Legal & Regulatory > Americas

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

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

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

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

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

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

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

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

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

Key legal info on marketing, manufacturing, packaging & labeling, advertising in Venezuelan Pharma. Prepared in association with Hoet Pelaez Castillo & Duque (HPCD), a leading law firm in Venezuela, this is an extract from The Pharma Legal Handbook:Venezuela, available to purchase here for USD 99.   1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? To request the authorization of a clinical protocol of a Pharmaceutical Specialty, the…

The key facts about preclinical and clinical trial requirements in Venezuelan Pharma. Prepared in association with Hoet Pelaez Castillo & Duque (HPCD), a leading law firm in Venezuela, this is an extract from The Pharma Legal Handbook:Venezuela, available to purchase here for USD 99.   1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? Yes.   2. How are clinical trials funded? Clinical trials are funded by those interested in obtaining…

All legal aspects surrounding regulatory, pricing and reimbursement in Venezuelan Pharma. Prepared in association with Hoet Pelaez Castillo & Duque (HPCD), a leading law firm in Venezuela, this is an extract from The Pharma Legal Handbook:Venezuela, available to purchase here for USD 99.   1. What are the Regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? The Regulatory authority is the National Institute of Hygiene.   2. What is the regulatory framework for the authorization,…

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

Biosimilars & biologics in Brazil – a comprehensive legal overview. Prepared in association with Trench, Rossi e Watanabe one of Brazil’s most prestigious law firms, this is an extract from The Pharma Legal Handbook: Brazil, which can be purchased for GBP 75, here.   1. Are biosimilar medicines considered the same as generic medicines in your country? No, a biosimilar drug is not considered to be the same as a generic drug. There are specific rules governing generic and similar drugs, and they…

Want to know more about localization in Brazil? Read on! Prepared in association with Trench, Rossi e Watanabe one of Brazil’s most prestigious law firms, this is an extract from The Pharma Legal Handbook: Brazil, which can be purchased for GBP 75, here.   1. Are there any rules or regulations requiring and/or encouraging localization in your country? What is the legal framework defining these localization rules and policies? Yes, there are rules encouraging localization in Brazil, such as the Federal Law No.…

The key facts about orphan drugs & rare diseases in Brazil. Prepared in association with Trench, Rossi e Watanabe one of Brazil’s most prestigious law firms, this is an extract from The Pharma Legal Handbook: Brazil, which can be purchased for GBP 75, here.   1. What is the definition of Rare Diseases in your country? According to Resolution RDC No. 205/2017 issued by the National Health of Surveillance Agency (“ANVISA”), “rare diseases” are defined as diseases with incidence of up to 65…

All about cannabinoid drugs, medicinal cannabis and opioid drugs in Brazil. Prepared in association with Trench, Rossi e Watanabe one of Brazil’s most prestigious law firms, this is an extract from The Pharma Legal Handbook: Brazil, which can be purchased for GBP 75, here.   Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? The National Health Surveillance Agency (“ANVISA”) recently approved (on December 11, 2019) the Resolution RDC No. 327/19 defining the procedure for granting the Sanitary Authorization for manufacturing and…

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

The low-down on the situation regarding localization in Argentina. Prepared in association with Marval, O’Farrell & Mairal, a leading global law firm, this is an extract from The Pharma Legal Handbook: Argentina, available to purchase here for GBP 99.   1. Are there any rules or regulations requiring and/or encouraging localization in your country? What is the legal framework defining these localization rules and policies? As a preliminary comment, please note that to carry out activities in Argentina on a permanent basis,…

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

On 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 GBP 75.   1. Are biosimilar medicines considered the same as generic medicines in your country? No, they are different. On one side biosimilar products are biologically synthesized products which require a much more complex procedure to elaborate due to the fact that bigger…

Key legal info on orphan drugs & rare diseases in Peru. Prepared in association with Osterling Abogados, a leading global law firm, this is an extract from The Pharma Legal Handbook: Peru, available to purchase here for GBP 75.   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 GBP 75.   BIOSIMILARS AND BIOLOGICS in Panama are regulated by Law 1 January 10, 2001, Executive Decree No. 95 of May 14, 2019   1. Are biosimilar medicines considered the same as generic medicines in your country? No. Generic medicines are defined as medicines…

