If, like me, you’re a medical translator who has two European languages as your working pair, you’ll no doubt be familiar with the constant stream of work that comes from the EU pharma regulatory field. In fact, right now you’re probably snowed under, because there is a pressing deadline. By law*, Marketing Authorisation Holders have until 2 July 2012 to submit electronic information on all their medicinal products for human use authorised in the European Union. According to 2011 figures, we’re talking about a total of 263,444 medicinal products authorised in the different Member States.
* Implementation of Pharmacovigilance Legislation: Article 57(2), second subparagraph of Regulation (EC) No. 726/2004 as amended by Regulation (EU) 1235/2010.
Languages in medicinal product information
Deadlines aside, pharma companies already have to submit marketing authorisation applications to the European Medicines Agency in all EEA languages. That means that all product information must be translated from English to the 23 other official, working languages of the European Union, plus Icelandic and Norwegian. The EMA website has a useful list of official languages (updated in November 2013 to include Croatian). It explains which languages should be used in each country. And it’s not all as simple as Danish for Denmark and Polish for Poland. For example:
- Malta: the Summary of Product Characteristics (SmPC) must be in Maltese, but the package leaflet (PL) and labelling can be submitted in Maltese or English for the purpose of marketing.
- Ireland: English is mandatory and Irish is optional.
The EMA also has a list of all EU country names and the official translations that should be used in regulatory documents.
Interestingly, in the case of SMEs (small and medium-sized enterprises), it’s the EMA itself that translates the regulatory documents involved in the centralised marketing authorisation procedure (SmPC, labelling, PL, Annexes A, II and IV) into all EU official languages, not including Norwegian and Icelandic. So SMEs actually have these documents translated through the CdT – the Translation Centre for the Bodies of the European Union.
If you’re worried that incoming pharma translation work might dry up after the looming deadline on 2nd July, don’t lose sleep over it. There are plans to implement electronic submission of drug substances, periodic safety update reports (PSURs) and additional monitoring measures. Also, after the deadline itself, information on newly authorised medicinal products in the EU will have to be submitted electronically to the EMA within 15 days of the date of authorisation. So I’m sure there’ll be enough work to keep us all busy.
What about you? Do you work in an EU language pair? Have you noticed the snowball effect as July approaches?