Reporting of Adverse Reactions
Legal acts:
- Regulation of the Ministry of Health from 17 February 2003
- Directive of the European Parliament and European Council 84/2010/UE
Directive 84/2010/EU provides that the medicinal product adverse reaction is any unfavourable and unintended effects.
Reporting of adverse reaction are subject to the situation, which might include:
- Using drugs according to prescription and at the recommended dose
- Off – label use
- Abuse
- Using of the drug in non-medical
- Overdose- intentional or unintentional
- Medication error
The report announcement must contain at least the following information:
- An identifiable patient: initials, age group and gender
- An identifiable reporter: name, last name, address, phone number and name stamp with legible signature
- Name of the suspected medicinal product: expiry date and batch number
- Description of adverse reaction
Applications adverse reaction should be sent to:
- The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
181C Al. Jerozolimskie Str., 02-222 Warsaw, Poland
+48 22 49 21 309
The form to report of side effects, including an instruction is available at: https://smz.ezdrowie.gov.pl/view-smz/login
Initial report of adverse reaction can be announced by phone to Qualified Person or other Imed Poland Sp. z o.o. employees. Apart from the phone information the submission in form of the formulary remains the obligation of the reporter.
Qualified Person for Pharmacovigilance (QPPV):
314 Puławska Str.
02-819 Warsaw
Poland
+48 22 663-43-03 - Mon. – Fri., 8 am - 4 pm
+48 691 702 426 - 24/7 availability
+48 882 911 844 - 24/7 availability
+48 22 663 43 39