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

The ins and outs of traditional medicines and OTC products in Zimbabwe. Prepared in association with Honey & Blanckenberg, a leading law firm in Zimbabwe, this is an extract from The Pharma Legal Handbook: Zimbabwe, available to purchase here for USD 99.   1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? The regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices as per the Medicines and Allied Substances Control (Complementary Medicines)…

Marketing, manufacturing, packaging & labeling, advertising in Zimbabwe – an overview. Prepared in association with Honey & Blanckenberg, a leading law firm in Zimbabwe, this is an extract from The Pharma Legal Handbook: Zimbabwe, available to purchase here for USD 99.   1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? The process is set out in the Medicines Control Authority of Zimbabwe (Guidelines on Submission of Documentation…

All legal aspects surrounding preclinical and clinical trial requirements in Zimbabwe. Prepared in association with Honey & Blanckenberg, a leading law firm in Zimbabwe, this is an extract from The Pharma Legal Handbook: Zimbabwe, available to purchase here for USD 99.   1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? There is no such requirement. The Medicines and Allied Substances Control Act only requires that a medicine be registered. In…

Key legal info on regulatory reform in Ireland. Prepared in association with Mason Hayes & Curran, a leading law firm in Ireland, this is an extract from The Pharma Legal Handbook: Ireland, available to purchase here for USD 99.   1. Are there proposals for reform or significant change to the healthcare system? In Ireland, there is currently no mechanism for class actions; however, the Multi-Party Action Bill 2017 is making its way through the legislative system. If this piece…

Want to know more about patents & trademarks in Ireland? Read on! Prepared in association with Mason Hayes & Curran, a leading law firm in Ireland, this is an extract from The Pharma Legal Handbook: Ireland, available to purchase here for USD 99.   1. What are the basic requirements to obtain patent and trademark protection? Patents The requirements to obtain patent protection are outlined on the website of the Intellectual Property Office of Ireland (IPOI). Any person can make…

The low-down on the situation regarding product liability in Ireland. Prepared in association with Mason Hayes & Curran, a leading law firm in Ireland, this is an extract from The Pharma Legal Handbook: Ireland, available to purchase here for USD 99.   1. What types of liability are recognized in your jurisdiction? There are four different sources of product liability available in Ireland and these are as follows: Statute The Liability for Defective Products Act (1991) transposed EU Product Liability…

An insight into traditional medicines and OTC products in Ireland. Prepared in association with Mason Hayes & Curran, a leading law firm in Ireland, this is an extract from The Pharma Legal Handbook: Ireland, available to purchase here for USD 99.   1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? Traditional, herbal, complementary or alternative medicines and devices on the Irish market must be either authorised or registered with the HPRA which, as…

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

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

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

The low-down on the situation regarding biosimilars & biologics in Turkey. Prepared in association with Moroğlu Arseven, a leading Turkish law firm, this is an extract from The Pharma Legal Handbook: Turkey, available to purchase here for USD 99.   1. Are biosimilar medicines considered the same as generic medicines in your country? Generic medicines include identical molecules with the original reference product, and these molecules are small and chemically stable molecules produced through chemical synthesis. However, biosimilar is the name of…

The ins and outs of localization in Turkey. Prepared in association with Moroğlu Arseven, a leading Turkish law firm, this is an extract from The Pharma Legal Handbook: Turkey, available to purchase here for USD 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? Localization is a developing and ongoing plan in Turkey. Increasing employment, attracting foreign investment, and maintaining the quality reached in…

Keen to learn more about orphan drugs & rare diseases in Turkey? Read on! Prepared in association with Moroğlu Arseven, a leading Turkish law firm, this is an extract from The Pharma Legal Handbook: Turkey, available to purchase here for USD 99.   1. What is the definition of Rare Diseases in your country? There is no definition of rare diseases in Turkey.   2. Does the designation of ‘Orphan Drug’ exist in your country? (Does it correspond with the definition of…

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

Want to know more about localization in Russian Pharma? Read on! Prepared in association with Lidings, a leading global law firm, this is an extract from The Pharma Legal Handbook: Russia, available to purchase here for USD 99.   1. Are there any rules or regulations requiring and/or encouraging localization in your country? What is the legal framework defining these localization rules and policies? The Strategy of the pharmaceutical industry development until 2020 (“Pharma-2020”) defines localization as one of the main tendencies…

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

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 USD 99.   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 Q2). It should be noted…

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 USD 99.   Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? No. In Japan, usage of cannabis (all kinds) is severely restricted by two acts. The first is the Cannabis Control Act, under which “Cannabis” is…

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

On October 27th, 2019, presidential candidate Alberto Fernández was elected president of Argentina defeating the Macri Administration with more than 48% of votes. The key proposals of Fernández’s political campaign were based on socially-friendly reforms, such as helping the most vulnerable population to progress in the struggling economy, aiding the local industry and blue-collar workers, and ending with the increasing external debt and economic crisis. Another key element to the campaign was his political message promising everyone’s better access to…

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 USD 99.   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 USD 99.   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…

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 USD 99.   Biological medicines in Panama are regulated by Law 1 January 10, 2001 and Executive Decree 40 of May 14, 2019.   1. Are biosimilar medicines considered the same as generic medicines in your country? No. Generic medicines are defined as medicines distributed…

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 USD 99.   Orphan Drugs in Panama are regulated by Law 1 January 10, 2001, Executive Decree 40 of May 14, 2019 and Executive Decree 1217 of December 7, 2015; Rare Diseases are regulated by Law 28 of October 28, 2014…

