With each major revision this Q&A document grows. This time it grew substantially with the addition of 21 new questions and answers and updates to four previously posted answers.
But there is one provision of the FMD that defies explanation, even though the Q&A document burns two Q&As to attempt it. That provision in the FMD is Section 1 of Article 45a, which basically says, in part, that you cannot put an anti-tamper device on non-prescription drugs unless the EC or a Member State specifically says you can. What’s going on here? Continue reading The Most Head-Scratching Section Of The FMD→
Chuck Schramek passed away on January 9 after losing his battle with cancer. See his obituary here. As I understand it, he spent most of his career working in IT at McNeil Consumer Healthcare, a Johnson & Johnson company, eventually serving in the role of Executive Director of Information Architecture for J&J. He spent the last few years of his career as an executive-on-loan to GS1 EPCglobal from J&J. In that capacity he filled the role of facilitator of work groups related to pharmaceutical supply chain integrity/security. That’s where I met him.
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