10. Prior to 9 February 2019, is it possible to print the abbreviations PC and SN on the packaging of a medicinal product without printing the PC and SN details/2D code at the same time?

The packaging of batches of medicinal products the manufacture of which has been completed (i.e. those which have been certified for release by the qualified person - for more details, please refer to question 11) prior to 9 February 2019, may show the abbreviations PC and SN, without showing the specific PC and SN details and the 2D code. It is not possible, however, to show the specific PC and SN details for the abbreviations without printing the 2D code (or vice versa) on the packaging of a medicinal product. Furthermore, it is not possible to print a specific detail for only one of the two abbreviations - PC or SN. In case the specific PC and SN details are printed on the packaging, the marketing authorisation holder shall ensure that the PC and SN details be also uploaded to the repositories system.

The following groups of packaging will co-exist on the market at the same time:

  • Those with the complete data, i.e. PC, SN, and the 2D code.
  • Those showing only the abbreviations PC and SN, but without specific details of the PC and SN and the 2D code.
  • Completely without these data.

After 9 February 2019, the obligations set forth by the Commission Delegated Regulation (EU) 2016/161 shall apply to the first group; but not to the second and third group. Compliance with the aforementioned information in the implementation of the requirements stipulated by the Commission Delegated Regulation (EU) 2016/161 will allow for an easy and unequivocal distinction among these groups of medicinal products.