On December 5, 2019, the Supreme Decree (SD) 026-2019-SA was published in the Official Gazette, which regulates the Emergency Decree (ED) 007-2019.

ED 007-2019 defines that medicines, biological products and medical devices are an essential part of the right to health and provides for measures to ensure their availability. This regulation aims to establish mechanisms to optimize and guarantee the availability of strategic health resources and access to effective, safe and quality medicines for the entire population. The Decree applies to several government entities, including the Ministry of Health.

The activities to be developed by the entities of the Ministry of Health were regulated by SD 026-2019-SA.

The main impact for marketing authorization holders is the mandatory notification of temporary or permanent import or manufacture discontinuation. The notification must be made through the web system provided by DIGEMID, informing the type of discontinuation, its estimated start and end (if applicable) dates and its reasons.

The reasons accepted by SD are described below:

• Logistical aspects: increased demand or import problems;

• Commercial reasons: lack of interest in selling the product;

• Manufacturing aspects: change of manufacturer or of some manufacturing step to another plant, or change of manufacturing step, by decision of the manufacturer or by sanitary requirement;

• Raw materials: difficulties in obtaining raw materials;

• Safety or effectiveness problems;

• Others.

Unplanned discontinuation due to unforeseen circumstances or force majeure must also be notified.

Notification must be submitted 90 days in advance for temporary discontinuation, 180 days in advance for permanent discontinuation, and up to 5 days after the unscheduled discontinuation is set up.

The SD also establishes the activities that must be carried out by the logistics operators together with the National Center for the Supply of Strategic Resources in Health to maintain the availability.

With regards to pharmaceutical establishments, they must demonstrate the availability of medicines, keeping at least 80% of the medicines on the list made available by the Ministry of Health in stock and, for each one, a minimum stock sufficient for a complete treatment regimen with the medicine, also according to the mentioned list.

The links to consult the information available in the news are described below:

• The list of discontinued drugs: https://bit.ly/31LxAPV;

• The notification system – DIGEMID: https://bit.ly/2OKHkVa;

• ED 007-2019: https://bit.ly/2SmpslD;

• SD 026-2019: http://bit.ly/3bUuZaU.

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