Cannabinoid drugs, medicinal cannabis & opioid drugs in India – a comprehensive legal overview. Prepared in association with Nishith Desai & Associates, a leading law firm in India, this is an extract from The Pharma Legal Handbook: India, available to purchase here for USD 99.   Cannabinoid Drugs Global Comment: For the purpose of this chapter, we will assume that Cannabinoid Drugs are preparations made out of extract or tincture of Cannabis. If a drug contains cannabinoids which have been…

An insight into biosimilars & biologics in Indian Pharma. Prepared in association with Nishith Desai & Associates, a leading law firm in India, this is an extract from The Pharma Legal Handbook: India, available to purchase here for USD 99.   1. Are biosimilar medicines considered the same as generic medicines in your country? Biosimilar medicines are not regulated in the same manner as generic medicines in India. While biosimilars and generic medicines are classified as drugs under the Drugs…

The key facts about the localization in Indian Pharma. Prepared in association with Nishith Desai & Associates, a leading law firm in India, this is an extract from The Pharma Legal Handbook: India, available to purchase here for USD 99.   1. Are there any rules or regulations requiring and/or encouraging localization in your country? What is the legal framework defining these localization rules and policies? There are no specific legislations or regulations requiring and/or encouraging localization in India. The…

Want to know more about orphan drugs & rare diseases in India? Read on! Prepared in association with Nishith Desai & Associates, a leading law firm in India, this is an extract from The Pharma Legal Handbook: India, available to purchase here for USD 99.   1. What is the definition of Rare Diseases in your country? India does not have a definition of rare diseases. The National Policy on Treatment of Rare Diseases 2017 (“NPTRD 2017”), which is currently…

Biosimilars & biologics in Egypt – a legal guide. Prepared in association with Youssry Saleh Law Firm, a leading global law firm, this is an extract from The Pharma Legal Handbook: Egypt, available to purchase here for USD 99.   1. Are biosimilar medicines considered the same as generic medicines in your country? In Egypt, Biosimilars are considered different from Generic Medicines but similar to biological products, where the “Biosimilar” definition according to the Guidelines for Registration of biosimilar products…

The key facts about the localization in Egypt. Prepared in association with Youssry Saleh Law Firm, a leading global law firm, this is an extract from The Pharma Legal Handbook: Egypt, available to purchase here for USD 99.   1. Are there any rules or regulations requiring and/or encouraging localization in your country? What is the legal framework defining these localization rules and policies? Yes, the legal framework of localization is regulated through Ministerial Decree No. 425 of the year…

All legal aspects surrounding orphan drugs & rare diseases in Egypt. Prepared in association with Youssry Saleh Law Firm, a leading global law firm, this is an extract from The Pharma Legal Handbook: Egypt, available to purchase here for USD 99.   1. What is the definition of Rare Diseases in your country? In Egypt, there is no definition of the “Rare Diseases” however, in accordance with the conclusion of medicine professors’ researches and studies a disease is considered a…

Cannabinoid drugs, medicinal cannabis and opioid drugs in Egypt – an overview. Prepared in association with Youssry Saleh Law Firm, a leading global law firm, this is an extract from The Pharma Legal Handbook: Egypt, available to purchase here for USD 99.   Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? No, Cannabinoid Drugs are not authorized in Egypt, however, they are regulated by Law No. 182 of the year 1960 concerning combating drugs and regulating their use…

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 USD 99.   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 USD 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, as a starting point there are no rules or regulations requiring and/or encouraging localization…

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

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

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

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

All about marketing, manufacturing, packaging & labeling, advertising in Italy. Prepared in association with DLA Piper, a leading law firm in Italy, this is an extract from The Pharma Legal Handbook: Italy, available to purchase here for USD 99.   1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over the-counter medications, and other medicinal products? a. Medicinal Products As a general rule, medicinal products may only be placed on the market once authorization has been granted…

Key legal info on preclinical and clinical trial requirements in Italy. Prepared in association with DLA Piper, a leading law firm in Italy, this is an extract from The Pharma Legal Handbook: Italy, available to purchase here for USD 99.   1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? No. However, having conducted part of the medicinal product development (including clinical trials) in Italy may place the marketing authorization holder in a stronger…

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

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

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

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

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

All about marketing, manufacturing, packaging & labeling, advertising in Belgium. Prepared in association with ALTIUS, a leading law firm in Belgium, this is an extract from The Pharma Legal Handbook: Belgium, available to purchase here for USD 99.   1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? First of all, the medicines must be the subject of clinical trials. These clinical trials must be submitted to the FAMHP and an…

All legal aspects surrounding preclinical and clinical trial requirements in Belgium. Prepared in association with ALTIUS, a leading law firm in Belgium, this is an extract from The Pharma Legal Handbook: Belgium, available to purchase here for USD 99.   1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? No, clinical trials are not required to be conducted locally to receive marketing approval in Belgium. In order to obtain marketing approval, for new drugs,…

A brief overview of the situation regarding biosimilars and biologics. Prepared in association with SAARPE Association, a leading law firm in Algeria, this is an extract from The Pharma Legal Handbook: Algeria, available to purchase here for USD 99.   1. Are biosimilar medicines considered the same as generic medicines in your country? The Health Law No 18-11, dated of 2 July 2018 and published in the Official Gazette, has made a clear distinction between similar biotherapeutic products and generic…

The ins and outs of localization in Algeria. Prepared in association with SAARPE Association, a leading law firm in Algeria, this is an extract from The Pharma Legal Handbook: Algeria, available to purchase here for USD 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? According to Article 206 of Health law No 18-11, dated of 2 July 2018 and published in…

A brief overview of the situation regarding orphan drugs and rare diseases in Algeria. Prepared in association with SAARPE Association, a leading law firm in Algeria, this is an extract from The Pharma Legal Handbook: Algeria, available to purchase here for USD 99.   1. What is the definition of Rare Diseases in your country? Rare diseases are defined in Algeria as those listed in the Ministerial Decree, dated of 6 February 2013 and published in the Official Gazette, fixing…

