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Obtain product registration certificate  (4) expand_more expand_less

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Summary of the procedure

Institutions involved 1 expand_more expand_less

Pharmacy and Poisons Board (PPB) (x 2)

Results 1 expand_more expand_less

Product registration certificate

Required Documents expand_more expand_less

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

Cost detail

Estimate your cost

USD 0 -
USD  1,000 per product
For product registration, for foreign products.
  Min. Max.
Total time (sum): 90 d 366 d
of which:
Waiting time in queue (sum): 10mn 20mn
Attention at counter: 15mn 3h. 30mn
Waiting time until next step (sum): 90 d 365 d
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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