PRODUCT SAFETY MANAGEMENT AND ADVERSE EVENT HANDLING

At Genomma Lab Internacional S.A.B. de C.V. and its subsidiaries, we are committed to improving and preserving the health and well-being of our consumers. To achieve this, we offer innovative, safe, and effective products manufactured under the highest quality standards and in compliance with current regulations in every country where we operate.

With this purpose, we implement practices and processes to review, manage, and prevent adverse events related to our products. Depending on the type of product, these activities are known as Pharmacovigilance, Technovigilance, Cosmetovigilance, or Nutrivigilance. All of them allow us to monitor the safety of our products during their development, authorization, and marketing, with the goal of confirming and ensuring their appropriate safety profile for the well-being of our consumers.

These actions are based on international Good Practice guidelines and applicable local regulations in each country where Genomma Lab is present.

Adverse Event Reporting System
To ensure proper monitoring of the safety of our products, we have an Adverse Reaction or Event Reporting System available in all countries where we market our products.
If you experience any unexpected effect or safety issue when using one of our products, you may report it through our official contact channels in your country:

Product Safety Management Units (ULGSP)

When you contact us, an agent from our customer service center will register your report and forward it to the Safety Unit of the country where you are located. This unit will evaluate your case and provide a response. Additionally, your report will be notified to the corresponding authorities when required, in accordance with local regulations.

Before submitting your report, please take the following into account:

What is an adverse reaction?
It is any harmful, unintentional, and unexpected effect that occurs when using a product normally or as directed.

Who can report an adverse reaction?
Any person who becomes aware of the event, including:

- The affected consumer
- Family members
- Healthcare professionals (physicians, nurses, pharmacists, etc.)
- Technical staff or personnel responsible for the establishment where the product was purchased or used
- Third parties authorized by the consumer

What minimum information should your report include?
- Consumer or patient data: name or initials, age, gender, weight, and height
- Product information: brand name, presentation, batch number, and expiration date
- Event details: description of the adverse reaction or event, start and end dates
- Reporter’s information: phone number and email
- Any other relevant information, as applicable

When is the ideal time to report?
- Preferably within the first 24 hours after the event occurs, even on weekends or holidays
- When indicated by the treating physician (if applicable)
- No more than 45 days after the event has occurred

Note: In the case of a serious reaction, it is essential to seek immediate medical attention from the treating physician or the nearest emergency service.

Privacy Notice:
The information you provide will be processed by the Medical Area of Genomma Lab Internacional and protected according to applicable privacy and personal data protection regulations. The information may be shared with local and international health authorities, always maintaining the confidentiality of your identity.