Pharmacovigilance

Pursuant to the General Health Law, the current NOM 220 SSA1 regulation "Installation and operation of Pharmacovigilance", the Good International Pharmacovigilance Practices, and the several regulations regarding the safety and use or consumption of national and international drug products, hereafter "THE REGULATIONS", LABORATORIOS SILANES S.A. DE C.V. "SILANES" makes the PHARMACOVIGILANCE UNIT available; the latter is in charge of carrying out all activities related to the detection, evaluation, understanding, and prevention of adverse events, suspected adverse reactions, adverse reactions or any other safety problem regarding the use of drug products.

The adverse events, suspected adverse reactions, adverse reactions or any other safety problem regarding the use of drug products, "THE PHARMACOVIGILANCE INFORMATION" encloses all the safety information that may be reported by the user, hereafter “THE PATIENT”, regarding the PRODUCT or by any health care professional and/or the legal representative, and/or the guardian of "THE PATIENT", as well as by any person "THE THIRD PARTY" who has knowledge regarding any "PHARMACOVIGILANCE INFORMATION" in connection with and/or produced following the use of the drug product.
The "PHARMACOVIGILANCE INFORMATION" that will be recorded through the telephone line and/or the existing forms available on the website www.silanes.com.mx/farmacovigilancia, may include the following:

  1. Adverse events
  2. Adverse reactions
  3. Overdose
  4. Lack of efficacy
  5. Off-label use
  6. Use during pregnancy or breast feeding
  7. Product misuse
  8. Medication error
  9. Counterfeit/adulterated product
  10. Suspicion of transmission of an infectious agent through a product
  11. Pediatric use
  12. Occupational exposure
  13. Unexpected benefits from the product
  14. Drug-drug interaction or drug-food interaction
  15. Product-quality complaints (Non-compliance with the established physical, chemical and/or biological specifications)

For "SILANES" keeping up to date the information regarding its marketed products is very important since this affects the safety of our PATIENTS; therefore, if you report the presence of a side effect associated with any of THE PRODUCTS, we will contact you within the next 24 hours to process all the information concerning your health status.

"SILANES" will not be able to prepare any report containing "PHARMACOVIGILANCE INFORMATION" until THE THIRD PARTY or THE PATIENT and/or their legal representative submits a written consent through any mean deemed appropriate for the treatment of the personal data and/or sensitive personal data that they provide at the time of reporting the "PHARMACOVIGILANCE INFORMATION". In view of the above, the PHARMACOVIGILANCE UNIT makes the following privacy notice available for you:

PRIVACY NOTICE FOR THE PROTECTION OF PERSONAL DATA PROVIDED TO THE SILANES PHARMACOVIGILANCE UNIT.

Pursuant to the provisions of the Federal Law on the Protection of Personal Data Held by Private Parties, please be advised that LABORATORIOS SILANES, S.A. DE C.V. ("SILANES") which registered office is located at Avenida Paseo de las Palmas No. 340, 3rd floor, Col. Lomas de Chapultepec, Miguel Hidalgo, C.P. 11000, Mexico City, Mexico, is responsible for the use and protection of your personal data, and, in this regard, you are provided with the following information:
What are the personal data we gather and use?
For the purposes described in this privacy notice, we will use the following information:

  • Name
  • Gender
  • Date of birth
  • Phone number where you can be reached
  • E-mail
  • Full address (Street, house number, county/municipality, State, Country, Zip Code)

What sensitive and personal information we will use?
In addition to the above personal information, for the purposes of this privacy notice, we will use the following personal information regarded as sensitive and, therefore, requiring especial protection:

  • Information describing your health status
  • Contact information of your treating physician
  • Information regarding your affiliation to public health institutions
  • Used drugs and their dose

For which purposes will we use your personal information?
We will use the personal data we gather from you for the following purposes that are necessary for the service you are requesting:

  • Production of reports and/or documents regarding the PHARMACOVIGILANCE INFORMATION associated to the consumption of products, supplements, herbal medicinal and/or cosmetic products distributed, produced and/or marketed by “SILANES” within any territory.
  • Compliance with the obligations specified in the General Health Law, the current NOM 220 SSA1 "Installation and operation of Pharmacovigilance", the Good International Pharmacovigilance Practices, and the several regulations regarding the safety and use or consumption of drug products; (including, among others, the adverse reactions that must be reported to the applicable regulation or Health Authorities.)
  • Compliance with national and international Pharmacovigilance regulations.
  • Creation and maintenance of several databases to control the registration of the "PHARMACOVIGILANCE INFORMATION".
  • Compliance with the regulations of the National Pharmacovigilance Center.
  • Information provision in response to your requests.
  • When needed, communication and contact establishment with the Holder of the Marketing Authorization.

