Chief Pharmaceutical Inspectorate

As part of the supervision of the safety and quality of medicinal products, the Chief Pharmaceutical Inspector takes actions aimed at protecting public health. These actions include decisions to suspend or withdraw a drug from circulation. Both concepts are often confused, although their meanings and consequences are different - below we present the most important differences.

Suspension is a temporary suspension of a given drug from circulation. This means that it cannot be sold, issued or administered to patients until certain doubts have been clarified. Suspension may apply to a specific or all series of the product. This is a preventive action taken to conduct additional analyses - e.g. qualitative, laboratory or documentary.

• A suspension does not mean that the drug is unsafe, but that it needs to be checked.
• Once the verification is complete, the drug can be re-approved or withdrawn.

A withdrawal is the definitive removal of a specific drug or its batch from the market due to a confirmed violation of the applicable quality, safety or compliance requirements with the registration documentation.

The decision to withdraw is made to protect patients and ensure that the medicines available on the market meet the highest standards.

Both the suspension and withdrawal of a medicinal product are standard pharmacovigilance activities, demonstrating the effectiveness of the drug quality assurance system.

More on the procedure for the suspension and withdrawal of a medicinal product from circulation can be found here.