Mexico’s COFEPRIS
Medical Devices
Mexico’s Regulatory Health Authority:
Medical Devices are regulated by COFEPRIS (Comision Federal para la Proteccion contra Riesgos Sanitarios). All medical devices imported into or distributed within Mexico must first undergo registration with COFEPRIS.
Medical Device Registration in Mexico:
Registering a device or IVD in Mexico can be extremely difficult for non-Spanish speakers. COFEPRIS, the regulatory authority that oversees medical device and IVD registration , provides very limited information on their website in English, furthermore, they require all documentation and communication to take place in Spanish. GRP office located in Mexico City has a team of bilingual regulatory experts that can help you access Mexico’s medical device market.
Cofepris Medical Device Definition:
“A substance, mixture of substances, material, apparatus or instrument (including the computer program necessary for its appropriate use or application), used alone or in combination for the diagnosis, monitoring or prevention of diseases in humans or in the treatment of the same and of the disability, as well as those used in the replacement, correction, restoration or modification of the anatomy or human physiological processes.”
Authorized local agent
Mexican Health Authority (COFEPRIS) requires that any foreign pharmaceutical or biologic company, without a physical location in Mexico, to appoint a Mexican Registration Holder in Mexico before registering and selling any product in Mexico. In Mexico, GRP Mexico office is licensed by COFEPRIS to act as your Local Representative in Mexico.
GRP-Mexico Local Agent Services:
- Communication with COFEPRIS
- Product Registration
- Assistance with COFEPRIS inspection
- Adverse Effect Reporting
- Support Importation Process
- Organize and support COFEPRIS consultation meetings.
- Recall or incident report assistance
Regulatory intelligence
Regulatory intelligence (RI) is an essential tool for regulatory professionals. RI allows professionals to develop the most appropriate regulatory strategy for a successful, efficient, and cost- effective product development, registration, and commercialization. Due to the continuously evolving nature of the Regulatory environment, it is becoming more challenging for regulatory professionals to stay up-to-date and collect the appropriate RI related to their product in a timely manner.
At Global Regulatory Partners Inc., a team of professionals can provide you with tailored Regulatory Intelligence that includes the latest regulatory information and our recommendations for the most appropriate and effective strategy to address your particular- needs in Mexico.
Regulatory Strategy
Registering your medical device for sale in Mexico requires approval from the Comisiόn Federal para la Protecciόn contra Riesgos Sanitarios (COFEPRIS), a division of Mexico’s Ministry of Health. Some devices that have previously obtained market authorization in the US, Canada or Japan qualify for expedited review by COFEPRIS. However, registering a device or IVD in Mexico can be challenging. Little information on the registration process is available in English from COFEPRIS, the division of the Mexican Ministry of Health (Secretaría de Salud) responsible for medical device and IVD oversight.
GRP’s consultants know how to combine the classification and grouping documents with years of practical experience working with COFEPRIS to help you find the optimal and most cost-effective registration strategy, based on your company’s needs and goals for the market.
GRP Regulatory Strategy Services (Mexico):
- GRP can determine the proper classification for your medical device and can provide an initial assessment on grouping acceptability, if necessary.
- Many manufacturers work with us on standard Third-Party Review submissions, as well as the equivalency route available to certain devices already approved by the US FDA, Health Canada, or Japan.
- Our in-depth knowledge of the Mexican medical device market ensures that we provide the most efficient and cost-effective regulatory approval strategy for your device.
- We can assist you in preparing medical device registration documents that demonstrate compliance with COFEPRIS.
- Our Mexico Registration Holder services allow us to submit devices for COFEPRIS approval on your behalf.
Regulatory Affairs
Global regulatory Partner, Inc., provides a full regulatory affairs service from product concept throughout product development till product registration. Our Regulatory affair’s team helps medical device companies understand and efficiently manage the demanding complexity of the diverse Regulatory requirements of COFEPRIS in order to successfully register and commercialize their products in the Mexican market and maximize the value of their assets.
GRP Regulatory Affairs Services:
- Regulatory Intelligence (RI)
- Regulatory Strategy
- Regulatory operations, and publishing
- Product registration
- Registration amendments
- Consulting meetings with regulatory authorities
Product registration
COFEPRIS classifies medical devices into four categories based on risk to the patient. Table 1 summarizes the 4 Device Classes and their associated risk description. Table 2 summarizes various registration pathways for Medical Devices.
