Data operator: Slavia Pharm

The Data Protection Officer (DPO) can be contacted at: dpo@slaviapharm.ro

The data you provide - including health information - is processed by the Operator in accordance with EU Regulation 679/2016 (“Regulation”) for compliance with Pharmacovigilance requirements. After data collection, the Operator is obliged to process the data in order to fulfill a legal obligation and/or to fulfill a public interest, which constitutes the lawful basis for processing in accordance with Article 9.2 of the Regulation.

We hereby inform you that whenever you provide personal data of third parties, you warrant that you have been authorized to do so in accordance with applicable law.

In order to meet the legal obligations mentioned above, data will be retained as long as the product is authorized and for at least 10 years after the expiration of the marketing authorization, unless EU or national law requires a longer retention period. The data is accessible to the European Medicines Agency and competent health authorities, such as the National Agency for Medicines and Medical Devices or the Ministry of Health, in accordance with applicable law, Slavia Pharm and the personnel authorized to process personal data; companies from which the product in question has been licensed or to which it has been licensed; service providers supporting companies in fulfilling their legal Pharmacovigilance obligations as well as other legitimate recipients as required by applicable law. The Company may use personal data to establish, exercise or defend legal claims in court.

As regards the transfer of your data to non-EU countries, including countries that do not provide the same level of protection under EU data protection laws, please be informed that the transfer will take place in accordance with one of the methodologies provided for by the Regulation, such as, for example, the adoption of model contractual clauses approved by the European Commission or the selection of recipients that have joined the EU's legal schemes for the free movement of personal data (e.g. EU-US “Privacy Shield”) or that operate in countries considered by the European Commission as safe.

By sending a request to the data controller or DPO at the above address you can receive a list of the recipients of your data, the persons empowered and/or to exercise the applicable rights provided by Articles 15-22 of the Regulation, including, for example, obtaining confirmation that we are processing your data, verifying the content, origin, accuracy, location, obtaining a copy, ensuring that your data is complete, up-to-date, rectified, anonymized, etc. Finally, please note that you have the right to lodge a complaint with the responsible supervisory authority, the National Supervisory Authority for Personal Data Processing.

A copy of this information note is available on request.