Keen to learn more about orphan drugs & rare diseases in Panama? Read on! Prepared in association with AFRA, a leading global law firm, this is an extract from The Pharma Legal Handbook: Panama, available to purchase here for GBP 75.   Orphan Drugs in Panama are regulated by Law 1 January 10, 2001, Executive Decree No. 95 of May 14, 2019 and Executive Decree 1217 of December 7, 2015; Rare Diseases are regulated by Law 28 of October 28,…

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,…

Key legal info on cannabinoid drugs, medicinal cannabis and opioid drugs in Argentina. Prepared in association with Marval, O’Farrell & Mairal, a leading global law firm, this is an extract from The Pharma Legal Handbook: Argentina, available to purchase here for GBP 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 14 of this Chapter for further information about…

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 GBP 75.   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 GBP 75.   1. Are there any rules or regulations requiring and/or encouraging localization in your country? What is the legal framework defining these localization rules and policies? Any new productive investments, including investments made on the pharmaceutical sector, that are initiated until…

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 GBP 75.   1. What is the definition of Rare Diseases in your country? Our law states a specific definition for rare diseases which is the following: They are the ones that are mainly considered life threatening or that debilitate in the…

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…

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

Regulatory reforms in Peru – an overview. Prepared in association with Osterling Abogados, a leading global law firm, this is an extract from The Pharma Legal Handbook: Peru, available to purchase here for GBP 75.   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  

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 GBP 75.   1. Are there proposals for reform or significant change to the healthcare system? Currently there are no proposals to change the Law.   2. When are they likely to come into force? It is unlikely that the new law will be approved this year…

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 GBP 75.   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…

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 GBP 75.   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…

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 GBP 75.   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…

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 GBP 75.   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 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 GBP 75.   1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? Have a distributor authorized by the Ministry of Health that has a valid health license. Grant power to a…

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 GBP 75.   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…

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 GBP 75.   1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? The National Health Regulation Authority (ANRS) has been created, which is the competent body of the Ministry of Health, which will…

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 GBP 75   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 GBP 75.   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 GBP 75.   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…

The legal framework for product liability in Panama. Prepared in association with AFRA, a leading global law firm, this is an extract from The Pharma Legal Handbook: Panama, available to purchase here for GBP 75.   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…

The low-down on the situation regarding cannabinoid drugs, medicinal cannabis and opioid drugs in Panama. Prepared in association with AFRA, a leading global law firm, this is an extract from The Pharma Legal Handbook: Panama, available to purchase here for GBP 75.   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…

All legal aspects surrounding regulatory reforms in Panama. Prepared in association with AFRA, a leading global law firm, this is an extract from The Pharma Legal Handbook: Panama, available to purchase here for GBP 75.   1. Are there proposals for reform or significant change to the healthcare system? Current enforce new healthcare related regulations are due to Covid-19 preventions, extraordinary and temporary measures enacted until the state of emergency is declared by the Panamanian Government.   2. When are they likely…

All about patent and trademarks in Panamanian Pharma. Prepared in association with AFRA, a leading global law firm, this is an extract from The Pharma Legal Handbook: Panama, available to purchase here for GBP 75.   1. What are the basic requirements to obtain patent and trademark protection? The basic requirements for obtaining a patent are the following: Power of attorney granted by the applicant; no legalization nor notarization required Assignment Document legalized by Panamanian Consulate or Apostille Specifications, claims, abstract and…

A brief overview of the situation regarding traditional medicines and OTC products in Panama. Prepared in association with AFRA, a leading global law firm, this is an extract from The Pharma Legal Handbook: Panama, available to purchase here for GBP 75.   1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? The requirements for traditional, herbal, complementary, or alternative medicines and devices that have therapeutically property are the same as for drugs. Please see Question 1…

An insight into marketing, manufacturing, packaging & labeling, advertising in Panama. Prepared in association with AFRA, a leading global law firm, this is an extract from The Pharma Legal Handbook: Panama, available to purchase here for GBP 75.   1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over the-counter medications, and other medicinal products? To obtain authorization to develop and market a product, each product must obtain a sanitary registration before the Ministry of Health.…