TABLE 1: MEDICAL DEVICES CLASSIFICATION
| Device Class | Description |
|---|---|
| Class I | Lowest Risk |
| Class IA | Low Risk |
| Class II | Medium Risk |
| Class III Devices | High Risk |
GRP-Mexico IVD/Device Registration Services:
- Act as your Mexico Registration Holder
- Determine classification of your medical device or IVD
- Help you determine the proper regulatory pathway for your devices
- Inform you of the documentation required within the applicable registration route.
- Help you determine a grouping strategy for your registration
- Prepare and submit registration application documents to COFEPRIS
- Coordinate translation of submission materials into Spanish
- Work to answer questions from COFEPRIS during the submission process
Medical writing
Medical Writing is an important function of regulatory affairs. It plays a critical role in the development and preparation of regulatory documents and defines the success or failure of new products. As Regulatory authorities expect precise, clear and well-written documents, any bad writing can raise health authorities queries and consequently delay product approval. Global Regulatory Partners, Inc., has a team of professional medical writers who can write regulatory and clinical documents in Electrical Common Technical Documents (eCTD) and CTD modules
Health authority consultation
Consultation meetings can serve as a valuable tool to discuss needs and challenges specific to the development of the product and design of their proposed nonclinical studies. Sponsors can also discuss their Chemistry, Manufacturing and Controls (CMC) development plan and discuss their overall development plan. Global Regulatory Partners Inc., (GRP) regulatory affairs team has the expertise in preparing consultation meeting with COFEPRIS heath authorities before starting key milestone of your product development.
GRP Regulatory Affairs Support Team Services:
- Prepare and submit of the meeting package to the health authority
- Prepare the questions to health authority based on the status of your product’s development and future plan
- Provide support during the meeting
- Write the meeting minutes and develop the appropriate action plan after the consultation meeting.
Clinical Trials
Clinical Trials in Mexico are known as Ensayos Clínicos. Clinical trials authorizations with the purpose of registering a pharmaceutical product are requested based on the type of research, the origin of the product or the research procedure. Applicants may submit the documents to gain authorization to perform Clinical Trials/Human Subjects Research Protocol directly to Cofepris or request a preliminary evaluation report to a UHAP (support units enabled to emit preliminary report).
UHAP Evaluations:
UHAP evaluations are voluntary. Contact method and costs are not standardized among UHAPs. The preliminary report attached to the file submitted to Cofepris may speed up the processing process. Applications including UHAP reports may be issued in up to 30 business days.
Figure 2: Clinical Trial Protocol Authorization Process
Table 1: Submission Material
| Module | Included Documents |
|---|---|
| I | Application Form and/or Escrito Libre (Detailed Cover Letter with Product Specifications) |
| II | Proof of payment – Original and 2 copies |
| III | Letter accepting research involvement and responsibilities of researcher(s)/sponsor(s) expressing also prevention measures of conflict of interests, especially if there is monetary compensation involved. Letter issued by the CRO/sponsor describing the human resources and materials to be destined in the research in all research sites. Letter from the sponsor with a monitoring/auditing plan |
| IV | Research Protocol, Informed Consent Letters, Timeframe/Schedule |
| V | Ethics Committee Certificate (Copy), Research Committee Certificate (Copy), Research and Ethics Committee Approval Report, Research Committee Approval Report |
| VI | Other Documents requested by current health regulations in the field of research for human health |
Research Protocol Forms
COFEPRIS 04-010 A: Pharmaceutical Products (Biologics and Biotechnological) Cost: $ 5,880 MXN
COFEPRIS 04-010 B: Pharmaceutical Products (Bioequivalence Studies) Cost: $5,880 MXN
COFEPRIS 04-010 C: New Resources (Materials, grafts, transplants, prostheses, physical, chemical procedures and other methods of prevention, diagnosis and treatment) Cost: $5,880 MXN
COFEPRIS 04-010 D: Risk-free Research (Observational studies that employ techniques, methods of documentary research and those in which no intervention or intentional modification is made in the physiological, psychological and social variables of the research subjects) Cost: $5,880 MXN
Registration Timelines:
Requests submitted directly to Cofepris, for any Research Protocol (clinical trials) unless having preliminary report from a UHAP, are taking an estimate of 90 business days for processing.
