State Institute for Drug Control

The State Institute for Drug Control (hereinafter referred to as “SÚKL”) provides an overview of ways of showing the general classification for supply on medicinal product labelling, particularly with a view to the updates of guidance stipulating blue-box requirements for medicinal product labelling, on which SÚKL informed here.

It is not required to include the general classification for supply on the labelling, nevertheless, with regard to the established practice, SÚKL recommends to provide information on the general classification for supply on the labelling.

Medicinal products authorised via MRP/DCP/national procedures

Where the labelling includes the general classification for supply, its wording has to be compliant with Annex 5(A)(8) of Decree No 228/2008 Coll., on marketing authorisation of medicinal products, as amended; the below provided text has to be used. Below please find a complete overview of all general classification for supply categories relevant for the Czech Republic.

Medicinal products authorised via the centralised procedure

Annex II.B to the QRD template for products authorised via the centralised procedure lays down the following categories of general classification for supply:

1. Medicinal product subject to medical prescription.
2. Medicinal product not subject to medical prescription.
3. Medicinal product subject to special medical prescription.
4. Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
5. Medicinal product subject to special and restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).

These categories, however, are not consistent with the aforementioned Decree on marketing authorisation of medicinal products, and some of them are relevant only for centrally authorised medicinal products. Furthermore, the general classification for supply laid down under point 3 is not considered a dispensing subcategory in the Czech Republic; rather, it concerns the particulars of the prescription or order form (“blue-stripe” prescription). On the other hand, the QRD template for centrally authorised medicinal products does not include other categories of the general classification for supply referred to in the Decree on marketing authorisation of medicinal products, which are relevant only for the Czech Republic.

With a view to the aforementioned, the labelling of centrally authorised medicinal products may only show the following general classification for supply, using the wording specified below:

The aforementioned text may be placed on the labelling of the medicinal product in the area reserved for blue-box information or it may be stated under section 14 of the labelling.

Marketing Authorisation Section

10th June 2021