Asclepios attaches great importance to patient safety. We make every effort to ensure that patients and doctors feel safe when choosing therapies with drugs distributed by Asclepios S.A.

Please send reports of adverse reactions to the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products via the website: https://www.urpl.gov.pl

Where can I report an adverse reaction to a medicine?

1. Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: using the electronic form available in the Hazard Monitoring System (HMS) at: https://smz.ezdrowie.gov.pl or via the form available on the URPL website. Please send the completed form:
   • electronically to the address: ndl@urpl.gov.pl via the ePUAP platform
   • by fax – to the number (22) 49 21 309;
   • by traditional mail – the printed form should be put in an envelope marked: ‘Undesirable effect’. This envelope should be placed in a second (outer) envelope and sent to the following address: Departament Monitorowania Niepożądanych Działań Produktów Leczniczych Urzędu Rejestracji PL, WM i PB, Al. Jerozolimskie 181C, 02-222 Warsaw.
   You can also report adverse reactions by calling (22 49 21 301) from Monday to Friday between 9:00 a.m. and 2:00 p.m.
2. Responsible entity – you will find information on this at the end of the leaflet enclosed with the medicine. Many entities provide a ‘Report an adverse drug reaction’ tab on their websites – it is worth taking advantage of this option to make a report quickly and efficiently.
   
3. A medical professional – doctor, pharmacist, nurse or paramedic. These people can help fill out the form and send the completed report on behalf of the patient or their guardian.
4. Asclepios – if it is not possible to report an adverse reaction to the above entities, please report it via Asclepios S.A. In the event of an adverse reaction (to a medicine or cosmetic product) or a medical incident, contact a qualified member of staff farmaceuci@asclepios.pl or by telephone: 71 769 84 10

Processing of personal data as part of the reporting of an adverse reaction to a medicine.

As a rule, reports of adverse drug reactions should be made to the Office for Registration of Medicinal Products or to the competent Marketing Authorisation Holder. However, if the report is made to Asclepios, this will involve the processing of personal data contained in the report by Asclepios.

However, Asclepios will act as the entity accepting such a report, not as the entity dealing with it substantively. Therefore, the processing of personal data by Asclepios in this respect will be aimed at further forwarding the report to the relevant entities specified by law.

Below you will find information on the processing of personal data by Asclepios as part of the reporting of a side effect of a medicine:

1. The administrator of personal data, persons reporting the occurrence of a side effect and persons concerned by the report is Asclepios S.A., ul. Hubska 44, 50-502 Wrocław (hereinafter referred to as the ‘Administrator’).
2. In matters related to the processing of personal data, the Administrator can be contacted via e-mail: iod@rbo.pl or by post, to the address: Asclepios S.A., ul. Hubska 44, 50-502 Wrocław, with the note ‘Personal data protection’.
3. Personal data will be processed respectively:
   1. for the purpose of fulfilling a legal obligation in the form of, among others, the Pharmaceutical Law Act and the Regulation of the Minister of Health on the form for reporting a major incident – the basis for processing is Article 6(1)(c) of Regulation (EU) 2016/679 of the European Parliament and of the Council (hereinafter referred to as the ‘GDPR’);
   2. for the purpose of realising the legitimate interest of the Administrator – the basis for the processing of personal data is Article 6(1)(f) of the GDPR. The legitimate interest of the administrator is the necessity to establish, investigate or defend possible claims;
4. Personal data will only be transferred to entities authorised by law, i.e. the responsible entity and the Office for Registration of Medicinal Products.
5. The data will not be transferred outside the European Economic Area.
6. The data will only be stored for the period necessary to fulfil the purpose of their processing, i.e. until the expiry of the storage obligation resulting from generally applicable laws.
7. The administrator will not make automated decisions based on the collected personal data, and the personal data will not be profiled.
8. The data subject has the right to request access to the data, to rectify it, to delete it, to limit its processing, to object to its processing on grounds relating to his or her particular situation based on the legitimate interests pursued by the Controller, and also has the right to data portability. In each case, you also have the right to lodge a complaint with the President of the Personal Data Protection Office.
9. Providing data is voluntary, and the fact of providing it and submitting a request to the Administrator constitutes a voluntary action of the person submitting the request.