Labeling of medicines exclusively intended for public sector in Mexico

December 4, 2020

The Decree amending article 26 of the Health Law Regulation (HLR) is pending publication in the Official Gazette of the Federation and its eventual entry into force.

This decree details the guidelines for the labeling of drugs for the public sector. In general terms, it indicates that the primary and secondary packaging of a medicine must be differentiated from that destined for the public sector and the labeling must include the legend “its sale prohibited” or “property of the Public Health Sector.” Likewise, the general provisions regarding labeling will be maintained.

Overall, this reform provides greater certainty regarding the requirements that must be met in the labeling of medicines destined exclusively for public health and social security institutions. However, it imposes an additional obligation on holders of sanitary registration.

OLIVARES is permanently attentive to changes and modifications to legal provisions, with the purpose of timely inform our clients thereof.