SÚKL Notice on Updated Guidance for Adverse Drug Reaction Reporting Listed in the SmPC and PL

The State Institute for Drug Control (SÚKL) informs marketing authorisation holders about changes in the Appendix V, where specific contact details for adverse drug reaction reporting are listed. Due to the change of SÚKL’s web address (introduction of the “sukl.gov.cz” domain) and clarification of the SÚKL´s postal address, the information in this Appendix has been updated.

The web address www.sukl.cz/nahlasit-nezadouci-ucinek, which provides access to the online form for reporting adverse drug reactions of medicinal products and which has so far been listed in the SmPC, PL, and the Appendix V, has been changed to: sukl.gov.cz/nezadouciucinky

SÚKL guarantees that the original web address www.sukl.cz/nahlasit-nezadouci-ucinek will be redirected to the online reporting form at least until the year 2030.

Additionally, an option to submit adverse drug reaction reports via e-mail farmakovigilance@sukl.gov.cz has been added.

The postal address has also been clarified as: State Institute for Drug Control, Šrobárova 49/48, 100 00 Prague 10. It should be noted that the SÚKL has not relocated; this is purely an administrative clarification of the address.

Therefore, all newly submitted marketing authorisation applications shall already have the updated information on adverse drug reaction reporting in the Product Information (SmPC and PL) in accordance with the guidance provided in the article Information on adverse drug reaction reporting in SmPC and PL.

Requirements for updating the adverse drug reaction reporting information in pending new marketing authorisation applications and existing marketing authorisations

New authorisation applications

For ongoing marketing authorisation applications, SÚKL requires that the information on adverse drug reaction reporting is updated in line with the guidance provided in the article Information on Adverse Drug Reaction Reporting in SmPC and PL.

• For nationally authorised products, the update has to be included during the authorisation procedure.
• For products authorised via the MR/DC procedure, the update has to be made during the national phase.
• For centrally authorised products, the process remains unchanged, as the electronic version of the Product Information shall include an active hyperlink to the Appendix V, while the printed version shall contain the information in accordance with the Appendix V (see the article above).

Renewals and Variations of Marketing Authorisations

In the ongoing applications for renewal or variation of marketing authorizations, SÚKL will not actively require the marketing authorisation holders to update the adverse drug reaction reporting information. This decision is based on the fact that no transition period has been set, and SÚKL guarantees that the original web address will remain active and redirected until the year 2030. The decision to update this information is left entirely up to the marketing authorisation holders.

If the marketing authorisation holder decides to update the information, it must be applied simultaneously to all texts (SmPC, PL).

For updating the adverse drug reaction reporting details in already authorised products (nationally or via the MR/DC procedure), the following regulatory procedures can be used:

• separate type IB variation (C.I.z classification)
• renewal of the marketing authorization, if Product Information is updated
• classification “C” variation affecting Product Information, with another scope of the variation (i.e. not solely related to adverse drug reaction reporting). Both the SmPC and PL must be submitted, even if the variation has no impact to both documents
• type IB variation, classification A.2.b– change in the (invented) name of the medicinal product – for Nationally Authorised Products
• transfer of marketing authorization

For centrally authorised products, the updated information on adverse drug reaction reporting may be included in the printed materials without regulatory action, as the electronic version has to contain an active hyperlink to the Appendix V.

Since no transition period has been defined, SÚKL requests that the updates of adverse drug reaction reporting information for already authorised medicinal products should not be submitted via classification “A” variations (except for A.2.b) or classification “B” variations.

Information on adverse drug reaction reporting has also been updated in Appendix V.