Pharmaceutical

  • Product Registration
  • Compliance Licensing & Inspecting (CCLI)
  • Pharmaceutical Care
  • Medicine Quality Control Laboratory

INTRODUCTION

PHARMACEUTICAL SERVICES STANDARDS BRANCH (PSSB)
Pharmaceutical Services Standards Branch (PSSB) is responsible for administration and implementation of the Medicines and Cosmetics Act 1999 and its regulations to ensure that medicinal products and medical devices are safe, effective and of good quality for use by people of Papua New Guinea.

PHARMACEUTICAL SERVICES STANDARDS BRANCH (PSSB) FUNCTIONS
Provides regulatory oversight to pharmaceutical services and medical products as mandated under the Medicines and Cosmetics Act, 1999, including implementation, enforcement of monitoring of medicinal product registration, laboratory testing of medicines, inspection/enforcement and pharmacovigilance activities.

Under health sector partnership policy and signed MOUs, strengthen partnership and coordination with relevant stakeholders in upholding regulatory harmonization and convergence aiming to ensure quality, safety and efficacy of medicines marketed in Papua New Guinea.

Provide secretariat to governance bodies including Pharmacy Board, Pharmaceutical Advisory Board, Medicines Evaluation Committee, Antimicrobial Resistance (AMR) and health workforce regulation sub working group.

Provides Technical support to Medical Supplies Procurement and Distribution Branch with medicinal product quality assessment and selection for public sector procurement.

Regulate importation and provides quarterly reports to International Narcotics Control Bureau (INCB) on imports of Narcotics and Psychotropic substances used for therapeutic purposes.

According to National Health Service Standards (NHSS) blueprint, pharmaceutical services are a core clinical support services in ensuring availability and accessibility of medicinal products for both curative and preventative care.

SECTIONAL UNITS
There are four (4) sectional units within PSSB with respective functions.

Product Registration Unit

  • Responsible for medicinal product registration as per the Guidelines for Medicines in Papua New Guinea developed.
  • The registration process ensures that medicinal products or medical devices brought into the country are safe, effective and of good quality.

Compliance Licensing & Inspecting Unit (CCLI)

  • Responsible for facilitating inspection of prospective pharmaceutical establishments for issuance of valid licenses for pharmacy outlets, importers, wholesalers, exporters and issuance of licenses for pharmacy technicians, pharmacists.
  • Only registered pharmaceutical establishments and persons will deal with medicinal products or medical devices.
  • On average K200, 000 is collected in license fees and goes into government consolidated revenue.

Pharmaceutical Care Unit

  • Responsible for reviewing and updating medicinal product specification in the Medical and Dental Catalogue
  • Provides secretariat duties for Pharmacy Board of Papua New Guinea (PBPNG) and Pharmaceutical Advisory Committee (PAC) and facilitates payment of PBPNG members' sitting allowances, printing of board meetings minutes and agenda papers.
  • Provides training in hospitals to establish Medicines Therapeutic Committees (MTCs) as entry points to undertake pharmacovigilance activities of monitoring adverse drug reactions and provides report to Uppsala Monitoring Centre in Sweden.

Application Form for Retention of name in the register Preview Download
Application Form – Full Registration (Pharmacy) Preview Download
Application Form – Provisional Registration (Pharmacy) Preview Download
Pharmacy Registration Forms 1(a) Preview Download
Application Form for Retention of Name in the Register (Pharmacy Technician) Preview Download
Licensing Application Form Preview Download

Pharmaceutical Information Advertisement

Circular Number 35/2015 Preview Download
Registered Pharmaceutical Establishments-2015 Preview Download
Application Form – Full Registration (Pharmacy) Preview Download
Circular Number 36/2015 Preview Download
Unregistered retail outlets, Supermarkets, and Individuals, Who sell medicines Preview Download
Public awareness on the sale of medicines Preview Download
Registered Pharmacist and Pharmacy Technicians-2015 Preview Download
Registered Full Pharmacist and Pharmacy Technicians Lists Preview Download
Licensing Authority Preview Download
Marketing Authorization Launching Program Preview Download
Circular Instructions Preview Download

Medicine Quality Control Laboratory

  • Responsible for testing of medicines quality to ensure medicines coming into the country are of good quality and they will be safe and effective when administered to people of Papua New Guinea.
  • Medicine Quality Control Laboratory was opened on 30/11/17, by Minister for Health and HIV/AIDS, Hon Sir Dr Puka Temu, KBE, CMG, MP.
  • MQCL has the 'state of the art' equipment that must be maintained and serviced regularly so as to maintain peak performance and fit for service status.
  • MQCL has potential to service Pacific Island nations and become the regional center of excellence.