Mexico: Commercialisation Of Healthcare In Mexico: Overview

Last Updated: 17 August 2017
Article by Alejandro Luna, Erwin Cruz and Ingrid Ortiz

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.

Regulatory overview

1. What is the regulatory framework for medical products?

Legislation

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.

Private parties

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

3. What are the general requirements for a drug to be manufactured, advertised and sold?

Manufacturing

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.

Advertising

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).

Sale

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.

4. 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 for, the corresponding patent recorded before IMPI.
  • State under oath that the application does not violate any of the products included in the linkage gazette and complies with patent law.

5. What authority is responsible for regulating the manufacture, advertising and sale of drugs?

The authority responsible for regulating the manufacture, advertising and sale of drugs is the Federal Commission for Protection against Sanitary Risk (Comisión Federal para la Protección contra Riesgos Sanitarios) (COFEPRIS).

For more information on the COFEPRIS see box: The regulatory authority.

6. Are there fewer or different requirements for drugs that have already been licensed/approved in another jurisdiction?

There is a special procedure for drugs to be approved for the first time in Mexico and that have previously been approved by one of the following foreign agencies:

  • European Medicines Agency.
  • US Food and Drug Administration.
  • Health Canada.
  • Swiss Agency for Therapeutic Products.
  • Australian Therapeutic Goods Administration.

These specific rules were issued by the Federal Commission for Protection against Sanitary Risk (Comisión Federal para la Protección contra Riesgos Sanitarios). The approval procedure is based on the dossier filed with the foreign regulatory agency, to reduce approval time frames by up to 60 working days.

Industry participants have welcomed these rules, although they are still being tested.

7. Is it possible to sell drugs to or buy drugs from other jurisdictions?

A marketing authorisation issued by the Federal Commission for Protection against Sanitary Risk (Comisión Federal para la Protección contra Riesgos Sanitarios) (COFEPRIS) is required to sell drugs manufactured in other jurisdictions. In Mexico, selling drugs without a marketing authorisation can be prosecuted as a criminal offence.

Salvador, Ecuador and Colombia announced that drugs with a marketing authorisation issued by the COFEPRIS can be sold in these countries, as the COFEPRIS has been recognised as a continental regulatory agency by the Pan American Health Organization.

8. Is it permitted to advertise drugs to consumers? Are there restrictions on advertising?

Only over-the-counter drugs can be advertised to the general public, subject to approval by the Federal Commission for Protection against Sanitary Risk (Comisión Federal para la Protección contra Riesgos Sanitarios) (COFEPRIS). Media channels must require certified copies of the corresponding marketing authorisations for medicines before releasing the advertisements.

An advertisement must be limited to indicating the general characteristics of the product, its therapeutic properties and use.

Any visual or audio advertisement for over-the-counter drugs must (Article 43, Regulation of the General Law of Health regarding Advertising (Reglamento de la Ley General de Salud en Materia de Publicidad) (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.

Advertising prescription medicines to the general public is prohibited (Article 310, General Health Law). Prescription medicines can be advertised to health professionals. However, advertisements directed to health professionals can only be published in specialised media and must be based on medical prescription information (Article 42, RLGSMP).

On 19 January 2012, the RLGSMP was amended, granting the COFEPRIS strong powers to:

  • Request media channels to remove any suspected illegal advertisement within 24 hours.
  • Impose a fine of up to 16,000 times the minimum wage (about US$83,000) on entities that publish illegal advertisements.

Electronic advertisement is governed by the general rules on advertising in Article 2 of the RLGSMP. The COFEPRIS is currently increasing its monitoring of internet advertisements for medical products, which had been less strict than for television or radio advertisements.

Medical devices

9. What are the general requirements for a medical device to be manufactured, advertised and sold?

Manufacturing

Companies manufacturing medical devices must file an operation notice with 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 medical devices (NOM-241-SSA1-2012).

Medical devices are classified as follows:

  • Class I. Well-known devices with proven safety and efficacy, which are not commonly introduced in the human body.
  • Class II. Devices which are introduced in the human body and may have materials or concentrations modifications.
  • Class III. Devices recently accepted in medical practice, which are introduced in the human body for more than 30 days.

