Percentage Correct 67% Score 0.67 5 Is there a standard application form publicly available for submission of application for registration of medicinal products? Publicly accessible Readily available at government office Requires description of the product: name of product (brand name & ), composition per unit dose Brief summary of method of manufacture Specification of pharmaceutical ingredients and excipients Summary Product Characteristics (SPC): Pharmacological action, therapeutic classification, indications, contraindications, etc. Packaging material and inserts Labelling 1 1 1 1 1 1 1 1 Percentage Correct 100% Score 1 6 Are there written guidelines setting limits on how and where medicines registration officers meet with applicants? Yes/No 0 Percentage Correct 0% Score 0 7 Is there a functioning formal committee responsible for assessing applications for registration of pharmaceutical products? Yes/No 1 Percentage Correct 100% Score 1 8 Are there clear written criteria for selecting the members of the committee? Written criteria Criteria publicly available Specify professional qualification required Specify the technical skills and work experience related to the area Require declaration of conflict of interest (e.g. investment in pharmaceutical business) Require research experience in the area of expertise Specify organization to be considered when selecting members Give a timeframe to serve as a committee member 1 1 0 0 0 0 0 0 Percentage Correct 25% Score 0.25 9 Is there a written document that describes the composition and terms of reference of the committee? Up-to-date document Publicly accessible Includes names of the members Includes duties, responsibilities and obligations of the members Includes the accountability of the members Includes quorum requirement Includes membership terms/rotation requirements Includes the financial benefits of the members, if any 0 0 0 0 0 0 0 0 Percentage Correct 0% Score 0 10 Are there written guidelines on conflict of interest (COI) with regard to registration activities? Guidelines on COI exist in writing Form for declaration of COI for members of registration committee exists Include rules on the acceptance of gifts Include rules on reporting conflict of interest Include a mechanism protecting informers of COI Include actions to be taken in case of failure to comply with policy Evidence of enforcement of these regulations 0 0 0 0 0 0 0 0 Percentage Correct 0% Score 0
11 To what extent do you agree with the following statement: “The members of the registration committee are systematically and objectively selected based on the written criteria in force in your country?” Strongly disagree 12 Are there clear and comprehensive guidelines for the committee’s decision making process? Describe clearly the mandate of the committee Available publicly and in writing Describe the number of meetings it should convene Describe procedures for decision-making Include clear time limits for decision-making process for the committee Describe the reporting structure Decisions of meetings need to be publicly available 1 0 1 1 1 1 0 Percentage Correct 71% Score 0.71 13 Is there a formal appeals system for applicants who have drug applications rejected? Yes/No 1 Percentage Correct 100% Score 1 14 To what extent do you agree with the following statement: “Gifts and other benefits given to the officials in charge of medicines registration have no influence at all on the final decisions? Strongly agree II. PROCUREMENT OF DRUGS Question Criteria 1 Does the government use transparent and explicit procedures for procurement of pharmaceutical products? Written procedures publicly available Describe the internal process to be followed by staff on how to process the bids Require the use of generic names Require procurement to be based on the national essential medicines list Require advertisement of tenders Require that contract specifications be publicly available Require that criteria for adjudication of tender be included as part of the tender package Require that contract awards be made by the tender committee Require that information on tender process and results are made public (to the extent permitted by law) 1 1 1 1 1 0 1 1 1 Percentage correct 89% Score 0.88 2 Is there written guidance for procurement office staff on the type of procurement method to be used for different types of products? Yes/No 1 Percentage correct 100% Score 1 3 Is procurement done with an objective quantification method to determine the quantity of pharmaceuticals to be purchased? Yes/No 1 Percentage correct 100% Score 1 4 Is there a formal appeals process for applicants who have their bids rejected Yes/No 1 Percentage correct 100% Score 1 5 Is there a tender committee (TC)? If so, are the key functions of the procurement office and those of the tender committee clearly separated? There is a TC formally established TC responsible for suppliers’ selection for restricted tenders TC responsible for contract decisions 1 1 1
4 Is there systematic and orderly shelving of drug products in warehouses? Drugs are stocked by therapeutic category or alphabetically 1 Percentage correct 100% Score 1 5 Is there a security management system in place to oversee storage and distribution Monitoring of entry and exist to warehouses Limited access Alarm system for security breaches Security cameras Security force or responsible individuals 1 1 0 0 1 Percentage correct 60% Score 0.6 6 Are there independent audits of warehouses by national inspectors or outside contractors? Clear and comprehensive Performed by independent persons Regular audits 1 1 1 Percentage correct 100% Score 1 7 Are sanctions imposed on individuals for theft or corrupt practices? Evidence of sanction enforcement 0 Percentage Correct 0% Score 0 8 Has any public official been dismissed in the past two years for unethical behaviour? (i.e. theft; corrupt practices) Evidence of sanctions imposed for corrupt practices 1 Percentage Correct 100% Score 1 9 Is there an information system (computerized or manual) to track the movement of pharmaceuticals from a warehouse to a health facility Type of drugs left at warehouse Amount of drugs left at warehouse Intended recipient of drugs Time and date of drug arrival 1 1 1 1 Percentage Correct 100% Score 1 10 Is there coding used to identify government drugs? Clear and effective coding system 0 Percentage Correct 100% Score 1 11 Is there a formal process to verify that the drugs received by the provider match those shipped from the warehouse or the supplier? Receipts are checked against the packing slip 1 Percentage Correct 100% Score 1 12 Does a program exist for monitoring and evaluating the performance of the drug distribution system? Performance is evaluated on a regular basis Evaluated by an independent authority Identified weaknesses are addressed 1 1 1 Percentage Correct 100% Score 1 13 Is there a well-functioning communication system between distribution points? Confirmation of effective communication system by all points in the distribution 1 Percentage Correct 100% Score 1