Regulatory Law newsletter

To keep you informed about the latest developments in regulatory law, please find below a summary of the relevant updates:

With the implementation of Resolution 1896 of 2023, it is no longer necessary to obtain authorization from the Health Authority (Invima) to advertise medications and herbal products. However, it is still mandatory to inform the authority in advance about the media through which the advertising will be disseminated.

In addition, the authority will conduct the respective monitoring and post-report control of the advertising to verify compliance with the advertising content. Therefore, the following requirements must be considered:

Sale by Prescription: Sales may only be made in publications with restricted access exclusively directed at professionals authorized by law to prescribe these medications. The advertisements must specify the actions, indications, therapeutic uses, contraindications, side effects, administration risks, and dependency risks, as authorized in the product's health registration.

Over the Counter (OTC):

• Do not encourage indiscriminate, unnecessary, or inappropriate use.
• Must be objective, truthful and not exaggerate its properties.
• Indications or uses of the products must be written in Spanish, using a clear language to avoid confusion within the consumers, adhering to the truth, and clearly and precisely stating the authorized indications.
• Respect free competition within the framework of applicable health regulations for the products covered by this resolution.
• Avoid technical terms unless they have become common expressions.
• Ensure that the advertisement does not conflict the promotion of healthy habits and general health policies.
• Do not mislead prescribers, dispensers or users by assertion or omission.
• For radio advertisements, the message should be clear and slowly delivered without speeding up.
• Advertising should not include messages, symbols or images of any nature that distort, mislead or confuse regarding the origin, results, benefits, characteristics, therapeutic use, traditional use or the approved indication in the product's health registration.
• Do not use visual, auditory, or general sensory elements that attract the attention of minors inducing them to consume over the counter of freely sold medications and herbal products.
• Do not use expressions that generate fear, anxiety, or suggestion about potential harm if these products are not used.
• Advertising must not excessively praise the targeted audience in a misleading way, harm the dignity of the referenced gender, or contain degrading or discriminatory elements based on sex, age, race, social status, sexual preference, health condition or other reasons.
• Include mandatory laws.

This new regulation extends responsibility beyond the holders of health registrations to include third parties, influencers, importers, marketers, distributors, drugstores, pharmacies, among others.

Since November 2023, following the enactment of Decree 1474 of 2023, which established indefinite validity for medications in Colombia, the pharmaceutical industry will no longer have to undergo the renewal process for their registrations every five years. This change represents a significant achievement for the industry as it eliminates the waiting time for the approval of such renewals, thereby reducing the medication shortages in Colombia. However, it remains essential for the pharmaceutical companies to keep the health registrations updated to ensure the health of Colombians.

In this context, it is important to note that health registrations that have not undergone the Pharmacological Evaluation process as required by Decree 1782 of 2014, must request and submit a modification of their health registration due to regulatory changes to the health authority.

Holders of health registrations for Medical Devices and In Vitro Diagnostic Reagents with valid registrations as of February 7, 2024, must report the semantic standard or codification of these devices. These includes the names, qualities, or properties of the Medical Devices for human use and the In Vitro Diagnostic Reagents, in terms of their generic, regulatory, and commercial descriptions, required by the health system in Colombia.

Deadlines:

• Phase 1: Class III Medical Devices for human use and Category III In Vitro Diagnostic Reagents: From February 8, 2024, through February 08, 2025.
• Phase 2: Class IIb Medical Devices for human use and Category II In Vitro Diagnostic Reagents: From February 8, 2024, to August 8, 2025.
• Phase 3: Class IIa and I Medical Devices for human use and Category I In Vitro Diagnostic Reagents: From February 8, 2024, to February 08, 2026.

However, for those products that obtain health registration after February 8, 2024, they must obtain and report the code prior to the commercialization of the products.

As a result, the health authority, Invima is offering training to users to expedite this process; however, the platform for these reports is not yet fully operational, which is why work on these issues has not been able to begin.

Considering the new food regulations that have been implemented in recent years, manufacturers must comply with the stipulations regarding front warning labeling. The following are the deadlines to adjust their labels and comply with current regulations:

• February 28, 2023: Was the last date to request label exhaustion before Invima.
• December 15, 2023: Until this date, labels could be exhausted without authorization from Invima.
• June 14, 2024: Last day to exhaust labels if authorization from Invima is obtained.

From June 15, 2024, all food manufacturers and marketers must comply with nutritional labeling and warning seals on the labels, otherwise their products must be withdrawn from the market.

Since 2016 cannabis for medicinal and industrial use has been authorized in Colombia, allowing its production and commercialization for these purposes.
Different license holders, in collaboration with the Colombian Association of Cannabis Industries - Asocolcanna, are undertaking the necessary steps to regulate the sale of cannabis flower in Colombia for medicinal purposes. The goal is to sell it under medical prescription to counteract the informal use of the flower and thus ensure safety without compromising public health for Colombians.

Recently, the Ministry of Health issued a Draft Decree, which aims to eliminate the requirement for Good Manufacturing Practices (GMP) for obtaining the health registration of alcoholic beverages that are manufactured, processed, hydrated, packaged, exported, imported, and marketed in Colombia. The decision to obtain this certification will be at the discretion of the interested party.

The National Institute for Food and Drug Surveillance (Invima) has published a Draft Resolution establishing the procedures and administrative processes for the authorization of food factories located abroad or the inspection, surveillance, and control system of countries interested in exporting high-risk public health foods of animal origin (milk and dairy products, meat derivatives, fish and fish products, and egg products) to Colombia.

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