Notification of product defects and recalls
The State Institute for Drug Control receives notifications about product defects in medicines via the Rapid Alert System. A quality defect in a medicinal product that is on the market can result in serious harm being done to patients.
Reporting product defects
Anyone who puts a medicinal product on the market in Slovak Republic is obliged to report quality defects to the State Institute for Drug Control. In addition, for example, pharmacists can also send a notification. If you are a patient and you suspect a defect in the quality of the medicinal product, please contact your pharmacist, who can forward your complaint to us.
Recalls
When a notification is submitted the State Institute for Drug Control, the responsible person immediately decides if there is a risk to public health.
Whether or not a recall is required depends on the classification of the risk. The classification also determines whether the recall is done at the:
• patient level
• pharmacy level
• wholesaler level
A notification often does not require a recall. The risk is then not serious, whereas a recall can in fact generate major risks for the availability of the medicinal product.
If the State Institute for Drug Control does consider a recall, it will first consult the marketing authorisation holder.
State Institute for Drug Control does not carry out the recall itself. That is something that the marketing authorisation holder must do.
Notifications from abroad
We also receive notifications from foreign inspectorates. These are about medicinal products that are on the market in the world and therefore possibly in the SLovak republic too. We analyse the notifications every year and use them to prioritise our inspection activities.
List of withdrawn medicinal products
The European Medicines Agency makes annually public a list of human medicinal products which have been withdrawn from the EU market. This includes products for which marketing authorisations have been refused, revoked or suspended, and products whose supply has been prohibited or which have been withdrawn from the market (Article 123(4) of Directive 2001/83/EC). The list covers centrally authorised products as well as nationally authorised products (including products authorised via the mutual recognition and decentralised procedures).
The products which have been withdrawn from 1 January 2022 to 31 December 2022 due to concerns relating to their safety, quality or efficacy are available in document EMA/938992/2022. You can see the products withdrawn from Slovak market using the filter in the column under the name „Member State(s) concerned by the actions“.
