Legal & Regulatory > Colombia

An intro to the legal situation for orphan drugs and rare diseases in Colombia. Prepared in association with Cavelier Abogados, a leading global law firm, this is an extract from The Pharma Legal Handbook: Colombia, available to purchase here for GBP 119.   1. What is the definition of Rare Diseases in your country? According to Act 1438/2011 Orphan diseases are chronically debilitating, serious, life-threatening diseases with a prevalence of less than 1 per 5,000 people, including rare, ultra-orphan and neglected…

The key facts about biosimilars and biologics in Colombia. Prepared in association with Cavelier Abogados, a leading global law firm, this is an extract from The Pharma Legal Handbook: Colombia, available to purchase here for GBP 119.   1. Are biosimilar medicines considered the same as generic medicines in your country? No, generic medicines are understood as medicines with the same structure of the active substance as the reference medicine. And biosimilar medicines are those biotech molecules that can have a…

All legal aspects surrounding cannabinoid drugs, medicinal cannabis and opioid drugs in Colombia. Prepared in association with Cavelier Abogados, a leading law firm in Colombia, this is an extract from The Pharma Legal Handbook: Colombia, available to purchase here for GBP 119. Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? Yes, cannabinoid drugs are authorized in Colombia. However, they are subject to government control and to a specific regulatory framework.   2. What are the regulatory authorities with…

Regulatory reforms in Colombia – a legal guide. Prepared in association with Cavelier Abogados, a leading global law firm, this is an extract from The Pharma Legal Handbook: Colombia, available to purchase here for GBP 119.   1. Are there proposals for reform or significant change to the healthcare system? Yes, currently is in course a modification for the Decree 677 which is the principal regulatory framework for drugs, cosmetics, pharmaceutical preparations based on natural resources, cleaning and hygiene products and…

Read more to find out about patents and trademarks in Colombian pharma. Prepared in association with Cavelier Abogados, a leading global law firm, this is an extract from The Pharma Legal Handbook: Colombia, available to purchase here for GBP 119.   1. What are the basic requirements to obtain patent and trademark protection? Colombia, as WTO Member, complies with the  Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). Therefore, in Colombia patent applications in all technical fields must satisfy the…

Find out about product liability in Colombian pharma. Prepared in association with Cavelier Abogados, a leading global law firm, this is an extract from The Pharma Legal Handbook: Colombia, available to purchase here for GBP 119.   1. What types of liability are recognized in your jurisdiction? Contractual and extracontractual responsibility under the general principle that anyone causing damages to a given person is liable for those damages.   2. How do these types of liabilities apply to the manufacturers of…

Get the lowdown on traditional medicines and OTC products in Colombian pharma. Prepared in association with Cavelier Abogados, a leading global law firm, this is an extract from The Pharma Legal Handbook: Colombia, available to purchase here for GBP 119.   1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? Traditional medicines are ruled through Decree 2266/2004, Decree 4927/09, and Decree 1156/18 which establishes regulatory requirements for Phyto therapeutics.   The main requirements for traditional…

A structured legal guide to marketing, manufacturing, packaging & labelling and advertising in Colombian pharma. Prepared in association with Cavelier Abogados, a leading global law firm, this is an extract from The Pharma Legal Handbook: Colombia, available to purchase here for GBP 119.   1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? Please refer to Chapter 1: Regulatory, Pricing, and Reimbursement Overview.   2. What is the authorization…

The key requirements for conducting preclinical and clinical trials in Colombia. Prepared in association with Cavelier Abogados, a leading global law firm, this is an extract from The Pharma Legal Handbook: Colombia, available to purchase here for GBP 119.   1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? No. INVIMA accepts clinical trials conducted abroad if they sufficiently demonstrate safety and efficacy of the drug product.   2. How are clinical…

Need to know about regulation, pricing and reimbursement in Colombian pharma? Read on! Prepared in association with Cavelier Abogados, a leading global law firm, this is an extract from The Pharma Legal Handbook: Colombia, available to purchase here for GBP 119.    1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? Jurisdiction over drugs, biologicals and medical devices is centralized at the Colombian National Food & Drug Surveillance Institute, better known as INVIMA.…