A Q&A guide to the commercialisation of healthcare in Mexico.
This Q&A provides an overview of the regulatory framework for the commercialisation of medical products in Mexico. It covers the key requirements for manufacturing, advertising and selling drugs, medical devices, biological products and natural health products.
To compare answers across multiple jurisdictions, visit the commercialisation of healthcare Country Q&A tool.
This Q&A is part of the Commercialisation of Healthcare Global Guide.
What is the regulatory framework for medical products?
The regulatory framework for medical products (that is, drugs, medical devices and biological products for human use) is set out in the following federal laws:
General Health Law (Ley General de Salud). General Health Law Regulations (Reglamento de Insumos para la Salud). Official Mexicans Standards (Normas Oficiales Mexicanas) (NOMs). Regulatory authorities
The Mexican authority responsible for enforcing the regulatory framework relating to medical products is the Federal Commission for Protection against Sanitary Risk (Comisión Federal para la Protección contra Riesgos Sanitarios) (COFEPRIS), which is part of the Ministry of Health (Secretaria de Salud).
For more information on the COFEPRIS see box: The regulatory authority.
The health system in Mexico includes some private parties that are involved in the commercialisation of medical products, including:
Pharmaceutical companies. Distributors. Third health institutions (that is, private or public companies authorised to pre-examine regulatory submissions). 2. What types of medical products are regulated?
The medical products that are regulated in Mexico are:
Drugs. Biological products. Traditional medicines. Homeopathic medicines. Medical devices. Drugs
What are the general requirements for a drug to be manufactured, advertised and sold?
Companies manufacturing medicinal products must obtain a manufacturing licence/approval (licencia sanitaria) from the Federal Commission for Protection against Sanitary Risk (Comisión Federal para la Protección contra Riesgos Sanitarios) (COFEPRIS).
The requirements for manufacturing approval are set out mainly in the General Health Law, its regulations and Official Mexican Standards (NOMs) setting good manufacturing practices for medicinal products (NOM-059-SSA1-2015) and health requirements for manufacturing (NOM-176-SSA1-1998). They regulate and provide guidelines and standards relating to:
Workforce conditions in the manufacturing facilities (including, for example, responsibilities, uniforms, and medical examinations). Legal and technical documentation. Facility requirements. Manufacturing, validity and quality controls and protocols. Standard operation procedure. Biosafety measures. Packaging. Equipment. Destruction and elimination of waste. The General Health Law Regulations set 60 working days as the time frame for reviewing an application for a manufacturing approval. This is reduced by up to ten working days if the application has been previously reviewed by an authorised third health institution (that is, a private or public company authorised by the COFEPRIS to review regulatory submissions).
The COFEPRIS ensures that applicable NOMs are followed, from when a facility starts production and at least every two years after then.
The advertising of medicinal products in Mexico is governed by the:
General Health Law Regulation regarding Advertising (Reglamento de la Ley General de Salud en Materia de Publicidad) (RLGSMP). Opinions issued by the Advertising Council. The COFEPRIS is responsible for enforcing the provisions above.
The Industrial Property Law and the Federal Law for Protection of Consumers also contain provisions on advertising.
Additionally, the National Chamber of the Pharmaceutical Industry issued a Code of Ethics that includes provisions on advertising. Although those provisions are not mandatory, failure to comply may result in a suspension of rights as a member of the Chamber or in expulsion from it.
Only over-the-counter drugs can be advertised to the general public, subject to prior approval from the COFEPRIS. Media channels must request certified copies of the corresponding marketing authorisations before releasing the advertisements. Any visual or audio advertisement for over-the-counter drugs must (Article 43, RLGSMP):
Include the message "consult your physician". Mention any required precautions when the use of the drug represents a danger in the case of an existing pathology. It is not possible to advertise prescription medicines to the general public (Article 310, General Health Law). Prescription drugs can be advertised to health professionals. However, advertisements directed to healthcare professionals can only be published in specialised media and must be based on the approved prescription information (Article 42, RLGSMP).
To sell any drug, manufacturers must obtain a marketing authorisation from the COFEPRIS. To obtain a marketing authorisation, the manufacturer must:
Have an authorised manufacturing facility, either in Mexico or abroad. Provide a certiﬁcate of good manufacturing practices. Provide a certiﬁcate of free sale, for products manufactured abroad. Appoint a legal representative. Have a pharmacovigilance unit. Have a storage facility. Provide information on patent rights. Provide scientiﬁc information on safety and efﬁcacy (for new drugs) or interchangeability tests (for generic drugs). Provide information on stability, identity and purity. Provide information on prescription. File a draft label. Pay government fees. The requirements may vary depending on the manufacturer and type of drug.
The applicable regulations establish a system of co-operation between the COFEPRIS and the Mexican Institute of Industrial Property. The main reason for this is to prevent the granting of marketing authorisations in violation of exclusive rights.
Are there different requirements for patented and generic drugs?
There are different requirements for patented and generic drugs.
For patented drugs, applicants must prove the safety and efﬁcacy of new products through standard clinical trials. New products include:
Medicines to be approved for the ﬁrst time in Mexico. Medicines with a new combination of two compounds that do not exist in Mexico. Drugs or medications that are on the market but with a different therapeutic indication. For generic drugs, applicants must only provide information concerning dissolution proﬁles or bioavailability studies regarding the innovator product, instead of their own clinical trials.
The Federal Commission for Protection against Sanitary Risk (Comisión Federal para la Protección contra Riesgos Sanitarios) and the Mexican Institute of Industrial Property (IMPI) will co-operate to prevent the granting of marketing authorisations in violation of exclusive rights.
Under the IP Regulations, IMPI must publish every six months a gazette that includes compound patents (linkage gazette). Formulation patents have been included since 2010, in accordance with a ruling of the Mexican Supreme Court.
When ﬁling the application, the generic applicant must either:
Prove ownership of, or the holding of a licence...