Personal Data Protection Policy in relation to Pharmacovigilance

Contents

1. What is Pharmacovigilance
2. Definition
3. Personal Data Controller for the processing of personal data relating to
4. Scope of this
5. Purpose of the collection and processing of personal data relating to
6. Personal data collected when you report to
7. Managing your report in the context of
8. Processing of your personal data in the context of
9. Retention period for your report under
10. Security of your personal data about
11. Your rights regarding the processing of your personal data in the context of
12. Amendment of this Protection Policy
13. Submission of adverse reaction reports in the framework of
14. Contact

1. What is Pharmacovigilance

Pharmacovigilance (PV), as defined by the World Health Organization, is: “the science and activities related to the detection, evaluation, understanding and prevention of adverse reactions and any other drug-related problems”.

Pharmacovigilance is governed by a system for monitoring and evaluating the safety of medicinal products with the aim of minimising risk and improving therapeutic outcomes from their use. This requires, inter alia, the recording of adverse reactions to medicinal , their reporting to the competent authorities and their evaluation.

ZWITTER PHARMACEUTICALS follows procedures to ensure that

• The sources of information are systematically checked

• The required actions take place in case of the appearance of new

• Competent authorities, health professionals and patients are informed of any changes in the characteristics of the products

2. Definitions

For the purposes of this Protection Policy, the following definitions apply

“Personal data” means any information relating to an identified or identifiable natural person (“data subject”); an identifiable natural person is one whose identity can be established, directly or indirectly, in particular by reference to an identifier such as a name, an identification number, location data, an online identifier or one or more factors specific to the physical, physiological, genetic, psychological, economic, cultural or social identity of that ;

“Special categories of personal data“: personal data revealing racial or ethnic origin, political opinions, religious or philosophical beliefs or trade union membership, as well as the processing of genetic data, biometric data for the purpose of positive identification of a person, data concerning health or data concerning the sex life of a natural person or sexual orientation

“Health-related data” means personal data relating to the physical or mental health of a natural person, including the provision of health care services, which disclose information about the health status of that person

‘processing‘ means any operation or set of operations which is performed, whether or not by automated means, on personal data or on sets of personal data, such as collection, recording, organisation, structuring, storage, adaptation or alteration, retrieval, consultation, use, disclosure by transmission, dissemination or otherwise making available, alignment or combination, restriction, erasure or destruction

‘controller’ means the natural or legal person, public authority, agency or other body which alone or jointly with others determines the purposes and means of the processing of personal data; where the purposes and means of such processing are determined by Union or Member State law, the controller or the specific criteria for its appointment may be provided for by Union or Member State law

“Processor“: the natural or legal person, public authority, agency or other body which processes personal data on behalf of the controller

“Data protection officer“: the natural person designated by the controller and the processor, for the purposes provided for by law, on the basis of his or her professional qualifications and expertise in the field of law and data protection practices, with the main task of participating in all matters relating to the protection of personal data

‘Consent‘ of the data subject: any freely given, freely given, specific, explicit and informed indication of the data subject’s wishes by which the data subject signifies his or her agreement, by a statement or by a clear affirmative action, to the processing of personal data concerning him or her

“Adverse event” means any adverse, unintended or harmful event related to or resulting from the use of a ZWITTER PHARMACEUTICALS medicinal product

3. Personal Data Controller for the processing of personal data relating to pharmacovigilance

ZWITTER PHARMACEUTICALS, 34 Pendeli Avenue, 15234, Halandri, Attica, Greece Phone: +30 210 6821098, Email: info@zwitter.gr Website: www.zwitter.gr

4. Scope of this Policy

This Personal Data Protection Policy on Pharmacovigilance describes how ZWITTER PHARMACEUTICALS collects and processes personal data for the purpose of fulfilling its obligations on pharmacovigilance, i.e. its obligation to monitor the safety of all products that ZWITTER PHARMACEUTICALS markets or for which clinical studies are currently being conducted and which ZWITTER PHARMACEUTICALS markets as its own products, as well as collaborative products in the Greek market and abroad.

This Privacy Policy applies to the information that ZWITTER PHARMACEUTICALS collects from you by telephone, fax and e-mail, following your own contact with the company, through social media and its website

If you are a patient, we may be provided information about you about side effects that affected you while taking a ZWITTER PHARMACEUTICALS product and by a third party, such as health care professionals, relatives, lawyers or others. To the extent that the processing of such data is subject to the General Data Protection Regulation (2016/679) we collect and process your data in order to comply with our legal obligations (Article 6(1)(c) and Article 9(2)(i)).  may also need to report the data to the relevant governmental or regulatory authorities, possibly outside the EEA and in no case will it be used for other purposes.

5. Purpose of the collection and processing of personal data relating to pharmacovigilance

Thank you for reporting any side effects or complaints or other information related to Pharmacovigilance in connection with a ZWITTER PHARMACEUTICALS product. Your report is very important for public health. Ensuring patient safety and the safe use of our medicines is extremely important to ZWITTER .

