Quality defects and enforcement

Quality Defects Department

The Quality Defects Department (QDD) is responsible for receipt and investigation of quality defect issues for human pharmaceuticals or components and for the implementation of measures to protect human health. The QDD also deals with the GMP non-compliance cases with regards to impact on the quality of medicinal products on the Czech market. 

In cases of identified quality defects of pharmaceuticals that do not pose a threat to the life or human health, the QDD initiates administration proceeding and decides whether the respective pharmaceutical or its individual batch may be distributed, dispensed, placed on the market or used in the healthcare services delivery.

QDD address the issue of falsified medicinal products in the legal distribution chain in order to protect the public health and also address the cases of unsuccessful verification of safety features of medicinal products according to applicable legislation.

QDD is part of the international Rapid Alert system serving for information about quality defects and counterfeits of medicinal products.

Advertising Regulation Department

Departement identifies illegal conduct and gives sanctions for such conduct and enforces law in cases where an illegal situation has been identified. Unauthorised handling of pharmaceuticals includes manufacturing, import, distribution, supplying or sale, preparation and parallel import of medicinal products without an effective authorisation or licence, incl. the conduct of the clinical trial and the conduct of activities of the control laboratory without appropriate authorisations or notifications. In its enforcement activities the Institute cooperates with other institutions in the Czech Republic and abroad (in particular with the Czech Police, Customs Administration, Czech Agriculture and Food Inspection Authority (CAFIA), and control authorities of the EU Member States).

The staff of the information centre will be happy to answer your general questions.