RegulatoryOfficial

ŠÚKL updates marketing authorisation transfer forms, splitting out holder declarations

🇸🇰 ŠÚKL · Mon 26 Oct 2026

Slovakia's medicines agency has published revised forms for human-medicine MA transfers, with the current and proposed holders' declarations now provided as separate annexes.

The Slovak State Institute for Drug Control (ŠÚKL) announced on 26 October 2026 that it has published updated forms for applying to transfer the marketing authorisation of a human medicine.

The main change is structural. The declarations of the current and the proposed marketing authorisation holder have been taken out of the transfer application itself and are now available as standalone documents.

The package comprises three forms: TL SRL 004, the application for transfer of a human medicine's authorisation; TL SRL 004a, Annex I, the declaration of the current holder; and TL SRL 004b, Annex II, the declaration of the proposed holder. All are interactive PDFs, available in ŠÚKL's document library and in the related documents section beneath the announcement.

ŠÚKL also reminded applicants that a transfer application is considered complete only if it includes the filled-in application form together with both Annex I and Annex II. The source does not give an effective date or say whether earlier versions of the forms will still be accepted.

What it means for your team

  • Teams handling Slovak MA transfers should download the new TL SRL 004, 004a and 004b forms and retire older templates.
  • Plan for the current and proposed holders to complete their declarations as separate documents, which may affect internal sign-off and coordination between the two companies.
  • Check submissions before filing: a missing Annex I or II means the application will not be treated as complete by ŠÚKL.

Official source: ŠÚKL ↗

Article written by VigiEye from the official source (ŠÚKL). AI-assisted; check the source before acting.

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