GRP Clinical Trial Services (Mexico):
Clinical Trial Consulting Services
GRP will provide clinical trial consulting services, including consultations with all local government. We can help you develop an effective Clinical Investigation Plan with clinical trial strategy, clinical trial study design, and clinical trial protocol.
Regulatory Support
We can assist with clinical trial applications (CTA) and clinical trial notifications (CTN) as required for clinical trial initiation in Mexico. Our on-the-ground teams consist of experienced professionals who will meet with the appropriate regulatory agencies on your behalf throughout the clinical study. We will provide guidance on meeting the Institutional Review Board (IRB) and Independent Ethics Committee (IEC) requirements.
Clinical Trials Management
We can comprehensively manage the clinical trials process by conducting the trials and completing the clinical trial reports. Our experts will evaluate clinical trial and non-clinical trial data; conduct gap analyses; and determine safety and efficacy, along with primary and secondary endpoints, as required for your specific product.
Quality Compliance and Audits
We can conduct on-site audits of your clinical trials and consult on the guidelines for Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Pharmacovigilance Practices (GVP), Good Quality Practice (GQP), Good Manufacturing Practice (GMP), etc.
Adverse Events and Post Market Surveillance
We will report adverse events and implement suggestions on additional tests and required data. We can assist in post-approval and post-clearance clinical trials to maintain the safety, efficacy, and performance of the product through its life cycle.
Quality
Implementing and maintaining a quality management system (QMS)
Implementing and maintaining a quality management system (QMS) is a crucial part of regulatory compliance for most markets worldwide. For small medical device manufacturers in the pre-production phase, an initial implementation of a partial quality system is an extremely beneficial way to ensure compliance with product development regulations, such as Design Controls. Pre-production QMS for eventual compliance with FDA QSR and ISO 13485.
While a quality system typically does not have to be fully implemented until you begin your medical device registration, implementing an initial partial QMS system can make implementing a full QMS less burdensome, and may shorten your time to commercialization in the long run.
Pre-Production QMS:
A pre-production QMS is ideal for medical device manufacturers that are 18-24 months away from commercialization and distribution. The benefit for this approach is to allow the organization to build and improve their quality system as they proceed through design and development, validation testing, conducting clinical trials, and eventually market launch.
Compliance with design control procedures.
The US Food and Drug Administration (FDA) and other market regulators including COFEPRIS require proof of compliance with established design control procedures for some device classifications. It is important to show ongoing compliance all the way from device conception through release to market.
To ensure ongoing compliance with quality system procedures, you should;
- evaluate your pre-production QMS using internal audits at least once a year.
- Conducting periodic internal audits also supports the evolution of the QMS when new processes are added to the system as the organization approaches launch of the product.
GRP QMS implementation Services:
- Document and records control
- Training on regulatory requirements and internal procedures
- Design and development
- Risk management
- Software development (if applicable)
- Supplier evaluation
- Control of measurement equipment
- Perform internal quality system audits
GRP Extensive Quality Experience:
GRP has extensive expertise helping companies worldwide establish quality systems compliant with ISO 13485, FDA Quality System Regulation and other global QMS requirements including COFEPRIS . Our experienced consultants can establish procedures for regulatory compliance tailored to the specific markets you’re interested in entering. We can also perform internal quality system audits if you do not have the staff or resources to do so.
Pharmaceuticals
Mexico’s Health Authority:
Pharmaceuticals in Mexico are regulated by COFEPRIS (Comision Federal para la Proteccion contra Riesgos Sanitarios).
GRP Pharmaceutical Services:
Through our local office in Mexico, GRP can act as your local authorized agent in Mexico and our regulatory team can support your company throughout the whole products’ lifecycle, ensuring compliance with local regulations and providing vital scientific and strategic advice from products’ development till commercialization.
Cofepris Drug Definition:
According to Article 221, Section I of the General Health Law a drug is defines as;
“Any substance or mixture of substances of natural or synthetic origin that has a therapeutic, preventive or rehabilitative effect, that is presented in a pharmaceutical form and is identified as such by its pharmacological activity, physical, chemical and biological characteristics. When a product contains nutrients, it will be considered a medicine, as long as it is a preparation that contains individually or in association: vitamins, minerals, electrolytes, amino acids or fatty acids, in concentrations higher than those of natural foods and it is also present in some defined pharmaceutical form and the indication of use contemplates therapeutic, preventive or rehabilitative effects.”
