1. What are the national requirements for product code (PC), how is it generated and what format should it assume?

The product code shall comply with Article 4(b)(i) and Article 5(5) of Commission Delegated Regulation (EU) 2016/161 (so called Delegated Acts). The product code is not allocated or approved by the Institute. The marketing authorisation holder has to safeguard the upload of the data elements of the unique identifier, the coding scheme of the product code, and other data to the repositories system, as referred to under Article 33(2) of Delegated Acts, prior to the release of the medicinal product by the manufacturer. Pursuant to the Delegated Acts, the product code has to be coded as a data element of a unique identifier in the data matrix in compliance with the coding scheme and at the beginning has to bear characters specific for the applied coding scheme. Furthermore, it has to contain characters or character sequences identifying the product as a medicinal product. The resulting code has to have less than 50 characters and has to be globally unique. Product codes which are compliant with the ISO/IEC 15459-3:2014 and ISO/IEC 15459-4:2014 standards are considered to be meeting the requirements set forth by these Delegated Acts. In the Czech Republic, 2D codes are allocated by GS1 Czech Republic. The product code may assume the GTIN, NTIN, EAN format or another code format.