Wiegard Andrea, Heuermann Matthias
Landeszentrum Gesundheit Nordrhein-Westfalen, Von-Stauffenberg-Str. 36, 48151, Münster, Deutschland.
Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2017 Nov;60(11):1214-1220. doi: 10.1007/s00103-017-2624-8.
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.
官方药品控制实验室（OMCL）对打击假冒和非法药品做出了重要贡献。OMCL支持主管当局对合法供应链中授权药品的质量进行控制。为了在合法供应链中检测假冒药品，在产品选择上采用基于风险的方法。此外，OMCL还为任何其他当局分析来自非法供应链的可疑药品。需要对可疑样品进行化学分析，以确定该样品为假冒药品。分析结果对于评估产品的合法状态以及评估其对公众健康的内在危害至关重要。非法药品的全球市场正在迅速变化。因此，实验室与当局之间良好的国家和国际工作联络与合作对于保护公众健康是必不可少的。OMCL提供有关假冒和非法药品新趋势的重要知识。因此，它是药品监管的重要组成部分。高效的网络连接能够迅速进行官方干预。因此，不合格药品对公众健康的风险得以降低。除了化学分析，OMCL还可以帮助提高公众对假冒和非法药品的认识。在德国，通过合法供应链到达患者手中的假冒药品风险仍然较低，但这种可能性不能被忽视。
