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)?

SÚKL code should not form part of the unique identifier or human readable data associated with the UI.

Nevertheless, SÚKL code has to be printed elsewhere on the packaging. This obligation is set forth by Section 37, paragraph 1 of Act No 378/2007 Coll., on Pharmaceuticals and on Amendments to Some Related Acts (Act on Pharmaceuticals), as amended, and also by point A, paragraph 7 of Annex 5 to Decree No 228/2008 Coll., on Marketing Authorisation of Medicinal Products, as amended. To facilitate identification, SÚKL recommends to introduce the SÚKL code with the words “SÚKL kód”. Neither this code, nor the introductory words are to be provided as part of the texts of the labelling (in the QRD template).

The Act on Pharmaceuticals does not set forth the implementation of a national reimbursement number or another national number identifying the medicinal product in the NN format on the outer packaging of medicinal products. In case point 18 of the particulars to appear on the outer labelling (in the QRD template) contains the abbreviation “NN”, this abbreviation shall be deleted from the text within the scope of subsequent variations to marketing authorisation with impact upon the labelling. For the deletion of the NN from the labelling, it is not necessary to submit any separate variation to marketing authorisation. Cases where the NN is provided in the labelling (in the QRD template), but not on the product mock-up shall not be considered noncompliance or quality defect.