Croatia Joins the EU at the 28th Member
The 2011 Treaty of Accession regarding Croatia’s accession to the European Union (EU) went into effect on July 1st of this year. To facilitate the phasing-in following Croatia’s accession, the European Medicines Agency (EMA) issued a warning to pharmaceutical companies that Croatia would be joining the EU, requiring the translation of all drug labeling as well as submission to Croatia’s regulatory authorities. As of July, all regulations governing the pharmaceutical and medical device industries in other EU countries also apply to Croatia.
Translation Requirements
As with other EU member nations, there is a standard language translation services requirement for products entering the Croatian market:
- All pharmaceutical companies will need to have translated labeling in Croatian for new products submitted for approval.
- Marketing Authorization Holders must provide translations of drug product information leaflets in Croatian that must pass linguistic review prior to putting a new product on the Croatian market.
As a language service provider specializing in the life sciences, we know the importance of accuracy and quality when it comes to translating drug labels, inserts and other related content.
About Language Connections:
Language Connections is one of the top language service companies in the US. Over the last 30 years, we’ve focused on providing the best business translation services, interpreting services, as well as interpreter training and customized language training programs. In addition to top-tier corporate language training, we offer certified corporate interpreters and professional business translation services in 200+ languages. Our network includes linguists with backgrounds in all major industries. They’re ready to meet your needs, whether they’re for technical translation services, legal translation, government translation services, international development translation services, education translation services, life sciences translation, or something else. Reach out to us today for a free quote on our cost-efficient and timely translation services, interpreters, or other linguistic services.
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