New Molecule Definition:
“Active Principle of a medication, of natural or synthetic origin, not previously used in the country and whose efficacy, safety and therapeutic purposes have not yet been completely reported in the scientific literature.
Cosmetics
Mexico’s Regulatory Health Authority:
Cosmetics are regulated by COFEPRIS (Comision Federal para la Proteccion contra Riesgos Sanitarios).
GRP Cosmetic Services:
Global Regulatory Partners Inc. (GRP) office in Mexico City provides end-to-end regulatory affairs services for cosmetics that include: regulatory intelligence, regulatory strategy, product classification, formulation review, claim assessments and labeling assessment in compliance with COFEPRIS requirements.
Through our local office in Mexico, GRP can act as your local authorized agent in Mexico and our regulatory team can support your company throughout the whole products’ lifecycle, ensuring compliance with local regulations and providing strategic advice concerning product classification from products’ development till commercialization.
Cofepris Cosmetic Definition:
In Mexico, cosmetics are defined as:
“Products intended to be brought into contact with the parts of the human body to clean, perfume, help and with the principal purpose of cleaning, perfuming, helping to modify their appearance, protecting, keeping in good condition, correcting body odors or reducing alterations in the functioning of healthy skin.”
Authorized local agent
Global Regulatory Partners Inc. (GRP) has local offices in Mexico and is licensed by the COFEPRIS to act as your authorized local agent for your Cosmetic and Personal Care Products. GRP- Mexico team of professionals are experts in worldwide supply, registration, manufacturing and labeling of Cosmetics and PCPs. GRP-Mexico helps manufacturers, distributors, and marketers of cosmetics in Mexico.
GRP -Mexico Cosmetic Services:
- Authorized local Agent
- Regulatory intelligence
- Regulatory Strategy
- Regulatory affairs
- Product Registration
- Cosmetic packaging and labeling review
- Product classification & Formulation Review
Regulatory intelligence
Mexico’s cosmetic Regulatory history:
In 2015, Mexico’s FDA equivalent, the Federal Commission for the Protection Against Sanitary Risks (COFEPRIS), updated regulatory standards that apply to cosmetics, perfumes, and personal care products. The objective was to harmonize Mexican requirements for cosmetics and personal care products with international standards to facilitate trade. The new regulations modify two standards, NOM 159 and NOM 259, which describe requirements for best practices in production, labeling, and packaging for cosmetics and personal care products, as well as the list of permitted substances used in the manufacture of cosmetics and perfumes.
Market Overview:
According to the Brazilian Association of Personal Hygiene, Perfumery and Cosmetics Industry, Latin America accounts for 14.1 percent of the world market and Mexico, being the second-largest market in Latin America, had a value of 10 billion dollars in 2018 and is forecast to reach a value of 10,649.8 million dollars by 2022.
Current cosmetic Trends in Mexico:
Current Trends in Mexico include the growing beauty consciousness among the male consumers which is seen with the increase in the number of brands foraying into internet retailing. In Mexico this segment is expected to grow at rates of over 10 percent through 2023 due to the positive image that mainstream media and hipster trends have helped create among younger generations.
Changes to consumer lifestyle has also affected cosmetics as their is an increase in women employees at the workplace are expected to heavily impact the consumption of beauty and personal grooming products in Mexico.
GRP RI Cosmetic Services:
Cosmetics are regulated differently from country to country. While some countries require registration of cosmetic products others only require a notification. GRP-Mexico team of experts can collect the following regulatory and requirements applicable to your product entry into Mexico’s Market such as:
- Registration dossier
- Claims
- Prohibited list of ingredients
- Importation regulations
- Specification of ingredients
- Labeling requirements
Regulatory Strategy
Cosmetic Regulatory Strategy in Mexico:
Developing the right regulatory strategy for your products in Mexico is crucial for successful product development, registration, and commercialization. Global Regulatory Partners, Inc., (GRP) team has expertise in developing the appropriate and effective regulatory strategy for different types of products in the Mexican market.
