Is there an official national drug policy document updated in the past 10 years? | + |
Is there drug legislation updated in the past 10 years? | + |
Have regulations based on the drug legislation been issued? | + |
Is there a drug regulatory authority whose mandate includes registration and inspection? | + |
Is there a licensing system to regulate the sale of drugs (wholesalers, pharmacists,...)? | + |
Are pharmacists legally entitled to substitute generic drugs for brand name products? | + |
Are there legal provisions for penal sanctions? | + |
Is there a check-list for carrying out inspections in different types of pharmaceutical establishments? | + |
Are there any institutions where quality control is carried out? | + |
Is the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce used systematically? | + |
Are there controls on drug promotion based on regulations and consistent with the WHO Ethical Criteria for Medicinal Drug Promotion? | + |
Is there a national essential drugs list (EDL)/formulary using INN officially adopted and distributed countrywide? | + |
Is there an official drug committee whose duties include updating the national drugs list? | + |
Has the national essential drugs list /formulary been updated and distributed countrywide in the past five years? | + |
Do drug donations comply with the national drugs list? | + |
Are there formal procedures for registering drugs? | + |
Is there a drug registration committee? | + |
Is drug registration renewal required at least every five years? | + |
Number of drug outlets inspected, out of total number of drug outlets in the country. | 100% (132/132) |
Number of drug outlets in violation, out of total number of drug outlets inspected. | 70% (92/132) |
Number of sanctions and administrative measures implemented, out of total number of violations identified. | 0% |
Number of advertisements in violation of regulations on the ethical promotion of drugs, out of total number of advertisements monitored. | 10% (5/49) |
Number of sanctions implemented for advertisements in violation of regulations, out of total number of violations identified. | 100% (5/5) |
Value of drugs from the national drugs list procured in the public sector, out of total value of drugs procured in the same sector. | 27% (415/1516) |
Number of drugs from the national drugs list prescribed, out of total number of drugs prescribed. | 95% (1440/1516) |
Number of drugs from the national drugs list sold, out of total number of drugs sold. | 95% (1440/1516) |
Number of locally manufactured drugs sold in the country from the national drugs list, out of the total number of drugs from the national drugs list. | 60% (910/1516) |
Number of combination drugs newly registered, out of total number of newly registered drugs. | 0% (0/243) |
Number of registered drugs, which are banned in other countries, out of total number of registered drugs. | 0% (0/243) |