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Health Sciences Authority

Reclassification process

Submit product-specific reclassification applications and find out more about HSA's exemptions of supply of POM without prescription

Last updated 29 May 2026

Overview

The following forensic classifications describe the three levels of access controls for therapeutic products in Singapore:

  • Prescription Only Medicines (POM): A therapeutic product that can only be obtained from a doctor or from a pharmacist with a valid prescription.

  • Pharmacy Only Medicines (P): A therapeutic product that can be obtained from a pharmacist at a retail pharmacy without a prescription. 

  • General Sale List (GSL): A therapeutic product that can be obtained from any retailer. 

The access control of therapeutic products can be changed through the following two mechanisms:

  • Product-specific reclassification.

  • Exemptions of supply of POM without a prescription.

Product-specific reclassification

MAV-2 application

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.

"Me-too" reclassification

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.

Eligibility

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, Switzerland and Australia (if applicable).

  • Period of product registration in Singapore, UK, US, Canada, Switzerland 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.

Submission requirements

Application checklists

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.

Application dossier requirements

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, Switzerland 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.

How to submit the dossier

Application dossiers must be submitted to HSA within 5 working days of the PRISM application submission.

Non-eCTD submissions (ICH and ACTD formats)

Submit via PRISM, CD/DVD or EasiShare

  • 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, CD/DVD or third-party cloud-based file exchange software (EasiShare).

To submit via EasiShare:

  1. Prepare your documents: 

  2. Request for access (click here (opens in new tab)) to EasiShare for dossier submissions.

eCTD submissions (ICH format only)

Submit via SG-HSA eCTD portal

Applicants must prepare the dossier according to the current SG-HSA eCTD Specification and submit the eCTD package via the SG-HSA eCTD portal (opens in new tab).  In addition, applicant must upload a file named with the eCTD ID in PRISM document section 7.1 – CD Submission to indicate that the submission is via eCTD


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 (opens in new tab) or call 6776 0168 (from 7.00 am to midnight daily).

Refer to our Guideline on PRISM Submission (opens in new tab) for more details on how to submit.

More details on submission requirements may be found in our Guidance on Therapeutic Products Registration

Exemptions of supply of POM without a prescription

We may enable the limited supply of a POM by pharmacists without a prescription, upon review that the product can be used in a safe and effective manner under the supervision of a pharmacist.

This can be effected through legislative mechanisms in the absence of an application made by the product registrant to reclassify the therapeutic product, with specified conditions for the following:

  • Indication

  • Strength

  • Maximum daily dose

  • Maximum supply

  • Age restriction


List of POMs with exemptions for supply without prescription


List of prescription-only medicines (POM) with exemptions for supply without prescription

Active ingredient

Exemptions for supply of POM without prescription

Effective date

Acyclovir ( Patient Information Leaflet (opens in new tab))

As a dermatological preparation not exceeding 5%.

· Indication: Treatment of cold sore

· Maximum supply: 2g

2000/01/17

Adapalene ( Patient Information Leaflet (opens in new tab))

As a topical preparation not exceeding 0.1%.

· Indication: Treatment of acne vulgaris

· Maximum daily dose: Apply to affected areas once a day

· Maximum supply: 30g

· Minimum age: 12 years

2016/03/31

Alcaftadine 

As eyedrops not exceeding 0.25%.

· Indication: Prevention of itching associated with allergic conjunctivitis

· Maximum daily dose: One drop into affected eye, once daily

· Maximum supply: 3ml

· Minimum age: 3 years

2017/06/01

Ambroxol (Patient Information Leaflet (opens in new tab))

As an oral solid preparation containing not more than 30mg.

· Indication: To clear the chest by thinning the mucus in air passages

As an oral liquid preparation containing not more than 30mg/5ml.

· Indication: To clear the chest by thinning the mucus in air passages

2011/07/01


Atovaquone/Proguanil HCl (Patient Information Leaflet (opens in new tab))

As an oral solid preparation containing Atovaquone and Proguanil HCl 250mg/100mg

· Indication: Malaria prophylaxis

· Official guidelines and local information on the prevalence of resistance to antimalarial drugs should be taken into consideration in the selection of chemoprophylaxis of malaria.

· Maximum daily dose: One 250mg atovaquone/100mg proguanil tablet daily

· Maximum supply: Max supply is determined by the duration of travel. Prophylaxis should start 1 to 2 days before entering a malaria-endemic area, and be continued daily until 7 days after leaving the area

· Minimum age: Adults 18 years and above, with body weight of at least 40kg.

