Pharmacovigilance, Technovigilance and Cosmetovigilance

Welcome to the Pharmacovigilance, Technovigilance and Cosmetovigilance section of Genomma Lab Internacional.

 

At Genomma Lab Internacional S.A.B de C.V., we are committed to improving and / or preserving the health and well-being of our consumers by offering innovative, safe and effective products; with the highest quality standards attached to compliance with the corresponding National and International regulations. Pharmacovigilance, Technovigilance and Cosmetovigilance practices, actions and activities in Genomma Lab are established, that allow us to monitor the safety profile of our products during the development, authorization and marketing periods of the same, with the mail goal of monitoring, analyzing, establishing and / or confirming the appropriate safety profile and thus seeking the welfare and safety of our consumers.

These actions and practices have their operation bases in NOM-220-SSA1-2216 and its modifications, published in the Official Journal of the Federation, on September 30, 2020 and NOM -240-SSA1 2014 in the case of Mexico and is based on key elements of the Good Pharmacovigilance Practices for the Americas- PAHO & WHO and the applicable local regulations for the Genomma Lab subsidiaries in the region.

Within the pharma, techno and cosmetovigilance actions to carry out the monitoring of the safety profile, we have established the "Reporting Adverse Drug Reactions System" that may arise during the commercialization period.

Whereby,

F If you present any adverse drug reaction or adverse events, with the use of any our products, you can report it, through our official communication channels, that are:

 

Pharmacovigilance Unit, Genomma Lab Internacional.

 

• ( call center:

 

Phone: 800 7171 305

Phone: 800 3436 662

 

• + e mail:

 

farmacovigilancia@genommalab.com

 or atencion@genommalab.com

 

 

or to our local Pharmacovigilance Units in the countries (see list below).

 

 

·        Process: an agent from our call center will assist you, take the data from your report and assign the Pharmacovigilance Unit of the country where you are. In the Pharmacovigilance Unit, your case will be evaluated and a response will be issued through the means that was communicated, so it is also important to let you know that your report will be notified to the Regulatory Authorities according to the corresponding regulations and within the times established in the applicable regulations.  On the other hand, before making your report, we want communicate you, the following concepts so that you take into consideration.  What is an adverse drug reaction? A response to a drug which is noxious and unintended, and which occurs at doses normally used in man for the prophylaxis, diagnosis, or therapy of disease, or for the modifications of physiological function'. (WHO 1972). Can adverse reactions or adverse events occur from the use of cosmetics? Yes, it is possible, the correct cosmetovigilance term for cosmetic adverse events is adverse incident and you should report it, too.

Who can report?

The patient or consumer, consumer's family member, and the health profesionals.  

What kind of information is required?

• An identifiable patient (i.e. patient initials/age/sex/record number)
• An identifiable medicinal product (i.e. product name or active substance if brand is unavailable)
• An identifiable reporter
• An identifiable reaction

* These data are not limiting.

 

What is the time to report an adverse drug reaction or adverse event?• If possible, within the first 24 hours after the event occurred, even if it occurred on weekends or non-working days in your country.• When indicated by the treating physician (when applicable).• No more than 45 days after the adverse event occurred. Note: It is suggested once an adverse event has occurred, it is necessary to refer the patient immediately to his treating physician or to the nearest emergency service, in case the reaction is severe. Notice of use and privacy of data: The data that you provide us will be processed by the Pharmacovigilance Area of ​​Genomma Lab Internacional. Your personal data will be protected in strict adherence to international regulations that apply to privacy and data protection. The information can be transmitted to local and international health authorities (in this case your identity is confidential).

 

• Pharmacovigilance Local Units.