Reporting of adverse events


In accordance with the Pharmaceutical Law Act of 6 September 2001 (Dz. U. [Polish Journal of Laws] of 2008, No. 45, item 271, as amended) and relevant European legislation, healthcare professionals are required to report any suspected adverse events. In the light of the aforementioned Act, any detrimental and unintended effect of a drug is understood as an adverse event.

 

Techdow strives to obtain any and all information on the safety of its products. Any information reported is registered and monitored. This action stems from the values pursued by Techdow, in particular social responsibility, which requires a rapid response to a possible risk in order to protect the patient’s health.

Adverse events may be reported by phone or by e-mail to:

The Pharmacovigilance Department at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Al. Jerozolimskie 181c
02-222 Warszawa
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: ndl@urpl.gov.pl

 

SciencePharma – the marketing authorisation holder of the Neoparin medicinal product Detailed information on how to report adverse events, together with the application form, are available at: http://www.sciencepharma.pl/pl/neoparin/zglaszanie-dzialan-niepozadanych-leku

SciencePharma spółka z ograniczoną odpowiedzialnością sp. k., ul. Chełmska 30/34, 00-725 Warszawa, is the controller of the personal data collected in connection with the application. The personal data provided are processed solely for the purpose of fulfilling the obligation of monitoring the safety of medicinal products in accordance with Regulation (EU) no. 520/2012 of 19 June 2012. Provision of the reporting person’s details is essential in order to accept the application. Each reporting person has the right to access and correct their data.

 

Consent to the processing of personal data
We kindly inform that the personal data collected in connection with the application will be processed by Techdow Pharma Poland Sp. z o.o. with its registered office in Warsaw at ul. Pl. Marsz. Józefa Piłsudskiego 1, pursuant to the Personal Data Protection Act of 29 August 1997 (Dz. U. [Polish Journal of Laws] of 2002, No. 101, item 926, as amended) solely for the purpose of fulfilling the obligation of monitoring the safety of medicinal products. Each reporting person has the right to access and correct their data. The provision of personal data by persons obliged to report adverse events related to medicinal products is mandatory and results from the provisions of the Pharmaceutical Law of 6 September 2001 (Dz. U. [Polish Journal of Law] of 2008, No. 45, item 271, as amended) and other provisions of law. In the case of persons, the provision of personal data is voluntary, but necessary to accept the application.