This month really got my heart racing, and it had nothing to do with Valentine’s Day. The one thing that releases large amounts of adrenaline in any pharmaceutical translator is an update of the EMA QRD template for product information. On 9th February 2016, the European Medicines Agency (EMA) published version 10 of the templates for product information for use by applicants and marketing-authorisation holders for human medicines, and I rushed to EMA’s official website to see what changes had been made to the reference documents we use religiously in our everyday work.
Why the EMA QRD templates needed updating
On 2nd October 2015, the European Commission adopted the Commission Delegated Regulation (EU) 2016/161 which lays down detailed rules for the safety features appearing on the packaging of centrally authorised medicinal products for human use. According to the requirements outlined in this newly delegated act, which came into effect on 9th February 2016, and in the Falsified Medicines Directive (Directive 2011/62/EU), safety features, such as a unique identifier (UI) carried by a 2-D barcode and an anti-tampering device (ATD), now need to appear on the packaging of prescription medicines and certain over-the-counter drugs. These measures are in place to ensure all such medicines available in the EU market are authentic and can be identified. In other words, this is to prevent any falsified medicinal products from entering into the legal supply chain across the EU. The product information templates had to accommodate these new legislative requirements, so two new sections were added in Annex III. All relevant Marketing Authorisation Holders (MAHs) and new applicants will need to adopt these changes within the 3-year transition period (i.e. until 9th February 2019). You can find more details about these new legislative requirements and the implementation timeline on the official EMA website.
What changes were made in the English EMA QRD template
In the English version of Annex III LABELLING AND PACKAGE LEAFLET, A. LABELLING, PARTICULARS TO APPEAR ON <THE OUTER PACKAGING> <AND> <THE IMMEDIATE PACKAGING>, we now have two new sections:
What changes were made in the EMA QRD template
The two additional sections in Annex III LABELLING AND PACKAGE LEAFLET, A. LABELLING, PARTICULARS TO APPEAR ON <THE OUTER PACKAGING> <AND> <THE IMMEDIATE PACKAGING> are officially translated in the version as follows:
Linguistic improvements in the EMA QRD template
Apart from the addition of these two sections required by the newly adopted regulation, some language versions of the updated template had undergone what the EMA calls ‘linguistic improvements’.
Let’s have a closer look at the new template and how it compares to its predecessor, version 9.1, 06/2016.
- A minor stylistic change was introduced in ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS, Section 4.8 Undesirable effects:
- The typo in Annex II, C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION, Periodic Safety Update Reports was finally corrected! Phew! Also, in this paragraph ‘these products’ was changed to ‘this product’ in line with the English original.
- Two other typos were corrected in ANNEX III LABELLING AND PACKAGE LEAFLET, B. PACKAGE LEAFLET, Package leaflet: Information for the <patient> <user>, Section 2 What you need to know before you <take> <use> X:
- A few formatting adjustments were made throughout the document.
You can see all the changes I’ve discussed here in this EMA QRD template version 10 for which I annotated for you.
I hope you find this article useful. Please do get in touch if you have any questions!