As a product registrant, you may submit an MAV-2 application proposing the reclassification of your therapeutic product for our review. Medicines may be reclassified from POM to P, or P to GSL, if they have been deemed sufficiently safe for use with reduced or without medical supervision.
You may only submit an MAV-2 application through the abridged evaluation route.
If an MAV-2 application is riding on a previous reclassification of an analogous product, you may submit a "me-too" reclassification.
A "me-too" reclassification will be considered if the forensic classification of your product is to be aligned with that of a similar product with the same active ingredient and intended use.
Note: All MAV-2 applications require our approval before the change can be implemented.
A change of forensic classification of a Prescription Only Medicines (POM) or Pharmacy Only Medicines (P) drug to a less stringent classification may be considered if the following criteria are met:
- The use of the product has been sufficiently extensive.
- The product has been marketed for a sufficient period of time to establish a post-marketing adverse event profile.
- The product’s safety profile gives no cause for concern during the marketing period.
- The product is presented in an appropriate pack size with consumer-friendly labelling (PIL/outer carton).
Additionally, you must provide the following justifications for the reclassification of a pharmaceutical drug:
- Forensic classification and approved indication and dosing regimen of the product in the UK, US, Canada and Australia (if applicable).
- Period of product registration in Singapore, UK, US, Canada and Australia, with information on its forensic classification and duration of sale in that classification (if applicable).
- Period of actual product sale in Singapore.
- Rationale for requesting a change in the forensic classification.
- Patient exposure to the product and its safety profile based on worldwide spontaneous adverse drug reaction reports, data from post-marketing surveillance studies, clinical trials, published literature and locally reported adverse drug reactions.
- Potential problems and hazards arising from the inappropriate use of the product.
Application dossier requirements
You must submit the variation application dossier within two working days of the PRISM application. The dossier submitted for variation applications should be in the same Common Technical Document (CTD) format as that used for the original registration application.You need to submit all documents in English.
All MAV-2 applications require Module 1/Part I. Module 2/Part IV - Summary of Clinical Safety is also required and must include the following information:
- Forensic classification of the product in the UK, US, Canada and Australia, with specific information on its forensic classification and duration of sale in that classification.
- Experience of patient exposure to the product, such as sales volume and patient-years.
- Summary of the product safety profile based on worldwide and local spontaneous adverse drug reaction reports, post-marketing surveillance data, clinical trials and published literature.
- A list of the potential problems arising from using the product without medical supervision.
- An analysis of the hazards arising from therapeutic misuse or drug abuse, whether deliberate or accidental, such as the consequence of delay in seeking medical attention.
Note: Module 2/Part IV - Summary of Clinical Safety is not required for 'me-too' application.
All administrative documents under Module 1 (ICH CTD) or Part I (ACTD) must be submitted in soft copy in PRISM.
The other parts of the ICH CTD or ACTD may be submitted online via PRISM, or in a CD/DVD labelled with the following information:
- PRISM application number.
- PRISM submission date.
- Product name.
- Application type.
- Contents of the CD/DVD (e.g. Module 2 and 5)
Each application must be accompanied by a checklist, completed by the applicant and attached in PRISM.
Use one of the following application checklists for your choice of CTD. Each checklist provides details on the specific documents that need to be submitted with your application. Submit the completed checklist together with your application dossier for application screening.
Note: Your choice of CTD submitted for your original NDA will determine the submission format for the rest of your product's post-approval applications.
Fees and processing time
Refer to therapeutic product fees and turnaround time for more information.
How to apply
Submit your application through PRISM. Ensure you have the following before you access the e-service:
If you encounter technical issues, e-mail the HSA helpdesk or call 6776 0168 (from 7.00 am to midnight daily).
Refer to our Guideline on PRISM Submission2051 KB for more details on how to submit.
More details on submission requirements may be found in our
Guidance on Therapeutic Products Registration