Step 3: Submit the Application

Actions

3.1 You need to complete the online application through the Fiji MRA Online Services Portal accessed via https://fijimedreg.conforma.systems/login.

3.2 All communication between you and the Fiji MRA must be conducted through the Portal or via email.

Required Information

Compulsory:

  1. Registration status in Australia or New Zealand.
  2. Registration status in other countries.
  3. Brand/trade name.
  4. International Non-proprietary Name (INN), also referred to as the ‘generic name’ of the active substance.
  5. The amount, that is, the strength and unit of the active substance per dosage form.
  6. Dosage form.
  7. Route of administration.
  8. Packaging sizes.
  9. Shelf life.
  10. Finished product manufacturer(s).
  11. Pharmacopeial standard.

Optional (Recommended)

  1. Medicinal Products Classification (Schedule) in Fiji.
  2. Anatomical Therapeutic Chemical (ATC) Code and Category.
  3. Good Manufacturing Practice (GMP) Certificate(s) of the manufacturer.
  4. Product registration certificate(s) from other countries.

 

Fees or Charges

Free

Estimated Total Time

N/A

Contact Address

Ministry of Health and Medical Services, Dinem House, 88 Amy St, Suva, Fiji

Phone: +679 892 665

e-mail: FIJIMRA@health.gov.fj

Website: www.health.gov.fj

 

 

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