Privacy Policy

Medicalix Ltd. Is Pharmacovigilance and Medical Information service provider for Pharmaceutical and Medical equipment companies in Israel (hereinafter referred to as Medicalix), 

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As regards to the exercise of Pharmacovigilance and Vigilance activity, Medicalix must comply with certain legal obligations in order to enable effective monitoring of the safety of medicinal products authorized in Israel with its customers.

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For such purpose, within the scope of contractual obligations with its customers and in compliance with existing legislation in force regarding Pharmacovigilance and Vigilance in Israel, Medicalix must identify the adverse events and/or reactions (i.e., the harmful and unintended reactions that may originate by a medicine), as well as special situations, as defined in the Good Pharmacovigilance Practices (GVPs), which may occur in relation to medicinal products authorized by Medicalix’ clients.

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 The existence and management of a Pharmacovigilance system is a legal obligation for marketing authorization holders in Israel.

To this end, one of the main obligations of entities, in particular for marketing authorization holders for medicinal products, is the designation of a QPPV, a QPPV Deputy.

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Therefore, it is, among others, in this context that Medicalix is contracted by its clients to perform these functions, and in this sense, regarding to Personal Data and its processing, Medicalix acts as a processor, never as personal data controller regarding to pharmacovigilance and vigilance activities.

Thus, Medicalix acts not only in compliance with its legal obligations and the legal obligations of its clients, but also within the scope and with the delimitations which may be eventually established in the celebrated contracts.

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In the scope of the contracts celebrated with clients in Medicalix’ area of activity, Medicalix has as main competence and obligation to identify and record adverse events/reactions and special situations in relation to medicines, cosmetic products, food supplements, biocides, medical devices, among other products in the activity area, of which it has direct knowledge to whom it was reported by any means.

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To this end, it is essential for Medicalix to process personal data (in particular, health data), not only of patients, but also of those who reported to Medicalix, or its clients, the circumstances described above. The processing and transmission of personal data and reports relating to adverse events and special situations allows the management and control of these circumstances, which, consequently, allows the protection of public health and the quality and safety assurance of authorised medicinal products in Israel.

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The personal data under consideration, as well as the adverse events/reactions, special situations and their reports, after registered and analyzed, are sent to the competent regulatory and supervisory authorities – namely the Israeli Ministry of Health, as well as to the customers themselves (considering that the processing of the data is done on their behalf, under their instructions and in compliance with the subject-matter of the contract), in order to allow the creation of a genuine and global pharmacovigilance/vigilance system, thereby ensuring the quality and safety of medicines and other authorized products, and, consequently, the quality and safety of public health.

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With this declaration, Medicalix is intended to provide relevant information on the form of action, especially regarding the processing of personal data for pharmacovigilance purposes, in particular by referring the categories of personal data subject to processing, the purposes of the processing, the possibility and mandatory transmission of the personal data concerned, the retention period, the legal basis and the rights of the personal data subject.

Medicalix performance, in the context of personal data processing within the scope of Pharmacovigilance and Vigilance, is strictly governed by the Israeli Data Protection Laws.

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Personal data is processed only for the purposes of Pharmacovigilance and Vigilance, in accordance with the terms in which they are relevant, necessary and appropriate to register, evaluate, report and transmit the adverse events/reactions, and special situations according to the obligations related to the activity.

Notwithstanding the provisions of this declaration, and in case of doubt or need of clarification on matters relating to this declaration, or on the processing of your personal data, you may contact us through the contacts placed at your disposal and stated at the end of this document.

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I – Personal Data Categories

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Within the Pharmacovigilance activity, it may be necessary to process the following personal data of the patient:

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• Name or initials;

• Date of birth or age group, gender, weight, height;

• Information on health, racial or ethnic origin and sexual activity;

• Contacts, in particular, email address, telephone number or mobile phone, especially in order to be able to track the adverse event;

• History and clinical situation, which may include:

• Date of start of adverse reaction;

• Duration of adverse reaction;

• Seriousness of adverse reaction;

• Evolution of adverse reaction;

• Identification of the suspected medicinal product;

• Date of beginning of drug administration;

• Date of drug administration suspension;

• Route of administration of the suspected medicinal product;

• Daily dose;

• Therapeutic indication;

• First use;

• Last use;

• Data on concomitant medication;

• Existence of previous reactions to the same drug;

• Reintroduction of the same drug;

• Suspected interaction;

• Clinical data;

• Auxiliary diagnostic tests;

• Allergies;

• Pregnancy;

• Last menstrual Date;

• Medical assessment on the causal relationship.

