Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use (Text with EEA relevance) (c. 161)

CHAPTER II TECHNICAL SPECIFICATIONS OF THE UNIQUE IDENTIFIER

Article 7 Human-readable format

1. Manufacturers shall print the following data elements of the unique identifier on the packaging in human-readable format:

(a) the product code;

(b) the serial number;

(c) the national reimbursement number or other national number identifying the medicinal product, if required by the Member State where the product is intended to be placed on the market and not printed elsewhere on the packaging.

2. Paragraph 1 shall not apply where the sum of the two longest dimensions of the packaging equals or is less than 10 centimetres.

3. Where the dimensions of the packaging allow it, the human-readable data elements shall be adjacent to the two-dimensional barcode carrying the unique identifier.