Latest updates

Software – the unregulated medical device
Sanchez DeVanny Eseverri SC
  • Healthcare & Life Sciences
  • Mexico
  • 26 June 2019

It is a basic constitutional principle that no activity or product can be restricted or limited unless a legal provision establishes such restriction or limitation. This principle has resulted in a number of legal gaps regarding products and activities of a technical nature, as Mexican law is rarely as dynamic as technology and innovation. One of the most visible technological advances has been in the software and app arena, particularly with regard to healthcare. This has led to a challenging situation for the health authorities.

Ministry of Health announces new cannabis regulations
Sanchez DeVanny Eseverri SC
  • Healthcare & Life Sciences
  • Mexico
  • 10 April 2019

The Ministry of Health recently announced that the Federal Commission for the Protection against Sanitary Risk guidelines regarding industrial products with a tetrahydrocannabinol content of less than 1% have been suspended. In addition, all permits granted under the suspended guidelines will be reviewed and new draft regulations will be prepared in coordination with the Ministry of the Interior.

Importing and marketing medicines and medical devices
Sanchez DeVanny Eseverri SC
  • Healthcare & Life Sciences
  • Mexico
  • 03 April 2019

Numerous laws and regulations govern the import and marketing of medicines and medical devices. In addition to purely regulatory and health-related requirements, a number of provisions which govern import procedures and products in general must be observed. Most importantly, parties which intend to market a medicine or medical device in Mexico (whether imported or manufactured domestically) must obtain the corresponding marketing authorisation from the health authorities.

Traditional indigenous medicine: historic asset or mere political move?
Sanchez DeVanny Eseverri SC
  • Healthcare & Life Sciences
  • Mexico
  • 20 March 2019

Traditional medicine is still a primary health resource for millions of people who do not have access to so-called 'modern medicine'. However, traditional medicine and knowledge are not covered by the general legal provisions which govern human health or specifically recognised by the Mexican health authorities. In some cases, traditional medicine has even been deemed illegal and attempts have been made to outlaw its practice and promotion.

Medical investigations: can regulation keep up with technology?
Sanchez DeVanny Eseverri SC
  • Healthcare & Life Sciences
  • Mexico
  • 12 December 2018

It is well known that the law often struggles to keep up with new products and activities. In many cases, the legal provisions which apply to regulated activities lose their applicability due to the speed with which technology enables parties to operate outside the scope of the law or the jurisdiction of the relevant authorities. This is particularly true for physical research involving humans, as advancements in communication and the transfer of data have significantly broadened the scope of such research.

Recent changes to cannabis legal landscape
Sanchez DeVanny Eseverri SC
  • Product Regulation & Liability
  • Mexico
  • 29 November 2018

A number of changes to the cannabis legal landscape have taken place in Mexico over the past few weeks. For example, the Federal Commission for the Protection against Sanitary Risk recently published on its website guidelines on the sanitary control of cannabis and cannabis derivatives. Further, the Supreme Court issued its fifth decision granting constitutional protection against the adult use prohibition and Congress was presented with a bill to implement the General Law for Cannabis Control.

The great hemp debate: marijuana or not?
Sanchez DeVanny Eseverri SC
  • Healthcare & Life Sciences
  • Mexico
  • 19 September 2018

Although Mexico has some of the most stringent regulations regarding the growth, use and marketing of marijuana, this position has recently changed, as evidenced by the amendments to the General Health Law which permit the health authorities to design and execute public policies regarding the use of pharmacological derivatives of marijuana. However, the question remains as to whether hemp constitutes a narcotic under the General Health Law.

Evolution of medical marijuana regulation
Sanchez DeVanny Eseverri SC
  • Healthcare & Life Sciences
  • Mexico
  • 05 September 2018

Mexico has some of the most stringent regulations regarding the growth, use and marketing of marijuana and marijuana-based products. Over the past few decades, considerable resources have been devoted to combating all activities relating to psychoactive plants. However, the government's position on the use of marijuana from a medical or pharmaceutical perspective has changed in recent years.