• As for the reporter, the data to be processed is as follows:

• Name;

• Contact details (which may include address, email address, phone number, mobile phone number, fax number):

• Profession/ocupation, therefore, can determine the issues that can be asked, which may be more or less technical, especially if it is a healthcare professional;

• Relation with the patient.

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Regarding the other health products mentioned above, in the context of vigilance, if it is necessary to process personal data, it will be only those referred to in pharmacovigilance, with the remaining data being transferred only relating to the products themselves.

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II – Purpose of Personal Data Processing under Pharmacovigilance

The personal data processing will be carried out so that Medicalix can comply with its obligations and the obligations of its customers, related with Pharmacovigilance and Vigilance, and the concrete purpose for the processing will be as follows:

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Collection, analysis and investigation of the adverse event or special situation;

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Contact the reporter of the adverse event to obtain additional information and monitor the evolution of that same event, in order to be able to effectively know all its consequences;

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Carry out mandatory reports on adverse events and special situations, and to transmit them to Medicalix customers (controllers of the personal data and marketing authorization holders for medicinal products), and for the fulfilment of legal obligations relatively to other health products referred above, transmitting that reports also to the Israeli Ministry of Health in order to analyse the quality and safety of the medicinal product and other products concerned.

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III – Transmission of Personal Data

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In order to be able to comply with the legal obligations related to Pharmacovigilance and Vigilance on the part of Medicalix and its customers, it is essential to Medicalix to transmit the collected personal data.

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Thus, Medicalix may have to transmit processed personal data to its customers, which will be done internally and by electronic means, subject to high control and protection, and is not in any way disseminated internally by other ways, other than those preconceived for that purpose, such as direct and restricted contacts of the client and the employee responsible, designated by Medicalix for the provision of the contracted service.

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Moreover, Medicalix, where its competences so permit, should transmit processed personal data under Pharmacovigilance and Vigilance, and their reports, to the competent regulatory authorities of Israel.

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Medicalix shall also transmit the concerned personal data to external service providers and may include security database providers, IT Support, in order to ensure the effective protection of such personal data.

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Medicalix ensures the implementation of appropriate protection measures with their customers and with external suppliers, also implementing these measures in the context of the directly carried out treatment.

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Personal data databases relating to pharmacovigilance and vigilance and subject to processing by Medicalix are hosted in Israel, and the transmission of personal data carried out by Medicalix to its customers (controllers of personal data), will be carried out through databases of customers based in third countries.

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IV – Store of Personal Data

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Processed personal data in pharmacovigilance and vigilance shall be used and stored in accordance with the legally laid down requirements, namely, the obligation to store data related to adverse events/reactions and special situations during the life cycle of the medicinal product and other health products referred to in this document and even after revoked or withdrawal authorisation of the medicinal product and/or other health products concerned on the market for at least ten years, according to the rules for the store and notification of information to the competent regulatory authorities.

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The personal data is stored through the implementation of appropriate technical and organisational measures for the protection of personal data, in particular by encrypting the stored personal data, as well as by limiting access or any other type of processing of the data only to Medicalix employees who perform functions in the area of Pharmacovigilance and Vigilance and with proper authorization.

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All physical, electronic, technical, procedural and training measures are implemented, appropriate to the effective protection of personal data subject to processing, any loss, destruction, unauthorized damage, use and disclosure, among other mishaps.

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V – Rights of Data Subjects

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Medicalix shall inform the data subjects to the processing of their rights in relation precisely to such processing.

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In short, the data subjects have the following rights relating to their personal data:

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Right to access their own personal data, in the event that they are treated;

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Right to be informed about the processing of personal data;

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Right to rectification of their own personal data, if they are inaccurate or incomplete, and may request the limitation of the processing until the necessary rectification is verified;

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Right to erasure their personal data, when the purpose of the processing, the legal obligations related with the processing of personal data and the legal basis for the processing (in particular, for additional retention), are no longer applicable;

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Right to object and to the restriction of processing the personal data, within legal limits;

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Right to data portability, for the data subject or for another person, in a format of current use, within legal limits;

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Right to lodge complaints with the competent authority, in accordance with the legally provided limitations. 

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It should be noted that these rights may be limited to the strict extent of compliance with legal obligations, related with Pharmacovigilance and Vigilance, but can only be limited with an adequate legal basis.

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VI – Contacts

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For questions related to the protection and privacy of your personal data processing, you can contact the Medicalix Data Protection Officer by email: info@Medicalix.com.