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 area 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.

Form 1(a): Pharmacy Registration Form	Preview	Download
Form 1(b): Licensing Application form (Import, Wholesale, Export, Manufacture	Preview	Download
Form 17: Application form Provisional Registration (Pharmacist)	Preview	Download
Form 18: Application form Full Registration (Pharmacist)	Preview	Download
Forn 19: Application form for retention of name in the register (Pharmacist)	Preview	Download
Forn 22: Application form for retention of name on register (Pharmacist Technician)	Preview	Download