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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:

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U.S. Senate: Initiative to introduce readability testing for PMI

For several years, the usability and safety of package inserts for drug products, or Patient Medicine Information (PMI), has been a source of growing concern for regulators, politicians, and patient organisations alike. At the centre of this concern is mostly the question whether patients, particularly those with lesser degrees of literacy and language competence or poor eyesight, are able to find and understand all necessary information to use the medicine safely and effectively.

The latest move to ensure the quality of leaflets handed to patients together with their (prescription) drug products now comes from the United States: in a bill introduced in the U.S. Senate under the name of Cody Miller Initiative for Safer Prescriptions Act on May 22, Sen. Kirsten Gillibrand proposes amendments to the existing legislation.

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