Traditional Medicines and OTC Products
The key points to know from a legal standpoint about traditional medicines and OTC products in Mexico. Prepared in association with Olivares, a leading global law firm, this is an extract from The Pharma Legal Handbook: Mexico, available to purchase here for GBP 99.
1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices?
Traditional herbal medicinal products are regulated by the General Health Law and its regulations.
This type of products can contain excipients and additives besides vegetable materials, but they must not:
- Be isolated or chemically defined active ingredients.
- Be injectable.
- Include psychotropic or narcotic substances.
- Be mixed with conventional medicines or other substances that represent a health risk.
2. Can these traditional, herbal, complementary, or alternative products be advertised directly to the public?
Yes, they can be advertised to the general public. Any visual or audio advert must bear the message “consult your physician”. Adverts must limit themselves to indicating the general characteristics of the product, its therapeutic properties and use.
3. What health, advertising, and marketing claims may be made for traditional, herbal, complementary, or alternative products?
The advertising of traditional, herbal, complementary, or alternative products directed to the general population may include the description of the diseases specific to the human being, diagnosis, treatment or rehabilitation expressed in the terms of their sanitary registration and in language appropriate to the target audience. These messages must identify the issuer with the brand of the product or its business name.
Information on how to use the medication may be included on the label.
Advertising of herbal products must comply with the following requirements:
- The generic denomination will be the scientific name and will be printed according to the botanical nomenclature.
- The phrase “herbal medicine” should be included at the bottom of the main display surface.
- The declaration of the formula must be expressed by indicating the physicochemical form of the ingredient (dry extract, fluid extract, essential oil, powder, etc.) the part of the plant used, the scientific name, the name in parentheses common and the amount of the active ingredient.
4. What are the regulatory requirements for over-the-counter (non-prescription) medications?
The over-the-counter medication should meet certain requirements; initially it should have demonstrated efficacy and safety over time (at least 5 years) to be used in the relief of symptoms and signs of mild and short-term illnesses and be easily recognizable by to the consumer. It should be indicated for common, self-limiting, easy self-diagnosis, self-management and simple self-assessment of response; it had to demonstrate efficacy and safety in all age groups of the population or at least in the majority, as well as in the pediatric, geriatric, pregnant and lactating population. The over-the-counter medication must possess a wide therapeutic margin, so that voluntary or involuntary administration, at a time or dose higher than recommended or for an unapproved use, does not represent a direct or indirect serious harm to the health of the consumer, which means that the drug must have low toxicity, it should not mask serious or serious diseases that delay the diagnosis and timely treatment of an underlying disease.
5. Are there any limitations on locations or channels through which OTC products may be sold?
Medications can be dispensed at establishments other than pharmacies, so the medical advice or recommendation focuses on the labeling of the product or its instructions.
The General Health Law states that no over-the-counter or other health supplies can be sold in semi-finished, mobile or mobile modules.
6. What health, advertising, and marketing claims may be made for OTC products?
The advertising of OTC products directed to the general population may include the description of the diseases specific to the human being, diagnosis, treatment or rehabilitation expressed in the terms of their sanitary registration and in language appropriate to the target audience. These messages must identify the issuer with the brand of the product or its business name.
7. Can OTC products be marketed or advertised directly to the public?
Over-the-counter products can be advertised to the general public. Any visual or audio advert must bear the message “consult your physician”, and must mention any required precautions when use of the medicine represents any danger, in the case of an existing pathology.
COFEPRIS’s advertisement guidelines state that this regulatory agency will not approve an ad providing disease awareness to be followed by another ad of an over-the-counter medicinal product related to that disease, unless both ads are approved jointly.
8. What is the mechanism by which a prescription-only product can be converted to an OTC product?
There is no an expressly established process by COFEPRIS in order to convert a prescription-only product to an OTC product, but if there is a change in its production process and it have demonstrated efficacy and safety over time (at least 5 years) to be used in the relief of symptoms and signs of mild and short-term illnesses and easily recognizable by the consumer, the marketing authorization holder may present a written request to COFEPRIS asking to reclassify the prescription-only product to an OTC product.
9. What are the requirements for the importation of either traditional medicines or OTC products?
In order to import either traditional medicines or OTC products, it is necessary to obtain a sanitary authorization from COFEPRIS, to have a marketing authorization for the product, the person who will import the product must have the proper installation, and medicines expiration date must be greater than twelve months, counting from the entry of medicines to the country.