Key legal info on cannabinoid drugs, medicinal cannabis and opioid drugs in Algeria. Prepared in association with SAARPE Association, a leading law firm in Algeria, this is an extract from The Pharma Legal Handbook: Algeria, available to purchase here for USD 99.    Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? Cannabinoid drugs, i.e. drug products as defined in Article 208 of Health Law No 18-11, dated of 2 July 2018, where the active substance is cannabinoids, can…

Regulatory reforms in Algerian Pharma – a comprehensive legal overview. Prepared in association with SAARPE Association, a leading law firm in Algeria, this is an extract from The Pharma Legal Handbook: Algeria, available to purchase here for USD 99.   1. Are there proposals for reform or significant change to the healthcare system? Yes, there is an important reform that is ongoing and which concerns the authority in charge of regulating drugs, biologicals and medical devices for human use at…

Want to know more about patents & trademarks in Algerian Pharma? Read on! Prepared in association with SAARPE Association, a leading law firm in Algeria, this is an extract from The Pharma Legal Handbook: Algeria, available to purchase here for USD 99.   1. What are the basic requirements to obtain patent and trademark protection? Patents Ordinance No 03-07 and Trademarks Ordinance No 03-06, both dated of 19 July 2003 and published in the Official Gazette, form the legislative framework…

The key facts about product liability in Algerian Pharma. Prepared in association with SAARPE Association, a leading law firm in Algeria, this is an extract from The Pharma Legal Handbook: Algeria, available to purchase here for USD 99.   1. What types of liability are recognized in your jurisdiction? In Algeria, any product intended for consumption and/or use, under normal or reasonably foreseeable conditions of use, including of duration, must present no risk or only reduced risks at a low…

All legal aspects surrounding traditional medicines and OTC products in Algeria. Prepared in association with SAARPE Association, a leading law firm in Algeria, this is an extract from The Pharma Legal Handbook: Algeria, available to purchase here for USD 99.   1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? Traditional, herbal and complementary products are commonly regulated by Ministry of Commerce under provisions of Consumer Protection and Fraud Repression Law No 09-03 dated…

Marketing, manufacturing, packaging & labeling, advertising in Algerian Pharma – an overview. Prepared in association with SAARPE Association, a leading law firm in Algeria, this is an extract from The Pharma Legal Handbook: Algeria, available to purchase here for USD 99.   1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? To obtain market authorization for new drugs, biologics and medical devices in Algeria, submission of application to…

The legal framework for preclinical and clinical trial requirements in Algeria. Prepared in association with SAARPE Association, a leading law firm in Algeria, this is an extract from The Pharma Legal Handbook: Algeria, available to purchase here for USD 99.   1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? The Health Law No 18-11, dated of 2 July 2018, replacing Health Protection and Promotion Law No 85-05, dated of 16…

An insight into regulatory, pricing and reimbursement in Algeria. Prepared in association with SAARPE Association, a leading law firm in Algeria, this is an extract from The Pharma Legal Handbook: Algeria, available to purchase here for USD 99.   1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? Ministry of Health, Population and Hospital Reform (“MSPRH” – “Ministère de la Santé, de la Population et de la Réforme Hospitalière”) is the national…

In the 1st Supplement of the Official Gazette No. 107 of December 24, 2019, the Reform of the Criminal Law was published, which will enter into force in June 21, 2020.   Included among the reforms, is the decriminalization of possession of drugs that contain cannabis or derivatives as their active ingredient for therapeutic, palliative or medicinal ends, or for the practice of alternative medicine. In addition, the Law of  Control and  Prevention of the use of  Drugs   has been amended,…

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

Regulation of medical devices in India has speedily evolved in the preceding two years. Before the introduction of the Medical Device Rules, 2017 (“MDR 2017”), the regulation of medical devices and drugs was inextricably linked. In the 18 months since the MDR 2017 has come into force, the biggest challenge has been evolving unique enforcement protocols for regulating medical devices. In 2019, the Indian Government is stepping up to this challenge. By constituting a special vertical at the apex drug…

2019 so far has witnessed a lot of activity in the pharma space, so much so that the e-pharmacy saga – a pressing development towards the close of 2018 – has taken a temporary backseat this year. Instead, the new stars of 2019 so far have been price regulation and regulation of electronic nicotine delivery systems. 2019 also saw a significant piece of legislation introduced – the New Drugs and Clinical Trial Rules, 2019 – which has already begun making…

The Indian Government has had a busy 2019 so far with respect to healthcare regulation. From passing the controversial National Medical Commission Bill, 2019 through Parliament to releasing a digital health blueprint, the Indian Government has had a very clear vision for the future of healthcare in India. That vision largely focuses on health services being controlled and administered centrally, with states playing supporting roles in this process. The Government is also encouraging and regulating alternative forms of medicine such…

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

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

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

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

An insight into marketing, manufacturing, packaging & labeling, advertising in United Kingdom. Prepared in association with Clyde & Co, a leading law firm in United Kingdom, this is an extract from The Pharma Legal Handbook: United Kingdom, available to purchase here for USD 99.   1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? The authorisation process is discussed in the answer to Questions 2 and 3 in Regulatory, Pricing and…

A brief overview of the situation regarding preclinical and clinical trial requirements in United Kingdom. Prepared in association with Clyde & Co, a leading law firm in United Kingdom, this is an extract from The Pharma Legal Handbook: United Kingdom, available to purchase here for USD 99.   1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? There is no requirement to conduct clinical trials locally to receive marketing approval. The steps that have…

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

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 USD 99.   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 medicines…

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 USD 99.   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…

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 USD 99.   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 other…

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 USD 99.   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 Act’s…

