Implementation of mandatory notification procedures of advertising before ANMAT
On August 13th, 2015, the Argentine's National Administration of Drugs, Food and Medical Devices (“ANMAT”) issued Regulation No. 6.516/2015 (the “Regulation”) published in the Official Gazette on August 20th, 2015.
This Regulation establishes that all companies which are owners of products subject to ANMAT’s sanitary surveillance (i.e. pharmaceutical products, food, dietary supplements, cosmetic products, household products, medical technology devices, dental products and “in vitro” diagnostic devices) must notify ANMAT of any advertising (traditional or non traditional advertising) issued through any means of communication. Along with the notification, companies shall have to file with the ANMAT the advertising piece in the format that it will be communicated to public.
The Regulation states that the above notification must be done, within 48 hours once the advertising is issued, through ANMAT’s web site (www.anmat.gov.ar) using a user and password given by the ANMAT’s IT Department. The notification shall be considered as a sworn statement and shall be signed by the legal Representative or attorney in fact and the company’s Technical Director.
The Regulation also establishes that, in case of breach of advertising prevailing regulations, ANMAT would be able to demand companies to take down the infringing advertising (and may publish this demand on ANMAT’s website), without prejudice of other actions that may correspond. Breach of ANMAT’s advertising regulations shall make the product’s owner – and the technical director if corresponds, subject to penalties set forth in the Pharmaceuticals Law, Argentine Food Code and other regulations.
Thus, a mechanism is created through the Regulation to facilitate the monitoring and advertising control and promotion of products subject to health surveillance that was created by Regulation 2845/2011.
Originally, the Regulation was intended to be in force as of September 20th, 2015 but, on September 30th, 2015, ANMAT issued the internal Provision 00010 that postpone the effective date of the Regulation to October 15th, 2015.
This article contains information of general interest and it does not constitute a legal opinion about this matter.