Preclinical and clinical trial requirements in Panamanian Pharma – an overview. Prepared in association with AFRA, a leading global law firm, this is an extract from The Pharma Legal Handbook: Panama, available to purchase here for GBP 75.   Preclinical & Clinical Trial in Panama are regulated on Law 1 January 10, 2001; Law 78 November 20, 2003; Law 84 of May 14, 2019; Executive Decree 1110 June 6, 2012; Resolution No. 512 of June 28, 2019; Executive Decree 1843 December 16,…

An intro to the legal situation for regulatory, pricing and reimbursement in Panamanian Pharma. Prepared in association with AFRA, a leading global law firm, this is an extract from The Pharma Legal Handbook: Panama, available to purchase here for GBP 75.   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 GBP 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. On January 12,…

The legal framework for cannabinoid drugs, medical cannabis and opioids in Chile. Prepared in association with Carey, a leading global law firm, this is an extract from The Pharma Legal Handbook: Chile, available to purchase here for GBP 99.   Cannabinoid Drugs   1. Are Cannabinoid Drugs authorized in your country? So far, only pharmaceutical products containing an extract of flowers and leafs of cannabis sativa (Sativex solución para pulverización bucal) have been approved for sanitary registration (marketing authorization) by…

An insight into upcoming regulatory reforms affecting Chile pharma. Prepared in association with Carey, a leading global law firm, this is an extract from The Pharma Legal Handbook: Chile, available to purchase here for GBP 99.   1. Are there proposals for reform or significant change to the healthcare system? A bill that will modify the Sanitary Code is currently under discussion. Main topics covered by this bill of law are: (i) prescription by INN; (ii) labeling; (iii) interchangeability of…

The low-down on the situation regarding patents and trademarks in Chile pharma. Prepared in association with Carey, a leading global law firm, this is an extract from The Pharma Legal Handbook: Chile, available to purchase here for GBP 99.   1. What are the basic requirements to obtain patent and trademark protection? a. Patents: Any invention that has novelty, inventiveness and industrial application may be subject to patentability. In general terms, the basic requirements to obtain patent protection are the…

All about product liability in Chile pharma. Prepared in association with Carey, a leading global law firm, this is an extract from The Pharma Legal Handbook: Chile, available to purchase here for GBP 99.   1. What types of liability are recognized in your jurisdiction? In our jurisdiction, the liability system is mainly based on negligence. Regarding defective products, since there are no special liability rules, general rules of liability will be applicable. General rules are set forth in Chilean…

An intro to the legal situation for traditional products and OTC medicines in Chile. Prepared in association with Carey, a leading global law firm, this is an extract from The Pharma Legal Handbook: Chile, available to purchase here for GBP 99.   1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? In Chile, Traditional Herbal Medicines shall be understood as those constituted by plants or parts of plants, fresh or dried, whole or crushed,…

The key facts about marketing, manufacturing, packaging & labeling, and advertising in Chile. Prepared in association with Carey, a leading global law firm, this is an extract from The Pharma Legal Handbook: Chile, available to purchase here for GBP 99.   1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? Please refer to Chapter 1: Regulatory, Pricing, and Reimbursement Overview, question 3.   2. What is the authorization…

Preclinical and Clinical Trial Requirements in Chile – a legal guide. Prepared in association with Carey, a leading global law firm, this is an extract from The Pharma Legal Handbook: Chile, available to purchase here for GBP 99.   1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? No. Chilean legislation and regulations do not require for clinical trials to be conducted locally in order to file for or obtain a…

A brief overview of the situation regarding regulation, pricing and reimbursement of drugs in Chile. Prepared in association with Carey, a leading global law firm, this is an extract from The Pharma Legal Handbook: Chile, available to purchase here for GBP 99.   1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? In Chile the regulatory authority responsible for the enforcement of the regulatory framework for pharmaceutical products, including biologicals, and medical…

It is not a secret anymore, many in the industry now know that Health Canada is working on a new version of the policy entitled: The Distinction Between Advertising and Other Activities, dated more than 20 years ago. Earlier this week, Health Canada provided some insights about the reformed policy and offered target timelines for publication and entry into force.   The new Distinction Policy should be published in a draft format before the end of this month, in late…

