Operating Notice to COFEPRIS, more important than you think

If you are about to start or already have a business related to health products or services in Mexico, it is essential that you know what the Operating Notice is. This procedure is essential to operate legally and avoid sanctions. Below, we provide you with detailed information about what it is, how it is processed, who should do it and the penalties for not processing it properly.

What is the Operating Notice?

The Operating Notice is a mandatory procedure through which Notification to the Federal Commission for Protection against Health Risks (COFEPRIS) the initiation of health-related activities in an establishment. This notice allows this authority to control and monitor businesses that influence the health of the population.

How is the Operating Notice presented?

Currently, the procedure is carried out through the digital platform DigiPris, dependent on COFEPRIS, designed to facilitate and streamline this type of administrative process. Something very important to consider is that, in order to enter the notice, it is necessary to have a e.signature (electronic signature) in force, since it is required for registration and authentication in the system.

Who should process the Operating Notice?

There are many establishments that are required to submit it, it all depends on the type of activities they carry out and the products or services they handle. Let's remember that these are industries that have a certain level of impact on health. Some more common examples are:

• Products and Supplies:
  • Pharmacies.
  • Dietary supplements.
  • Cosmetics.
  • Alcoholic beverages.
  • Cleaning and grooming products.
• Health Services Establishments:
  • Medical and dental offices.
  • Clinics.
  • Clinical laboratories.
• Other Establishments:
  • Beauty salons and spas.
  • Tattoo studios.
  • Drug distributors.
  • Food and beverage establishments.

Penalties for not submitting the Operating Notice

The omission of this procedure may result in penalties in accordance with the General Health Act and its regulations. Penalties may include:

• Economic fines from to: $207,480.00 MXN.
• Closure temporary or definitive of the establishment.
• Product Assurance.
• Other health security measures.

It is important to note that, in addition to economic sanctions, the reputation of your business can be severely affected, which could result in loss of customers and business opportunities.

Conclusion

The Notice of Operation is an essential procedure for any establishment that offers health-related products or services in Mexico. Make sure you comply with this obligation to operate within the legal framework and avoid sanctions that could harm your business.

In Rodriguez, Manzano & Garcia Lawyers, we are specialists in health law, come to us for personalized advice and find out how we will help you.