Marketing, Manufacturing, Packaging & Labeling Advertising
Key legal info on marketing, manufacturing, packaging & labeling, advertising 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 is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products?
The authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products are mentioned in question 3 in Regulatory, Pricing, and Reimbursement Overview.
2. What is the authorization process for the marketing of generic versions of these products?
Applicants for marketing authorizations have to prove basically that their products are bioequivalent to the innovator product. They have to provide information concerning dissolution profiles or bioavailability studies regarding the reference product. COFEPRIS periodically issues a list of reference medicinal products.
Recently, the NOM setting the test to prove that a generic drug is interchangeable with a reference drug was updated (NOM-177-SSA1-2013).
Legally, COFEPRIS should not grant marketing authorization for generics breaching exclusivity rights.
3. What are the typical fees for marketing approval?
Government fees for analyzing marketing authorization applications are around:
- For new molecules/biologics: US$8,600.
- Generics/biocomparables: US$4,800.
4. What is the period of authorization and the renewal process?
Marketing authorizations must be renewed every five years for medications of new molecules, generics, biologics (biotech products) and biocomparables (follow-ons), while Orphan drugs must be renewed every two years.
Applicants must prove compliance with good manufacturing practices, safety and efficacy standards, pharmacovigilance, labelling standards and all other applicable provisions.
5. What are the requirements, if any, for post-approval pharmacovigilance?
Under the Health Law Regulations and the NOMs, COFEPRIS´s monitoring is focused, among other things, on the following:
- Ensuring compliance with good manufacturing practices and standard operating procedures.
- Ensuring the activities do not exceed the limits set by the authorization and do not differ from those activities which are authorized.
- Ensuring the performance of validation analysis of the manufacturing processes and systems involved.
6. Are foreign marketing authorizations recognized?
Foreign marketing authorizations are not valid in Mexico. However, COFEPRIS has set a special procedure for drugs to be approved for the first time in Mexico, already approved by equivalent regulatory authorities abroad.
In this procedure, the requirements for approval of these agencies are recognized as equivalent to those in Mexico. According to the equivalence agreement, marketing authorizations which have been approved by the following agencies:
- The European Medicines Agency;
- The US Drug and Food Administration;
- Health Canada;
- The Swiss Agency for Therapeutic Products (Swissmedic); and
- The Therapeutic Goods Administration in Australia.
7. Are parallel imports of medicines or devices allowed?
Any import of drugs, health products or raw material for drugs must be approved by COFEPRIS. Marketing authorization in Mexico is required. In certain circumstances, for example, clinical trials and orphan drugs, import of a minimal quantity of products without marketing authorization can be approved.
Regarding IP rights, parallel imports are allowed in Mexico in relation to trademarks where both:
The product was legally introduced in the country of origin.
The trade mark is owned by the same company or a related company in Mexico.
The Intellectual Property Law does not specifically address patents in this context as it does for trademarks. However, it is likely that the principle of exhaustion of rights also applies to patents.
8. What are the restrictions on marketing practices such as gifts, sponsorships, consultancy agreements, travel and entertainment, or other incentives for healthcare organizations and individual medical practitioners?
Government officers must not request, accept or receive any gifts or donations from persons whose commercial or industrial activities they are directly linked to, or that they regulate or supervise (Article 8, Federal Law of Responsibilities for Government Officers).
Doctors working for the IMSS or ISSSTE are considered to be government officers and are therefore not allowed to receive gifts or donations from pharmaceutical companies when on duty and working in the name of facilities of IMSS or ISSSTE.
The General Health Law and its regulations do not address doctors in private practice, although they specify that private doctors must act according to professional ethics.
Companies must not provide doctors with goods or incentives of any kind to use, prescribe, purchase or recommend a medicinal product or to influence the result of a clinical trial (Article 4.9.1, Code of Good
Practices of Advertising of the National Chamber of the Pharmaceutical Industry (CANIFARMA). The corresponding sanctions range from a warning to a fine.
Similarly, CANIFARMA’s Code of Ethics indicates, in general terms, that companies should act responsibly in relation to sponsorships and donations.
Mexico does not currently have any anti-bribery laws to limit these practices, and there is no domestic legislation to regulate these cases beyond Mexico’s jurisdiction. However, Mexico has ratified certain international treaties which do regulate, and in some cases prohibit, these practices.
9. How is the manufacturing of medicines and devices regulated and by which agencies?
The Mexican authority responsible for enforcing the regulatory framework relating to medical products is the Ministry of Health and the Federal Commission for Protection against Sanitary Risks (COFEPRIS). COFEPRIS can request reports from marketing authorization holders, and make on-site inspection visits in the manufacturing, distribution or storage facilities.
The requirements for manufacturing approval are set out mainly in the General Health Law, its regulations and 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 essentially for:
- Workforce conditions in the manufacturing facilities (including, for instance, responsibilities, uniforms, and medical examinations).
- Legal and technical documentation.
- Facility requirements.
- Manufacturing, validity and quality controls and protocols.
- Standard operating procedure.
- Biosafety measures.
- Destruction and elimination of waste.
The authority responsible for enforcing the regulatory framework in relation to medicines is COFEPRIS.
10. Are local manufacturing requirements compatible with Good Manufacturing Practices (GMPs) as defined by the U.S. Food & Drug Administration and/or the European Medicines Agency?
Yes, they are. In Mexico, the certificates of Good Manufacturing Practices issued by those agencies shall be recognized and validated, as well as the ones issued by Health Canada (Canada), Therapeutic Goods Administration (TGA, Australia), Swissmedic (Switzerland), Ministry of Health, Labour and Welfare (MHLW, Japan) and Ministry of Food and Drug Safety of the Republic of Korea (MFDS, South Korea).
