A side effect of a medicinal product is any adverse and unintended effect of a medicinal product (according to Directive 84/2010/EU).
The responsible entity is obliged to collect information on adverse reactions to medicinal products (in accordance with the Regulation of the Minister of Health of 17 .02.2003 on monitoring product safety).
Patients, legal representatives and legal guardians are now entitled to directly report adverse reactions to medicinal products that they have experienced or observed in third parties (in accordance with Directive 2010/84/EU of the European Parliament and of the Council of 15.12.2010 amending - as regards pharmacovigilance - Directive 2001/83/EC on the Community code relating to medicinal products for human use).
For a report to be made, the responsible entity is obligated to collect information on adverse reactions to medicinal products (in accordance with Directive 2010/84/EU of the European Parliament and of the Council of 15.12.2010 amending - as regards pharmacovigilance - Directive 2001/83/EC on the Community code relating to medicinal products for human use).
- name of the medicinal product;
- description of the adverse reaction ( listing at least one symptom);
- data of the patient (initials, gender or other data identifying the patient);
- data of the reporting person (name, surname, method of contact - address, telephone, e-mail).
Please provide the most detailed description with all available information. We do not expect the submitter to make a case evaluation.
Please kindly report to us any suspected adverse drug reaction and any other information about the safety of our product through one of the following options:
1. by phone at: +48 22 863 72 81
Initial reporting of an adverse reaction can be made by phone to the person responsible for monitoring adverse reactions or any other employee.
2. by completing the form and submitting it by email to: ndl@woerwagpharma.pl
form intended for the consumer
form intended for the healthcare professional
form intended for pregnant women
3. By mail: sending the printed and completed form to the following address:
Woerwag Pharma Polska Sp. z o.o.
1 Dziekońskiego St.
00-728 Warsaw
Information clause - information about the processing of personal data* The administrator of the personal data included in the form is Wörwag Pharma GmbH & Co. KG . with its registered office at Flugfeldallee 24, 71034 Böblingen, Germany. Your personal data is processed on the basis of Article 6(1)(c) and Article 9(2)(i) of the General Data Protection Regulation (RODO, EU 2016/679 of April 27, 2016). The personal data provided are processed solely for the purpose of fulfilling the obligations of monitoring the safety of use of medicinal products in accordance with Regulation (EU) No. 520/2012 of June 19, 2012. Provision of data of the notifier is necessary to accept the notification. Recipients of your personal data will be only entities authorized to obtain personal data under the law. You have the right to access the content of your data and the right to correct, delete, restrict, the right to data portability and the right to object to its processing after the expiration of the storage period. Your personal data will be kept for the entire period of drug approval and for a period of 10 years after the expiration of approval. Contact details of the Data Protection Officer for further information:
Wörwag Pharma GmbH & Co. KG
based at Flugfeldallee 24
71034 Böblingen, Germany
Email: datenschutz@woerwagpharma.com
You have the right to lodge a complaint with the President of the Office for Personal Data Protection if you consider that the processing of your personal data violates the provisions of the RODO. For further information on data processing, please contact us by email at: info@woerwagpharma.de