Advertising

The advertising of medical devices must be authorised by the COFEPRIS. The authorisation must state whether the product can be advertised to the general public or to health professionals only.

Advertising to the general public must:

  • Be clear and easily comprehensible.
  • Contribute to hygiene education.
  • Include cautions if use of the product can involve health risks.

Sale

Selling certain medical devices require a marketing authorisation from the COFEPRIS, in particular those classified in classes II and III. To obtain a marketing authorisation, an applicant must:

  • Have an authorised manufacturing facility, either in Mexico or abroad.
  • Provide a certificate of good manufacturing practices (GMP).
  • Provide a certificate of free sale, for products manufactured abroad.
  • Appoint a legal representative.
  • Have a vigilance unit.
  • Have a storage facility.
  • Provide information on stability and quality of the device.
  • Provide scientific information on non-toxicity, safety and efficacy.
  • Provide instructions for use for the device.
  • File a draft label.
  • Pay government fees.

The above requirements can vary depending on the applicant and type of medical device.

Certain medical devices are exempt from marketing authorisation (for example, bandages, immobilisers, pads, and so on).

Exempted devices must still comply with GMP and with the labelling standards set out in relevant legislation (for example, the Consumer Protection Regulations), since regulatory authorities have wide powers to verify any potential health risk at any time. In addition, information provided on devices must be truthful and communicated in a way that does not mislead consumers (Consumer Law).

10. What authority is responsible for regulating the manufacture, advertising and sale of medical devices?

The authority responsible for enforcing rules relating to medical devices is the Federal Commission for Protection against Sanitary Risk (Comisión Federal para la Protección contra Riesgos Sanitarios) (COFEPRIS).

For more information on the COFEPRIS see box: The regulatory authority.

11. Are there fewer or different requirements for medical devices that have already been licensed/approved in another jurisdiction?

The Federal Commission for Protection against Sanitary Risk (Comisión Federal para la Protección contra Riesgos Sanitarios) (COFEPRIS) follows a special procedure for medical devices that have already been approved by:

  • The US Food and Drug Administration.
  • Health Canada.
  • The Ministry of Health, Labour and Welfare of Japan.

Approval is essentially based on the dossier filed with the foreign regulatory agency, to reduce approval time frames by up to 30 working days.

12. Is it possible to sell devices to or buy devices from other jurisdictions?

It is possible to sell devices to or buy devices from other jurisdictions. Medical devices can either require or be exempt from a marketing authorisation.

Exempted devices must still comply with good manufacturing practices and with the labelling standards set out in the applicable provisions, such as the Consumer Protection Regulations, since regulatory authorities have wide powers to verify any potential health risk at any time.

In addition, under the Consumer Law, information provided on products must be truthful and communicated in a way that does not mislead consumers.

13. Is it permitted to advertise medical devices to consumers? Are there restrictions on advertising?

It is permitted to advertise medical devices to consumers. However, advertising must be authorised by the Federal Commission for Protection against Sanitary Risk (Comisión Federal para la Protección contra Riesgos Sanitarios). Advertising to the general public must:

  • Be clear and easily comprehensible.
  • Contribute to hygiene education.
  • Include cautions if use of the product can involve health risks.

Biological products

14. What are the general requirements for a biological product to be manufactured, advertised and sold?

Manufacturing

Companies manufacturing biological products must obtain a manufacturing authorisation from the Federal Commission for Protection against Sanitary Risk (Comisión Federal para la Protección contra Riesgos Sanitarios) (COFEPRIS).

The General Health Law and its regulations were recently amended to include provisions on the approval of biologics and biocomparables (biosiomilars). New rules on the approval of biological innovators and biocomparables were published in February 2015. These new rules give the Assessment Sub-Committee on Biotech Products (Subcomité de Evaluación de Productos Biotecnológicos) (SEPB) powers to:

  • Assess technical and scientific data in connection with clinical trials, approval or renewal of innovator biologics or follow-on biologics (biocomparables).
  • Issue opinions on the characterisation of biologics as innovators, reference products or biocomparables.