ZWITTER PHARMACEUTICALS needs to be able to communicate with the people who have submitted their report to it about its products

The information requested when you submit your report to the company is necessary in order to enable the Pharmacovigilance Department to contact you further, if necessary, in order to obtain additional information from you, to monitor your case and to answer your questions. At the same time, the data of the recipient of the medicines are necessary to avoid multiple recording of the same incident in the database of ZWITTER PHARMACEUTICALS.

All information you provide in this ZWITTER PHARMACEUTICALS information is strictly confidential and is intended for use only by the appropriate ZWITTER PHARMACEUTICALS health care professionals/health scientists for the purpose of fulfilling ZWITTER PHARMACEUTICALS’ obligations regarding pharmacovigilance.  will use and/or disclose your personal data solely for the purposes of Pharmacovigilance.

6. Personal data collected when you report to Pharmacovigilance

ZWITTER PHARMACEUTICALS collects your personal data either directly from you after you report it to our company or through a third party after reporting to our company about adverse reactions to one of our products that have affected you. To the extent that the processing of such data is subject to the General Data Protection Regulation (2016/679), we collect and process your data in order to comply with our legal obligations (Article 6(1)(c) and Article 9(2)(i))

Given the great importance of , when reporting, please provide as much information as possible, including information about the description of the adverse reaction, the start and end dates of treatment, the time of occurrence of the adverse reaction, your medical history, the co-administration of other medicines, etc.

The personal data that you will need to disclose to our company include “health-related data”, and may also include other data belonging to “special categories of personal data” under the current GDPR legislation (2016/679). Special care is taken for these data, which are disclosed to us and processed in accordance with all legal formalities.

In particular, the personal data we may collect about you if you are a patient – recipient of the product that caused the adverse reactions are

•  full name or initials

• Contact details

•  age and date of birth

• Your gender

•  weight and height

• Details about the product that caused the side effects, such as the dose you received, the reason for prescribing and/or taking it

• The start and end dates of

• The date(s) of onset of the adverse (s)

• Details (such as dose, reason for prescription, time of treatment, etc.) of any other medicines or pharmaceutical products you may have been taking at the same time and which you were taking at the time of the adverse

• Your medical history

• Your history of taking medicines and

• Other information about the incident and the circumstances of the adverse reaction

In addition, in the context of ZWITTER PHARMACEUTICALS’ legal obligations on pharmacovigilance and the purposes of the collection and processing of your personal data, as described above, we may collect from the patient – recipient of the product and from the reporter, if it is a third party and not the patient – recipient of the product, the following information

• Your full name

• Your contact details, including postal address, email address, telephone, fax

• Your profession

• Your relationship with the patient – recipient of the

7. Managing your report under Pharmacovigilance

All reports collected in the above manner are processed, after pseudonymization, by the Pharmacovigilance Department of ZWITTER PHARMACEUTICALS, both as regards the data of the reporter and the data of the patient. The relevant personal data shall in principle only be disclosed to the ZWITTER PHARMACEUTICALS Pharmacovigilance Department and, under certain conditions, to third parties as described below.

Our company has developed and implements detailed internal procedures (SOPs) for the correct and timely recording of adverse events and pharmacotechnical complaints and medical issues related to the receipt of our products by patients, the correct and safe retention and storage of this information and its appropriate forwarding to the relevant bodies and third parties

Specifically, the procedure followed by ZWITTER PHARMACEUTICALS in the event of a report submitted to our company through the means described in detail below is as follows

1. The necessary information is obtained for the completion of the report form from the Pharmacovigilance Department of ZWITTER PHARMACEUTICALS. If a company representative outside the Pharmacovigilance Department receives the information, he/she shall forward it immediately to the Pharmacovigilance Department of ZWITTER PHARMACEUTICALS.
2. Each of the reported cases of adverse reactions is recorded and evaluated by the company’s qualified personnel
3. Each report is stored and maintained in hard copy in a special locked, watertight and fireproof cabinet of the Pharmacovigilance Department and, once digitized, in the company’s server databases
4. The necessary decisions shall be taken for any further action or appropriate action to be taken in respect of the report concerned

8. Processing of your personal data in the context of pharmacovigilance

In compliance with its legal obligations on pharmacovigilance, ZWITTER PHARMACEUTICALS processes your personal data in order to investigate and evaluate the adverse reactions reported by or for you to its products. In this context we may:

• contact you again for any further  needed

• collect, register, organize, structure and store your personal data in accordance with the internal procedures of  company.

• process your personal data submitted in the context of a report, associating or combining it with other relevant reports submitted for the same product or for the same adverse

• provide and forward the necessary information to the competent bodies and/or third

Your personal data collected by our company in accordance with the procedure described in detail below and this Privacy Policy, may also be disclosed to third parties, in particular to other pharmaceutical companies with which it cooperates, if the adverse event report concerns one of the products that ZWITTER PHARMACEUTICALS markets in the framework of its cooperation with these companies. In this respect, additional information may be provided on the companies to which the above data are transmitted. The processing of your personal data by these partner companies of ZWITTER takes place in accordance with their respective Personal Data Protection Policies on Pharmacovigilance and in accordance with the agreements between them.