All of the Requirements for the Sanitary Registration of Medical Devices 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 GBP 75.   CLASS I. LOW RISK: Sanitary license of the establishment, issued by the Directorate of Registration of Medical Devices of the Ministry of Health. Free sale certificate that demonstrates its use in the country of origin. Certificate of Good Manufacturing…

In the light of several recent regulatory updates to Canada’s cannabis laws, lawyer Jean-Raphaël Champagne examines the potential for cannabis to be legalised for use in cosmetic products in Canada.   One thing that Bill C-51 did not change was the relationship between cannabis substances and cosmetic products in Canada Cannabis legislation in Canada has come with its fair share of legislative amendments. Bill C-51 not only enacted the Cannabis Act; it also introduced a number of amendments and transitional…

Want to know more about patents and trademarks in Bolivian pharma? Read on! 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. What are the basic requirements to obtain patent and trademark protection? The formalities to request a trademark registration are: Name and design (if applicable) of the brand International Classification Nice Basic information of the applicant (if the applicant is a…

The ins and out of product liability 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. What types of liability are recognized in your jurisdiction? Civil liability occurs when an individual or a legal entity causes harm to another. Given the event, the aggrieved party must claim the reparations for the compensatory damages caused. The complaint must be…

Bolivian regulation regarding traditional medicines and OTC products. 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. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? Products must contain vegetal, mineral or animal components in order for them to be classified as “traditional, herbal, complementary or alternative medicines”.   2. Can these traditional, herbal, complementary, or…

All you need to know about Marketing, Manufacturing, Packaging & Labeling, Advertising 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. What is the authorization process for the marketing of new drugs, biologics, medical devices, non-prescription medications, and other medicinal products? The first step in order to obtain the corresponding authorization to commercialize products in Bolivia is to…

Preclinical and Clinical Trials in Bolivia – an overview. 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 clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? No, it’s not a set condition. Studies issued by other countries are accepted.   2. How are clinical trials funded? The interested party is responsible for…

An overview of the regulation, pricing and reimbursement of drugs in Bolivia. 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. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? In Bolivia the authority that regulates all matters is the State Agency for Medical Products and Health Technology (Agencia Estatal de Medicamentos y…

An outline of the situation regarding patents and trademarks in Peruvian pharma. Prepared in association with Osterling Abogados, a leading global law firm, this is an extract from The Pharma Legal Handbook: Peru, available to purchase here for GBP 75.   1. What are the basic requirements to obtain patent and trademark protection? A patent application must comply with 3 basic requirements, meaning that a patent must have: Novelty Inventive Level Industrial Application A trademark application must both be distinctive and must…

Get to know the legal situation around product liability in Peru. Prepared in association with Osterling Abogados, a leading global law firm, this is an extract from The Pharma Legal Handbook: Peru, available to purchase here for GBP 75.   1. What types of liability are recognized in your jurisdiction? Regarding the quality of the pharmaceutical products and medical devices the responsibility will lie with the manufacturing company when these are made in the country, with the importer holding the Sanitary Registration…

The ins and outs of the legal requirements for traditional medicines and OTC medicines in Peru. Prepared in association with Osterling Abogados, a leading global law firm, this is an extract from The Pharma Legal Handbook: Peru, available to purchase here for USD 99.   1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? Storage, Commercialization, importation, distribution require, with the exception of alternative medicine, a Sanitary Registration for each product.   2. Can these traditional, herbal,…

The key info on marketing, manufacturing, packaging & labeling and advertising pharmaceuticals in Peru. Prepared in association with Osterling Abogados, a leading global law firm, this is an extract from The Pharma Legal Handbook: Peru, available to purchase here for 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? Any new drug, biologic, medical device, over the counter medication and in general medicinal product require a Sanitary Registration.…

Want to know about preclinical and clinical trial requirements in Peru? Read on! Prepared in association with Osterling Abogados, a leading global law firm, this is an extract from The Pharma Legal Handbook: Peru, available to purchase here for USD 99.   1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? Peruvian law only regulates clinical trials conducted locally.   2. How are clinical trials funded? Clinical trials are funded by…

