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In brief

There is a clear increase of enforcement actions taken by health authorities, both at the Federal and State level, where authorities are verifying if both physician and dining rooms at manufacturing plants, from all industries, have been properly supported by the applicable Notices of Operation. At the same time, many local health authorities are unduly requesting companies to have a Notice of Operation for their manufacturing operations. Companies shall comply the former and be prepared to reject the latter in order to prevent disruptions of operations and future sanctions.


Recommended actions

  1. Manufacturing plants shall review if they have properly:
    1. Filed a Notice of Operation for the physician room they have opened at the plant, and
    2. Filed a Notice of Operation for the dining room they have opened at the site.
  2. At the same time, companies shall be prepared to reject any demand to:
    1. File a Notice Operations for their manufacturing activities, if their activities are not explicitly listed in an official list published by the Ministry of Health.

In more detail

Although certain notifications obligations under the health law regime have existed for a long time, they may not have been actively enforced at the local level, facilitating that for some companies, these obligations may have gone off their radar.

However, the COVID-19 pandemic and the extraordinary measures adopted by different authorities, have resulted in several waves of inspection visits in all over the country.

These waves took place both early on, with the first adopted measures, when labor and health authorities started inspection visits to verify the essentiality of operations, and later on when the authorities were mandated the verification of compliance with either (i) the Strategy for Reopening Activities1, and (ii) the Specific Technical Guidelines for Resuming Activities2.

During those visits, it has become a trend to find out that many manufacturing plants have not filed or updated the applicable Notices of Operation for the physician rooms and dining rooms that they have operated for long.

To recall, having a physician room at the manufacturing site derives from an obligation foreseen under the labor law regime, for places of work that have more than 100 employees. In contrast, having a dining room at the plant for employees is not a legal obligation, but it is generally requested in collective agreements and is accepted as it offers tax benefits.

In fact, during inspection visits, authorities are verifying compliance not only with the aforementioned Notices of Operation, but also with two applicable Technical Standards: (i) NOM-005-SSA3-2018 on infrastructure and equipment requirements for physician rooms, and (ii) NOM-251-SSA1-2009 on hygiene requirements for the preparation of food and beverages. However, the most common irregularity is not having the Notice of Operation.

At the same time, health authorities, particularly local ones, have been unduly requiring that companies have a Notice of Operations for their manufacturing activities even if that is not applicable. Companies should be ready to defend and reject this, on the legal bases that only those activities that are explicitly included in an official list published by the Ministry of Health, require such notification. This is often referred to as the “List of SCIAN Codes”.

The Healthcare & Life Sciences Group at Baker McKenzie can gladly support companies, both before and during these inspection visits, to comply with the applicable Notices of Operation for physician and dining rooms, as well as to articulate a defense against unduly requests to have one when not applicable.

#LifeSciencesBakerMcKenzie


1 On May 14, 2020, the Ministry of Health published in the Official Gazette of the Federation (“DOF”), the Agreement establishing a strategy for the reopening of social, educational and economic activities, as well as a system of traffic light by regions to weekly assess the epidemiological risk related to the reopening of activities in each federal entity, as well as extraordinary actions.

2 On May 29, 2020, the Ministries of Health, Economy, and Labor; as well as the Mexican Institute of Social Security, jointly published in the DOF the Agreement establishing the Specific Technical Guidelines for the Reopening of Economic Activities.

Author

Dr. Lopez Silva is the head of Healthcare & Life Sciences Industry Group in Mexico, as well as a member of the Steering Committee of the North American and Latin America Healthcare Group. He has more than 17 years of experience in regulation of life sciences, pharmaceutical law and biotechnology matters, having worked in the private and public sectors and at the national and international level. For several consecutive years, Dr. Lopez Silva has led the rankings for Life Sciences both nationally (Chambers Latin America) and internationally (Chambers Global).

Author

David Campos is a senior associate of the Healthcare & Life Sciences Practice Group of Baker McKenzie’s Mexico City office. David joined the Firm in 2019 after completing an LL.M. in Global Health Law and a Certificate in Food and Drug Law at Georgetown University Law Center (Washington, DC). David has more than seven years of experience advising clients in connection with regulation of life sciences and general corporate matters of the pharmaceutical industry.

Author

Alejandra Roman-Gonzalez is a support specialist in Baker McKenzie Mexico office.