In addition, the relevant information is also communicated to the competent national and regional authorities and bodies, in accordance with the existing legislation on pharmacovigilance. ZWITTER cannot guarantee the processing of your personal data by these authorities and bodies.

Subject to the anonymity of the reporter and the patient, our company may disclose information about reported adverse reactions for medical, public health and safety and/or other reasons

9. Retention period of your report under Pharmacovigilance

Your personal data are kept on file for as long as required by the current legislation on pharmacovigilance and under the applicable laws, such as Ministerial Decision D.YΓ3a/G.P. 32221/2013, as amended, the GDPR, etc

As patient safety is very important to us and your reports of any adverse reactions to our products are valuable for public health reasons, we retain and do not destroy all the data and information we collect from you as part of our Pharmacovigilance, in order to ensure that we are able to assess the safety of our products over time

10. Security of your personal data about Pharmacovigilance

ZWITTER PHARMACEUTICALS takes all necessary measures to ensure the security of your personal data and to protect it from accidental loss and unauthorized access, use, modification or disclosure

Particularly strict security measures are taken for each piece of information and the above personal data that are communicated to us in the context of Pharmacovigilance, with separate care for their collection, storage and processing at all stages of this process

Specifically, the information and Pharmacovigilance-related personal data provided to ZWITTER PHARMACEUTICALS are stored and maintained in the company’s server databases, to which a limited number of its qualified employees have access. In addition, each of your written report forms completed by an authorized employee of our company, when providing the above information by or for you either in writing via fax or email or social media or the company’s website, or verbally over the telephone, is kept in a special locked, watertight and fireproof cabinet in the Pharmacovigilance Department of ZWITTER PHARMACEUTICALS

11. Your rights regarding the processing of your personal data in the context of pharmacovigilance

ZWITTER PHARMACEUTICALS protects your personal data, which it processes, in accordance with the applicable legislation and in full compliance with the General European Data Protection Regulation (Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of individuals with regard to the processing of personal data)

Your rights regarding the use and processing of your personal data are fully respected, with the only limitation being the company’s right to lawful processing if this is necessary to comply with its legal obligations regarding pharmacovigilance

At your request, you may ask ZWITTER PHARMACEUTICALS to inform you about which of your personal data we collect and maintain and for what purposes, as well as to provide you with a copy of this information

In justified cases, you may also request the rectification or restriction of the processing of your personal data. You may also reserve the right to object to their processing, without prejudice, however, to the legal obligations of ZWITTER PHARMACEUTICALS, which require the processing of such .

If you have any questions about the way we process your personal data in the context of pharmacovigilance and to exercise your above rights, you can contact both the Pharmacovigilance Department of ZWITTER PHARMACEUTICALS and the Data Protection Officer of our company, at the contact details provided below

In addition, if you have exercised any or all of your rights and you still maintain your concerns about our policy in relation to the processing of your personal data, in any case you may also contact and lodge a complaint with the competent supervisory authority, in this case the Data Protection Authority (DPA)

Personal Data  Authority

1-3 Kifissias 1-3 P.K. 115 23, , Greece

Call Centre: 210

Fax: 210

Email: contact@dpa.gr

12. Amendment of this Protection Policy

ZWITTER PHARMACEUTICALS reserves the right to modify and/or update this Privacy Policy at any time. Please review our published Personal Data Protection Policy regarding our Pharmacovigilance regularly. In the event of material changes to this Policy, a posting will be made on the Company’s website and the “update date” of this Policy will be amended accordingly. You may also be notified in other ways, via email or other contact information provided by you to ZWITTER PHARMACEUTICALS

13. Submitting an adverse event report as part of Pharmacovigilance

To report any adverse reactions you have experienced while taking ZWITTER PHARMACEUTICALS products, you can contact our company directly via

• Telephone: 2106821098

• Email: info@zwitter.gr  

For more information, please refer to the following link on the ZWITTER PHARMACEUTICALS website: www.zwitter.gr  

It is reminded that adverse reactions can, according to the national spontaneous reporting system, be reported alternatively to the National Medicines Agency (EOF), to the Adverse Reactions Department, by submitting the Yellow Card in the following ways

• Electronic submission of the Yellow Card via the online form that you will find on the EOF website at the following link: https://www.kitrinikarta.gr

• Send a printed copy of the Yellow Card by post, free of charge, to the Adverse Reactions Department of the EOF (Mesogeion 284, Cholargos 15562). Contact telephone: 213.20.40.380 or 213.20.40.337

• Submit the Yellow Card by fax at 210.6549.585

For more information, please see the following link on the EOF website: http://www.eof.gr/web/guest/yellowgeneral

14. Contact

For any questions regarding the Pharmacovigilance, Privacy Policy and Privacy Policy regarding ZWITTER PHARMACEUTICALS Pharmacovigilance, you may contact our company directly

ZWITTER PHARMACEUTICALS, 34 Penteli Avenue, 15234, Halandri, Attica, Greece  

• Telephone: 2106821098

• Email: info@zwitter.gr  

For more information, please refer to the following link on the ZWITTER PHARMACEUTICALS website: www.zwitter.gr