Medius AG - Data privacy note for pharmacovigilance, medical information and product-related complaints
At MEDIUS AG (hereafter “Medius”, “we”, us”), we take data privacy seriously and treat all your personal data in accordance with our Data Privacy Policy and applicable privacy and data protection laws.
This note is intended to explain how we collect and process your personal data for the purposes of pharmacovigilance related activities, medical information inquiries and product complaints. The scope of this note is limited to the collection and processing of your personal data for pharmacovigilance, medical information inquiries and product complaints. For general information about data processing please visit under Privacy the general privacy note.
Humans vary in their biological reactions to medicinal products or medical devices and not all effects associated with the use of products can be detected during clinical development, not even by the most comprehensive clinical trials. Monitoring of adverse events is called Pharmacovigilance (“PV”). PV requirements exist to allow us and competent regulatory authorities to manage adverse events and to protect public health and ensure high standards of quality and the safety of medicinal products. As a pharmaceutical company, Medius has a legal responsibility to monitor the safety of medicinal products marketed in the Territory of Switzerland and Liechtenstein.
Purpose of data processing and recipients
Pharmacovigilance: Any personal data provided to us related to adverse events or other activities related to pharmacovigilance will be used solely for these purposes. This information is very important for public health and will be used for the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem.
If and to the extent the data processing is subject to data protection laws, we collect and process your data for these purposes in order to comply with our legal obligations. This processing is necessary to comply with pharmacovigilance (Good Vigilance Practice - GVP) obligations. Your data will not be used for any other purposes.
We are contractually oblidged to report such data to our client pharmaceutical companies with proprietary rights in relation to the products marketed. Your personal data may be transferred to other countries that provide the same level of protection as Switzerland. We may also be required by law to report the data to supervisory authorities. Such report contain details about the incident but will only contain limited personal data:
We are contractually oblidged to report such data to our client pharmaceutical companies with proprietary rights in relation to the products marketed. Your personal data may be transferred to other countries that provide the same level of protection as Switzerland. Where required by law, we may also be required to report the data to regulatory authorities. Your personal data related to a medical inquiry might be related to pharmacovigilance or product complaints.
Product Complaints: Any personal data provided to us related to a product complaint will be used solely for these purposes. This information is very important for public health and will be used for the evaluation, classification and assessment of the product complaint and to follow up on such requests. This processing is necessary to comply with legal Good Dirstribution Practice (GDP) obligations.
We are contractually oblidged to report such data to our client pharmaceutical companies with proprietary rights in relation to the products marketed. Your personal data may be transferred to other countries that provide the same level of protection as Switzerland. Where required by law, we may also be required to report the data to regulatory authorities. Your data will not be used for any other purposes.
As information related to drug safety are important for public health, reports are kept for a standard period defined in our Quality Management System. The retention period depends on the nature of data.
Categories of personal data
Pharmacovigilance: We collect the name, contact details, and affiliations/profession of the reporting individual and relationship with the subject of the report. We may get general personal data (name, age, sex, weight) and sensitive data (racial or ethnic origin, health data, which could include sexual life, medication and medical history) of the patient, for pharmacovigilance purposes.
Medical Inquiries: We may collect the name, contact details and affiliation/profession of the individual making the inquiry.
Product Complaints: We may collect the name, contact details and affiliation/profession of the individual reporting the complaint. We may collect some additional personal data related to health and medical history of the individual affected by the product complaint if such information is relevant to evaluate, classify and assess the product complaint.
Your rights
If the processing of your personal data is covered by data privacy regulations, please note that you have the right to request from Medius information on which personal data we store and the purpose for which we process them. You can also request access to and rectification of your personal data. You can request the deletion of your Personal Data if they are no longer necessary for the purposes of processing or there is no legal ground for their further processing Please note that due to our legal obligations we may not be able to erase or restrict processing of your data if processed for pharmacovigilance. If data processing is based on consent, kindly note that you have the right to withdraw your consent at any time, however, without affecting the lawfulness of processing based on consent before its withdrawal. If you would like to contact us to exercise your right to withdraw consent, please see find our contact details below.
We might contact you for further information about adverse events you reported to us. You have the right to express that you do not wish to be contacted. In such case we might keep your name in our files with a note «do not contact».
Please direct any questions and requests related to this note to [email protected]
In the event you have the impression that our data processing is non-compliant with data privacy regulations, you have the right to claim to the responsible supervisory authority (https://www.edoeb.admin.ch/edoeb/de/home.html).
References: Article 18(b), Article 27a., Article 27e.(2) FADP; Article 6(1)(c), Article 9(2)(i) GDPR; chapter I.B.10 GVP module I.
Last updated: 07-JUL-2020
Disclaimer Medical Information requests:
On our partner’s behalf, Medius may respond to your spontaneous medical request. Please note that the information provided is to be understood solely in the context of your spontaneous request.
Information enclosed (letter, literature etc.) may contain information outside the authorised drug information of registered products. This scientific data is intended to enable you to draw your own conclusions and make your own decisions. This information should not be construed as an advertisement or recommendation for any indication, dosage or other aspect not listed in the approved drug information. For more information see the related SmPC at www.swissmedicinfo.ch.
Medius does not recommend any uses of its partner’s products (products, where Medius acts as MAH or not) other than those described in the relevant SmPC.
Information is provided to the best of our knowledge and as a direct response to a specific medical request. All archive data and information provided for the purpose of responding to this enquiry that is not publicly available is subject to confidentiality and is protected by copyright. It may not be distributed, disclosed or passed on without the prior written consent of Medius AG.
Last updated: 29-MAR-2022
At MEDIUS AG (hereafter “Medius”, “we”, us”), we take data privacy seriously and treat all your personal data in accordance with our Data Privacy Policy and applicable privacy and data protection laws.
