Legal & Regulatory > Ecuador

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

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,…

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…

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 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…

  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…