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
    ndl@urpl.gov.pl

The form to report of side effects, including an instruction is available at : www.urpl.gov.pl

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

+48 605 290 533  - 24/7 availability

+48 22 663 43 39

 adr@imed.com.pl