Methodological Guidance of the Ministry of Health of the Slovak Republic on a Uniform Procedure for Indicating the Prescribing of Authorised Medicinal Products for Human Use Outside Their Approved Therapeutic Indications and on Changes to the Legal Framework Governing the Therapeutic or Diagnostic Use of Medicinal Products for Human Use Pursuant to Section 46 of Act No. 362/2011 Coll.
The guidance was developed following an amendment to Act No. 362/2011 Coll. on Medicinal Products and Medical Devices and on Amendments to Certain Acts. Its purpose is to ensure a uniform approach among prescribing physicians in fulfilling their statutory obligations related to the off-label prescribing of medicinal products for human use, and to inform the professional community of the legislative changes taking effect on November 1st 2026.