What is SÚKL's interpretation of the presentation of the sources of safety data in Annex C of the PSMF? Is it possible to only refer to the data from Annex B in Annex C to avoid duplicates?

GVP (Module II.B.4.3. The PSMF section on the sources of safety data) states that this section should include all parties responsible, on a global basis, for solicited and spontaneous case collection for products authorised in the EU. It is also stated that information about third parties (licence partners or local distribution/marketing arrangements) should also be included in the section describing contracts and agreements (Annex B).

For PSMFs located in the territory of the Czech Republic, SÚKL requires that the information on the sources of safety data in Annex C is complete, references to data in other PSMF Annexes are not allowed. Each PSMF Annex has its own purpose, and a different reader. Moreover, it is clear from the text of the GVP that partial duplication of data is directly required in this case.