COFEPRIS revokes criticized Criterions and Guidelines published by the former Administration.

September 11, 2019

During its former administration, the Federal Commission for the Protection against Sanitary Risks (COFEPRIS) issued the general administrative acts listed below, with the alleged purpose of consolidating the criterions for the analysis and prosecution of different advertisement authorizations before such authority:

• Attention criterions for the prosecution of advertisement authorizations for drugs, homeopathic medicines and herbal remedies.
• Guidelines establishing the criterions for the advertisement promoting healthy habits with the purpose of avoiding possible health risks.
• Criterions for the analysis of applications for alcoholic beverage advertisement authorizations.
• Guidelines for administrative simplification of the procedure and authorization of digital advertisement.
• Attention criterions for the prosecution of applications for drug advertisement authorizations.
• Attention criterions forth prosecution of advertisement authorization for over the counter drugs, homeopathic medicines and herbal remedies.

We considered that these Guidelines were issued against the provisions of the General Law for Regulatory Improvement and the Federal Law of Administrative Procedure, because the decree projects were not reviewed by the National Regulatory Improvement Commission (CONAMER) and were not published in the National Gazette.

Nonetheless, COFEPRIS enforced the above listed administrative acts for the prosecution and resolution of administrative procedures. This circumstance generated legal uncertainty for the applicants, as the authority decided the cases based on general administrative acts with no formal validity.

On June 25^th, 2019, the new Commissioner for Protection against Sanitary Risks issued an official communication directed to the hierarchically inferior authorities revoking the administrative acts under comment. The Commissioner recognized that due to procedural flaws in their creation process and the fact that they were not published in the Official Diary, these could not have legal effect.

The Commissioner also urged the sanitary authorities to solve the pending marketing authorizations in accordance with the General Health Law and its Regulations.

Our firm was involved in the litigation against the Circular S00/102/2017 entitled “Criterions for the analysis of applications for alcoholic beverage advertisement authorizations”, wherein the Courts solved that it could not be considered as a mandatory law or regulation but only as an administrative instruction from the Commissioner to the hierarchically inferior authorities. The conclusions reached by the Courts in such litigation is consistent with the official communication revoking the Guidelines and criterions.