Legal & Regulatory > Chile

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, 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…