that regulates drugs, biologicals and medical devices in Panama is the Ministry of Health through the following authorities:  Pharmaceutical…

Biosimilars & biologics in Brazil – a comprehensive legal overview. Prepared in association with Trench, Rossi e Watanabe one of Brazil’s most prestigious law firms, this is an extract from The Pharma Legal Handbook: Brazil, which can be purchased for GBP 119, here.   1. Are biosimilar medicines considered the same as generic medicines in your country? No, a biosimilar drug is not considered to be the same as a generic drug. There are specific rules governing generic and similar drugs, and they…

Want to know more about localization in Brazil? Read on! Prepared in association with Trench, Rossi e Watanabe one of Brazil’s most prestigious law firms, this is an extract from The Pharma Legal Handbook: Brazil, which can be purchased for GBP 119, here.   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, there are rules encouraging localization in Brazil, such as the Federal Law No.…

The key facts about orphan drugs & rare diseases in Brazil. Prepared in association with Trench, Rossi e Watanabe one of Brazil’s most prestigious law firms, this is an extract from The Pharma Legal Handbook: Brazil, which can be purchased for GBP 119, here.   1. What is the definition of Rare Diseases in your country? According to Resolution RDC No. 205/2017 issued by the National Health of Surveillance Agency (“ANVISA”), “rare diseases” are defined as diseases with incidence of up to 65…

All about cannabinoid drugs, medicinal cannabis and opioid drugs in Brazil. Prepared in association with Trench, Rossi e Watanabe one of Brazil’s most prestigious law firms, this is an extract from The Pharma Legal Handbook: Brazil, which can be purchased for GBP 119, here.   Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? The National Health Surveillance Agency (“ANVISA”) recently approved (on December 11, 2019) the Resolution RDC No. 327/19 defining the procedure for granting the Sanitary Authorization for manufacturing and…

A brief insight into upcoming regulatory reforms in Brazilian pharma. Prepared in association with Trench, Rossi e Watanabe one of Brazil’s most prestigious law firms, this is an extract from The Pharma Legal Handbook: Brazil, which can be purchased for GBP 119, here.   1. Are there proposals for reform or significant change to the healthcare system? There are plenty of Law projects under discussion. Before National Congress, there is Bill No. 667/2021, which provides for the creation of Risk Sharing Agreement for the…

An overview of the legal framework for patents and trademarks for pharmaceuticals in Brazil. Prepared in association with Trench, Rossi e Watanabe one of Brazil’s most prestigious law firms, this is an extract from The Pharma Legal Handbook: Brazil, which can be purchased for GBP 119, here.    1. What are the basic requirements to obtain patent and trademark protection? Industrial Property Rights are regulated in Brazil through Federal Law No. 9,279/1996 (“IP Law”).  Under its Article 8, the main requirements for the grant…

The ins and outs of product liability in Brazilian pharma. Prepared in association with Trench, Rossi e Watanabe one of Brazil’s most prestigious law firms, this is an extract from The Pharma Legal Handbook: Brazil, which can be purchased for GBP 119, here.   1. What types of liability are recognized in your jurisdiction? The scope of liability for suppliers and the standards for consumer protection in Brazil are, in some cases, more severe than the consumer rules applicable in other countries.  The Brazilian…

A guide to the state-of-play regarding traditional medicines and over-the-counter (OTC) products in Brazil. Prepared in association with Trench, Rossi e Watanabe one of Brazil’s most prestigious law firms, this is an extract from The Pharma Legal Handbook: Brazil, which can be purchased for GBP 119, here.    1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? Resolution RDC No. 26/2014 provides for traditional and herbal drugs requirements. These drugs are subject to registration, simplified registration…

Everything you need to know about the marketing, manufacturing, packaging & labeling and advertising of pharmaceuticals in Brazil. Prepared in association with Trench, Rossi e Watanabe one of Brazil’s most prestigious law firms, this is an extract from The Pharma Legal Handbook: Brazil, which can be purchased for GBP 119, here.   1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? The company should be licensed before ANVISA (at the…

The requirements for conducting preclinical and clinical trials in Brazil.  Prepared in association with Trench, Rossi e Watanabe one of Brazil’s most prestigious law firms, this is an extract from The Pharma Legal Handbook: Brazil, which can be purchased for GBP 119, here.   1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? No.   2. How are clinical trials funded? Clinical trials are funded by sponsors (an individual or legal entity, public or…

A brief legal overview of the situation regarding the regulation, pricing and reimbursement of pharmaceuticals in Brazil.  Prepared in association with Trench, Rossi e Watanabe one of Brazil’s most prestigious law firms, this is an extract from The Pharma Legal Handbook: Brazil, which can be purchased for GBP 119, here.   1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? In Brazil, the authorities are the National Health Surveillance Agency (“ANVISA”), which…

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 119. 1. Are there proposals for reform or significant change to the healthcare system? Act  on Medical Devices In May 2022, a new Act on medical devices went into effect. Nevertheless, it has not entered into force in its entirety.…

The key facts about biosimilars and biologics 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 biosimilar medicines considered the same as generic medicines in your country? No, in Ukraine, biosimilar medicines are not considered the same as generic medicines. According to the Order of the Ministry of Health of Ukraine “On Approval of the Procedure to Examining Registration…

Want to know more about localization 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 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 localisation with respect to medicinal products.   2. Have there been any…

Cannabinoid drugs, medicinal cannabis and opioid drugs in Saudi Arabia – a comprehensive legal overview.. 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.   Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? Cannabinoid Drugs are not authorized in Saudi Arabia.   2. What are the regulatory authorities with jurisdiction over Cannabinoid Drugs? The concerned authorities are the Saudi FDA…

The key facts about Regulatory Reforms 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 there proposals for reform or significant change to the healthcare system? The government is now ardently pursuing private sector development and has initiated privatization and marketization as a core strategy of reforms in its health system. The review has indicated that…

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 119.   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…

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 GBP 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 regulation…

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 GBP 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 GBP 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 GBP 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 an procedure for the MA of traditional medicines, including herbal and homeopathic medicines, whilst the new Medical…

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 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 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 GBP 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 GBP 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…