Table 2 Composition of Monitoring the Private Market

5.02.08

Equal to one if medicines registration always includes the INN (International Nonproprietary Names).

5.02.12S

Equal to one if legal provisions require publication of a Summary of Product Characteristics (SPCs) of the medicines registered.

5.05.01

Equal to one if legal provisions exist requiring manufacturers to be licensed

5.05.02

Equal to one if legal provisions exist requiring both domestic and international manufacturers to comply with Good manufacturing Practices (GMP)

5.05.05

Equal to one if legal provisions exist requiring wholesalers and distributors to be licensed

5.05.06

Equal to one if legal provisions exist requiring wholesalers and distributors to comply with Good Distributing Practices

5.05.08

Equal to one if legal provisions exist requiring pharmacists to be registered

5.05.09

Equal to one if legal provisions exists requiring private pharmacies to be licensed.

5.07.01

Equal to one if legal provisions exist to control the promotion and/or advertising of prescription medicines

5.03.05.01

Equal to one if local manufactures are inspected for GMP compliance.

5.03.05.02

Equal to one if private wholesalers are inspected.

5.03.05.03

Equal to one if retail distributors are inspected-

5.03.05.05

Equal to one if pharmacies and dispensing points of health facilities are inspected.

Inspections

Equal to one if manufactures, retail distributors, and pharmacies and dispensing points of health facilities are inspected at least every three years.

Or

Equal to one if either manufactures, retail distributors, or pharmacies and dispensing points of health facilities are inspected at least every year.

5.04.02

Equal to one if legal provisions exist allowing the sampling of imported products for testing

5.04.03

Equal to one if legal provisions exist requiring importation of medicines through authorized ports of entry

5.04.04

Equal to one if legal provisions exist allowing inspection of imported pharmaceutical products at the authorized ports of entry.

5.05.04

Equal to one if legal provisions exist requiring importers to be licensed

5.10.01

Equal to one if there are legal provision that provides for pharmacovigilance activities as part of the MRA mandate.

5.10.02

Equal to one if legal provisions exist requiring the Marketing Authorization holder to continuously monitor the safety of their products and report to the MRA

5.10.03

Equal to one if legal provisions about monitoring Adverse Drug Reactions (ADR) exist in your country

5.10.22S

Equal to one if there training courses in pharmacovigilance.

5.10.05

Equal to one if an official standardized form for reporting ADRs is used.

5.10.06

Equal to one if a national ADR database exists.

5.10.10

Equal to one if there a national ADR or pharmacovigilance advisory committee able to provide technical assistance on causality assessment, risk assessment, risk management, case investigation and, where necessary, crisis management including crisis communication.

5.10.16S

Equal to one if ADR database is computerized.