Papua New Guinea Drug Product Registration

MoH: 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.