Pre-accession linguistic check for Croatian underway
The European Medicines Agency, together with the Croatian national competent authorities, has started a pre-accession linguistic checking process for product information in the Croatian language.
This procedure aims to facilitate the phasing-in of Commission Decisions on centrally authorised medicines once Croatia joins the European Union (EU). This is to avoid delays in the supply of medicinal products in Croatia and to prevent the circulation of products with Croatian translations of sub-standard quality, which could lead to public health concerns. The pre-accession check also aims to avoid peaks of activity for regulators and industry around the time of accession.
Croatia is currently due to join the EU on 1 June 2012. All marketing-authorisation holders are strongly encouraged to start translating their product information into Croatian as early as possible and to submit it for checking. This will avoid difficulties in marketing their products once Croatia has joined the EU.
All product information templates have now been translated into Croatian and are available, together with the relevant reference documents, separately for human medicines and for veterinary medicines. A timetable of dates for sending translated documents for checking is also available. The first sending slot is scheduled for 1 March 2011.
Information on the practical considerations concerning the phasing-in of Commission Decisions of centrally authorised products in Croatia are outlined in the document 'Practical guidance on the extension of Commission Decision Annexes in the new accession country language'.