Procedures

Medicinal products with quality defects do not meet the quality standards required by the marketing authorisation.

Examples of quality defects include deficiencies in the medicinal product itself, incorrect labelling, damaged packaging or dosing equipment, unusual appearance of the product, deviations from the conditions of the marketing authorisation such as non-compliance with specifications, lack of GMP compliance by the manufacturer of the active substance or the finished product.

Quality defects in medicinal products must be reported to the Agency for Medicinal Products and Medical Devices (HALMED) by:

healthcare professionals who come into contact with the medicinal product or its user,
legal and natural persons involved in the manufacture or distribution of medicinal products,
in accordance with the provisions of the Ordinance on the Suspension of the Placement on and Withdrawal of Medicinal Products from the Market (Official Gazette No. 122/14).

The Agency must suspend the placing on the market and request the recall of a medicinal product in the following cases:

when the medicinal product makes an unacceptable risk to health,
when the medicinal product is insufficiently therapeutically effective,
when the risk-benefit balance is unfavourable,
when the qualitative and/or quantitative composition of the medicinal product does not match the declared information,
when quality control of the medicinal product, its composition, or intermediates has not been performed,
when the medicinal product has not been manufactured in accordance with the manufacturing authorisation,
when the medicinal product is falsified.