PRIVACY NOTICE REGARDING THE PROCESSING OF THE DATA SUBJECTS’ PERSONAL DATA REGARDING COMPAINTS/QUESTIONS/REPORTS ON PRODUCTS’ ADVERSE REACTIONS OF “GEROLYMATOS INTERNATIONAL SOCIETE ANONYME COMMERCIAL AND INDUSTRIAL COMPANY”
1.1 The Company under the trade name “GEROLYMATOS INTERNATIONAL SOCIETE ANONYME COMMERCIAL AND INDUSTRIAL COMPANY” and the distinctive title “GEROLYMATOS INTERNATIONAL S.A.”, with registered seat in Kryoneri, Attiki, at 13 Asklipiou Street, P.C. 14568 (hereinafter as “GEROLYMATOS INTERNATIONAL S.A.” or/and the “Company” or/and “We”) for the purposes of managing complaints/questions/reports on products’ adverse reactions, collects and processes data for quality control purposes, management of the pharmacovigilance system kept by the Company and for the effective and meaningful investigation of your issue.
1.2 This Privacy Notice is referred to all persons (each of whom will hereinafter be referred to as “the Data subject”) who submit to the Company any questions/complaints or any adverse events/incidents or undesirable side effects arising from the use of products distributed by the Company (hereinafter the referred to as the “Products”).
1.3 Specifically, this Privacy Notice aims to provide you with information on the processing of your personal data, including your sensitive personal data, and on the rights you have as data subjects.
2. DATA CONTROLLER
2.1 The Company is the Data Controller under the Regulation (ΕU) 679/2016 of the European Parliament on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation).
3. LEGAL BASIS FOR THE PROCESSING
3.1 The legal basis on which your personal data are processed pursuant to this Notice is (a) the Company’s compliance with statutory obligations especially in the context of statutory obligations to report any undesirable side effects of a drug or incident; b) the fulfillment of the legitimate interests of the Company in particular regarding the substantive investigation of the issue/question/complaint you submit to us as well as the effective management of the pharmacovigilance system and (c) your consent regarding the processing of your personal data.
4. CATEGORIES OF PERSONAL DATA
4.1 The Company collects, for the purposes of the processing described herein, simple and sensitive personal data, as outlined, including but not limited to the following:
i. Name, surname, postal address, telephone number (fixed or/and cell phone), email address, city, postal code, profession.
ii. If you are a patient, gender, date of birth, age, pregnancy related information, height, weight, health history and other health data relevant to the incident you are reporting.
iii. Any other information you disclose on your own initiative to the Company when you communicate with us.
4.2 Data provided by you to the Company regarding other persons (ex. relatives, etc.) will be processed by us in accordance with the terms of this Privacy Notice. You are responsible for the accuracy of those data and information and you should ensure that the aforementioned data subjects are aware of the personal data provided by you and of how they will be processed by the Company.
5. PURPOSES FOR THE PROCESSING OF YOUR PERSONAL DATA
5.1 Your personal data will be used primarily in order to investigate in an effective and meaningful way the issue/complaint/question you submit to us and in order to effectively manage the pharmacovigilance system kept by the Company.
5.2 Your personal data may be used for the following, included but not limited, purposes:
(i) For the compliance of our statutory obligations and the effective management of the Company’s pharmacovigilance system,
(ii) For the effective and meaningful investigation of the issue/complaint/question you submit to us and in order to communicate with you,
(iii) For the purposes of conducting quality controls of our Products and in order to carry out analysis and research for these purposes,
(iv) For statistics and historical reasons,
(v) In the context of any judicial and/or extrajudicial actions directly related to the complaint you have submitted to us for the purposes of safeguarding the Company’s legitimate interests.
6. RECIPIENTS OF YOUR PERSONAL DATA
6.1 Recipients of your personal data will only be available to appropriately authorized employees of the Company who are in charge of tasks related to the management of the abovementioned processing purposes.
6.2 For the purposes of fulfilling the processing purposes described in this Notice, the Company may disclose your personal data to third parties, such as marketing authorization holders/producers of products distributed by our Company or to competent auditing and supervisory authorities (ex. to the National Organization for Medicines).
6.3 Furthermore, for the purposes of the processing purposes described herein, the Company may disclose your personal data to third parties who may process your data on our behalf, such as pharmaceutical service providers, in particular pharmacovigilance service providers, information technology service providers, as well as other natural or legal persons with whom we may directly or indirectly cooperate for those purposes. We forbid such recipients to use your personal data or to disclose them for any purpose other than providing services on our behalf.
6.4 We may decide for strategic or other business purposes, to sell or transfer our business in whole or in part. In the context of such sale or transfer, we may transfer information that we have collected and stored, including your personal data collected according to this Notice, to any party involved in the sale or transfer.
6.5 Exceptionally, we may disclose your personal data to third parties, including the competent police and prosecuting authorities, only if there is a statutory obligation to do so or we are obliged by decision/order of a judicial, regulatory or other public authority.
