Reporting

Adverse drug reaction (CS only)

Suspected defect in the quality of a medicine

Suspected presence of a counterfeit medicine

Use of an unauthorized medicinal product

Reporting of stocks of medicinal products

Placing, suspension, renewal or withdrawal of a medicine on the market

Reporting by marketing authorisation holders (according to Medicinal Products Act)

Non-interventional post-registration studies

Failed verification of protective elements

Status and movement of stocks of addictive substances listed in Annex 1 or 5 to the Government Regulation

Opening/termination of pharmacies, sales of reserved medicinal products and specialised departments of medical facilities

Reporting the originator’s price

Establishment, method of operation and change of address of a publicly accessible professional information service on medicinal products

Supplies of distributed medicines

Haemovigilance reporting

Batch release for selected medicines

Mail order dispensing of medicines

Change of contact details