Products Safety

Adverse events

The companies forming Synektik Group – Synektik SA and Synektik Pharma Sp. z o.o – as responsible entities are under an obligation, as part of pharmacotherapy safety supervision, to collect all the information regarding any adverse events, which resulted from using the company’s medicinal products.

This obligation results directly from the regulations included in the Pharmaceutical Law Act dated 6th September 2001.

It is every adverse and unintended effect of a medicinal product. Adverse events of the medicinal products manufactured by Synektik SA and Synektik Pharma Sp. z o.o. can be reported:

– by calling the number +48 22 327 09 40 (24-hour voicemail)
– or sending an email to: phv@synektik.com.pl.

Further information regarding monitoring safety of medicinal products as well as form templates regarding adverse events reporting can be found on the following website: Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych (The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products).

RODO

We would like to infom you that the personal data collected in connection with receiving reports is administered by the companies forming the Synektik Group, i.e. Synektik SA (based at ul. Józefa Piusa Dziekońskiego 3, 00-728 Warsaw) or Synektik Pharma Sp. z o.o. (based at Józefa Piusa Dziekońskiego 3, 00-728 Warsaw).

Personal data supplied will be processed in accordance with the Personal Data Protection Act dated 10th May 2018 (Dz. U. 2018 r. pos.1000), exclusively for the purpose of fulfilling the safety monitoring obligations related to the use of medicinal products. Supplying personal data of the people in medical profession who are under the obligation to report the adverse events related to the medicinal products is mandatory and results from the regulations of the Pharmaceutical Law Act dated 6th September 2001 (unified text Dz. U. 2017 pos. 2211 with amendments). In case of any other people, supplying personal data is voluntary, although strictly necessary for the report to be accepted. Every person has a right to access their personal data and to make amendments.