Our strategy will help you meet your business objectives and goals and reduce your risk of failure. In developing the regulatory strategy, our team takes into consideration different factors such as;
- Information on your products and similar products on the market
- Product development status and milestones
- Business goals and timelines
- The regulatory requirements related to your product,cost, and risk assessment
With a global presence and a local team of experts, GRP-Mexico regulatory strategy will give you confidence in the forecast of key milestones, a list of the necessary documentation needed for product development and registration, timelines and cost of the different activities, and action plan to meet your milestones.
Regulatory Affairs
Company Registration with Cofepris:
In Mexico, a cosmetic company must register with the SSA (Secretariat of Health) for a physical and chemical analysis, complete with a Spanish translation and / or a free sale certificate and consular legalization. The Ministry has laid down a fixed set of requirements and recommendations to ensure that each product enters the market meeting regulatory standards, providing that cosmetic companies follow the new labeling procedures stringently. This standard is mandatory in the national territory to persons or entities engaged in the process or importation of cosmetic products.
Our Regulatory affairs teams in Mexico help medical device companies understand and efficiently manage the demanding complexity of the diverse Regulatory requirements in order to successfully register and commercialize their products in the Mexican market and maximize the value of their assets.
GRP Regulatory Affairs Services:
Global Regulatory Partner MX provides a full regulatory affairs service from product concept throughout product development till product registration. Our regulatory affairs services include:
- regulatory intelligence
- regulatory strategy
- regulatory operations
- and publishing
- product registration
- registration amendments;
- consulting meetings with COFEPRIS regulatory authorities.
Product Registration
The Ministry of Health in Mexico, through the Federal Commission for the Protection against Sanitary Risks (COFEPRIS) standardized the regulation that applies to the cosmetics products industry in order to meet International best practices that compare them with those of developed countries.
With the recent change in the regulations is no longer mandatory to apply for product classification or sanitary license to COFEPRIS for cosmetic products. As the process isn’t as stringent anymore so cosmetics can just be notified to COFEPRIS by including the product in the business license and importation permit application in order to import the product.
Cosmetic Product Registration Process in Mexico
Cosmetic packaging and labeling review
The Mexico’s Ministry of Health has published a labeling standard for pre-packaged cosmetics to clear up instances where a product might be misinterpreted or even misbranded. The standard PROY‑NOM‑141‑SSA1/SCFI‑2010 ‘Labeling of pre‑packaged cosmetic products, Health and commercial labeling,’ is published in the administration’s official journal (Diario Oficial de la Federación).
The labeling for a cosmetic product should contain :
- All the labeling content should be in Spanish.
Include generic and specific name of the product
Include identification of the person responsible for the product.
Include the batch number
Include the Instructions or mode of use
Not include prohibited property statements
Comply wit the commercial information as per the provisions of NOM-008-SCFI-2002 General System of Measurement Units
Include the sanitary information
GRP Labeling Services:
Global regulatory Partners, Inc., (GRP) provides end-to-end cosmetics packaging and labeling services to enable manufacturers effectively navigate region-specific regulations, manufacture and sale compliant products. GRP’s services include cosmetic packaging and labeling review to ensure that their content is in compliant with COFEPRIS requirements and cosmetic products can be used safely by Mexican consumers.
Product classification & Formulation Review
Ingredient compliance:
The company must check that the ingredients included in the cosmetic product are not listed in the forbidden or restricted list of ingredients as defined in Articles 234 and 245 of the General Health Law, drugs, prepared drugs and the following may not be used in the preparation of perfume and beauty products.
GRP Product Classification and Formulation Review Services:
Global Regulatory Partners Inc. (GRP) provides a comprehensive range of Regulatory Services related to the analysis of the list of cosmetic and PCP ingredients, the review of their formulation and labeling. GRP-Mexico can review your products and make sure they comply with the COFEPRIS regulations.
More Resources:
- “Read More” -For more information on Cosmetics and GRP’s services in Mexico
- GRP Presentation. Registration of Cosmetics in Mexico
Nutraceuticals
Regulatory Health Authority:
The Federal Commission for Protection again health risks (COFEPRIS) is the main body in charge of Nutraceutical regulation in Mexico.
GRP Dietary Supplement Services:
Global Regulatory Partners, Inc. (GRP), has a team of experts in Mexico who can help Nutraceutical and food supplements companies in Mexico during their products’ development. The team reviews the list of ingredients to make sure that they are safe for consumers and are within the daily dose limits allowed by local regulations. The team also reviews and validate the content of the products labeling and packaging and makes sure that nutrient content claims and health claims made by the manufacturer are validated and supported by scientific data before any products’ commercialization.
