Label Generic Drugs Should Include the Words 'Generic Drug' 

November, 2013 - Bustamante & Bustamante

In a statement issued by the National Regulatory Agency, Control and Surveillance (ARCSA), drugs that are sold in Ecuador must have labels stating the words 'generic', otherwise it can not be marketed as of January 24, 2014.

This requirement is covered in the Registration Regulations General Health Drugs, which provides: "In the case of a generic drug, it is mandatory in its external label appear in legible and indelible words 'GENERIC DRUG' in capital letters, in red, code Pantone Red 032 and larger than about 20% relative to the product name. "

Furthermore, the transitional provision 6 of Ministerial Agreement No. 2883, was granted a period of 360 days, from January 29, 2013, for the fulfillment of this obligation by the manufacturers of generic drugs.

The Ministry of Health, through its competent agencies monitor compliance with this obligation and apply appropriate sanctions, as provided in art. 237 of the Health Act, which states that the health infringements will be sanctioned subject to the civil, administrative and criminal penalties that may be incurred.



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