2018/02/01

Azelaic acid (Patient Information Leaflet (opens in new tab))

As a topical preparation containing 20% w/w

· Indications: Mild to Moderate Acne Vulgaris

· Maximum daily dose: Apply to the affected area twice daily

· Maximum supply: 30g

· Minimum age: 12 years

2012/07/01

Beclomethasone (Patient Information Leaflet (opens in new tab))

As a nasal spray

· Indication: Prevention and treatment of allergic rhinitis.

· Maximum Daily Dose: 200 mcg/nostril

· Maximum Supply: Up to 3 months' duration.

· Minimum Age: 18 years

2000/01/17


Betamethasone (Patient Information Leaflet (opens in new tab))

As a topical preparation (as valerate or dipropionate salt) as a single agent not exceeding 0.1%

· Indications: Symptomatic relief of inflammatory skin or scalp disorders such as dermatitis and eczema.

· Maximum Daily Dose: Apply to the affected areas twice daily

· Maximum Supply: 15g for cream/ointment/gel

· 30ml for topical solution

· Minimum age: 18 years

2016/03/31


Bromhexine ( Patient Information Leaflet (opens in new tab))

As an oral solid preparation containing not more than 8mg

· Indication: To clear the chest by thinning the mucus in air passages

As an oral liquid preparation containing not more than 4mg/5ml

· Indication: To clear the chest by thinning the mucus in air passages

2011/07/01


Budesonide 

As a nasal spray

· Indication: Prevention and treatment of allergic rhinitis.

· Maximum Daily Dose: 200 mcg/nostril

· Maximum Supply: Up to 3 months' duration.

· Minimum Age: 18 years

2002/11/19

Cimetidine (Patient Information Leaflet (opens in new tab))

As an oral preparation

· Indications:

· (a) Short-term relief of heartburn, dyspepsia and hyperacidity and

· (b) Prophylactic management of nocturnal heartburn.

· Maximum Daily Dose: (a) 200 mg and (b) 100 mg (as a single night-time dose).

· Maximum Supply: Up to 2 weeks' duration

1995/11/10

Clindamycin ( Patient Information Leaflet (opens in new tab))

As a topical preparation not exceeding 1%

· Indication: Treatment of acne vulgaris

· Maximum daily dose: Apply to affected areas twice daily*

· *Once daily for fixed combination products containing topical clindamycin not exceeding 1% and benzoyl peroxide

· Maximum supply: 30g for gel

· 30ml for topical solution/lotion

· Minimum age: 12 years

2016/03/31

Desloratadine (Patient Information Leaflet (opens in new tab))

As an oral solid preparation containing not more than 5mg

· Indications: For relief of symptoms associated with allergic rhinitis and urticaria

· Dosing regimen:

· Adults and adolescents 12 years and older: 5mg daily

· Maximum daily dose: 5mg

· Maximum supply: 2 weeks

· Minimum age: 12 years

· As an oral liquid preparation containing not more than 0.5mg/ml

· Indications: For relief of symptoms associated with allergic rhinitis and urticaria

· Dosing regimen:

· 12 years and above: 5mg once daily

· 6-11 years: 2.5 mg once daily

· 2-5 years: 1.25 mg once daily

· Maximum daily dose:

· 12 years and above: 5mg

· 6-11 years: 2.5 mg

· 2-5 years: 1.25 mg

· Maximum supply: 2 weeks

· Minimum age: 2 years

2011/07/01

Desloratadine/ Pseudoephedrine ( Patient Information Leaflet (opens in new tab))

As a modified release oral solid dosage form containing desloratadine 2.5mg and pseudoephedrine 120mg

· Indications: For the relief of symptoms associated with allergic rhinitis including nasal congestion, sneezing, runny nose, itching of the nose and/or eyes

· It should be administered when both the antihistaminic properties of desloratadine and the decongestant effect of pseudoephedrine are required.

· Dosing regimen: 1 tablet twice daily

· Maximum daily dose: 2 tablets

· Maximum supply: 10 tablets

· Minimum age: 12 years

2012/01/01


Desonide (Patient Information Leaflet (opens in new tab))

As a topical cream or lotion preparation containing not more than 0.05% w/w

· Indication: Treatment of redness, swelling and itching that is associated with minor skin ailments such as eczema.

· Maximum daily dose: 2 to 3 times daily depending on severity.

· Maximum supply: 15 g (cream) or 60 ml (lotion)

· Minimum age: 18 years

2013/01/01


Domperidone (Patient Information Leaflet (opens in new tab))

As an oral solid preparation containing not more than 10mg or an oral liquid preparation containing not more than 1mg/ml

· Indications: Relief of postprandial symptoms of excessive fullness, nausea, epigastric bloating and belching occasionally accompanied by epigastric discomfort and heartburn.