7. TRANSFER OF PERSONAL DATA
7.1 The personal data are stored on secure servers located within the European Union (EU).
7.2 In the context of the processing described in this Privacy Notice, we may assign the processing or disclose your personal data to third parties established outside the EU. Irrespective of which country your personal data are transferred, the Company will only share your Personal Data under a strict ‘need to know’ basis and always under appropriate safeguard measures (such as EU Standard Contractual Clauses).
7.3 You have the right to request a copy of the above by contacting us at firstname.lastname@example.org.
8. TIME RETENTION OF YOUR PERSONAL DATA
8.1 We will retain your personal data for as long as it is strictly necessary for the purposes for which they are collected and according to the relevant legislation. Your personal data that we collect pursuant to this Notice will be retained until the resolution of the issue you bring to our attention, including the necessary time period in order to comply with any statutory obligations or/and bring any judicial or extrajudicial actions in order to fulfill the Company’s legitimate interests. Where your personal data are not necessary for the abovementioned purposes, they will be safely destroyed.
9. DATA SUBJECTS’ RIGHTS
9.1 Subject to the applicable legislation, you have the right to access, i.e. to be informed, upon your request, whether or not your personal data are subject to processing and to receive further information on such processing. In addition, you have the right to request the rectification of any inaccurate personal data. Also, as long as the requirements under the applicable legislation are met, you have the right to erasure, the right to restriction of processing, the right to data portability and the right to object to the processing. To the extent that processing requires your consent, you may withdraw your consent at any time. However, the withdrawal of your consent will not affect the lawfulness of processing based on consent before its withdrawal. You may exercise these rights by contacting the Data Protection Officer (DPO) email@example.com.
9.2 If such a results in a breach of the obligations arising from the Company’s laws, regulations or codes of conduct, we may not be able to answer your request but in any case you will be able to request that we limit the use of your personal data for further processing.
9.3 Finally, you may lodge a complaint with the competent Data Protection Authority, for issues concerning the processing of your personal data. For the Authority’s competence and the way to lodge a complaint, you may visit its website (www.dpa.gr => My Rights => Submit a Complaint) where detailed information is available.
10. PERSONAL DATA SAFETY
10.1 We undertake to ensure that we implement a series of security technologies and safety procedures to protect the integrity and security of all our information, including personal data we retain.
11. CONTACT US- DATA PROTECTION OFFICER (DPO)
11.1 The Company has entrusted the Data Protection Officer (DPO) with overseeing the compliance of the Company with the personal data protection legislation with whom you can contact at firstname.lastname@example.org in case of any questions or concerns on the processing of your personal data or if you wish to exercise one of the rights you have as data subject.
PRIVACY STATEMENT REGARDING PHARMACOVIGILANCE (PV) FOR BOEHRINGER INGELHEIM VETERINARY PRODUCTS
Purpose of the data collection
Thank you for reporting an adverse event or other pharmacovigilance relevant information to a Boehringer Ingelheim Animal Health product to the company GEROLYMATOS INTERNATIONAL S.A. (send your Adverse Event reporting Form concerning any Boehringer Ingelheim veterinary medicinal product to: email@example.com).
Your report is very important for animal health. We will use and share this data solely for pharmacovigilance purposes. (Pharmacovigilance is the collection, detection, assessment, monitoring and prevention of adverse effects with veterinary medicinal products).
Handling of the report (sharing with Boehringer Ingelheim companies and authorities)
GEROLYMATOS INTERNATIONAL S.A. will share the report with Boehringer Ingelheim Vetmedica GmbH who is operating the global pharmacovigilance database.
Boehringer Ingelheim is obliged to report pharmacovigilance relevant information to health authorities worldwide. The reports will contain details about the incident but only limited personal data:
For the reporting individuals, the report will include case role (e.g. attending veterinarian, pharmacist, or owner) and initials. The contact information is required to be able to follow‐up with the reporter to gain high quality and complete information on adverse events. If the reporter does not wish to provide his contact details to Boehringer Ingelheim or authorities, “Withheld” or “Refused” is entered in reporter’s names field.
If a human exposure event is reported, the report will only contain age, gender and initials as provided, but never the patient’s name.
Where your data is shared with other Boehringer Ingelheim companies, business partners or service providers outside of the EU, we will provide an adequate protection of personal data.
As reports about adverse events are important for public health reasons, reports are kept for minimum of 10 years after withdrawal of the product in the last country where the product is marketed.
Information requests about the handling of your personal data
Upon your request, we will inform you which data we store about you and for which purposes. In justified cases, and if legal requirements allow, you may also request the deletion, correction or limitation of the processing of your personal data.
Please send your request to: GEROLYMATOS INTERNATIONAL S.A.
In addition and in case of concerns, you can also contact the competent data protection authority:
Postal Address: Data Protection Authority Offices: Kifissias 1-3, 115 23 Athens, Greece
Call Centre: +30-210 6475600
Fax: +30-210 6475628