In many countries, including Poland, physicians, pharmacists, nurses, and midwives are legally obliged to report adverse drug reactions. Such information may also be provided by other healthcare professionals, i.e., paramedics or pharmaceutical technicians.

Patients, their families, and guardians also have the possibility to report adverse reactions.

Thus, everyone may report an adverse reaction whereas, for some professionals, it is a legal obligation.

The applicable laws stipulate that those, on whom a legal obligation on reporting adverse reactions is imposed, shall report the case without undue delay and no later than within 15 days from becoming aware of it – if the matter concerns adverse reactions that meet the criterion of serious adverse reaction and no later than 90 days if the patient’s reactions to the applied drug were qualified as not meeting the criterion of severity.

Serious adverse reaction – an adverse reaction which results in death, is life-threatening, requires in-patient hospitalisation or
prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or is
a congenital anomaly/birth defect [DIR 2001/83/EC Art 1(12)].

Life-threatening in this context refers to a reaction in which the patient was at risk of death at the time of the
reaction; it does not refer to a reaction that hypothetically might have caused death if more severe (see Annex IV,
ICH-E2D Guideline).

Medical and scientific judgement should be exercised in deciding whether other situations should be considered
serious reactions, such as important medical events that might not be immediately life threatening or result in
death or hospitalisation but might jeopardise the patient or might require intervention to prevent one of the other
outcomes listed above. Examples of such events are intensive treatment in an emergency room or at home for
allergic bronchospasm, blood dyscrasias or convulsions that do not result in hospitalisation or development of
dependency or abuse (see Annex IV, ICH-E2D Guideline).

Other adverse reactions are considered to be non-serious.

An adverse reaction is any adverse and unintended effect of the medicinal product. It means that any adverse reaction observed in the patient while taking the drug (or after treatment) shall be reported.

Reporting of an individual case of adverse drug reaction should contain at least:

1) initials, gender or age of the patient to whom the report applies;

2) First and last name of the person who submits the report (signature if the report is not submitted online; in the case of healthcare professionals their work address is needed as well);

3) in relation to medicinal product at least:

a) the name of the product whose application could cause an adverse reaction,

b) description of a provoked adverse reaction.

If a notifier does not have full data about the particular case while submitting the report on adverse drug reaction, the supplemented report should be submitted immediately after receiving such additional information.

The Polish law indicates two recipients of reports on adverse reactions while not favoring any of them:

1. The Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products (URPL)

Application forms and instructions for patients and healthcare professionals are available below:

The completed form may be sent via email to or by fax to +48 22 49 21 309.

2. Pharma company which is responsible for the drug that caused an adverse reaction.

Report to the pharma company shall be submitted by contacting the company’s representative, by phone, email, letter, or fax.

Contact information for the entity is provided in section 7. of the Summary of Product Characteristics and in section 6. of the package leaflet – (information for the patient).

Several pharma companies allow reporting of adverse reactions for their medicinal products directly through their publicly available websites (relevant interactive forms).

The primary source of information about the drug is the Summary of Product Characteristics which is developed by the responsible entity (pharma company or distributor who has received the marketing authorization) and the package leaflet containing selected information.

These documents have the status of registration documents for a given medicinal product, which means that the competent authorities have authorized them (in Poland – URPL or EMA).

The current versions of SPC (Polish: ChPLs) and leaflets for the patients are available on the relevant pharma companies’ websites (responsible entities) as well as on the website of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products.

The summaries of products characteristics with the most current information on the safety of the drug are available in the database of medicinal products at

The characteristics of reimbursed medicinal products are available in the database of medicinal products at

Information on adverse drug reactions is provided by the employees of the Department for the Monitoring of Adverse Reactions of Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, tel. +48 22 45 20 648 or appropriate professionals in any pharma company.