Pharmaceutical and medical device company M&A: regulatory and tax implications
Sanchez DeVanny Eseverri SC
  • Healthcare & Life Sciences
  • Mexico
  • 22 August 2018

What happens to marketing authorisations (MAs) or sanitary registrations for pharmaceutical and medical devices may be one of the biggest questions to consider before, during and after a merger or acquisition of a legal entity active in the pharmaceutical or medical device industry. Parties undertaking a merger or acquisition which involves the transfer of an MA are advised to undertake a comprehensive analysis beforehand, as bundling the MA with other actual assets could trigger tax issues or exposure.

Tobacco products: what constitutes a crime?
Sanchez DeVanny Eseverri SC
  • Product Regulation & Liability
  • Mexico
  • 05 July 2018

The Secretariat of Health recently announced amendments to the General Law on Tobacco Control. The new Title Eight includes Articles 56 and 57, which specifically address crimes relating to tobacco products. The new provisions are particularly relevant for individuals and legal entities engaged in the tobacco industry. Industry players are advised to consider the scope of these amendments and determine how their business operations in Mexico may be affected.

USTR calls on Mexico to improve pharmaceutical and medical device innovation and market access
Sanchez DeVanny Eseverri SC
  • Healthcare & Life Sciences
  • Mexico
  • 23 May 2018

The Office of the United States Trade Representative recently issued its Special 301 Report. Section I.A.1 of the report, which concerns pharmaceutical and medical device innovation and market access, calls on Mexico to address pharmaceutical and medical device IP-related challenges, lists the steps that it should take in order to open its markets to IP-intensive pharmaceutical products and medical devices and encourages it to recognise the value of innovation in these fields.

M&A, asset sales and spin-offs in pharmaceutical and medical device industries – part two: marketing authorisations
Sanchez DeVanny Eseverri SC
  • Healthcare & Life Sciences
  • Mexico
  • 02 May 2018

Although it is common for the parties involved in mergers, acquisitions, asset sales, spin-offs or similar activities in the pharmaceutical, medical device and other health-related industries to treat marketing authorisations as assets which are subject to the general negotiation process, this approach is controversial. If incorrect, an allocation of a monetary value to or a transfer of a marketing authorisation could be considered an invalid act between the relevant individuals or legal entities.

M&A, asset sales and spin-offs in pharmaceutical and medical device industries: what you need to know
Sanchez DeVanny Eseverri SC
  • Healthcare & Life Sciences
  • Mexico
  • 25 April 2018

Mexico is the second largest market for the pharmaceutical and medical device industries in Latin America. Thus, as mergers and acquisitions, asset sales, spin-offs and similar activities in the pharmaceutical, medical device and other health-related industries are often global or at least multinational, they often affect companies that operate in Mexico. Although there have been many unfortunate situations where such activities have been delayed or cancelled, this can be avoided.

New regulations govern use of marijuana for health and industrial reasons
Sanchez DeVanny Eseverri SC
  • Product Regulation & Liability
  • Mexico
  • 05 April 2018

New legal provisions regarding the use of marijuana for medical and industrial purposes were recently published in the Federal Official Gazette and have sparked great interest in the potential development of such products in Mexico. However, the proposed regulations could contravene other federal laws, regulations and standards which explicitly state that marijuana and its derivatives cannot be used as ingredients or raw materials for food, beverages, cosmetics and other products bound for human consumption.

COFEPRIS issues new drug advertising guidelines
Sanchez DeVanny Eseverri SC
  • Healthcare & Life Sciences
  • Mexico
  • 14 March 2018

The Federal Commission for the Protection against Sanitary Risk recently published new guidelines for the authorisation of ad applications regarding prescription and over-the-counter drugs, herbal remedies and homeopathic medicines. As the guidelines include several provisions that appear to be against the General Health Law and the Health Law Regulations on Advertisements, they may give rise to a number of interesting scenarios.

Current search

Refine search

Work area