· Maximum Daily Dose: 30 mg

· Maximum supply: 14 days

· Minimum age: 12 years

2012/07/01


Emedastine

As eyedrops not exceeding 0.05%

· Indication: Short-term treatment of signs and symptoms of allergic conjunctivitis

· Maximum daily dose: One drop into the affected eye twice daily

· Maximum supply: 5ml

· Minimum age: 3 years

2017/06/01


Esomeprazole (Patient Information Leaflet (opens in new tab))

As an oral solid preparation not exceeding 20mg

· Indication: Relief of heartburn symptoms associated with acid reflux

· Maximum daily dose: 20mg

· Maximum supply: 2 weeks

· Minimum age: 18 years

2016/12/01


Erythromycin (Patient Information Leaflet (opens in new tab))

As a topical preparation not exceeding 4%

· Indication: Treatment of acne vulgaris

· Maximum daily dose: Apply to affected areas twice daily

· Maximum supply: 30g for gel

· 30ml for topical solution/lotion

· Minimum age: 12 years

2016/03/31


Famotidine (Patient Information Leaflet (opens in new tab))

As an oral preparation

· Indications: Short-term relief of heartburn, dyspepsia and hyperacidity.

· Maximum Daily Dose: 20 mg

· Maximum Supply: Up to 2 weeks' duration

2000/01/17


Fexofenadine (Tablets)(Patient Information Leaflet (opens in new tab))

As an oral solid preparation containing not more than 180mg

· Indications: For the symptomatic treatment of allergic rhinitis and chronic idiopathic urticaria

· Maximum daily dose: 180mg

· Maximum supply: 10 tablets

· Minimum age: 12 years

2013/07/01


Fexofenadine (Oral Solution)(Patient Information Leaflet (opens in new tab))

As an oral liquid preparation not exceeding 6mg/ml

· Indications: For the symptomatic treatment of allergic rhinitis and chronic idiopathic urticaria

· Maximum daily dose: 60mg

· Maximum supply: 150ml

· Minimum age: 2 years

2017/06/01


Fluconazole (Patient Information Leaflet (opens in new tab))

As an oral solid preparation containing 150mg

· Indication: Vaginal Candidiasis

· Maximum daily dose: 150mg

· Maximum supply: 1 tablet

· Min age: 16 years. Not recommended in adults older than 60 years of age.

2013/01/01


Fluticasone Furoate ( Patient Information Leaflet (opens in new tab))

As an intranasal spray not exceeding 27.5 mcg/actuation

· Indication: Prevention and treatment of allergic rhinitis

· Maximum daily dose: 110 mcg

· Maximum supply: 3 months

· Minimum age: 18 years

2017/06/01


Ibuprofen ( Patient Information Leaflet) (opens in new tab)

As an oral solid preparation containing not more than 200mg

· Indications: Relief of headache, menstrual pain, backache, muscular and arthritic pain, toothache, and the aches of cold and flu and reduction of fever.

· Maximum daily dose: 1.2g

· Maximum Supply: 10 days. The lowest effective dose should be used for the shortest duration necessary to relieve symptoms.

· Minimum age: 12 years

· As an oral liquid preparation not more than 100mg/5ml

· Indications: Reduction of fever, including post-immunisation pyrexia, and relief of mild to moderate pain such as sore throat, teething pain and toothache, earache, minor aches and sprains

· Maximum Daily Dose:

· 30 mg/kg, up to a maximum of 1.2g

· Maximum Supply: 3 days. The lowest effective dose should be used for the shortest duration necessary to relieve symptoms

· Minimum age: 6 months

2012/06/01


Ketotifen (Eye drops) (Patient Information Leaflet (opens in new tab))

As an eye drop not exceeding 0.25mg/ml

· Indication: For the short-term treatment of symptoms of allergic conjunctivitis (e.g. itchy or watery eyes)

· Dosing regimen:

· Adults, elderly and children (age 3 and older): One drop into the affected eye (s) twice daily (in the morning and evening)

· Maximum daily dose:

· 2 drops per affected eye

· Maximum supply: 10ml

· Minimum age: 3 years

2012/01/01


Ketotifen (Oral) ( Patient Information Leaflet (opens in new tab))

As an oral solid preparation not exceeding 2mg

· Indications: Symptomatic treatment of allergic rhinitis and chronic urticaria

· Maximum daily dose: 2mg

· Maximum supply: 10 days

· Minimum age: 3 years

As an oral liquid preparation not exceeding 1mg/5ml

· Indications: Symptomatic treatment of allergic rhinitis and chronic urticaria

· Maximum daily dose: 2mg

· Maximum supply: 120ml

· Minimum age: 3 years

2017/06/01


Levocetirizine (Patient Information Leaflet (opens in new tab))

As an oral solid preparation containing not more than 5mg

· Indications: For the symptomatic treatment of allergic rhinitis and chronic idiopathic urticaria.