This note is intended to explain how we collect and process your personal data for the purposes of pharmacovigilance related activities, medical information inquiries and product complaints. The scope of this note is limited to the collection and processing of your personal data for pharmacovigilance, medical information inquiries and product complaints. For general information about data processing please visit under Privacy the general privacy note.
Humans vary in their biological reactions to medicinal products or medical devices and not all effects associated with the use of products can be detected during clinical development, not even by the most comprehensive clinical trials. Monitoring of adverse events is called Pharmacovigilance (“PV”). PV requirements exist to allow us and competent regulatory authorities to manage adverse events and to protect public health and ensure high standards of quality and the safety of medicinal products. As a pharmaceutical company, Medius has a legal responsibility to monitor the safety of medicinal products marketed in the Territory of Switzerland and Liechtenstein.
Purpose of data processing and recipients
Pharmacovigilance: Any personal data provided to us related to adverse events or other activities related to pharmacovigilance will be used solely for these purposes. This information is very important for public health and will be used for the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem.
If and to the extent the data processing is subject to data protection laws, we collect and process your data for these purposes in order to comply with our legal obligations. This processing is necessary to comply with pharmacovigilance (Good Vigilance Practice - GVP) obligations. Your data will not be used for any other purposes.
We are contractually oblidged to report such data to our client pharmaceutical companies with proprietary rights in relation to the products marketed. Your personal data may be transferred to other countries that provide the same level of protection as Switzerland. We may also be required by law to report the data to supervisory authorities. Such report contain details about the incident but will only contain limited personal data:
- Patients: Information as provided, including age or date/year of birth (where permitted by regulations) and gender (note that patient name will never be transmitted)
- Reporting Individuals: Information as provided to allow the regulatory authority to follow up with the reporting individual, including name, profession, initials, address, email, phone number
We are contractually oblidged to report such data to our client pharmaceutical companies with proprietary rights in relation to the products marketed. Your personal data may be transferred to other countries that provide the same level of protection as Switzerland. Where required by law, we may also be required to report the data to regulatory authorities. Your personal data related to a medical inquiry might be related to pharmacovigilance or product complaints.
Product Complaints: Any personal data provided to us related to a product complaint will be used solely for these purposes. This information is very important for public health and will be used for the evaluation, classification and assessment of the product complaint and to follow up on such requests. This processing is necessary to comply with legal Good Dirstribution Practice (GDP) obligations.
We are contractually oblidged to report such data to our client pharmaceutical companies with proprietary rights in relation to the products marketed. Your personal data may be transferred to other countries that provide the same level of protection as Switzerland. Where required by law, we may also be required to report the data to regulatory authorities. Your data will not be used for any other purposes.
As information related to drug safety are important for public health, reports are kept for a standard period defined in our Quality Management System. The retention period depends on the nature of data.
Categories of personal data
Pharmacovigilance: We collect the name, contact details, and affiliations/profession of the reporting individual and relationship with the subject of the report. We may get general personal data (name, age, sex, weight) and sensitive data (racial or ethnic origin, health data, which could include sexual life, medication and medical history) of the patient, for pharmacovigilance purposes.
Medical Inquiries: We may collect the name, contact details and affiliation/profession of the individual making the inquiry.
Product Complaints: We may collect the name, contact details and affiliation/profession of the individual reporting the complaint. We may collect some additional personal data related to health and medical history of the individual affected by the product complaint if such information is relevant to evaluate, classify and assess the product complaint.
Your rights
If the processing of your personal data is covered by data privacy regulations, please note that you have the right to request from Medius information on which personal data we store and the purpose for which we process them. You can also request access to and rectification of your personal data. You can request the deletion of your Personal Data if they are no longer necessary for the purposes of processing or there is no legal ground for their further processing Please note that due to our legal obligations we may not be able to erase or restrict processing of your data if processed for pharmacovigilance. If data processing is based on consent, kindly note that you have the right to withdraw your consent at any time, however, without affecting the lawfulness of processing based on consent before its withdrawal. If you would like to contact us to exercise your right to withdraw consent, please see find our contact details below.
We might contact you for further information about adverse events you reported to us. You have the right to express that you do not wish to be contacted. In such case we might keep your name in our files with a note «do not contact».
Please direct any questions and requests related to this note to [email protected]
In the event you have the impression that our data processing is non-compliant with data privacy regulations, you have the right to claim to the responsible supervisory authority (https://www.edoeb.admin.ch/edoeb/de/home.html).
References: Article 18(b), Article 27a., Article 27e.(2) FADP; Article 6(1)(c), Article 9(2)(i) GDPR; chapter I.B.10 GVP module I.
Last updated: 07-JUL-2020
Disclaimer Medical Information requests:
On our partner’s behalf, Medius may respond to your spontaneous medical request. Please note that the information provided is to be understood solely in the context of your spontaneous request.
Information enclosed (letter, literature etc.) may contain information outside the authorised drug information of registered products. This scientific data is intended to enable you to draw your own conclusions and make your own decisions. This information should not be construed as an advertisement or recommendation for any indication, dosage or other aspect not listed in the approved drug information. For more information see the related SmPC at www.swissmedicinfo.ch.
Medius does not recommend any uses of its partner’s products (products, where Medius acts as MAH or not) other than those described in the relevant SmPC.
Information is provided to the best of our knowledge and as a direct response to a specific medical request. All archive data and information provided for the purpose of responding to this enquiry that is not publicly available is subject to confidentiality and is protected by copyright. It may not be distributed, disclosed or passed on without the prior written consent of Medius AG.
Last updated: 29-MAR-2022