EMA Marketing Authorization in Croatian

It's been some time since the number of languages required by the European Medicines Agency (EMA) for centralized marketing authorization in Europe settled at 24 - covering the EU official languages plus Icelandic and Norwegian.

The set of official EU languages is now bound to grow as well as the number of languages in which medicinal product information needs to be submitted as part of the single application procedure that is valid in all EU and EEA-EFTA states (Iceland, Liechtenstein and Norway).

On 30 June 2011, the EU closed accession negotiations with Croatia. Following the ratification procedure of the Accession Treaty, accession is now foreseen for 1 July 2013.

As a rule, Marketing Authorization Holders (MAHs) are legally obliged to provide translations of the product information in any new official language as of the date of accession. With around 800 centrally authorized products for both human and veterinary use in place at the moment, the clock is already ticking for any company using the centralized procedure for marketing in the EU.

Or to quote EMA, "...MAHs are strongly encouraged to initiate translation activities [into Croatian] as early as possible and to participate actively in this process in order to avoid difficulties in marketing these products during the post-accession period."

Pre-accession Preparation (is Better than Cure)

The EMA has been taking steps to set the stage for the eventual accession by launching The Instrument for Pre-accession Assistance (IPA) programme back in 2009. Its aim is to support the participation of the 9 beneficiary countries, including Croatia, Iceland, Serbia and Turkey, in the activities of the European Medicines Agency, in preparation for these countries' future collaboration in the EU regulatory network.

Specifically for Croatia, which has long been  mentioned as the most imminent candidate to join after Bulgaria and Romania became EU members in 2007, the Agency started a pre-accession linguistic checking process for product information in the Croatian language as early as January 2011. Its objective is to prevent regulators and pharma companies having to scramble to produce required Croatian translations for centrally authorized medicines around the time of actual accession in 2013.

This voluntary pre-accession checking procedure applies to Annex I, II, III and IV, if applicable, and has been set up in cooperation with the Croatian National Competent Authorities (NCA). The timeline for the checking of translations is 80 days.

Keeping the Linguistic Checking Process in Check

As part of this procedure, a full set of Product Information Annexes (i.e. including all SmPC, Labeling and Package Leaflet texts for all strengths and pharmaceutical forms), is submitted by MAHs to EMA in Croatian, along with the English language versions for reference.

The materials for different strengths of the same pharmaceutical form may be submitted in one document (the complete set of Annexes needs to be presented sequentially in the document), and different pack-sizes of the same strength can be presented in one labeling document. However, for the eventual official submission to EMA AFTER enlargement, translations will have to be provided in the same form as the approved English reference text, with Annexes separated according to the different presentations, etc.

After submission, the EMA then sends materials through Eudralink to the Croatian NCA for review. The NCA reviewer has 60 days to check the HR translation against the approved EN reference text and provide linguistic comments.

The MAH then has 10 days to check the revised version, implement the comments and submit the final translation to EMA, who forwards it to the Croatian NCA. They then have 10 days to perform the final check and acceptance, following which the MAH provides, by day 80, the clean and final translations to EMA along with a declaration confirming that the translations submitted are those agreed with the NCA.

The Bigger Picture

Whether this pre-accession checking procedure is applied or not, EMA has published a guidance document that details the practicalities and the different scenarios of phasing-in of Commission Decisions in Croatia - Practical guidance on the extension of Commission Decision Annexes in the new Accession Country language.

Importantly, MAHs should include a reference in their future cover letters to the status of this voluntary pre-accession linguistic check for Croatian.

In case such a pre-accession check has not been conducted, EMA warns MAHs that the existing post-opinion linguistic checking procedures may not be sufficient and the complete product information may not be reviewed within the available timeframes. In other words, this means delays in the post-opinion phase while the translation checks are being completed.

To facilitate the process of these pre-accession linguistic checks, EMA has drawn a plan with specific dates of sending translations for linguistic review and the maximum number of products per sending date.

Regulatory Situation in Croatia

The Croatian Agency for Medicinal Products and Medical Devices (HALMED) is the Croatian national regulatory authority that provides services related to human medicinal products, medical devices and homeopathic products in accordance with the Croatian legislation

Even before the eventual accession, the agency has put in place a fast track procedure for EU products thanks to nCADREAC, the New Collaboration Agreement between Drug Regulatory Authorities in Central and Eastern European Countries. The provisions of nCADREAC were incorporated in the Croatian legislation.

The nCADREAC procedures offer the possibility of harmonization of Summary of Product Characteristics (SPC), Patient Information Leaflet (PIL), labeling and documentation for a product between existing EU Member States and candidate countries, such as Croatia. In practice, marketing authorization is granted by the Croatian authority for medicinal products that were subjected to the centralized marketing authorization procedure in the EU.


Until now, the EMA centralized procedure has provided a handy way of accelerating market entry into Croatia. The approaching accession of Croatia to the European Union changes the equation. Translations of medicinal product information into Croatian will be required for any EMA centralized applications for marketing authorization in the whole European Union. The clock is ticking...

Published in August 2011.

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