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Independent certificates by newly appointed drug law cross-check expert

On September 1st, 2020, Mrs. Clarissa Kohn was appointed as an expert for the examination of drug counter-samples according to section 65, paragraph 4 of the AMG (German Medicines Act) by the drug monitoring control center of Tübingen regional council. BioChem Labor für biologische und chemische Analytik GmbH has been working with drug law cross-check experts for many years. 

They are entitled to accept officially sealed cross-samples, in particular taken by the supervisory authorities in pharmaceutical companies (manufacturer, distributor or importer), from contract manufacturers, wholesalers or pharmacies, and to check them analytically. In addition, they prepare independent test certificates on behalf of pharmacies in accordance with Section 6 and 11 of the Pharmacy Operating Regulations.

After studying pharmacy at Heidelberg University, which she completed with a license in pharmacy, Mrs. Kohn held management positions in quality assurance and control in the pharmaceutical industry for several years. Initially, she was head of quality assurance and quality control. In 2015 Mrs. Kohn became a Qualified Person (qualification and expertise according to section 14 / section 15 AMG) and worked as an information officer in the pharmaceutical industry. She has already worked trustfully with national and international authorities in the context of audits and inspections. Since the beginning of the year, she has been working as deputy head of quality assurance at BioChem.

“We got to know Mrs. Kohn as a very responsible, trustworthy and highly competent expert in the field of quality assurance and control” says Dr Jürgen Branke, Technical Managing Director of BioChem. “We are very pleased that the responsible regional council has confirmed Mrs. Kohn’s competence by appointing her as drug law cross-check expert.”

Mrs. Kohn has been included in the list of appointed drug law cross-check experts on the website of the Federal Ministry of Health (for more details see the list of drug law experts appointed by the competent state authorities for the examination of pharmaceutical samples in accordance with Section 65 (4) AMG (Annex III)).


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