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Croatia joins European medicines network

Follows country's membership of the European Union

Croatia this week joined the European Union and as part of its membership will now be part of the European medicines network.

Its accession will see the country's representatives involved in the activities of the European Medicines Agency (EMA), including all of the regulator's seven scientific committees.

For pharmaceutical companies the new enlargement of the EU means all medicines labelling will have to be translated and submitted to Croatia's regulators, something the industry was given advance notice of in 2012.

Going forward, companies will now have to make product labelling available in Croatian for new products approved through the centralised procedure.

To assist the industry the EMA last month produced revised guidance outlining practical considerations for the phasing-in of European Commission decisions on centrally authorised products in Croatia.

Part of guidance provides details on the inclusion of the Croatian language into the operational aspects of the centralised procedure.

The country's regulator, the Agency for Medicinal Products and Medical Devices of Croatia (HALMED), was established in 2003 to protect public health by ensuring safety, quality and efficacy of medicines.

With the accession of Croatia to the EU, HALMED highlighted the need for marketing authorisation holders to electronically submit information on all medicinal products for human use authorised in Croatia to the European Medicines Agency (EMA).

Companies can use in-house tools or the XEVMPD data-entry tool (also known as EVWEB) provided by the EMA to submit the information, HALMED said.

Croatia applied for EU membership in 2003 and the EMA said it has been working with Croatia's competent authorities since 2007 to prepare for working more closely together.

4th July 2013

From: Regulatory



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