Legal & Regulatory > Mexico

There is no doubt that COVID-19 has impacted almost every aspect of our lives. Due to the ongoing health crisis, among other efforts, governments have implemented measures expecting to break high rates of infection while trying to adapt the regulatory landscape to respond to the new virus and continuing to attend other illnesses. Moreover, the vaccination process has increased discussions over human rights, from right to health to patent rights.   An equitable and global distribution of the vaccine will…

Key facts about biosimilars and biologics in Mexico. Prepared in association with Olivares, a leading global law firm, this is an extract from The Pharma Legal Handbook: Mexico, available to purchase here for GBP 99. 1. Are biosimilar medicines considered the same as generic medicines in your country? No, biosimilars are not considered the same as generic medicines. Biosimilars are regulated by specific provisions within the sanitary legislation. The Mexican General Health Law defines a “biologic product” as any substance…

Key facts about Localization in Mexico. Prepared in association with Olivares, a leading global law firm, this is an extract from The Pharma Legal Handbook: Mexico, available to purchase here for GBP 99. 1. Are there any rules or regulations requiring and/or encouraging localization in your country? What is the legal framework defining these localization rules and policies? Largely, there are no specific rules or regulations requiring and/or encouraging localization in Mexico. Thus, there is no legal framework defining localization…

Important legal info for orphan drugs and rare diseases in Mexican pharma. Prepared in association with Olivares, a leading global law firm, this is an extract from The Pharma Legal Handbook: Mexico, available to purchase here for GBP 99.   1. What is the definition of Rare Diseases in your country? In accordance with the General health law, rare diseases are those that have a prevalence of not more than 5 people for every 10,000 inhabitants.   2. Does the…

Cannabinoid drugs, medicinal cannabis and opioid drugs in Mexico – a comprehensive legal overview. Prepared in association with Olivares, a leading global law firm, this is an extract from The Pharma Legal Handbook: Mexico, available to purchase here for GBP 99.   Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? The use of cannabis has been authorized for medicinal use, including investigational activities and granting marketing authorizations for medicines for which the active ingredient is THC. On January 12,…

Important legal info for regulatory, pricing and reimbursement in Mexican pharma. Prepared in association with Olivares, a leading global law firm, this is an extract from The Pharma Legal Handbook: Mexico, available to purchase here for GBP 99.   1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in Mexico? The authority responsible for applying and enforcing the regulatory framework in relation to drugs, biologicals, and medical devices is the Federal Commission for Protection against…

Upcoming regulatory reforms in Mexican pharma. Then read on! Prepared in association with Olivares, a leading global law firm, this is an extract from The Pharma Legal Handbook: Mexico, available to purchase here for GBP 99.   1. Are there proposals for reform or significant change to the healthcare system? INITIATIVE BIOTECHNOLOGY MEDICINES (amends article 222 Bis of the General Health Law) Public health institutions should establish an effective differentiation mechanism to ensure adequate pharmacovigilance and continuity of medical treatment, thus preventing…

  Need to know the legal situation for patents and trademarks in Mexican pharma? Then read on! Prepared in association with Olivares, a leading global law firm, this is an extract from The Pharma Legal Handbook: Mexico, available to purchase here for GBP 99.   1. What are the basic requirements to obtain patent and trademark protection? To obtain the protection of a trademark for a sign, it is required to file an application before the Mexican Intellectual Property Office…

All you need to know about product liability in Mexican pharma. Prepared in association with Olivares, a leading global law firm, this is an extract from The Pharma Legal Handbook: Mexico, available to purchase here for GBP 99.   1. What types of liability are recognized in your jurisdiction? A. LEGAL PROVISIONS In general terms, liability arises from provisions in federal or local civil codes in Mexico. Liability can also arise from statutory terms. The NOM for good manufacturing practices…

The key points to know from a legal standpoint about traditional medicines and OTC products in Mexico. Prepared in association with Olivares, a leading global law firm, this is an extract from The Pharma Legal Handbook: Mexico, available to purchase here for GBP 99.   1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? Traditional herbal medicinal products are regulated by the General Health Law and its regulations. This type of products can contain…

Key legal info on marketing, manufacturing, packaging & labeling, advertising in Mexico. Prepared in association with Olivares, a leading global law firm, this is an extract from The Pharma Legal Handbook: Mexico, available to purchase here for GBP 99.   1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? The authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products are…

Conducting preclinical or clinical trials in Mexico? Get the legal lowdown here. Prepared in association with Olivares, a leading global law firm, this is an extract from The Pharma Legal Handbook: Mexico, available to purchase here for GBP 99.   1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? Clinical trials for innovator biological products must take place in Mexico when the product is to be manufactured in Mexico. For products…