Guidelines for Submission of Dossier for Listing into the Ministry of Health Medicines Formulary

Guidelines for Submission of Dossier for listing into the Ministry of Health Medicines Formulary issued by the Pharmaceutical Services Division, Ministry of Health as an enhancement to the process of listing of medicines into the MOH Medicines Formulary (MOHMF) or Formulari Ubat Kementerian Kesihatan Malaysia (FUKKM).

The main part of this guideline focuses on the application for listing of medicines by pharmaceutical industries into the MOHMF. The requirements are designed to promote uniformity of application and minimizing variability in the quality of the dossiers submitted. The guideline is also intended for use by applicant within the Ministry of Health (MOH) facilities.

This guideline will provide practical information on how to prepare a complete dossier for this purpose. A complete dossier with accurate information is very important as it helps to expedite the review process of a submission. It will also facilitate comprehensive assessment of the proposed medicine by the reviewers and consequently the decision-making process by MOHMF Review Panel. 

Use of this updated guideline will take effect on January 2019. Suggestions or comments can be e-mailed to sekretariatfukkm@moh.gov.my. 

NOTE:

Minor revision on some phrases in the guideline has been conducted in October 2019.