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EU Enlargement: Deadlines for last PALC III slots for Croatian approaching fast

Time flies, and now that – despite all predictions to the contrary – the world has entered into yet another year, the EU accession date for Croatia (July 1st, 2013) is getting seriously close. So if you are a Marketing Authorisation Holder for a medicinal product in the EU, translation of your product information into Croatian and sending it to the Croatian Competent Authority for linguistic review should now take high priority.

The last slots to hand in your Croatian versions under the PALC III procedure are approaching very fast: for products for Human use, there are a mere 6 slots remaining, and for products for Veterinary use, even only 3 – the last ones being April 15th and April 1st, respectively. Here you will find the details:

European Medicines Agency: Regulatory and Procedural Guideline

While we at ADAPT will as always do our utmost to help you make the deadlines, the Commission has long announced that the authorities won’t go out of their way to make up for late submissions. So if you still have product information sitting idly on your desk, it will certainly be a good idea to get in touch with us and send it over quickly!

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Tuesday, 12 November 2019