Regulatory Focus™ > News Articles > EU Marketing Authorization Holders Have 40 Days to Make Labeling Changes

EU Marketing Authorization Holders Have 40 Days to Make Labeling Changes

Posted 22 March 2013 | By Alexander Gaffney, RAC 

The European Medicines Agency (EMA) is once again warning applicants and holders of marketing authorizations to be mindful of the pending addition of Croatia to the EU, which has a number of regulatory implications for pharmaceutical companies.

Holders of marketing authorizations (MAHs) are legally required to have their product information, including labeling, available in the official languages of all EU member states. As of March 2013, there are 27 such states, stretching as far west as Portugal, and as far east as Romania.

But that number will soon increase by one, and pharmaceutical companies need to be prepared to update their product labeling to allow Croatian citizens equal access to the information.

Croatia will legally and officially become a part of the EU on 1 July 2013, and companies need to have all product information updated by the end of April 2013, EMA said.

As part of the process, EMA has issued a "Practical guidance on the extension of Commission Decision Annexes in the new Accession Country Language," which is specifically tailored toward the phase-in decisions surrounding Croatia.

For new medicines, the process will largely be the same, only the companies will now need to consider 23 languages-one more than previously.

The guidance also covers other forms of changes, including Type II variations, Type IA/IAIN and IB variations, renewals, annual re-assessments, authorization transfers, arbitration referrals and product safety update reports. Most of these changes will require a 2-3 month lead time for EMA to review translations of all documents.

EMA may need more time than that to complete all translations, however. In a statement released in July 2012, the agency said it had only received a small number of product labeling changes, raising the possibility that it would have to review more of those products at once, thereby slowing down the review pace.

At the time, EMA was also clear to say that "no extension of the pre-accession linguistic review process (PALC III) will be granted" 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," noted EMA.


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