[The role of German official medicines control laboratories in combating counterfeit medicines]

Abstract

An official medicines control laboratory (OMCL) provides an important contribution to combat counterfeit and illegal medicines. The OMCL supports the competent authorities in controlling the quality of authorised medicinal products in the legal supply chain. For detecting counterfeit medicines in the legal supply chain, a risk-based approach in choice of products is conducted. Furthermore, the OMCL analyses suspicious medicines from the illegal supply chain for any other authority. The chemical analysis of a suspicious sample is needed to identify such a sample as a counterfeit medicine. The analytical results are fundamental for the evaluation of the legal status of the product and for the assessment of it's inherent hazard to public health. The global market of illegal medicines is rapidly changing. Therefore a good national and international working liaison and co-operation between laboratories and authorities is obligatory to protect public health. The OMCL provides important knowledge of new trends in counterfeit and illegal medicines. Hence, it is an essential part in surveillance of medicinal products. The efficient networking enables prompt official interventions. Thus, risks for the public health by substandard medicines were reduced. Beside the chemical analysis, the OMCL can help to raise public awareness about counterfeit and illegal medicines. In Germany, the risk of counterfeit medicines reaching patients through the legal supply chain is still low, but the possibility cannot be ignored.

Keywords: Counterfeit medicine; Drug analysis; Illegal medicine; Official medicines control laboratory; Surveillance of medicinal products.