In addition, we will use your personal data for the following purposes that are not necessary for the service requested however it allows us to provide you with a better service:

Participation in a posteriori clinical studies, preparation of statistical analyses, programs, reports and/or projects in connection with the activities performed by SILANES.

If you would rather not have your personal information treated for any of the secondary purposes detailed above, please send an e-mail to avisodeprivacidad@silanes.com.mx, explaining you don’t want your personal information to be treated for secondary purposes.

Data Transference

Recipient of the Personal InformationPurposeKnowledge required
Competent AuthorityCompliance with laws, treaties or agreements we’re bound by or compliance with official requirements.NO
Companies providing the website development service (acting on behalf of the responsible party)Website-related services.NO

How can you Access, Rectify, Cancel or Oppose to the use of your personal information?

You may exercise your ARCO rights by submitting a free letter addressed to the Department of Protection of Personal Data, through the email avisodeprivacidad@silanes.com.mx, containing the following information: 1) Name, address, phone number, and email of the owner of the data; 2) Copy of a valid official identification of the owner (INE, passport, military service card); 3) Legal representatives of the information owners must attach a copy of the public deed evidencing the powers granted by the latter or, where appropriate, a power of attorney signed by the information owner, his/her representative and two witnesses; 4) Clear and accurate description of the data to be Accessed, Rectified, Canceled or Opposed. In the event of personal data Rectification, you must indicate the exact modification you wish to be made and attach the supporting documentation; 5) Any other element facilitating the location of your personal data. If you want to know more about the procedure to be followed for the exercise of these ARCO Rights, you can send an email to the address indicated above.
Si desea conocer más detalles del procedimiento para el ejercicio de estos Derechos ARCO, puede enviar un correo electrónico a la dirección electrónica antes señalada.

Consent withdrawal

You can withdraw the consent that, where appropriate, you have given us for the processing of your personal data. However, you must take into consideration that we will not always be able to immediately respond to your request or terminate the use of your information since some legal obligation may compel us to continue treating your personal data, which is why they will remain blocked. Likewise, you should consider that, for certain purposes, the withdrawal of your consent will imply that we will be unable to continue providing you with the service you requested, or the termination of your relationship with us. In order to know the procedure and requirements to be fulfilled for the withdrawal of your consent, you can send an email to avisodeprivacidad@silanes.com.mx

How can you limit the use or disclosure of your personal information?

In order for you to limit the use and disclosure of your personal information, please be advised that you can subscribe to the following registry: Public Registry to Avoid Receiving Advertising, for more information visit the internet portal of the Federal Agency of Consumer Affairs (PROFECO by its Spanish acronym).

We use tracking technologies on our Internet portal.

Please be aware that we use cookies, web beacons, and other technologies on our website by means of which it is possible to monitor your behavior as an Internet user, provide you with a better service and user experience when browsing through our site, as well as offer you new products and services based on your preferences. On the other hand, such tools allow the internet server to remember your preferences for the display of pages therein.

Likewise, please be aware of the personal data that we gather from these tracking technologies, the purposes for their treatment, as well as whether this information is shared with people, companies, organizations or authorities other than us:

Data gathered:PurposesWhether these personal data are transferred:Name of the recipient of the personal data:
IP address
Date and time of access
Access Duration
State from where you access our site
City from where you access our site
Operating system
Browser type
Reference website
We use this information so you can access our website and/or application, for the control and management of our systems and to improve the design of the websites and/or applications. The information saved becomes anonymous.This information is not transferred to third parties.Not applicable

You are not obliged to accept the cookies that we send you and you can change your browser settings in order not to accept cookies.

These technological tools can be disabled by following these steps: "Do Not Track" is an optional browser setting that allows users to stop tracking the websites they visit, including analytics services, ad networks, and social platforms. You may adjust the settings of your browser and select the option "Do not track." Once you have done this, a "Do Not Track" request will be sent whenever you access a website using your browser and your user activity will not be tracked.

How can you know what changes are made to this privacy notice?

This privacy notice may be modified, changed or updated arising from: new legal requirements; our needs regarding the products or services we offer; our privacy practices; changes to our business model, or other causes.

We commit to keeping you informed of the changes that our privacy notice may undergo through this same website.