· Maximum daily dose: 5mg

· Maximum supply: 10 tablets

· Min age: 12 years

As an oral liquid preparation containing not more than 5mg/ml

· Indications: As above

· Maximum daily dose: As above

· Maximum supply: 1 bottle

· Min age: As above

2012/07/01


Olopatadine (Patient Information Leaflet (opens in new tab))

As an eyedrop not exceeding 0.2%

· Indication: Short-term treatment of symptoms of allergic conjunctivitis

· Maximum daily dose:

· 0.1%: One drop in each affected eye two times per day

· 0.2%: One drop in each affected eye once a day

· Maximum supply:

· 0.1%: 5ml

· 0.2%: 2.5ml

· Minimum age: 3 years

2016/12/01


Omeprazole ( Patient Information Leaflet (opens in new tab))

As an oral solid preparation not more than 20mg

· Indication: For the relief of heartburn symptoms associated with acid reflux

· Dosing regimen: The initial starting dose is 20mg daily. When symptoms improve the dose can then be reduced to 10mg daily, returning to 20mg daily if symptoms return. The lowest effective daily dose should always be used.

· Maximum dose: 20mg daily

· Maximum supply: 14 days

· Minimum age: 18 years

2009/09/30


Mometasone furoate (Topical)  (Patient Information Leaflet (opens in new tab))

As a topical preparation as a single agent not exceeding 0.1%

· Indications: Symptomatic relief of inflammatory skin or scalp disorders such as dermatitis and eczema.

· Maximum daily dose: Apply to the affected areas once daily

· Maximum supply: 15g for cream/ointment/gel

· 30ml for topical solution

· Minimum age: 18 years

2016/03/31


Mometasone furoate (Intranasal spray) (Patient Information Leaflet (opens in new tab))

As an intranasal spray not exceeding 50mcg/actuation

· Indication: Prevention and treatment of allergic rhinitis

· Maximum daily dose: 200mcg

· Maximum supply: 3 months

· Minimum age: 18 years

2016/12/01


Nystatin (Patient Information Leaflet (opens in new tab))

As an oral liquid preparation containing not more than 100,000 units per ml

· Indication: Treatment of oral candidiasis

· Maximum daily dose:

· Infants and children 6 months and older: 400,000 units

· Adults: 2.4 million units

· Maximum supply: 2 weeks

· Minimum age: 6 months

2015/04/01


Pantoprazole (Patient Information Leaflet (opens in new tab))

As an oral preparation containing not more than 20mg

· Indication: For the relief of heartburn symptoms associated with acid reflux

· Maximum daily dose: 20mg

· Maximum supply: 14 days

· Minimum age: 18 years

2014/01/01


Ranitidine (Patient Information Leaflet (opens in new tab))

As an oral preparation

· Indications: Short-term relief of heartburn, dyspepsia and hyperacidity.

· Maximum Daily Dose: 300 mg

· Maximum Supply: 2 weeks' duration

2000/01/17


Ruscogenins and trimebutine 

As a rectal cream not exceeding 0.5g/5.8g per 100g

· Indications: For the symptomatic relief of external and internal haemorrhoids, anal pruritis, anal fissure

· Maximum daily dose: One or two applications per day

· Maximum supply: 20g

· Minimum age: 18 years

· As suppositories not exceeding 10mg/120mg

· Indication: For the symptomatic relief of external and internal haemorrhoids, anal pruritis, anal fissure

· Maximum daily dose: One to two suppositories per day

· Maximum supply: 10 suppositories

· Minimum age: 18 years

2016/12/01


Triamcinolone acetonide (Oral Paste/ lotion)( Patient Information Leaflet (opens in new tab))

As a topical paste/lotion containing not more than 0.1%

Indication: For the treatment of mouth ulcers

2011/07/11 (paste)

2017/06/01 (lotion)

Triamcinolone (Intranasal spray)

As an intranasal spray containing not more than 55 mcg/actuation

· Indication: Prevention and treatment of allergic rhinitis

· Maximum daily dose: 220 mcg

· Maximum supply: 3 months

· Minimum age: 18 years

2012/07/01 

Triamcinolone (Topical) (Patient Information Leaflet (opens in new tab))

As a topical preparation as a single agent not exceeding 0.1%

· Indication: Symptomatic relief of inflammatory skin or scalp disorders such as dermatitis and eczema.

· Maximum daily dose: Apply to the affected area twice daily

· Maximum supply: 15g for cream/ointment/gel

· 30ml for topical solution

· Minimum age: 18 years

2016/03/31