A brief overview of the situation regarding patents & trademarks 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 USD 99.   1. What are the basic requirements to obtain patent and trademark protection? Patent The “subject matter” contained in a patent application may be patented if the following requirements are met: Novelty: Before the filing date, the subject matter must not…

The legal framework for product liability 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 USD 99.   1. What types of liability are recognized in your jurisdiction? The laws of Thailand provide for civil, criminal, and administrative liabilities. Fundamentally, product liability is recognized as part of sales and contract law wherein the seller shall be liable to the buyer for a…

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 USD 99.   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 Thailand.…

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 USD 99.   1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? The authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products are…

Key legal info on preclinical and clinical trial requirements 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 USD 99.   1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? No, the clinical trial does not need to be conducted locally in order to obtain marketing approval.   2. Clinical trials are funded…

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 USD 99.   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…

Cannabinoid drugs, medicinal cannabis and opioid drugs in Russia – a legal guide. Prepared in association with Lidings, a leading global law firm, this is an extract from The Pharma Legal Handbook: Russia, available to purchase here for USD 99.   Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? Cannabinoid Drugs are regarded as narcotic drugs of ‘List I’ which circulation within the Russian Federation is prohibited. Cannabinoid Drugs might be imported for scientific and expertise purposes only.   2. What…

Key legal info on cannabinoid drugs, medicinal cannabis and opioid drugs in Nigeria. Prepared in association with Olaniwun Ajayi LP, a leading law firm in Nigeria, this is an extract from The Pharma Legal Handbook: Nigeria, available to purchase here for USD 99.   Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? Generally, in Nigeria, it is an offence to manufacture, sell, possess, import, export or otherwise deal in cannabinoid drugs without an appropriate license. Cannabinoid drugs may however be used…

Regulatory reforms in Nigerian Pharma – a comprehensive legal overview. Prepared in association with Olaniwun Ajayi LP, a leading law firm in Nigeria, this is an extract from The Pharma Legal Handbook: Nigeria, available to purchase here for USD 99.   1. Are there proposals for reform or significant change to the healthcare system? There are currently various bills before the National Assembly (legislative arm in Nigeria) for the repeal and re-enactment of the extant National Health Insurance Scheme Act, which provides for…

Want to know more about patents & trademarks in Nigerian Pharma? Read on! Prepared in association with Olaniwun Ajayi LP, a leading law firm in Nigeria, this is an extract from The Pharma Legal Handbook: Nigeria, available to purchase here for USD 99.   1. What are the basic requirements to obtain patent and trademark protection? Patents and Trademarks are afforded Intellectual Property (IP) protection under Nigerian law. IP as defined by the World Intellectual Property Organization (WIPO) refers to the creations of…

A brief overview of the situation regarding product liability in Nigerian Pharma. Prepared in association with Olaniwun Ajayi LP, a leading law firm in Nigeria, this is an extract from The Pharma Legal Handbook: Nigeria, available to purchase here for USD 99.   1. What types of liability are recognized in your jurisdiction? In Nigeria, liability may arise from a breach of an obligation implied in law, from a breach of contract in which case a contractual liability will be imposed and from…

The low-down on the situation regarding traditional medicines and OTC products in Nigerian Pharma. Prepared in association with Olaniwun Ajayi LP, a leading law firm in Nigeria, this is an extract from The Pharma Legal Handbook: Nigeria, available to purchase here for USD 99.   1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? Herbal medicines and related products are products that contain exclusively active ingredients of one or more herbal substances or one or more herbal…

The legal framework for marketing, manufacturing, packaging & labeling, advertising in Nigerian Pharma. Prepared in association with Olaniwun Ajayi LP, a leading law firm in Nigeria, this is an extract from The Pharma Legal Handbook: Nigeria, available to purchase here for USD 99.   1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? NAFDAC is the body responsible for regulating and controlling the manufacture, importation, exportation, advertisement, distribution, sale and use…

All legal aspects surrounding preclinical and clinical trial requirements in Nigerian Pharma. Prepared in association with Olaniwun Ajayi LP, a leading law firm in Nigeria, this is an extract from The Pharma Legal Handbook: Nigeria, available to purchase here for USD 99.   1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? Clinical trials are not required in all cases, clinical trials will be required to be conducted as a condition for marketing approval…

The key facts about regulation, pricing and reimbursement in Nigerian Pharma. Prepared in association with Olaniwun Ajayi LP, a leading law firm in Nigeria, this is an extract from The Pharma Legal Handbook: Nigeria, available to purchase here for USD 99.   1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? The regulatory authorities with jurisdiction over drugs, biologicals and medical devices in Nigeria are: (i) The National Agency for Food and…

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 USD 99.   Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? The usage of Cannabinoid Drugs in Argentina is only authorized for medicinal purposes (medicinal cannabis). Please see Questions 12 to 24 below for further information about medicinal cannabis. Cannabinoid…

Fangda Partners’ Josh Shin gives an overview of recent regulatory upgrades affecting the Chinese pharmaceutical industry.   On August 26, 2019, China enacted the Amended Drug Administration Law as part of its efforts to strengthen and streamline its regulation of the pharmaceutical industry. The amended law seeks to address prominent problems in the pharmaceutical industry, such as counterfeit drugs, substandard drugs and high drug prices. To address these problems and to accomplish other goals, the Amended Drug Administration Law will…

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 USD 99.   CANNABINOID DRUGS 1. Are Cannabinoid Drugs authorized in your country? Cannabinoid Drugs, i.e. drugs containing active compounds of cannabis, such as tetrahydrocannabinol (THC) or cannabidiol (CBD), can be authorized in the Czech Republic under the general…

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 USD 99.   1. Are there proposals for reform or significant change to the healthcare system? Digitalization With respect to Czech legislation, the main topic of proposed regulatory changes is the ongoing process of digitalization. The Ministry of Health is keen…

