We at G.G. Papaloisou Ltd take the privacy and security of your personal data very seriously. This Reporting Privacy Notice outlines what personal data we may collect about you and how we may use it.

Who we are?

We are C.G. Papaloisou Ltd (“C.G. Papaloisou”, “We”, “Us”, “Our”). Our address is 35 Kilkis Avenue, 2234 Latsia. You can contact us by post at the above address, by email at [email protected] or by telephone at 0035722490305.

C.G. Papaloisou has assigned a Data Privacy Team responsible for overseeing our compliance with the General Data Protection Regulation, which you may contact at [email protected], or c/o the Data Privacy Team, C.G. Papaloisou, 35 Kilkis Avenue, 2234 Latsia, Cyprus in case of any questions or concerns regarding the processing of your personal data.

What information do we collect?

As part of completing the Medical Information, Adverse Event or Product Quality Complaint forms We will collect and use personal data about you. Depending on whether you are a healthcare professional, a patient, or someone completing the form on behalf of a patient (Other/Patient Representative), different personal data will be collected about you, as outlined below.

Medical Information
• Name
• Contact details (such as address, phone number, email address, fax)

Adverse Event
Healthcare Professional: If you are completing this form on behalf of a patient, as well as collecting details relating to the patient, We will collect the following personal data about you:

• Name
• Profession
• Contact details (such as address, phone number, email address, fax)

Other/Patient Representative: If you are completing this form on behalf of a patient, as well as collecting details relating to the patient, We will collect the following personal data about you:

• Name
• Contact details (such as address, phone number, email address, fax)

Patient: If you are completing this form yourself or someone else on your behalf, We will collect the following personal data about you:

• Initials
• Contact details (such as address, phone number, email address, fax)
• Date of birth
• Gender
• Details of the side effect(s) experienced, including the start and end date
• Details of the product you were taking, including reason for treatment with the product, details of the product taken, the start and end date of taking the product, the dose, unit and frequency of taking the product
• Any additional information you choose to provide us

If you are a Patient reporting an adverse event, C.G. Papaloisou may obtain sensitive personal data about you, including details about your physical or mental health, as part of the reporting process and tracking the side effect case you reported.

Product Quality Complaint
• Name
• Contact Details (such as address, phone number, email address, fax)

If you are a Patient reporting a product quality complaint, C.G. Papaloisou may obtain sensitive personal data about you, including details about your physical or mental health, as part of the reporting process.

Why do we collect your personal data?

Such information (including sensitive personal data) will be provided by you and is used by Us in accordance with applicable regulatory requirements to ensure high standards of quality and safety of health care and of medical products or devices and to support C.G. Papaloisou’s legal and regulatory obligations around reporting side effects associated with Our products.

As part of this We may contact you if we require further information about the adverse event, medical information or product quality complaint you have reported, as well as to provide you with feedback.
Therefore, if you fail to provide us your personal data, We may not be able to track the adverse event you reported or provide feedback on any of the matters described above. Note that if you are a Healthcare Professional you are encouraged to report any side effects you have observed or suspected, as well as to provide any additional information if requested by you in this regard.

With regards to adverse events, we will process the data you have provided on the basis of fulfilling Our legal obligations on pharmacovigilance. In some cases, We may need to process such information provided by you (including sensitive personal data) in accordance with Our legitimate interests in relation to establishing, exercising or defending legal claims related to Our products.

How long is personal data stored for?

C.G. Papaloisou will store your personal data in accordance with local laws and the company’s Retention Policy for as long as it is necessary in order to satisfy Our legal obligations, or in order to establish, exercise or defend legal claims. When your personal data is no longer necessary for these purposes, the personal data will be securely deleted. This may mean that your personal data is stored by C.G. Papaloisou for a number of years, depending on the purpose and need for that data to be processed. For more information on C.G. Papaloisou’s Data Retention policy you may go to www.papaloizou.com

Who will have access to your personal data?

For adverse events, your personal data (including sensitive personal data) may be transferred to local and/or foreign regulatory bodies and the Marketing Authorisation Holder of the specific product for the purposes set out in this notice. For medical information, your personal data may be transferred to the Marketing Authorisation Holder’s medical officer. For product quality complaints, the enquiry is transferred to the Marketing Authorisation Holder and/or Manufacturer of the specific product, without the inclusion of any personal data. We may also share your personal data with certain third parties such as: auditors and consultants to verify Our compliance with external and internal requirements; statutory bodies, law enforcement agencies and litigants, as per a legal reporting requirement or claim; and a successor or business partner to C.G. Papaloisou in the event that we sell, divest or set up a collaboration/joint venture for all or part of its business.

During the period your data is held by C.G. Papaloisou, personal data which identifies a patient will only be viewable by C.G. Papaloisou’s patient safety team and the patient safety team of the Marketing Authorisation Holder who provide local support on Pharmacovigilance. Please refer to the Marketing Authorisation Holders’ Privacy Notices, if you would like more information on how they process personal data obtained through adverse event reports. Information which is important for the medical assessment of the report, such as age and gender, may be disclosed to government or state bodies in order to comply with Our legal and regulatory obligations.

International transfer

Your personal data is not send outside of Cyprus, except for adverse events reporting. For adverse events reporting your personal data will be transferred, within the EU, to the Marketing Authorisation Holders’ patient safety team, to fulfill our pharmacovigilance obligations.

How we protect your information

We have in place appropriate privacy and security policies which are intended to ensure, as far as reasonably possible, the security and integrity of all Our information, including your personal data.

Data subject rights

You may contact C.G. Papaloisou at [email protected] at any time to request access to the personal data we hold about you, to correct any mistakes or to request deletion of the same, or to request the restriction of processing or object to certain types of processing of your personal data. If such a request places C.G. Papaloisou or its affiliates in breach of their obligations under applicable laws, regulations or codes of practice, then C.G. Papaloisou may not be able to comply with your request but you may still be able to request that we restrict the use of your personal data for further processing.

Your right to complain

If you have a complaint about our use of your information, you can contact the Office of the Commissioner for Personal Data Protection via their website at www.dataprotection.gov.cy or write to them at:

1 Iasonos str., 1082 Nicosia
P.O. Box 23378, 1682 Nicosia
Tel: +357 22818456
Fax: +357 22304565
Email: [email protected]

Last updated May 2018