Percentage Correct 67% Score 0.67 Is there a standard application form publicly available Publicly accessible 1 for submission of application for registration of medicinal Readily available at government office 1 products? Requires description of the product: name of product (brand 1 name & ), composition per unit dose Brief summary of method of manufacture 1 Specification of pharmaceutical ingredients and excipients 1 Summary Product Characteristics (SPC): Pharmacological 1 5 action, therapeutic classification, indications, contraindications, etc. Packaging material and inserts 1 Labelling 1 Percentage Correct 100% Score 1 Are there written guidelines setting limits on how and Yes/No 0 where medicines registration officers meet with Percentage Correct 0% 6 applicants? Score 0 Is there a functioning formal committee responsible for Yes/No 1 assessing applications for registration of pharmaceutical Percentage Correct 100% 7 products? Score 1 Are there clear written criteria for selecting the members Written criteria 1 of the committee? Criteria publicly available 1 Specify professional qualification required 0 Specify the technical skills and work experience related to the 0 area Require declaration of conflict of interest (e.g. investment in 0 pharmaceutical business) 8 Require research experience in the area of expertise 0 Specify organization to be considered when selecting 0 members Give a timeframe to serve as a committee member 0 Percentage Correct 25% Score 0.25 Is there a written document that describes the Up-to-date document 0 composition and terms of reference of the committee? Publicly accessible 0 Includes names of the members 0 Includes duties, responsibilities and obligations of the 0 members Includes the accountability of the members 0 9 Includes quorum requirement 0 Includes membership terms/rotation requirements 0 Includes the financial benefits of the members, if any 0 Percentage Correct 0% Score 0 Are there written guidelines on conflict of interest (COI) Guidelines on COI exist in writing 0 with regard to registration activities? Form for declaration of COI for members of registration 0 committee exists 0 Include rules on the acceptance of gifts 0 Include rules on reporting conflict of interest 0 Include a mechanism protecting informers of COI 0 10 Include actions to be taken in case of failure to comply with 0 policy Evidence of enforcement of these regulations 0 Percentage Correct 0% Score 0
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
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