The new rules also include transitional provisions for the renewal of marketing authorisations of biologics granted before the amendments to the General Health Law Regulations for Biologics came into force. These provisions establish that:

  • COFEPRIS will assess whether the renewal of biologics applications refer to innovators or biocomparables.
  • Renewal applications for innovators will not require assessment by the SEPB.
  • Renewal applications for biocomparables will require prior assessment by SEPB to identify the product of reference in order for applicants to submit the corresponding tests.

The transitional provisions only apply to renewal applications submitted before 31 December 2015.

Advertising

The advertising of biological products must be authorised by the COFEPRIS. The authorisation must state whether the product can be advertised to the general public or to health professionals only. However, due to the nature of this type of products, advertising is likely to be authorised in relation to health professionals only.

Sale

A marketing authorisation by the COFEPRIS is required to sell any biological product. Generally, an applicant for a marketing authorisation of an innovator 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.
  • Include monographs and technical details of the master cell bank, product and manufacturing process.
  • Provide scientific information on the quality, safety and efficacy of the product (clinical and pre-clinical trials).
  • Include stability, identity and purity tests.
  • Have an intensive pharmacovigilance programme.
  • Provide prescribing information.
  • File a draft label.
  • Pay government fees.

Clinical trials for innovator biological products must take place in Mexico where the product is to be manufactured in Mexico. For products manufactured abroad, the Ministry of Health can request that a clinical trial takes place in Mexico when the Sub-Committee on Evaluation of Biotechnological Products of COFEPRIS considers that this is necessary.

Applicants for biocomparables must comply with the above requirements. However, their pre-clinical and clinical tests must be based on a biological reference drug, which must be used to perform physico-chemical comparative studies. For this purpose, the applicant must submit the following:

  • In vitro studies, although the Ministry of Health can exempt an applicant from this requirement.
  • A report of comparative pharmacokinetic test, if required by the Ministry of Health, to demonstrate pharmacokinetic comparability on key parameters between the biocomparable and the reference biological product.
  • Pharmacodynamics test reports.
  • A comparative efficacy and safety clinical test to show the similarity between the biocomparable and the reference biological product.

The requirements above may vary. The Ministry of Health can impose specific requirements for any biological product on a case-by-case basis, taking into account the opinion of the COFEPRIS Committee of New Molecules, which will have consulted its Sub-Committee on Evaluation of Biotechnological Products.

15. What authority is responsible for regulating the manufacture, advertising and sale of biological products?

The authority responsible for enforcing the rules relating to biological products is the Federal Commission for Protection against Sanitary Risk (Comisión Federal para la Protección contra Riesgos Sanitarios) (COFEPRIS).

For more information on the COFEPRIS see box: The regulatory authority.

16. Are there fewer or different requirements for biological products that have already been licensed/approved in another jurisdiction?

Research and development companies can benefit from a special procedure for biological drugs to be approved for the first time in Mexico which have already been approved by the following regulatory agencies:

  • European Medicines Agency.
  • US Food and Drug Administration.
  • Health Canada.
  • Swiss Agency for Therapeutic Products.
  • Australian Therapeutic Goods Administration.

The Federal Commission for Protection against Sanitary Risk (Comisión Federal para la Protección contra Riesgos Sanitarios) recently issued rules to set up this new procedure. The procedure is essentially based on the dossier filed with the foreign regulatory agency, to reduce approval time frames. Industry participants have welcomed these new rules, although they are still being tested.

17. Is it possible to sell biological products to or buy biological devices from other jurisdictions?

A marketing authorisation from the Federal Commission for Protection against Sanitary Risk (Comisión Federal para la Protección contra Riesgos Sanitarios) is required to sell biological products manufactured in other jurisdictions. Selling biological products without a marketing authorisation can be prosecuted as a criminal offence.

