European Medicines Agency urges companies to submit Croatian product information for checking

News 05/07/2012

The European Medicines Agency reminds marketing-authorisation holders that they need to submit translations of product information in Croatian to the Agency for linguistic checking.

Croatia is scheduled to join the European Union (EU) in July 2013. To prepare for the addition of Croatian as an official EU language at that time, the Agency started the pre-accession linguistic review process (PALC III) for Croatia in March 2011.

This process enables the Croatian authorities to review product information in Croatian in advance of the country's accession. Its aim to facilitate the phasing-in of Commission decisions related to the EU centralised procedure and to avoid delays of supply of relevant medicinal products in Croatia after EU enlargement.

Unfortunately, the pace of submissions of Croatian product information for human centrally authorised medicinal products has been slow. So far, just over 90 products have gone through the process.

The Agency is warning marketing-authorisation holders that:

  • accumulation of a high number of products towards to the end of the process is likely to result in delays in the checking process;
  • no extension of the PALC III process will be granted. The timelines published on the Agency's website are final and cannot be extended;
  • any product that does not go through the PALC III process will be handled after Croatia's accession in the normal linguistic review process. This means that the Croatian national competent authority will need more time for the linguistic check, resulting in delays in the decision-making process for the product as a whole.

The Agency urges marketing-authorisation holders to speed up the preparation and submission of translation of product information in Croatian through PALC III, to avoid complications in the integration of Croatian product information in the lifecycle of their centrally approved products.

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