The National Agency for Regulation, Control and Sanitary Surveillance (ARCSA) has updated the official list of Over-the-Counter (OTC) Medicines in Ecuador, based on international guidelines from the World Health Organization and Ministerial Agreement No. 4917, which issues the Regulation for the Classification of Medicines and Natural Products.

What changed?
The update resulted in the exclusion of 30 active ingredients from the list due to factors such as toxicity risks, the need for medical supervision, or changes in their regulatory classification.

Regulatory Impact:
This update has practical implications for marketing authorization holders, distributors, pharmacies, retail chains, importers, and other operators involved in the commercialization of medicines and related products.

In particular, ARCSA reported that:

• Certain therapeutic groups will remain restricted to prescription-only dispensing, including cold medications containing acetylsalicylic acid, antitussives, and some anti-inflammatory drugs
• Substances that do not fall under the category of medicines, such as certain dietary supplements, were excluded
• Compounds with internationally recognized toxicity potential were removed
• Some medicines were reclassified and will now require a medical prescription

Recommendations:
Following this update, companies in the sector are advised to review their portfolios to identify products that have been reclassified or are subject to new dispensing restrictions. It is also advisable to verify the regulatory classification and commercialization method of each product, adjust sales and dispensing channels as appropriate, and coordinate these changes in a timely manner with distributors and points of sale.

You may review the list of Over-the-Counter Medicines at the following link:
List of Over-the-Counter Medicines 2026

This document is a summary of the referenced Resolutions and contains information that we consider relevant. It does not necessarily reflect the opinion of Robalino® and therefore cannot be considered as legal advice. If you would like further information regarding its content, please do not hesitate to contact us at unidadtributaria@robalinolaw.com.