11. What is the inspection regime for manufacturing facilities?
COFEPRIS is empowered to make on-site visits at any time to inspect premises and verify such compliance, and can initiate ex officio legal proceedings to sanction non-compliance. Ultimately, these legal proceedings can result in the revocation of the marketing authorization.
Good manufacturing practices, stability, and labelling standards and all other applicable provisions must be complied with. There must be a programmer to recall and destroy products that do not meet quality standards.
12. Are manufacturing facilities open for inspection by foreign inspectors or third-party inspectors as authorized by the FDA/EMA?
Yes, in Mexico COFEPRIS can authorize foreign inspectors or third party inspectors to make on-site visits.
13. What are the requirements for storage, packaging, and handling of medicines and devices and their constituent components?
In Mexico, establishments must obtain a health license from COFEPRIS and a certificate of Good Storage Practices in order to demonstrate that they comply with the requirements. Depending of the nature of the activities of the establishment it may require such a license or just an operation notice.
14. What information must be included in medicine and device labeling?
The labelling of medicinal products should include essentially the following information:
- Distinctive brand name.
- Generic name.
- Pharmaceutical form.
- Drug concentration.
- Formula description.
- Mode of administration.
- Conservation and storage information.
- Precaution and warning legends, including risks in case of pregnancy.
- Marketing authorization number.
- Batch number.
- Expiration date.
- Manufacturer’s and, if applicable, distributor’s information, including address.
- Maximum price to the public.
In cases of drugs with a biological origin, the specifications of the live organism that was used for the preparation of the medicinal product and the name of the disease for which it is indicated, according to the revised international nomenclature, must be given.
15. What additional information may be included in labeling and packaging?
The information can be additionally stated in any other language, provided it does not contradict the information in Spanish.
Moreover, a Decree has been issued amending article 26 of the Health Law Regulation (HLR) is pending publication in the Official Gazette of the Federation and its eventual entry into force.
This decree details the guidelines for the labeling of drugs for the public sector. In general terms, it indicates that the primary and secondary packaging of a medicine must be differentiated from that destined for the public sector and the labeling must include the legend “its sale prohibited” or “property of the Public Health Sector.” Likewise, the general provisions regarding labeling will be maintained.
Overall, this reform provides greater certainty regarding the requirements that must be met in the labeling of medicines destined exclusively for public health and social security institutions. However, it imposes an additional obligation on holders of sanitary registration.
16. What items may not be included in labeling and packaging?
The labelling of medicinal products may not include the following information:
- Additives present in the medicinal product.
- The number of the marketing authorization of the country or countries to be exported.
- Graphics that impede or impair the legibility and importance of the legends.
- Graphics that lead to confusion or quality criteria, or with food and beverages and that are caricatured according to the Mexican Official Standard (NOM-072-SSA1-2012).
17. What are the restrictions and requirements for the marketing and advertising of medicines and devices?
Only non-prescription medicines can be advertised to the general public, subject to approval by COFEPRIS. Media channels must require certified copies of the relevant marketing authorizations for medicines, before publishing related adverts.
Prescription medicines cannot be advertised to the general public.
Any visual or audio advert for non-prescription medicines must bear the message “Consult your physician”, and must mention any required precautions when use of the medicine represents any danger, in case of an existing pathology.
Prescription medicines can be advertised to health professionals. However, advertising directed to health professionals can only be published in specialized media and it must be based on medical prescription information.
18. Where can medicines and devices be sold or delivered? Can medicines and devices be sold or delivered via post?
Unless they are over-the-counter products, medicines must only be available in authorized drug stores and can only be sold to patients with a physician’s prescription.
The parcel companies can only store and deliver medicines if they have a Sanitary License, Notice of Sanitary Responsible and a special area for the storage and conservation of said medicines.
19. What are the restrictions and requirements for electronic marketing and advertising via email, by Internet, social media, and other channels?
The Health Law Regulations apply to any advertising activity, including ads through electronic means and other forms of technological media.
COFEPRIS is in charge of monitoring ads on the internet. It has been strongly monitoring drug-like products, known as “miracle products” (products with non-proven health-related claims).
The internet promotion of prescription-only medicines addressed to healthcare professionals must be duly approved by the corresponding authorities. The advertising must be disclosed on scientific websites. The sponsor must be clearly identified.
Companies must adopt the proper measures to ensure the promotion of prescription medicines on their websites will only be accessible to healthcare professionals.
Recently, COFEPRIS issued guidelines for digital advertising that apply to any product subject to be monitored/approved by COFEPRIS. These guidelines clarify that digital advertising campaigns must be approved by COFEPRIS before being used on any digital media.
20. May medicines and devices be advertised or sold directly to consumers?
Only non-prescription medicines can be advertised to the general public, subject to approval by COFEPRIS.
Unless they are over-the-counter products, medicines must only be available in authorized drug stores and can only be sold to patients with a physician’s prescription. Dispensers must keep original prescriptions regarding antibiotics.
21. How is compliance monitored?
COFEPRIS has a permanent pharmacovigilance programme. The strictness on the imposition of fines, in our experience, has been steadily increasing. COFEPRIS constantly monitors advertising activities throughout the country, particularly regarding drug-like products. COFEPRIS has been directing the efforts of coordination agreements related to publicity, and the enforcement of the same.
There has also been a strong coordination effort between COFEPRIS and pharmaceutical companies in the self-regulation of advertising, which is still monitored.
22. What are the potential penalties for noncompliance?
The penalties for failing to comply with the rules related to advertising are the suspension of advertising activities ordered either to the responsible party or directly to the media, and the imposition of a fine to each one, which can range from 2,000 to 16,000 minimum wages (around US$14,000 to US$115,000). The responsibility for imposing these penalties falls directly on the Ministry of Health, through COFEPRIS.