An intro to the regulatory, pricing and reimbursement scenario for pharmaceuticals in Peru. Prepared in association with Osterling Abogados, a leading global law firm, this is an extract from The Pharma Legal Handbook: Peru, available to purchase here for GBP 75.   1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? Drugs, biological and medical devices are regulated by the Directorate General of Medicines, Supplies and Drugs – (known in Spanish as…

An intro to the legal situation for medical cannabis, cannabinoid drugs and opioids in Ecuador. 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 GBP 75.   Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? On September 17, 2019, the Congress approved the production, commercialization, distribution, use and consumption of cannabis for medicinal or therapeutic uses in the country. lArt. 220 of…

The legal framework for cannabinoid drugs, medical cannabis and opioids in Canada. Prepared in association with Fasken, a leading global law firm, this is an extract from The Pharma Legal Handbook: Canada, available to purchase here for USD 99.   Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? Yes. Cannabinoids can be the active ingredient of a drug product in Canada, provided that such product meets applicable safety, effectiveness and quality requirements under the Food and Drugs Act and its regulations. This…

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

The low-down on the situation regarding patents and trademarks in Canadian pharma. Prepared in association with Fasken, a leading global law firm, this is an extract from The Pharma Legal Handbook: Canada, available to purchase here for USD 99.   1. What are the basic requirements to obtain patent and trademark protection? In order to obtain patent or trademark protection, one must submit an application to the Canadian Intellectual Property Office (“CIPO”) and comply with the formalities of the application process set out…

All about product liability in Canadian pharma. Prepared in association with Fasken, a leading global law firm, this is an extract from The Pharma Legal Handbook: Canada, available to purchase here for USD 99.   1. What types of liability are recognized in your jurisdiction? In general terms, product liability arises from claims in contract or civil wrongs under the common law or civil code, depending on the province. Plaintiffs can hold manufacturers concurrently liable in either contract or civil wrongs. Contractual Liability Plaintiffs…

An intro to the legal situation for traditional products and OTC medicines in Canada. Prepared in association with Fasken, a leading global law firm, this is an extract from The Pharma Legal Handbook: Canada, available to purchase here for USD 99.   1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? In Canada, traditional, herbal, complementary or alternative medicines are included under the previously defined term “NHPs.” NHPs are governed by the Food and Drugs Act and the Natural…

The ins and outs of the marketing, manufacturing, packaging & labeling, and advertising in Canadian pharma. Prepared in association with Fasken, a leading global law firm, this is an extract from The Pharma Legal Handbook: Canada, available to purchase here for USD 99.   1. What is the authorization process for the marketing of new drugs, biologics, medical devices, non-prescription medications, and other medicinal products? The authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal…

Preclinical and clinical trial requirements for pharma in Canada – a comprehensive legal overview. Prepared in association with Fasken, a leading global law firm, this is an extract from The Pharma Legal Handbook: Canada, available to purchase here for 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 local trials of a new drug to receive marketing approval. Rather, in order to obtain marketing…

A brief overview of the situation regarding regulation, pricing and reimbursement of drugs in Canada. Prepared in association with Fasken, a leading global law firm, this is an extract from The Pharma Legal Handbook: Canada, available to purchase here for USD 99.   1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? Health Canada is the federal authority responsible for regulating pharmaceutical drugs, biologicals, and medical devices for human use. Health Canada’s…

A brief insight into upcoming regulatory reforms in Brazilian pharma. Prepared in association with Trench, Rossi e Watanabe one of Brazil’s most prestigious law firms, this is an extract from The Pharma Legal Handbook: Brazil, which can be purchased for GBP 75, here.   1. Are there proposals for reform or significant change to the healthcare system? There are plenty of Law projects under discussion. Before ANVISA there are two relevant rules under public consultation, one to regulate Good Practices for Pharmacovigilance and other…

