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Do you have doubts about whether you are considering all the health regulations to be able to market and advertise your food supplement? Below we leave you the applicable regulatory framework.
The commercialization and advertising of food supplements in Mexico seems to be an easy task, however, there is a regulatory framework that establishes the minimum requirements related to the formulation, manufacture, storage, labeling and advertising of these, and that must be considered if we are manufacturers, distributors and/or importers to provide consumers with quality and safe products.
Below we leave you the current health regulations that regulate the commercialization of food supplements in Mexico and that will help us to introduce ourselves more in the field of this type of product.
We begin with the definition that is based on article 215, section V of the General Health Law (Ley General de Salud), which provides us with a clear idea of what Food Supplements are:
Food supplements: Herbal products, plant extracts, traditional foods, dehydrated or fruit concentrates, with or without added vitamins or minerals, which can be presented in pharmaceutical form and whose purpose is to increase the total dietary intake, complement it or supply any of its components.
We continue with the regulations applicable to the formulation of a Food Supplement, which serves as a guide for its development and/or analysis and determine if it can be marketed as a Food Supplement:
- Regulation of Sanitary Control of Products and Services (Reglamento de Control Sanitario de Productos y Servicios): Title Nineteenth, Articles 168-174, Appendices of numerals from XVII.1 to XVII.4.
- Agreement that determines the prohibited or permitted plants for teas, infusions and edible vegetable oils
- Agreement that determines the additives and adjuvants in food, beverages and food supplements, their use and health provisions
- Herbal Pharmacopoeia, contains a list of plants with recognized therapeutic effects, which cannot be used in food supplements.
- CEMAR evaluation: Substances with recognized pharmacological action or that are considered risky based on a risk analysis carried out by CEMAR.
Well, if we already know that our product is a Food Supplement and we are about to market it, we leave you the name of the Official Mexican Standard that establishes the minimum requirements of Good Hygiene Practices that must be observed in the process of food, beverages or food supplements and its raw materials to avoid contamination throughout its process.
- NOM- 251-SSA1-2009 Prácticas de Higiene para el proceso de Alimentos, bebidas o suplementos alimenticios (Hygiene practices for the process of food, beverages, or food supplements)
It is important to know that prior to processing the Advertising License for a Food Supplement, you must have an Official Letter of Positive Response to the Food Supplement Classification Consultation issued by COFEPRIS, for this we leave you the link where you can find the requirements to carry perform the classification query and that will help you design the content of the label with which it should be marketed:
- https://www.gob.mx/cofepris/documentos/consulta-de-clasificacion-de-producto-como-suplemento-alimenticio-2?state=published
Finally, the advertising of Food Supplements is regulated by the Regulations of the General Health Law on Advertising (Reglamento de la Ley General de Salud en Materia de Publicidad), which aims to regulate the health control of the advertising of products, services, and activities, among which are the Food Supplements, here we can find the guidelines to follow to define the content of the advertising project that we must present to COFEPRIS, to obtain the Advertising License.
As we can see, the regulatory framework for Food Supplements is broad and complex but applying it will help us market our product safely and with the required quality, without putting the health of the population at risk, as well as obtaining our Advertising License issued by COFEPRIS in a timely manner.
If you have doubts in the application of the Sanitary Regulation of Food Supplements, we support you or we can provide you with the PDF of any of the regulations, norms or agreements mentioned above.
We also invite you to leave your comments on which regulations applied to Food Supplements you would like us to address.
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In our blog titled "Types of Medicines" (https://bit.ly/3qMJ9nv) we met the medicines called "Alopathic" which today predominate in the Mexican market, so at this time we will address them again since For your request for Sanitary Registration, our Sanitary Authority (COFEPRIS) classifies them into New Molecule Medicine and Generic Medicine, this classification is extremely important since it defines the basis of the regulatory framework and the technical-scientific information that must be presented to guarantee its quality, safety and efficacy.
The first point that we will address are the definitions of medicine, new molecule, new molecule medicine categories, as well as generic medicine which will allow us to understand the differences that exist between this type of medicine and finally we will also know the general requirements for its registration.
Definitions
Medication: Any substance or mixture of substances of natural or synthetic origin with therapeutic, preventive or rehabilitative effect, presented in pharmaceutical form and identified as such by its pharmacological activity, physical, chemical and biological characteristics. When a product contains nutrients, it will be considered as a medicine, provided that 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 presented in a defined pharmaceutical form and the indication for use contemplates therapeutic, preventive or rehabilitative effects.
New Molecule: a substance of natural or synthetic origin that is the active ingredient of a drug, not previously used in the country, whose efficacy, safety and therapeutic purposes have not been fully documented in the scientific literature.
New molecule medicines are those corresponding to the following categories:
Generic Medicine: to the pharmaceutical specialty with the same drug or active substance and pharmaceutical form, with the same concentration or potency, that uses the same route of administration and that through the required regulatory tests, has verified that its pharmacopoeial specifications, dissolution profiles or its bioavailability or other parameters, as the case may be, are equivalent to those of the reference medicine.
General Requirements for the Sanitary Registry
In the following table we present the General Requirements for the Sanitary Registration of a New Molecule Medicine and a Generic Medicine in accordance with the current regulatory framework.
