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 abbreviations PC and SN may be printed on the packaging of medicinal product batches the manufacture of which had been completed (i.e. which had been certified for release by the qualified person – question 11 refers in more detail) prior to 9 February 2019, without printing the specific PC and SN details and the 2D code. At the same time, it is possible to print the specific detail for the PC only. It is not possible, however, to show both specific PC and SN details for the PC and SN abbreviations, and not print the 2D code (or vice versa).

The following groups of packaging will be available on the market at the same time:

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

After 9 February 2019, the obligations stipulated by the Commission delegated regulation (EU) 2016/161 shall fully apply to the first and second group, but not to the third, fourth, and fifth group. Following the aforementioned recommendations in the implementation of the requirements set forth by the Commission delegated regulation (EU) 2016/161 can ensure easy and clear distinction of these groups of medicinal products.

In those cases where the packaging of a medicinal product shows the 2D code, the respective UI should be uploaded in the repository system regardless of whether the ATD is also present on the packaging, or not.