An overview of the legal framework for patents and trademarks for pharmaceuticals in Brazil. Prepared in association with Trench, Rossi e Watanabe one of Brazil’s most prestigious law firms, this is an extract from The Pharma Legal Handbook: Brazil, which can be purchased for GBP 75, here.    1. What are the basic requirements to obtain patent and trademark protection? Industrial Property Rights are regulated in Brazil through Federal Law No. 9,279/1996 (“IP Law”). Under its Article 8, the main requirements for the grant…

The ins and outs of product liability in Brazilian pharma. Prepared in association with Trench, Rossi e Watanabe one of Brazil’s most prestigious law firms, this is an extract from The Pharma Legal Handbook: Brazil, which can be purchased for GBP 75, here.   1. What types of liability are recognized in your jurisdiction? The scope of liability for suppliers and the standards for consumer protection in Brazil are, in some cases, more severe than the consumer rules applicable in other countries. The Brazilian…

A guide to the state-of-play regarding traditional medicines and over-the-counter (OTC) products in Brazil. Prepared in association with Trench, Rossi e Watanabe one of Brazil’s most prestigious law firms, this is an extract from The Pharma Legal Handbook: Brazil, which can be purchased for GBP 75, here.    1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? Resolution RDC No. 26/2014 provides for traditional and herbal drugs requirements. These drugs are subject to registration, simplified registration…

Everything you need to know about the marketing, manufacturing, packaging & labeling and advertising of pharmaceuticals in Brazil. Prepared in association with Trench, Rossi e Watanabe one of Brazil’s most prestigious law firms, this is an extract from The Pharma Legal Handbook: Brazil, which can be purchased for GBP 75, here.   1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? The company should be licensed before ANVISA (at the…

The requirements for conducting preclinical and clinical trials in Brazil.  Prepared in association with Trench, Rossi e Watanabe one of Brazil’s most prestigious law firms, this is an extract from The Pharma Legal Handbook: Brazil, which can be purchased for GBP 75, here.   1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? No.   2. How are clinical trials funded? Clinical trials are funded by sponsor (individual or legal entity, public or private,…

A brief legal overview of the situation regarding the regulation, pricing and reimbursement of pharmaceuticals in Brazil.  Prepared in association with Trench, Rossi e Watanabe one of Brazil’s most prestigious law firms, this is an extract from The Pharma Legal Handbook: Brazil, which can be purchased for GBP 75, here.   1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? In Brazil, the authorities are the National Health of Surveillance Agency (“ANVISA”),…

Important legal questions related to cannabinoid drugs, medicinal cannabis and opioid drugs in Uruguay. Prepared in association with FERRERE, a leading law firm in Uruguay, this is an extract from The Pharma Legal Handbook: Uruguay, available to purchase here for USD 99.   Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? Yes. We understand Cannabinoid Drugs as psychoactive cannabis for recreational non-medical use, as opposed to Medicinal Cannabis (understood as cannabis used for pharmaceutical purposes), the regulatory framework of which is…

Key legal info on regulatory reforms in Uruguay. Prepared in association with FERRERE, a leading law firm in Uruguay, this is an extract from The Pharma Legal Handbook: Uruguay, available to purchase here for USD 99.   1. Are there proposals for reform or significant change to the healthcare system? Currently, a project to reform drugs regulations is being reviewed by the MSP (e.g. expedited proceedings, validity term of authorizations, etc.).   2. When are they likely to come into force? Between…

An insight into patents and trademarks in Uruguay. Prepared in association with FERRERE, a leading law firm in Uruguay, this is an extract from The Pharma Legal Handbook: Uruguay, available to purchase here for USD 99.   1. What are the basic requirements to obtain patent and trademark protection? For trademarks, the basic requirements are novelty, fancifulness and originality. The trademark must be inherently registrable, that is to say, it cannot be descriptive of the goods or services it intends to identify…

The legal framework for product liability in Uruguay. Prepared in association with FERRERE, a leading law firm in Uruguay, this is an extract from The Pharma Legal Handbook: Uruguay, available to purchase here for USD 99.   1. What types of liability are recognized in your jurisdiction? Product liability could be attributed to the manufacturer, importer and/or the sales channel (to consumer) and it could be administrative (e.g. regulatory), civil or criminal depending on the defect and the harm caused by the…

