Legal provisions

DIN1: What is title and date of enactment of the drug law/regulations and the article number of the provision requiring inspection of distribution channels?

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DIN2: Are there provisions in the drug law/regulations that define the powers and status of the inspectors?

Yes
No

DIN2.1: If yes, what are the powers of distribution channel inspectors?

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Organization

DIN3: Is there a distribution channel inspectorate?

Yes
No

DIN3.1: If yes, to whom does it report?

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DIN4: What is the relationship of the inspectorate with other bodies involved in drug regulation, particularly with the licensing unit?

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DIN5: Are there written guidelines for Good Distribution Practices (GDP)?

Yes
No

DIN5.1: If yes, give reference to title and date of publication of the guidelines:

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DIN6: Is there a job description pertaining to the duties and responsibilities of distribution channel inspectors?

Yes
No

DIN7: Are there inspection guidelines or SOP for inspectors of distribution channels?

Yes
No

DIN7.1: If yes, give reference to the date of publication of the guidelines or SOP:

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Human resources

DIN8: How many distribution channel inspectors are there in the whole country?

(a) Full-time ____________
(b) Part-time ____________

DIN9: Do inspectors of distribution channels receive training in distribution channel inspection?

Yes
No

DIN9.1: If yes, collect information on the qualifications, training and experience of the inspectors.

DIN10: What is the average net monthly salary of a distribution channel inspector compared to other categories indicated in the table?

Financing of distribution channel inspection

DIN11: Is there a specific budget for the distribution channel inspectorate?

Yes
No

DIN11.1: If yes, what was the budget of the distribution channel inspectorate during each of the last five years (US$):

DIN11.2: What was the source of the budget in the last five years (answer yes/no)?

DIN11.3: If the answer to DIN11 is no, what was the estimated expenditure of the distribution channel inspectorate in the last five years?

DIN12: If fees are collected for inspection services, collect information on the types of inspection services on which fees have been levied and the amount of the fees charged.

Activities

DIN13: Is responsibility for inspecting distribution channels decentralized?

Yes
No

DIN13.1: If yes, which body conducts inspections at the following levels?

DIN14: What is the structural and functional relationship between the various inspection levels? Is there a reporting mechanism? Explain.

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DIN15: Are there planned inspections of distribution channels at the different levels?

Yes
No

DIN15.1: If yes, what is the number of planned inspections conducted, out of the total number of planned inspections targeted in each of the last five years? (If possible, give information about each level.)

DIN16: What are the different enforcement measures (administrative or legal sanctions) taken against those who do not comply with the drug laws/regulations? Explain.

DIN17: Give information below on the total number of violations registered and the number of the different enforcement measures taken in each of the last five years. (If other enforcement strategies are used, describe them.)

DIN18: Do the inspectors collect samples from distribution channels as part of planned quality surveillance activities?

Yes
No

DIN18.1: If yes, provide the following information for each of the last two years:

DIN18.2: If the testing is targeted against a limited list of products, what are the products and what criteria are used for selecting them? If there is a written sampling procedure for inspectors provide information:

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DIN19: What actions/sanctions have been taken against products that failed laboratory test in each of the last two years?

DIN20 If inspectors of distribution channels have found any of the following in their planned inspection activities in the last two years, provide information below:

DIN21: Are quality requirements for drug products for export purposes the same as for those products for use within the country? Explain:

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Monitoring and evaluation

DIN22: Is there an audit and/or review system to examine the performance of inspectors and the inspectorate?

Yes
No

DIN22.1: If yes, indicate whether this is external, internal or both:

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DIN23: What actions have been taken as a result of the audits or reviews in the last five years?

DIN24: What are the main constraints, weaknesses or problems and the strengths of distribution channel inspection in the country?

If other strategies are used to prevent mistakes or improve compliance with the requirements of good distribution practice, describe them.

If there is any specific and important information that is not covered by the above questions, please provide additional information as appropriate.