Dietary Supplement Definition:
Article 215 of the General Health Act defines dietary supplements as “herbal products, plant extracts, traditional foods, dehydrated or concentrated fruit added or not, vitamins or minerals that may arise in a pharmaceutical form and intended use is to increase total dietary intake, supplement it or replace some component of one’s diet.”
Legislative Considerations:
According to Mexican health legislation, dietary supplements cannot be composed solely of vitamins and minerals – in which case they are considered a vitamin drug, not a dietary supplement. Nutritional supplements may also contain substances with pharmacological action (natural or synthetic), for example, saw palmetto (plant), ephedrine, amphetamines, among many others.
Authorized local agent
A marketing authorization issued by the Federal Commission for Protection against Sanitary Risk (COFEPRIS) is required to sell herbal, homeopathic and vitamin medicines manufactured in other jurisdictions. A recordal (clave alfanumérica), a type of approval, with COFEPRIS is required to sell herbal remedies. Selling medicines without a marketing authorization can be prosecuted as a criminal offence. Global Regulatory Partners, Inc. (GRP), team of experts in Mexico who can help Nutraceutical and food supplements companies in Mexico during their products’ development.
GRP-Mexico Nutraceutical Services:
- Authorized local agent
- Regulatory intelligence
- Regulatory strategy
- Regulatory affairs
- Product Registration
- Verification of Nutrient Content Claims
- Verification of Health Claims
Regulatory Affairs
Overview:
Supplements does not require license (registration in Cofepris), however, they need to be notified to COFEPRIS known as a “consultation of product classification” It is a free procedure, through which the health authority, based on the formulation and labeling of the products, corroborates whether or not they comply with the legal framework of food supplements and, in case of refusal, indicates the corresponding regulatory figure.
All food supplements, prior to their advertising permission process, importation and distribution must have a positive response to the classification query.
Food Supplement Definition
Products based on herbs, plant extracts, traditional foods, dehydrated or concentrated fruits, added or not, of vitamins or minerals, that can be presented in a pharmaceutical form * and whose purpose of use is to increase the total dietary intake, supplement it or supply some component.
Cofepris Classification:
There are 3 Possible answers to the classification:
- It is a Food supplement
- It is NOT a Food supplement
- Request for more information
Documents required for submission
Case study 058: Registration of food supplement in Mexico
The Client is a USA based nutrition supplement manufacturer that manufactures and sells innovative range of health supplements in USA and other countries.
GRP RA Expertise:
Global regulatory Partner, Inc., (GRP) provides a full regulatory affairs service from product concept throughout product development till product registration. Our regulatory affairs services include regulatory intelligence, regulatory strategy, product registration, product formulation and labelling review. GRP-Mexico team provides support to Nutraceutical companies during their products’ development. The team reviews the list of ingredients to make sure that they are safe for consumers, reviews and validates the nutrient content claims and health claims before products’ commercialization in Mexico.
Verification of Nutrient Content Claims
Nutritional claims are those that state, suggest or imply that a food has some particular- beneficial nutritional properties. This information helps consumers to take an informed decision about whether to purchase and consume the product or not. Nutritional labels and packaging should include information on energy, calories, fats, sugars, proteins and salts. It is important that all this information is accurate and correct, as all nutritional details must comply with the Regulations.
In addition, the regulations have certain rules governing the provision of voluntary nutrition information, particularly for the front of pack labeling, the nutritional labeling of non-pre-packaged foods and the energy labeling of alcoholic drinks. Some nutrients are now prohibited to be declared. A nutrient content claim expressly or by implication characterizes the level of a nutrient in a dietary supplement.
GRP-Mexico can review your products and make sure they comply with COFEPRIS regulated under Article 215 of the General Health Act
Verification of Health Claims
Health claims are directed to the general population or designated subgroups (e.g., the elderly) and are intended to assist the consumer in maintaining healthful dietary practices.
Global Regulatory Partners Inc. (GRP) team in Mexico has the expertise in reviewing and validating the health claims that you are making for you nutraceutical products or dietary supplements to make sure that they are supported by scientific data, are accurate and can be accepted by COFEPRIS standards. GRP-Mexico can review your products and make sure they comply with Article 215 of the General Health Act.