Policy on Treatment
of Personal Data For
Pharmacovigilance
Pharmacovigilance consists of a set of activities involving Competent Authorities, Marketing Authorization Holders (MAHs) of medicinal products, business partners involved in the management of pharmacovigilance or in the promotion and/or distribution and/or sale of medicinal products, health facilities, healthcare professionals, patients and citizens. The spontaneous reporting of suspected adverse drug reactions is a fundamental source of information for pharmacovigilance activities. The present Policy is aimed at clarifying the type of processing of personal data you may send us as well as the rights and duties that derive from such processing.
Aspargo Laboratories, Inc.
550 Sylvan Avenue, Suite 102
Englewood Cliffs, NJ 07632
201.408.483
info@aspargolabs.com
PURPOSE
The personal data received will be processed for all obligations related to pharmacovigilance, that is, the collection, evaluation and analysis of reports of adverse reactions or any other drug-related safety problem. The Data Controller will process personal data only to fulfill the legal obligations above reported ensuring that the treatment will take place, where possible, anonymously.
RECIPIENTS
The personal data provided may be made available, for the purposes indicated above, to some of the subjects obliged to carry out pharmacovigilance activities (e.g. National Competent Authorities, EMA, MAHs, potential distributors and partners, Third Parties involved in the management of adverse drug reaction, pharmacovigilance offices of hospitals or of scientific research and treatment institutes etc.).
In some circumstances, for the purposes indicated above, personal data may be shared with subjects located outside the European Union, including other Companies belonging to the same group. In these situations, taking into account the Agreements with the Companies, every measure will be adopted in order to guarantee an adequate level of protection of personal data.
There are no automated treatments but only traditional treatment, based on technological means and tools.
LEGAL BASIS OF THE PROCESSING
Pharmacovigilance is necessary for the protection of public health and is therefore provided for by the European legislation (EU Directive 2010/84, EU Directive 2012/26, Regulation (EC) 726/2004, EU Regulation 1235/2010, EU Implementing Regulation 520/2012, Good Pharmacovigilance Practices). The processing of personal data provided spontaneously is based on the pursuit of purposes of public interest in the health sector.
RIGHTS
Within the limits and under the conditions set out in Articles 15 - 23 of EU Regulation 679/2016 you may exercise the following rights:
Right of access;
Right to rectification, updating and cancellation;
Right to object to the processing for legitimate and specific reasons;
Right to obtain the correction of inaccurate personal data without undue delay;
Right to obtain the limitation of treatment pursuant to art. 18, paragraph 1 of EU Regulation 679/2016;
Right to data portability within the limits and in the ways provided for by art. 20 of EU Regulation 679/2016 and the guidelines on data portability;
Right to lodge complaints with the competent authority.
STORAGE
The retention of personal data for the purposes of internal management of pharmacovigilance obligations is guaranteed for the entire duration of the marketing authorization of the medicinal product concerned by the report and for the following ten years from the moment the authorization lapses. This time limit is extended indefinitely for scientific and research purposes only.
CONSENT
Pursuant to art. 9, paragraph 2 lett. i) of EU Regulation 679/2016, the personal data provided can be processed without consent.
COMPLAINT
If you wish, you can consult the relevant Member State Data Protection Agency to propose a formal complaint.