Finally, we can conclude that the characteristics of the Sanitary Registration request defined for each type of medicine have a specific regulatory framework that manufacturers must comply with in order to demonstrate the quality, safety, and efficacy of the medicines before reaching the population.
If you are in the process of registering a New Molecule or Generic Medications and you have doubts about the characteristics or requirements to present, call us, we can advise you or help you put together the dossier for the application of your Sanitary Registration.
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You are already a Medical Device Sanitary Authorization Holder, what's next?
Now that you are already a Medical Device Sanitary Authorization Holder or you are in the process of obtaining the title and you have wondered if you are prepared for the activities, responsibilities and obligations that you must comply with according to the current Health Regulation?
Don't be overwhelmed, you have arrived to GMVR's Sanitary Regulation blog, here we will help you to note these doubts, together we will review what is indicated in the current Sanitary Regulations, in order to give you an overview of what you are obliged to comply with being a Holder of a Sanitary Authorization of a Medical Device.
In our issue https://bit.ly/3NPm3px we reviewed that the Notice of Operation is the first Requirement to be a Holder of a Sanitary Authorization, with this Notice of Operation before COFEPRIS the Holders are obliged to comply with all the dispositions established in the General Law of Health and in the Health Supplies Regulation, as well as in other applicable regulations (Mexican Official Standards, Pharmacopoeia of the United Mexican States) in order to demonstrate that the Medical Devices have quality, safety, efficacy, purity or stability, so here are the main activities, responsibilities and obligations of a Sanitary Authorization Holder:
- Maintain in force the Certificate of Good Manufacturing Practices (CGMP) of MD.
Remember that if you are a holder-manufacturer you must comply with what is defined in NOM-241-SSA1-2021, Good Manufacturing Practices for Medical Devices and if you are a Holder-importer you must make sure that your manufacturer keeps its CGMP in force.
- To have the Supplement to the Pharmacopoeia of the United Mexican States (FEUM) for Medical Devices.
If you are an owner-manufacturer, you must have this Supplement, which defines and establishes the specifications that medical devices must meet in order to have the optimum quality and performance level, as well as the methods of analysis for their verification.
- To have and comply with all the guidelines indicated in the Supplement for establishments dedicated to the sale and supply of medicines and other health supplies of the FEUM (Manufacturer-Holder, Holder-Importer).
In this Supplement you will find the support to perform the various tasks ranging from the opening of an establishment, handling, distribution, storage, sale and supply of medicines and other health supplies, you will also find the documentary requirements, infrastructure and operation of your establishment.
- Have a Technovigilance Committee and carry out Technovigilance activities.
The law requires informing the Health Authority about the Adverse Events of Medical Devices that occur during the commercialization or use of these, those reported by health professionals, those published in the scientific literature and those reported by international health organizations, for this we recommend you to consult the following Standard: Norma Oficial Mexicana NOM-240-SSA1-2012, Instalación y operación de la tecnovigilancia.
- Inform the Health Authority of any change related to the Healthcare Provider.
When the person in charge of health ceases to render services in the establishment, notice must be given to the Ministry of Health in the format issued for such purpose, within ten days after the date of the termination and of the designation of the new person in charge of health within thirty days after the date on which the previous person in charge of health ceased to render services.
Likewise, to notify to the Health Authority in case of temporary absence greater than thirty calendar days of the Healthcare Provider the name of the person who will represent the Healthcare Provider.
- To answer to the Health Authority for any requirement of safety and efficacy of the Medical Device.
Respond within fifteen days from the date of notification to the Health Authority for any safety and efficacy requirement that the Health Authority determines due to evidence that a Medical Device lacks safety, efficacy, purity or stability.
- Communicate to the Health Authority in the event of temporary or permanent closure of the establishment.
Communicate to the Health Authority at least thirty days prior to the date on which it intends to close its establishment, except in the case of an act of God or force majeure.
- To have a person in charge to attend verification visits.
Is responsible for ensuring that, at all times, within the establishment's hours of operation, there are people who can inform the health authority about the operation of the establishment, in case of a verification visit).
- Comply with NOM-137-SSA1-2008. Medical Device Labeling
Express in the labeling of the products the alphanumeric code and the acronym SSA assigned by the Health Authority, as established in the corresponding Standard.
- Communicate to the Health Authority, in case a Maquila is needed.
To give written notice to the Health Authority when the product of which it is holder is manufactured all or in part, by any manufacturer. Guarantee that the maquila product is manufactured under the same conditions in which the Sanitary Registration was granted, for which we recommend you to consult the following Norm: Mexican Official Standard NOM-241-SSA1-2021, Good Manufacturing Practices for Medical Devices.
- Notify COFEPRIS upon confirmation that a medical device was falsified for its withdrawal from the market.
- Submit the Renewal of the Sanitary Registration in due time and form.
- Submit the Variations to the Sanitary Registration in case they are required.
- Submit the Revocation of the Sanitary Registration in case it is so decided.
As we can see, the activities, responsibilities and obligations of a Sanitary Authorization Holder are wide and varied, however, all of them are aimed at guaranteeing that the Medical Devices are safe, effective and of high quality for the Mexican population.
If you have any questions about this topic or about the application of any procedure before COFEPRIS contact us at (+52) 55 6167 7092, we can help you with your project.
Give us your opinion about this blog and share with us if there is any topic in Health Regulation that you would like us to review in the next issue.
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