1. EXPORT
  2. Commodities
  3. Licit drugs
  4. Preliminary registrations, licences and certificates
  5. Product registration certificate
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Properties

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Properties

Steps (4) arrow_drop_up arrow_drop_down
Obtain product registration certificate  (4) expand_more expand_less

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Summary of the procedure

Institutions involved 2 expand_more expand_less

Pharmacy and Poisons Board (PPB) Trade Portal (x 2)
1 4
Pharmacy and Poisons Board (PPB) (x 2)
2 3

Results 1 expand_more expand_less

Product registration certificate
4

Required Documents expand_more expand_less

Application for registration of a drug - Form 1
1
Certificate of analysis
1
Certificate of good manufacturing practices
1
Pharmacy and Poisons Board (PPB) invoice (x 2)
2 3
Pharmacy and Poisons Board (PPB) receipt
3

Cost

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Cost detail

Estimate your cost

USD 0 -
USD  500 per product
For product registration, for local products.
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Total Duration 91d - 366d  expand_more expand_less

  Min. Max.
Total time (sum): 91d 366d
of which:
Waiting time in queue (sum): 10mn 20mn
Attention at counter: 15mn 3h. 30mn
Waiting time until next step (sum): 90d 365d

Laws 2 expand_more expand_less

Drug registration - Guidelines to submission of applications Drug registration - Guidelines to submission of applications
Pharmacy and Poisons (Registration of Drugs) Rules Pharmacy and Poisons (Registration of Drugs) Rules
  Sections 4, 6
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