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Papua New Guinea Drug Product Registration

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Papua New Guinea Drug Product Registration

Safeguarding Public Health Through Comprehensive Regulation

Ministry of Health

Ministry of health PNG

MoH Website

https://www.health.gov.pg/

Regulatory Agency

Pharmaceutical Services Standards Branch (PSSB)

Regulatory Agency Website

https://www.health.gov.pg/subindex.php?pharm=1

Local Authorized Representative

Yes

License Validity

5 years

License Renewal 

3 months before expiry date.

Regulation

Medicines and Cosmetics Act 1999 and Medicines and Cosmetics Regulation 2002

Application for registration of Medicinal Product

Made in Form 6 as prescribed Schedule 2 of to the regulations.

Grant of Medicinal Product License

Issued in Form 7 as prescribed in

Schedule 2 to the regulations.

Application for license to Manufacture Medicinal Products

Form 1(b) as prescribed in Schedule 2 to the regulations. 

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