The key facts about traditional medicines and OTC products in Uruguay. Prepared in association with FERRERE, a leading law firm in Uruguay, this is an extract from The Pharma Legal Handbook: Uruguay, available to purchase here for USD 99.   1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? Regarding medicines and devices please refer to Question 3 in Regulatory, Pricing, and Reimbursement Overview. Decrees 403/016 and 404/016 state that any company undertaking operations with herbal…

All about marketing, manufacturing, packaging & labeling and advertising in Uruguayan pharma. Prepared in association with FERRERE, a leading law firm in Uruguay, this is an extract from The Pharma Legal Handbook: Uruguay, available to purchase here for USD 99.   1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? Please refer to Question 3 in Regulatory, Pricing, and Reimbursement Overview.   2. What is the authorization process for the marketing…

Preclinical and clinical trial requirements in Uruguay –  a legal guide. Prepared in association with FERRERE, a leading law firm in Uruguay, this is an extract from The Pharma Legal Handbook: Uruguay, 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.   2. How are clinical trials funded? Clinical trials can be funded by a promoter (individual, company, institution or organization responsible…

A brief overview of the situation regarding regulatory, pricing and reimbursement in Uruguay. Prepared in association with FERRERE, a leading law firm in Uruguay, this is an extract from The Pharma Legal Handbook: Uruguay, available to purchase here for USD 99.   1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? The authority responsible for applying and enforcing the regulatory framework in relation to drugs, biologicals and medical devices is the Ministry…

Important legal info for regulatory, pricing and reimbursement in Mexican pharma. Prepared in association with Olivares, a leading global law firm, this is an extract from The Pharma Legal Handbook: Mexico, available to purchase here for GBP 99.   1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in Mexico? The authority responsible for applying and enforcing the regulatory framework in relation to drugs, biologicals, and medical devices is the Federal Commission for Protection against…

  A structured legal guide about patents & trademarks 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 GBP 75.   1. What are the basic requirements to obtain patent and trademark protection? Any sign that is capable of distinguishing goods and services on the market shall constitute a mark. Signs that are capable of graphic representation shall be eligible for registration…

The inside track on product liability 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 GBP 75.   1. What types of liability are recognized in your jurisdiction? In general terms, liability arises from the Civil and Criminal Codes, and it is a personal responsibility for actions or omissions. However, the Consumer Protection Law establishes that civil damages may be claimed in…

Need info on traditional medicine and OTC products in Ecuador? Read on! 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 GBP 75.   1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? Traditional, complementary or alternative medicines are governed by the General Health Law (HL) and its regulations. These medicines are known as natural, whose active ingredients are…

Legal info on marketing, manufacturing, packaging & labelling 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 GBP 75.   1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? The authorization process for the marketing of new drugs, biologics, medical devices, OTC and other medicinal products is through a marketing…

Key info on preclinical and clinical trial requirements in Ecuador. 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 GBP 75. As a general introduction, Clinical Trials are regulated in Ecuador via Ministerial Agreement (MA) 0075-2017 related to regulations for the approval, development, monitoring and control of clinical trials. This regulation was enacted on June 30th, 2017. There are other rules and regulations which make…

All you need to know about regulation, pricing and reimbursement 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 GBP 75.   1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? The authority responsible for applying and enforcing the regulatory framework in relation to human medicines, biologicals, and medical devices is the…

An insight into upcoming regulatory reforms affecting Argentinian pharma. Prepared in association with Marval, O’Farrell & Mairal, a leading global law firm, this is an extract from The Pharma Legal Handbook: Argentina, available to purchase here for GBP 99.   1. Are there proposals for reform or significant change to the healthcare system? There are no proposals for reform or significant change of the healthcare system in the short term. Nonetheless, due to the COVID-19 pandemic, several new regulations and laws have…

A legal briefing on patents and trademarks in Argentina. Prepared in association with Marval, O’Farrell & Mairal, a leading global law firm, this is an extract from The Pharma Legal Handbook: Argentina, available to purchase here for GBP 99.   1. What are the basic requirements to obtain patent and trademark protection? Patents To obtain patent protection in Argentina, it is necessary to file a patent application with the National Institute of Industrial Property (the “INPI” after its acronym in Spanish). The…

