EU drugmakers say expect a year from OK to warehouse for new labels

EC takes pulse as new black symbol rule for labels looms
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Labeling changes carry a real cost that depends on how many labels or inserts with the old wording have to get dumped. And so the European Commission asked drugmakers how long it would take them to use up existing supplies and start meeting a new rule that requires a black dot on labels if regulators have tagged a drug for ongoing monitoring as a condition of its approval. According to in-PharmaTechnologist, their answers ran from two weeks to two years, but on average they think 6 to 9 months should do it. The new labeling requirement is supposed to take effect in July. The European Federation of Pharmaceutical Industries and Associations (EFPIA) not surprisingly said, it depends. It depends on how many are needed and the size of the company being asked to make the change. On average, the EFPIA said, the EC should expect it to take "up to 52 weeks after approval of the updated product information," until the new supplies hit the warehouse. So what has the EC decided? It hasn't. It is still thinking it over and will decide later this year. Story

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