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 USD 99.   1. What are the basic requirements to obtain patent and trademark protection? One can file for patent protection for any invention, in all fields of technology, provided the invention is new, involves an inventive step, and is capable of…

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 USD 99.   1. What types of liability are recognized in your jurisdiction? Two types of liability are recognized in the Czech Republic: contractual liability, arising from the failure to comply with one’s contractual obligations; non-contractual(civil)liability, arising as a consequence of…

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 USD 99.   1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? Traditional herbal medicinal products and homeopathic medicinal products are subject to specific regulation set out in the Act on Drugs. Traditional herbal…

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 USD 99.   1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? DRUGS The following authorization procedures are available in the Czech Republic for obtaining market authorization of…

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 USD 99.   1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? No, clinical trials may be also conducted abroad. If a clinical trial was conducted in a country outside of…

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

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

An insight into regulatory reforms in Malaysian Pharma. Prepared in association with Skrine, a leading law firm in Malaysia, this is an extract from The Pharma Legal Handbook: Malaysia, available to purchase here for USD 99.   1. Are there proposals for reform or significant change to the healthcare system? The followings are some of the regulatory proposals and reforms in the pharmaceutical industry in Malaysia: online registration system. In 2017, the NPRA, MOH officially launched the upgraded online registration system, QUEST3+…

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

All legal aspects surrounding product liability in Malaysian Pharma. Prepared in association with Skrine, a leading law firm in Malaysia, this is an extract from The Pharma Legal Handbook: Malaysia, available to purchase here for USD 99.   1. What types of liability are recognized in your jurisdiction? Violation of laws and regulations may result in civil liabilities, administrative penalties and criminal liabilities Civil Liability discontinuance of infringements; restitution (restoration of original condition); specific performance; compensation for loss; payment for breach of…

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

All about marketing, manufacturing, packaging & labeling, advertising in Malaysian Pharma. Prepared in association with Skrine, a leading law firm in Malaysia, this is an extract from The Pharma Legal Handbook: Malaysia, available to purchase here for USD 99.   1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? Although it is common for the marketing authorisation of medicines and devices to vest in the PRH, this is not necessarily…

The low-down on the situation regarding preclinical & clinical trial requirements in Malaysian pharma. Prepared in association with Skrine, a leading law firm in Malaysia, this is an extract from The Pharma Legal Handbook: Malaysia, available to purchase here for USD 99.   1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? Malaysia is actively developing its capability in all phases of clinical trials and there is currently no mandatory condition for clinical…

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

Biosimilars and biologics in Ecuadorian pharma – a comprehensive legal overview. Prepared in association with Corral Rosales, a leading global law firm, this is an extract from The Pharma Legal Handbook: Ecuador, available to purchase here for USD 99.   1. Are biosimilar medicines considered the same as generic medicines in your country? No, the generic term is used only for chemical synthesis medicines and the term biosimilar is used for medicines of biological origin. The biosimilar medicine is similar…

A brief overview of the situation regarding localization in Ecuadorian pharma. Prepared in association with Corral Rosales, a leading global law firm, this is an extract from The Pharma Legal Handbook: Ecuador, available to purchase here for USD 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? New companies or pharmaceutical investments, located in cities other than Quito and Guayaquil, receive a…

The key facts about orphan drugs and rare diseases in Ecuadorian pharma. Prepared in association with Corral Rosales, a leading global law firm, this is an extract from The Pharma Legal Handbook: Ecuador, available to purchase here for USD 99.   1. What is the definition of Rare Diseases in your country? Our law states a specific definition for rare diseases or orphan drugs which is the following: They are the ones that are mainly considered life threatening or that…

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 USD 99.   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. A biosimilar is a…

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 USD 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 and/or encouraging localization in Canada. Nonetheless, all drugs imported into Canada…

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 USD 99.   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 genetically…

The low-down on the situation regarding regulatory reforms in Bulgaria. Prepared in association with Kinstellar, a leading law firm in Bulgaria, this is an extract from The Pharma Legal Handbook: Bulgaria, available to purchase here for USD 99.   1. Are there proposals for reform or significant change to the healthcare system? The topic of changing the existing healthcare system has been thoroughly debated in Bulgaria. In the final quarter of 2018, the Bulgarian minister of healthcare proposed two alternative models (“Model A”…

A brief overview of the situation regarding patents and trademarks in Bulgaria. Prepared in association with Kinstellar, a leading law firm in Bulgaria, this is an extract from The Pharma Legal Handbook: Bulgaria, available to purchase here for USD 99.   1. What are the basic requirements to obtain patent and trademark protection? A) Patents In Bulgaria, the legislative framework regulating legal relations arising in connection with the creation, protection and use of patentable inventions comprises of the Patents and Utility Models Registration…

All legal aspects surrounding product liability in Bulgaria. Prepared in association with Kinstellar, a leading law firm in Bulgaria, this is an extract from The Pharma Legal Handbook: Bulgaria, available to purchase here for USD 99.   1. What types of liability are recognized in your jurisdiction? There are three types of liability recognised in Bulgaria, as follows: civil liability; administrative liability; and criminal liability. (A) Civil Liability There are two types of civil liability under Bulgarian law: contractual liability, which results from…

The key facts about traditional medicines and OTC products in Bulgarian Pharma. Prepared in association with Kinstellar, a leading law firm in Bulgaria, this is an extract from The Pharma Legal Handbook: Bulgaria, available to purchase here for USD 99.   1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? Bulgarian law regulates medicinal products and medical devices differently. Medicinal products are grouped in three categories: (i) conventional medicinal products; (ii) traditional herbal medicinal products; and (iii)…