Intro to product liability in Argentinian pharma. Prepared in association with Marval, O’Farrell & Mairal, a leading global law firm, this is an extract from The Pharma Legal Handbook: Argentina, available to purchase here for GBP 99.   1. What types of liability are recognized in your jurisdiction? In general terms, liability arises from provisions in the Argentine Constitution, the Civil and Commercial National Code, the Criminal Code, and other laws that apply to specific cases such as the Corporate Criminal Liability…

The environment surrounding traditional and OTC products in Argentina. Prepared in association with Marval, O’Farrell & Mairal, a leading global law firm, this is an extract from The Pharma Legal Handbook: Argentina, available to purchase here for GBP 99.   1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? Herbal and vegetable medicines are regulated by ANMAT. They are defined as medicine that contains as an active ingredient one or more plant medicines, or one or…

Outlining the legal situation for marketing, manufacturing, packaging & labelling in Argentinian pharma. Prepared in association with Marval, O’Farrell & Mairal, a leading global law firm, this is an extract from The Pharma Legal Handbook: Argentina, available to purchase here for GBP 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 answers to Questions 2 and 3 in Regulatory, Reimbursement and Pricing Overview.   2. What is…

Preclinical and clinical trial requirements in Argentina – a legal guide. Prepared in association with Marval, O’Farrell & Mairal, a leading global law firm, this is an extract from The Pharma Legal Handbook: Argentina, available to purchase here for GBP 99.   1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? No. It is not a condition for marketing approval to conduct a clinical trial in Argentina (the approval of pharmaceutical…

A brief overview of the situation regarding regulation, pricing and reimbursement of drugs in Argentina. Prepared in association with Marval, O’Farrell & Mairal, a leading global law firm, this is an extract from The Pharma Legal Handbook: Argentina, available to purchase here for GBP 99.   1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? The National Ministry of Health (“MoH”) is the main health authority in Argentina. Nonetheless, in the year…

Upcoming regulatory reforms in Mexican pharma. Then read on! Prepared in association with Olivares, a leading global law firm, this is an extract from The Pharma Legal Handbook: Mexico, available to purchase here for GBP 99.   1. Are there proposals for reform or significant change to the healthcare system? INITIATIVE BIOTECHNOLOGY MEDICINES (amends article 222 Bis of the General Health Law) Public health institutions should establish an effective differentiation mechanism to ensure adequate pharmacovigilance and continuity of medical treatment, thus preventing…

  Need to know the legal situation for patents and trademarks in Mexican pharma? Then read on! Prepared in association with Olivares, a leading global law firm, this is an extract from The Pharma Legal Handbook: Mexico, available to purchase here for GBP 99.   1. What are the basic requirements to obtain patent and trademark protection? To obtain the protection of a trademark for a sign, it is required to file an application before the Mexican Intellectual Property Office…

All you need to know about product liability in Mexican pharma. Prepared in association with Olivares, a leading global law firm, this is an extract from The Pharma Legal Handbook: Mexico, available to purchase here for GBP 99.   1. What types of liability are recognized in your jurisdiction? A. LEGAL PROVISIONS In general terms, liability arises from provisions in federal or local civil codes in Mexico. Liability can also arise from statutory terms. The NOM for good manufacturing practices…

The key points to know from a legal standpoint about traditional medicines and OTC products in Mexico. Prepared in association with Olivares, a leading global law firm, this is an extract from The Pharma Legal Handbook: Mexico, available to purchase here for GBP 99.   1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? Traditional herbal medicinal products are regulated by the General Health Law and its regulations. This type of products can contain…

Key legal info on marketing, manufacturing, packaging & labeling, advertising in Mexico. Prepared in association with Olivares, a leading global law firm, this is an extract from The Pharma Legal Handbook: Mexico, available to purchase here for GBP 99.   1. 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…

Conducting preclinical or clinical trials in Mexico? Get the legal lowdown here. Prepared in association with Olivares, a leading global law firm, this is an extract from The Pharma Legal Handbook: Mexico, available to purchase here for GBP 99.   1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? Clinical trials for innovator biological products must take place in Mexico when the product is to be manufactured in Mexico. For products…