Labelling and packaging for medicines for human use: amended guidelines

Market authorisation holders for medicines for human use must follow certain labelling and packaging guidelines. These guidelines are being amended.

The applicable ‘labelling of medicines’ guidelines within the context of a new market authorisation (MA), renewal or variation of medicines for human use have been amended. The guidelines have been amended to meet European guidelines and other national or international agreements.

The main changes are:

• section 16, 17, 18 and 19 of the packaging text according to the QRD template;
• definition of small packages;
• definition and submission of mock-ups;
• use of trademarks, symbols ® and TM or statement of ‘trademark of’;
• use of logos and use of QR codes;
• labelling of combination packaging and labelling of homeopathic medicines.