Croatia Joins Ranks of EU Member States, Raising New Requirements for Industry

Posted 01 July 2013 | By Alexander Gaffney, RAC 

The European Union is as of today one nation larger, with Croatia bringing its citizens into the union-and with them new responsibilities for companies marketing pharmaceutical products in the EU.

In July 2013, the European Medicines Agency (EMA) issued an advanced warning to pharmaceutical companies that Croatia would be joining the EU as of 1 June 2013, requiring all labeling for medications to be translated and submitted to Croatia's regulatory authorities.

"This process enables the Croatian authorities to review product information in Croatian in advance of the country's accession," EMA explained at the time. "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."

The pace of reviews at the time was described slow, but EMA had said 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.

In a subsequent statement in March 2013, EMA provided industry with a 40-day warning regarding Croatia's ascension to EU Member State status, issuing a practical guidance document on translating labeling into the language of a Member State. Pharmaceutical companies already had to meet the language requirements of 23 countries prior to Croatia joining the EU.

Welcome to the EU, Croatia

Now the day of reckoning for EU pharmaceutical companies has arrived, with EMA confirming that Croatia is officially a part of the EU, and that its representatives "will be fully involved in the activities of the seven Scientific Committees of the European Medicines Agency (EMA) as well as the Agency's other activities."

From this point forward, all pharmaceutical companies will need to have translated labeling available in Croatian for new products approved through the centralised procedure.

EMA: Croatia becomes a new member of the European medicines network

Tags: Croatia, EU

Regulatory Focus newsletters

All the biggest regulatory news and happenings.


Most Viewed Articles