Special security features for OTC omeprazole

Berlin - The implementation of EU anti-counterfeiting policy into practice approaches. Now the group of experts, submitted to the European Commission, which takes care of the remaining delegated acts for the policy proposals which prescription medicines exceptionally need not be equipped with the future mandatory security features ("White List") and which non-prescription medicines off rule should wear those ("blacklist").

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The Member States were invited by the European Commission to submit proposals in 2014 for the two lists of exceptions to early October. Subsequently, the Federal Ministry of Health had asked the manufacturers associations BAH, BPI, Pro generics and VFA in the summer of 2014 to draw up proposals for the White List. Created together with market research institutes such an extensive list of active ingredients. Apparently, the German forces were very much eager than their counterparts in other Member States. Most had demanded namely no or few exceptions for prescription drugs. This had an impact on the now evaluated proposals that have flowed into the lists now presented.

Even the proposal for the white list is laid out. It contains only 15 drugs and drug groups. Among other things, homeopathic medicines, certain radionuclides, contrast agents and drugs are exempted certain ATC codes of the verification required. The proposal for the blacklist is even fall much shorter: only contains the active substance omeprazole, 20 mg and 40 mg in the dosage form "gastro-resistant capsule, hard."

From the perspective of the Federal Association of Pharmaceutical Manufacturers scarce blacklist certainly encouraging - he himself and the European association of self-medication industry AESGP had seen her best yet. The white list holds the other hand BAH for too small.

Now the European Commission will discuss with Member States, the delegated act, which concerns the characteristics and technical specifications of the unique identifier for the safety features, including the two lists of exceptions again. The delegated act shall be published, according to the BAH expected at the end of the second quarter 2015. In order for the provisions relating to the serialization and verification are expected on 1 July 2018 'in focus'.