18. Is it permitted to advertise biological products to consumers? Are there restrictions on advertising?

The advertising of any biological product must be authorised by the Federal Commission for Protection against Sanitary Risk (Comisión Federal para la Protección contra Riesgos Sanitarios). As biological products are complex medicines, advertisement relating to these products cannot:

  • Mention non-analysed properties.
  • State that a product is indispensable.
  • State that being a biological product is an advantage over other products.

Natural health products

19. Is there a category for natural health products (including, for example, traditional medicines, homeopathic medicines, supplements, vitamins and minerals)?

There are specific provisions that regulate different types of natural health products, including:

  • Herbal, homeopathic and vitamin medicines.
  • Herbal remedies.
  • Dietary supplements.

20. What are the general requirements for natural health products to be manufactured, advertised and sold?

Manufacturing

Companies manufacturing natural health products must file an operation notice with the Federal Commission for Protection against Sanitary Risk (Comisión Federal para la Protección contra Riesgos Sanitarios) (COFEPRIS).

Advertising

The advertising of natural health products in Mexico is permitted and 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 enforces the provisions on advertising.

The advertising of any natural health product is subject to the following restrictions:

  • Media channels must request certified copies of the relevant marketing authorisation, alphanumeric key (that is, the registration number) or operating notice for this category of product, before publishing related advertisements.
  • Any visual or audio advertisement for non-prescription medicines must include the message "consult your physician".
  • The advertisement must not present the product as a solution to a disease or symptoms that are different from those included in the marketing authorisation.
  • The advertisement must not induce the consumers to acquire products through raffles and games of chance, or offer any other product or service in exchange.

Advertisements of herbal medicines must:

  • Be limited to one symptomatic effect based on the information contained on the label.
  • Not advertise the products as having curative properties.
  • Include the message "there is no scientific evidence supporting curative or preventive properties".

Advertisements of dietary supplements must:

  • Include the message "there is no scientific evidence supporting curative or preventive properties".
  • Not present these products as stimulants or modifiers of the physical or mental state.
  • Not induce or promote eating habits that have harmful effects on health.
  • Not affirm that a product complies with individual nutritional requirements.
  • Not attribute a higher or different nutritional value.
  • Not compare or undermine natural food properties.
  • Not have confusing, exaggerating or misleading information regarding the composition, origin, effects or other properties of the product, nor hold preventive indications, rehabilitative or therapeutics.
  • Not include denominations, shapes, statements related to diseases, symptoms, anatomic data, physiological phenomena, or messages that affirm that the product can replace any food or meal.

Sale

There are different requirements for the sale of different types of natural health product:

  • Herbal, homeopathic and vitamin medicines require a marketing authorisation from the COFEPRIS.
  • Herbal remedies require recordal (clave alfanumérica) (that is, a type of approval) with the COFEPRIS.
  • Distributors of dietary supplements must give notice (aviso de suplemento alimenticio) to the COFEPRIS.

Applicants for a marketing authorisation relating to herbal, homeopathic and vitamin medicines must:

  • Have an authorised manufacturing facility, either in Mexico or abroad.
  • Provide a certificate of good manufacturing practices (GMP).
  • Provide information on the manufacturing process.
  • Provide a certificate of free sale, for products manufactured abroad.
  • Provide information on stability, identity and purity.
  • Provide prescribing information.
  • Submit a draft label.
  • Include instructions for use, if applicable.
  • Pay government fees.

In addition, product monograph and information on storage conditions are required for vitamin medicines.

For recording herbal remedies, applicants must:

  • Have an authorised manufacturing facility, either in Mexico or abroad.
  • Provide certificate of GMP.
  • Provide a certificate of free sales, for products manufactured abroad.
  • Provide information on the product and manufacturing process.
  • Provide information on identity and purity.
  • Submit a draft label.
  • Include instructions for use, if applicable.
  • Pay government fees.

A notice of marketing for a dietary supplement must include:

  • Product information.
  • A certificate of GMP.
  • A draft label.

Some of the requirements above may vary depending on the specific product.

21. What authority is responsible for regulating the manufacture, advertising and sale of natural health products?

The authority responsible for enforcing the rules relating to health products is the Federal Commission for Protection against Sanitary Risk (Comisión Federal para la Protección contra Riesgos Sanitarios) (COFEPRIS).