Marketing, manufacturing, packaging & labeling, advertising in Bulgaria – a comprehensive legal overview. Prepared in association with Kinstellar, a leading law firm in Bulgaria, this is an extract from The Pharma Legal Handbook: Bulgaria, available to purchase here for USD 99.   1. What is the authorisation process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? Homeopathic and traditional herbal medicinal products may be placed on the market in Bulgaria based on registration…

The ins and outs of preclinical & clinical trial requirements: Bulgaria. Prepared in association with Kinstellar, a leading law firm in Bulgaria, this is an extract from The Pharma Legal Handbook: Bulgaria, available to purchase here for USD 99.   1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? There is no requirement for clinical trials to be conducted locally as a condition for obtaining market authorization. However, if the clinical trials have been…

Key legal info on regulatory, pricing and reimbursement in Bulgaria. Prepared in association with Kinstellar, a leading law firm in Bulgaria, this is an extract from The Pharma Legal Handbook: Bulgaria, available to purchase here for USD 99.   1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? The following authorities are responsible for applying and enforcing the regulatory framework pertaining to drugs (including biologicals) and medical devices in Bulgaria: The Bulgarian…

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

With the end of the Lithuanian Parliament’s Spring Session, a period of neverending discussions and misunderstandings has ended too, as the Parliament and the Ministry of Health have finally adopted a new medicines reimbursement system, writes Ruta Pumputienė.   Lithuanian Ministry of Health deserves compliments for getting involved in the dialogue around the new reimbursement system itself, as well as involving all stakeholders. They have also taken into account the comments of doctors, patients, and industry’s representatives. Finally, they have…

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 USD 99.   1. Are there proposals for reform or significant change to the healthcare system? There is no significant reform or change to the healthcare system in Japan. However, there are small changes every year. For example, changes due to technology, telemedicine, apps as…

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 USD 99.   1. What are the basic requirements to obtain patent and trademark protection? The Patent Act stipulates that an invention must be novel, non-obvious and have industrial applicability. The Trademark Act allows any trademark unless the mark is the same or similar…

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 USD 99.   1. What types of liability are recognized in your jurisdiction? Liability under contract and liability under tort law are two basic civil liabilities. The liability under tort law, in principle, requires intention or negligence. However, there is a Product Liability Law, under…

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 USD 99.   1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? Traditional, herbal, complementary, or alternative medicines and devices are subject to the PMD Act.   2. Can these traditional, herbal, complementary, or…

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 USD 99.   1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? To obtain marketing authorization for new drugs, biologics and medical devices, submission of application to PMDA is…

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 USD 99.   1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? Under the Pharmaceutical and Medical Device Act (PMD Act), in general, clinical trials for application of marketing authorization approval…

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 USD 99.   1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? Ministry of Health, Labour and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA)   2. What is the…

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

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

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

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

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

All about marketing, manufacturing, packaging & labeling, advertising in Spain. Prepared in association with Faus & Moliner Abogados, a leading law firm in Spain, this is an extract from The Pharma Legal Handbook: Spain, available to purchase here for USD 99.   1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? The AEMPS is the authority in charge of granting marketing authorizations in Spain, whether they result from…

Preclinical & clinical trial requirements in Spain – a comprehensive legal overview. Prepared in association with Faus & Moliner Abogados, a leading law firm in Spain, this is an extract from The Pharma Legal Handbook: Spain, available to purchase here for USD 99.   1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? No, clinical trial may be conducted abroad. For those cases whenever clinical trials are conducted outside the European…

Key legal info on regulatory, pricing and reimbursement in Spain. Prepared in association with Faus & Moliner Abogados, a leading law firm in Spain, this is an extract from The Pharma Legal Handbook: Spain, available to purchase here for USD 99.   1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? The main regulatory authorities in Spain are: The Spanish Ministry of Health, Consumption and Welfare (‘Spanish Ministry of Health’), which is…

An insight into orphan drugs and rare diseases in Denmark. Prepared in association with Gorrissen Federspiel, a leading law firm in Denmark, this is an extract from The Pharma Legal Handbook: Denmark, available to purchase here for USD 99.   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 as…

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 USD 99.   Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? Cannabinoid drugs, i.e. medicinal products where the active substance is cannabinoids, can be authorised in Denmark in accordance with the rules on development, manufacture and marketing under…

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 USD 99.   1. Are there proposals for reform or significant change to the healthcare system? Clinical Trial Regulation The aim of the Clinical Trial Regulation is to ensure greater harmonisation of the rules on clinical trials throughout the EU. To this end, it will introduce, i.a.:…

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 USD 99.   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”), 2) filing a patent application according to…

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 USD 99.   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 USD 99.   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 vitamin and mineral products are all special categories of medicinal products and are as a starting…

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 USD 99.   1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? Please see Question 3 of Regulatory, Pricing and Reimbursement Overview.   2. What is the authorization process…

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 USD 99.   1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? No, clinical trials are not required to be conducted locally as a condition for a marketing authorization. As a starting point, an application for a…

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 USD 99.   1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? The Danish Ministry of Health is responsible for defining the overall framework for the national healthcare system. As a governmental body…

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

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 USD 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  

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 USD 99.   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 is…

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 USD 99.   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  

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

The key facts about regulatory reforms in Ecuadorian Pharma. Prepared in association with Corral Rosales, a leading global law firm, this is an extract from The Pharma Legal Handbook: Ecuador, available to purchase here for USD 99.   1. Are there proposals for reform or significant change to the healthcare system? There is a new health law being discussed, which would change the underlying concepts behind the regulations, thereby making the healthcare system more protective.   2. When are they likely to come…

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 USD 99.   1. Are there proposals for reform or significant change to the healthcare system? No   2. When are they likely to come into force? N/A  

An insight into regulatory reforms in Bolivian Pharma. Prepared in association with Indacochea & Asociados, a leading Bolivian law firm, this is an extract from The Pharma Legal Handbook: Bolivia, available to purchase here for USD 99.   1. Are there proposals for reform or significant change to the healthcare system? For several years now they have been talking about a new law that will be issued but we don’t expect it to pass any time soon.   2. When are…

The ins and outs of regulatory reforms in Nicaragua. Prepared in association with Bendaña & Bendaña, a leading Nicaraguan law firm, this is an extract from The Pharma Legal Handbook: Nicaragua, available to purchase here for USD 99.   1. Are there proposals for reform or significant change to the healthcare system? No   2. When are they likely to come into force? N/A     Click the following links to read more legal articles from Nicaragua: Regulatory Pricing and Reimbursement Overview Preclinical…

The legal framework for patents and trademarks in Nicaragua. Prepared in association with Bendaña & Bendaña, a leading Nicaraguan law firm, this is an extract from The Pharma Legal Handbook: Nicaragua, available to purchase here for USD 99.   1. What are the basic requirements to obtain patent and trademark protection? Power of Attorney, duly legalized by Apostille For patents, all data related to the priority or PCT application, as well as a copy of the specification and claims in Spanish For trademarks,…

All legal aspects surrounding product liability in Nicaragua. Prepared in association with Bendaña & Bendaña, a leading Nicaraguan law firm, this is an extract from The Pharma Legal Handbook: Nicaragua, available to purchase here for USD 99.   1. What types of liability are recognized in your jurisdiction? Civil Liability Criminal liability   2. How do these types of liabilities apply to the manufacturers of medicines and devices? It must be shown that human health has been affected as a consequence of the…

An insight into traditional medicines and OTC products in Nicaragua. Prepared in association with Bendaña & Bendaña, a leading Nicaraguan law firm, this is an extract from The Pharma Legal Handbook: Nicaragua, available to purchase here for USD 99.   1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? Find attach a document with drugs Requirements. Find attachment document with Device Requirements.   2. Can these traditional, herbal, complementary, or alternative products be advertised directly to the…

The key facts about marketing, manufacturing, packaging & labeling, advertising in Nicaragua. Prepared in association with Bendaña & Bendaña, a leading Nicaraguan law firm, this is an extract from The Pharma Legal Handbook: Nicaragua, available to purchase here for USD 99.   1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? Have a distributor authorized by the Ministry of Health that has a valid health license. Grant power to a legal…

A brief overview of the situation regarding preclinical & clinical trial requirements in Nicaragua. Prepared in association with Bendaña & Bendaña, a leading Nicaraguan law firm, this is an extract from The Pharma Legal Handbook: Nicaragua, available to purchase here for USD 99.   1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? It is not a requirement that they be done locally.   2. How are clinical trials funded? The Manufacturer Laboratory is…

All you need to know about regulation, pricing and reimbursement in Nicaraguan pharma. Prepared in association with Bendaña & Bendaña, a leading Nicaraguan law firm, this is an extract from The Pharma Legal Handbook: Nicaragua, available to purchase here for USD 99.   1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? Ministry of Health, in the following departments: Pharmacy Management National Laboratory Directorate of Sanitary Regulation (medical devices) – Exhibit 1  …

Procedure for renewal of pharmaceutical products in Nicaragua – an overview. Prepared in association with Bendaña & Bendaña, a leading Nicaraguan law firm, this is an extract from The Pharma Legal Handbook: Nicaragua, available to purchase here for USD 99.   RENEWALS OF PRODUCTS THAT HAVE NOT BEEN MARKETED IN NICARAGUA Bill Authorization for sending a sample to file the application. The reference standard can be sent together with the sample to file the application or send it together with the first…

All of the requirements for Pharmaceutical Regulatory Affairs in Nicaragua. Prepared in association with Bendaña & Bendaña, a leading Nicaraguan law firm, this is an extract from The Pharma Legal Handbook: Nicaragua, available to purchase here for USD 99.   According to the RTCA, subsection 7. The requirements for sanitary registration are the following: 1. Power of attorney to the legal representative duly legalized or apostilled. We attach format. 2. Copy of the acknowledgment of receipt of the distribution power or contract…

All about pharmaceutical registrations in Nicaragua. Prepared in association with Bendaña & Bendaña, a leading Nicaraguan law firm, this is an extract from The Pharma Legal Handbook: Nicaragua, available to purchase here for USD 99.   REGISTRATION OF NEW PRODUCTS Bill Authorization for sending a sample to file the file The reference standard can be sent together with the sample to file the file or send it together with the first importation of the product. Filing of the application of sanitary…

All legal aspects surrounding cannabinoid drugs, medicinal cannabis and opioid drugs in Slovakia. Prepared in association with PRK Partners, a leading global law firm, this is an extract from The Pharma Legal Handbook: Slovakia, available to purchase here for USD 99.   Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? Yes. In our understanding, Cannabinoid Drugs are medicinal drugs containing active compounds of cannabis (such as THC and CBD) as opposed to psychoactive cannabis per se intended for recreational use.  …

The legal framework for regulatory reform in Slovakian Pharma. Prepared in association with PRK Partners, a leading global law firm, this is an extract from The Pharma Legal Handbook: Slovakia, available to purchase here for USD 99.   1. Are there proposals for reform or significant change to the healthcare system? E-Health With effect as of 1 January 2018, mandatory e-Health system has been introduced in the Slovak Republic. This reform included the introduction of an electronic health book of a patient, the…

An insight into patents & trademarks in Slovakian Pharma. Prepared in association with PRK Partners, a leading global law firm, this is an extract from The Pharma Legal Handbook: Slovakia, available to purchase here for USD 99.   1. What are the basic requirements to obtain patent and trademark protection? PATENTS One can file for patent protection for any invention, in all fields of technology, provided it is new, involves an inventive step, and is capable of industrial application and the fee…

