Extended responsibility in the management of medicines and pharmaceutical products

By Ministerial Agreement No. MAATE-2023-134, issued on November 22, 2023, and published in the Official Registry No. 490 on February 1, 2024, the Ministry of Environment, Water, and Ecological Transition issued the Technical Standard for the Implementation of the Extended Responsibility Principle in the Comprehensive Management of Medicines and Pharmaceutical Products (hereinafter referred to as the Standard).

The Standard applies to any entity engaged in the production, import, and initial placement on the national market. The term “initial placement on the market” refers to the introduction of medicines and pharmaceutical products into the market through any means, including national sale or donation through electronic or remote methods, i.e., when they are first distributed in the Ecuadorian territory.

Non-hazardous medicines and pharmaceutical products are excluded, as determined by the National Health Authority, as well as medical devices.

The main obligations of the producers are as follows:

1. Obtain the environmental administrative authorization for the manufacturing, storage, and transportation of medicines or pharmaceutical products.
2. Obtain the registration as a hazardous and/or special waste generator for medicines and pharmaceutical products that are out of specifications or expired within the scope of the producer’s extended responsibility and update it in case of any changes.
3. Develop and submit, individually or collectively, a Comprehensive Management Program (“CMP”). Report compliance with actions and goals established in the CMP in the first 10 days of March each year.
4. Inform the National Environmental Authority of emergency events, accidents, and incidents involving expired or out-of-specification medicines and pharmaceutical products within one (1) day of the occurrence, using any official means.

The main obligations of the distributors are:

1. Implement the CMP.
2. Deliver expired or out-of-specification medicines or pharmaceutical products to authorized waste managers.
3. Inform the Producer, within one (1) day of the occurrence of emergency events, accidents, and incidents involving expired or out-of-specification medicines and pharmaceutical products; and,
4. Provide the consumers with areas for the installation of collection points, equipped with measures for the safe handling and disposal of medicines and pharmaceutical products that are out of specifications or expired.

The CMP will have a validity of 5 years and must ensure that the management of expired or out-of-specification medicines is carried out in a technically sound manner with the lowest possible risk, incorporating gradual collection goals.

Rafael Serrano, partner at CorralRosales
rserrano@corralrosales.com
+593 2 2544144