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Mexico Update: Interinstitutional Accord

By Cecilia Stahlhut on August 3, 2020
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On July 31st 2020, the Interinstitutional Accord between the Ministry of Economy and the Ministry of Health, through the Federal Commission for the Protection against Sanitary Risks (COFEPRIS) and the Consumer Protection Federal Bureau (PROFECO) regarding the surveillance activities of the Amendment to the Modification of the Mexican Official Standard NOM-051-SCFI/SSA1-2010, was published on the Federal Official Gazette.

The Interinstitutional Accord mainly provides the following:

  • Non-sanction- From August 1st until November 30th, 2020, manufacturers, importers or marketers will not be sanctioned during the verifications/inspections visits carried out by PROFECO and COFEPRIS regarding those prepackaged foods and non-alcoholic beverages subject to the amendment of the NOM-051 and the Amendment.
  • Previous compliance- A period from August 1st, 2020, to September 30th, 2020, is granted in order for  products that comply in advance with the Amendment of the NOM-051 can be marketed to the final consumers before its entry into force (October 1st, 2020). It should be noted that this exemption is not applicable to importer of record of the products.
  • Extension – A period from October 1st, 2020 to November 30th, 2020, is exclusively granted, so that prepackaged foods and non-alcoholic beverages that complies with the NOM-051 but do not comply with the Front Warning Labeling System (labels and legends) referred in the Amendment can be marketed to the final consumers.

Please be informed, that it is expressly established that neither COFERPIS nor PROFECO will administratively sanction with warnings, fines, closure, arrest, suspension, revocation, cancellation, prohibit immobilization, insurance, withdrawal of the market and/or issuance of alerts, in the terms of the provisions referred above. The Interinstitutional Accord came into effect on August 1st, 2020.

 

Photo of Cecilia Stahlhut Cecilia Stahlhut

Counsel, Mexico City

Cecilia Stahlhut Espinosa represents life sciences and consumer products companies in Mexico, with a focus on health and consumer law matters. She works with clients throughout all stages of complex and innovative projects. Her years of experience as external counsel…

Counsel, Mexico City

Cecilia Stahlhut Espinosa represents life sciences and consumer products companies in Mexico, with a focus on health and consumer law matters. She works with clients throughout all stages of complex and innovative projects. Her years of experience as external counsel to many life sciences companies offer her unique insight into the industry.

She has a wealth of experience in regulatory drug matters (pharmaceutical), medical devices and equipment, research and development, biotechnology, compliance of new product technologies, and general health regulatory compliance. Cecilia has particular experience in the regulation of cosmetics, food, alcohol, tobacco, and consumer products in Mexico.

She has also participated in the planning and adoption of regulatory strategies for various companies, with respect to product advertising and labeling, product liability, marketing of high-tech products, and the launching of new products. She also advises clients on sophisticated regulatory structures and the restructuring of business models and operations, clinical research projects, approval and marketing authorization pathways, standards for regulated products, and challenging labeling and advertising issues.

Cecilia has reviewed promotional materials for an extensive range of products and advised clients on promotional activities and compliance of regulations regarding interactions with health care professionals and related organizations.

Recently, Cecilia was seconded to a major orphan drug company to advise on regulatory framework applicable to orphan drugs as well as the ongoing business activities of the client, including contracts, advertising, marketing, pharmacovigilance, and health-corporate governance.

Read more about Cecilia StahlhutEmail
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  • Posted in:
    Food, Drug & Agriculture
  • Blog:
    A Seat at the Table
  • Organization:
    Hogan Lovells
  • Article: View Original Source

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