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Table 3 Structural and process indicators of legislation and regulation, essential drug selection, and drug registration in Iran in 2002

From: Monitoring of National Drug Policy (NDP) and its standardized indicators; conformity to decisions of the national drug selecting committee in Iran

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)