Reporting an adverse action/event
CHEMA-ELEKTROMET collects all information regarding the safety of its products, registers and monitors it.
Please report to us any observed side effects and any other information about the safety of our products.
Reporting an adverse reaction/event of a medicinal product
An side effect of a medicinal product (the Pharmaceutical Law Act) is any harmful and unintended effect of a medicinal product.
If you are a patient, legal representative or actual guardian of a patient and would like to report side effects of one of our products, please complete the form attached below. Please complete the form as accurately as possible.
If you are a healthcare professional and want to report a side effect, please complete the form attached below.
If you want to report the use of CHEMA-ELEKTROMET medicinal product in a pregnant woman, please complete the form attached below.
To report a suspected side effect or an side effect caused by a medicinal product from Chema-Elektromet, please contact us by phone at 516 098 801 or complete and send the side effect reporting form to the company by email: pv@rapofarm.pl or to the company address: ul. Przemysłowa 9, 35-105 Rzeszów.
Your personal data must be provided so that the side effect reporting for the medicinal product of Chema-Elektromet Spółdzielnia Pracy w Rzeszów can be accepted. The data provided in the form will be processed by Chema-Elektromet Spółdzielnia Pracy in Rzeszów as the Controller of personal data and Rapofarm Kamil Rupieta, ul. Kazimierza Górskiego 3, 97-400 Bełchatów (as an entity cooperating with the Data Controller in accepting, analyzing, archiving and processing applications to relevant authorities).
Your data will be processed under the Act of May 10, 2018 on the protection of personal data and Article 6 (1) (c) and Article 9 (2) (i) of the EU Regulation 2016/679 of April 27, 2016.
This data will be processed only for the purposes of accepting the reporting and monitoring the safety of medicinal products, in accordance with the provisions of the Pharmaceutical Law of September 6, 2001. Any further transfer of information on side effects to other entities, including in particular administrative authorities, in order to perform obligations under the law, shall occur in an anonymous form without your personal data.
Providing your data is voluntary, but necessary for the implementation of the above-mentioned purpose in accordance with Article 36e of the Act of September 6, 2001 Pharmaceutical Law. Providing personal data by medical professionals is mandatory.
Please be advised that your data will NOT be transferred to other entities and that you have the right to access your data, the right to correct it, the right to object to its processing for the purpose described above, and the right to request the cessation of processing and deletion of your personal data.
Reporting an adverse reaction to a cosmetic
Regulation 1223/2009 on cosmetic products, Article 23, Communication of serious adverse reactions, provides the definitions of adverse reactions.
"Action undesirable” means an adverse effect on human health resulting from the normal or reasonably foreseeable use of a cosmetic product.
“Serious adverse effect” means an adverse reaction that causes temporary or permanent functional failure, disability, the need for hospitalization, congenital defects, an immediate threat to life or death.
Each serious adverse reaction must be reported to the Serious Adverse Reaction Information System Caused by the Use of Cosmetic Products, located at the Institute of Occupational Medicine in Łódź.
If you are a user and would like to report an undesirable effect on one of our cosmetic products, please complete the form attached below. 5. Please complete the form as much as possible.