For more information on the COFEPRIS see box: The regulatory authority.

22. Are there fewer or different requirements for natural health products that have already been licensed/approved in another jurisdiction?

The holder of a natural health product approved by a recognised foreign regulatory authority can use the dossier filed with this authority when filing a marketing authorisation/recordal application in Mexico. However, approval in another jurisdiction is not recognised by the Federal Commission for Protection against Sanitary Risk (Comisión Federal para la Protección contra Riesgos Sanitarios).

23. Is it possible to sell natural health products to or buy natural health products from other jurisdictions and/or electronically?

A marketing authorisation issued by the Federal Commission for Protection against Sanitary Risk (Comisión Federal para la Protección contra Riesgos Sanitarios) (COFEPRIS) is required to sell herbal, homeopathic and vitamin medicines manufactured in other jurisdictions. A recordal with COFEPRIS is required to sell herbal remedies. Selling medicines without a marketing authorisation can be prosecuted as a criminal offence.

Natural health products exempt from marketing authorisation/recordal must still comply with good manufacturing practices and labelling standards set out in relevant legislation (for example, the Consumer Protection Regulations), as regulatory authorities have wide powers to verify any potential health risk at any time. In addition, information provided on the products must be truthful and communicated in a way that does not mislead consumers.

24. Is it permitted to advertise natural health products to consumers? Are there restrictions on advertising?

Natural health products approved as over-the-counter medicines and herbal medicines can be advertised to the general public, subject to approval by the Federal Commission for Protection against Sanitary Risk (Comisión Federal para la Protección contra Riesgos Sanitarios). Before releasing advertisements, media channels must require certified copies of the marketing authorisation for the product.

Advertisements must be limited to indicating the general characteristics of the product, its therapeutic properties and use.

Any visual or audio advertisement of natural health products must:

  • Include the message "consult your physician".
  • Mention any required precautions when use of the product represents any danger for persons with an existing pathology.

Reform

25. Are there any plans to reform the rules on the development, manufacture, advertising and sale of medical products?

Mexico is taking part in the negotiations of the Trans-Pacific Partnership Agreement.

Regarding pharmaceutical patents and the regulation of healthcare, topics covered by the negotiations include commitments by participants to provide additional protections, including:

  • Patent linkage, extensions or compensation due to regulatory delays.
  • Data exclusivity for new chemical compounds and formulations, and secondary uses.

The regulatory authority

Federal Commission for Protection against Sanitary Risk (Comisión Federal para la Protección contra Riesgos Sanitarios) (COFEPRIS)

W www.cofepris.gob.mx

Principal responsibilities. COFEPRIS is part of the Ministry of Health (Secretaria de Salud) and is responsible for enforcing the regulatory framework relating to medical products.

COFEPRIS is in charge of protecting public health by ensuring the safety, efficacy and security of human drugs, biological products, medical devices, health services, food and beverages, tobacco, cosmetics, pesticides, fertilisers and any other substance that can be a risk to the population. Specifically, COFEPRIS' responsibility is to exercise sanitary regulation, control and promotion through the:

  • Control and supervision of health institutions.
  • Prevention and control of environmental factors that can harm the population.
  • Control of basic occupational health and hygiene.
  • Sanitary control of medical products and services (including their import and export) and of establishments that process such products.
  • Sanitary control of the process, use, maintenance, import, export, and final disposal of medical equipment, prosthetics, orthesis, functional aids, diagnostic agents, orthodontic goods and services, surgical and health materials, and of the establishments that process these products.
  • Sanitary control of the publicity for health activities, products and services.
  • Sanitary control of the disposal of organs, tissue and their components, and human cells.
  • International public health system.
  • Sanitary control of organ, tissue, and human cell donation and transplant.

Online resources

Federal Commission for Protection against Sanitary Risk (Comisión Federal para la Protección contra Riesgos Sanitarios) (COFEPRIS)

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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To Use Mondaq.com you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these Terms or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.

Disclaimer

The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use of the Content or performance of Mondaq’s Services.

General

Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions