Questions and answers

Questions and answers amending practical information on the implementation of safety features.  

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

2. What are the requirements governing the serial number (SN)?

3. Will it be mandatory to specify the SÚKL code as the national reimbursement number or another national number identifying the medicinal product? And is it necessary to incorporate the SÚKL code in the unique identifier (UI)?

4. What is the sequence of human-readable data?

5. When is it necessary to submit a mock-up in the implementation of a 2D code?

6. When, if an anti-tampering device (ATD) is implemented, is it necessary to submit a mock-up?

7. Is it possible to implement the ATD for medicinal products dispensed without medical prescription which, at the same time, are not included on the list provided by Annex II to Commission delegated regulation (EU) 2016/161 (so called “black list”)?

9. Will it be possible to show the EAN code on the packaging of a medicinal product after 9 February 2019?

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?

11. Will the statutory timeline of 180 days applicable to the placement of a product on the market in the presentation preceding a variation to marketing authorisation apply to the implementation of safety features?

12. Should be the new QRD template (introducing sections 17 and 18 of the labelling) implemented by the 9th of February 2019 also for medicinal products that shall not bear the safety features?

13. In what form should the safety features appear on the packaging of a medicinal product imported as a foreign-language batch?

14. In what form should the safety features appear on the packaging of a medicinal product which is subject to an approved specific therapeutic programme?

15. In what form should the safety features appear on the packaging of a parallelly imported medicinal product?