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Health Sciences Authority

HSA-approved controlled access programme or pregnancy prevention programme

Find out what information may be requested for HSA-approved controlled access programme or pregnancy prevention programme.

Last updated 18 March 2026

The registrant should have a system in place such that the following information can be provided to HSA upon request:

  • List of authorised prescribers/pharmacies that supplied the product to patients

  • Number of patients prescribed with the product

  • Distribution records of the educational materials, including

    1. Name and address of the healthcare institutions/clinics/pharmacies where the materials are distributed

    2. Date and distribution of educational materials

      The distribution records of the educational materials must be retained for two years from the date of distribution.

  • Number of potential pregnancy exposures in patients and pregnancy outcomes with congenital malformations (only applicable to pregnancy prevention programmes)

New or updated forms used in the controlled access programme or pregnancy prevention programme should be provided for updating of HSA’s document records when available.

How to submit

HSA will inform registrants of the method of submission