Privacy Policy

Information clause on the processing of personal data to meet the legal obligations of the controller for those reporting medicine side effects.

In accordance with Article 13(1) and (2) of 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 and on the free movement of such data, and repealing Directive 95/46/EC (hereinafter referred to as the "GDPR") we wish to inform you of the following:

The name and contact details of the Controller

Your Personal Data Controller is Przedsiębiorstwo Farmaceutyczne LEK-AM Sp. z o.o with its registered office in Zakroczym, ul. Ostrzykowizna 14a, 05-170 Zakroczym, Poland (hereinafter referred to as the "Controller"), contact: 22 635-80-41, biuro@lekam.pl.

Data Protection Officer (DPO) contact details

In matters concerning data protection, the Data Protection Officer (DPO) can be contacted by e-mail at iod@lekam.pl.

Purpose, legal basis and data retention period

Personal data, to the extent provided for in the medicine side effect reporting form, will be processed for the following purposes:

1. to ensure high quality and safety standards for medicines and in particular to monitor the safety of medicines, including keeping a record of reports of individual medicine side effect cases and reporting individual cases of medicine side effects to relevant authorities – in accordance with Article 6(1)(c) of the GDPR and Articles 36e(1)(2) and (3) of the Polish Pharmaceutical Law – for the marketing authorisation validity period of  the medicine to which the report pertains and for 10 years following the expiry of this authorisation
2. to establish, investigate or defend possible claims between you and the Controller – under Article 6(1)(f) of the GDPR, i.e. on the basis of a legally justified interest of the Controller, namely the possibility to assert claims.

Personal data recipients or categories of recipients

Public administration bodies, authorised employees of the Controller, data processors commissioned by and on behalf of the Controller under a data processing agreement in the scope of pharmacovigilance.

Rights of personal data subjects

Every data subject has the right to: access to their personal data, receive a copy of the data, rectify the data, erase the data, restrict processing and transfer data.

In addition, each person has the right to object to the processing of their personal data for the legitimate purposes of the Controller.

Information on freedom or obligation/requirement to provide data

The provision of your personal data is voluntary but necessary for the reporting of medicine side effects and the subsequent analysis of the medicine side effects reported by you. If you do not provide your personal data, you will not be able to submit your report.

President of the Office for Personal Data Protection

You shall have the right to lodge a complaint with the supervisory authority in charge of personal data protection, i.e. the President of the Office for Personal Data Protection with its seat in Warsaw, ul. Stawki 2. 00-193 Warsaw, Poland, if you consider that the processing of your personal data violates the provisions of the GDPR.

You shall have the right to lodge a complaint with the supervisory authority in charge of personal data protection, i.e., the President of the Office for Personal Data Protection with its seat in Warsaw, ul. Stawki 2. 00-193 Warsaw, Poland, if you consider that the processing of your personal data violates the provisions of the GDPR.