All about product liability in Slovakian Pharma. Prepared in association with PRK Partners, a leading global law firm, this is an extract from The Pharma Legal Handbook: Slovakia, available to purchase here for USD 99.   1. What types of liability are recognized in your jurisdiction? The Slovak legal order recognizes three types of liability: civil, criminal, and administrative. Civil liability may be further divided into contractual liability, which results from a failure to comply with contractual obligations (e.g. failure to perform a…

The low-down on the situation regarding traditional medicines and OTC products in Slovakia. Prepared in association with PRK Partners, a leading global law firm, this is an extract from The Pharma Legal Handbook: Slovakia, available to purchase here for USD 99.   1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? Traditional herbal medicinal products and homeopathic medicinal products are regulated by the Act on Medicinal Products and its regulations. Traditional herbal medicinal products may receive a…

A brief overview of the situation regarding marketing, manufacturing, packaging & labeling, advertising in Slovakia. Prepared in association with PRK Partners, a leading global law firm, this is an extract from The Pharma Legal Handbook: Slovakia, available to purchase here for USD 99.   1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? MEDICINAL PRODUCTS In the Slovak Republic, the following authorization procedures are available in order to obtain the market…

Preclinical and clinical trial requirements in Slovakian Pharma – a legal guide. Prepared in association with PRK Partners, a leading global law firm, this is an extract from The Pharma Legal Handbook: Slovakia, available to purchase here for USD 99.   1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? No, clinical trials can also be conducted abroad. If the clinical trial is performed outside the EEA, the applicant for the…

An intro to the legal situation for regulatory, pricing and reimbursement in Slovakian Pharma. Prepared in association with PRK Partners, a leading global law firm, this is an extract from The Pharma Legal Handbook: Slovakia, available to purchase here for USD 99.   1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? In the Slovak Republic, the main regulatory authorities over medicinal products, biologicals, and medical devices are the State Institute for Drug Control and…

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 USD 99.   Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? According to the national catalogue of medicines in Romania published by NAMMD, currently there are no cannabinoid medicinal products authorized for marketing in the country. By law, certain psychotropic substances extracted from…

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 USD 99.   1. Are there proposals for reform or significant change to the healthcare system? The Romanian authorities announced their intention to implement certain changes in the pharmaceutical legislation, including in relation to: the methodology for computing the prices of medicinal products; the clawback tax, a…

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 USD 99.   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 Trademark (“OSIM”), based on the…

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 USD 99.   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 other…

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 USD 99.   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 specific…

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 USD 99.   1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over the-counter medications, and other medicinal products? In order to be placed on the Romanian market, a medicinal product needs a marketing authorization, which…

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 USD 99.   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 in…

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 USD 99.   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 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 USD 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 persons…

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 USD 99.   Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? Cannabinoids are substances subject to national control for medical or scientific use.   2. What are the regulatory authorities with jurisdiction over Cannabinoid Drugs? The regulatory authority is the Pharmaceutical…

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 USD 99.   1. Are there proposals for reform or significant change to the healthcare system? There are considerable proposals under analysis to change the healthcare system and the Constitution of Panama.   2. When are they likely to come into force? The new government starts the period on July…

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 USD 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 drawings…

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 USD 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 22. Only…

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 USD 99.   1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over the-counter medications, and other medicinal products? To obtain authorization to develop and market a product, each product must obtain a sanitary registration before the Ministry of Health. STEPS…

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 USD 99.   1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? No, it is not a requirement to conduct the clinical trials for products locally. Moreover, clinical trials are only required when the product is an innovative…

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 USD 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…

Cannabinoid drugs, medicinal cannabis and opioid drugs in Mexico – a comprehensive legal overview. Prepared in association with Olivares, a leading global law firm, this is an extract from The Pharma Legal Handbook: Mexico, available to purchase here for USD 99.   Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? The use of cannabis has been authorized for medicinal use, including investigational activities and granting marketing authorizations for medicines for which the active ingredient is THC. The new Law for…

Cannabinoid drugs, medicinal cannabis and opioid drugs in Luxembourg – a comprehensive legal overview. Prepared in association with Wildgen, a leading global law firm, this is an extract from The Pharma Legal Handbook: Luxembourg, available to purchase here for USD 99.   Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? The use of recreational cannabis is prohibited according to the law of 19 February 1973 concerning the sale of medicinal substances and the fight against drug addiction as amended. The use…

The key facts about regulatory reform in Luxembourg. Prepared in association with Wildgen, a leading global law firm, this is an extract from The Pharma Legal Handbook: Luxembourg, available to purchase here for USD 99.   1. Are there proposals for reform or significant change to the healthcare system? Yes, the ongoing draft law n°7383 which has been filed to the Chamber of Deputies on 25 October 2018 by the Minister of Health contains several proposals for reform that includes, without being exhaustive:…

Patents and trademarks of drugs in Luxembourg – an overview. Prepared in association with Wildgen, a leading global law firm, this is an extract from The Pharma Legal Handbook: Luxembourg, available to purchase here for USD 99.   1. What are the basic requirements to obtain patent and trademark protection? i. The main legislations for patent and trademark protection in Luxembourg are the followings:  the law of 20 July 1992 amending the patent regime as amended; the Benelux Convention on Intellectual Property (trademarks…

An insight into product liability in Luxembourg. Prepared in association with Wildgen, a leading global law firm, this is an extract from The Pharma Legal Handbook: Luxembourg, available to purchase here for USD 99.   1. What types of liability are recognized in your jurisdiction? There are four types of product liability recognized in Luxembourg: Liability for defective products, governed by the law of 21 April 1989 on the civil liability for defective products as amended; Contractual liability foreseen by articles 1603 seq…