Key provisions

On 31 May 2021 a decree amending, adding and eliminating various provisions of the Health Supplies Regulation was published in the Federal Official Gazette.

Key provisions

There are specific provisions set out in relation to the labelling requirements for medicines whose use and distribution is exclusively intended for public health and social security institutions. These requirements are as follows:

  • The primary or secondary packaging must be clearly differentiated from the packaging for the private sector.
  • The packaging must contain the information set out in articles 24 and 24 bis of the regulations, which refer to the minimum information that labels must display, as well as the general requirements of the corresponding Mexican Official Standard.
  • The packaging must include the wording "not for sale" or "property of the public health sector".
  • The secondary packaging, or if applicable, the primary packaging, must contain the code given by the Health Supplies Compendium.

The provisions also state that the documents included in the application for goods marketing authorisation may be in Spanish as well as in English.

The number of documents and the amount of information that is required with applications for marketing authorisations, modifications or amendments regarding pharmaceutical products has been simplified.

The authority now has a deadline – 45 working days for technical modifications and 20 working days for administrative modifications – to resolve amendment requests and applications regarding the conditions of the marketing authorisation of pharmaceutical products.

The period that may be granted to the holder of the marketing authorisation to use up the existing stock of packaging materials and finished products is extended to a maximum of 240 days, with no further extensions allowed.

The amendments have eliminated a considerable amount of information and some of the documents referred to in articles 190 bis (1), 190 bis (2), 190 bis (3) and 190 bis (4) of the regulations regarding requirements to be included with the application for the marketing authorisation of pharmaceutical products, medical devices and other similar health supplies, whether of domestic or foreign origin.

The period allowed for submission of marketing authorisation extension requests is reduced to 150 calendar days before the date that the existing marketing authorisation expires. The compulsory response period for the authorities to resolve marketing authorisation extension requests is reduced from 150 to 120 calendar days.

The public sector is provided with a 180-calendar-day period to implement the necessary measures for the acquisition of medicines that comply with the new requirements regarding the labelling of these products.

Finally, any marketing authorisation applications filed before the decree came into force will be resolved based on the provisions in force at the time of their filing.


It is clear that the purpose of the amendments is to simplify the marketing authorisation request procedure for pharmaceuticals, medical devices and other health-related supplies to reduce the time that the health authorities normally need to resolve these types of request.

Recently, it has been seen that several efficiency-enhancing procedures have been implemented by the new head of the Federal Commission for the Protection Against Sanitary Risks to provide the individuals and legal entities subject to these kinds of obligations with more efficient and less time-consuming administrative burdens.

For further information on this topic please contact José Alberto Campos Vargas or Ernesto Vega Zaldivar at Sanchez-DeVanny Eseverri SC by telephone (+52 55 5029 8500) or email ([email protected] or [email protected]). The Sanchez-DeVanny Eseverri SC website can be accessed at