EMA to Applicants: Go Digital--and Don't Forget Croatia

| 06 July 2012

The European Medicines Agency (EMA) has two messages for applicants of marketing authorization applications: please submit all applications electronically, and don't forget to submit labeling translations to Croatian regulatory authorities.

In a statement released 5 July, EMA said it is imploring sponsors of pharmaceutical products to start taking advantage of its electronic application forms, including its eSubmission Gateway, due to its relative ease of use. The agency also highlighted its advantages in advance of the Olympics, which will be taking place around EMA's offices and may impact the delivery of paper applications or CD/DVD-based applications. EMA has already canceled nearly a dozen of its meetings due to the anticipated traffic situation in London.

To assist sponsors who have not yet utilized the electronic submission system, EMA said it will offer "enhanced support" until the end of July 2012.

Translation Reviews Advancing at a 'Slow' Pace

In a separate statement, also released 5 July 2012, EMA said it is reminding sponsors to submit Croatian translations of product information in advance of Croatia's July 2013 entry into the EU.

"This process enables the Croatian authorities to review product information in Croatian in advance of the country's accession," EMA explained. "Its aim [is] 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."

Because the pace of product reviews by Croatian regulatory authorities has thus far been "slow"-only 90 products have thus far undergone review-EMA is advising sponsors to submit their translations for their products early to avoid "delays in the checking process."

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.


© 2022 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy