Legal provisions

LI1: What is the title and date of enactment of the drug legislation/regulations and the article number of the provision giving power to issue licences:

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Organization

LI2: Give below the different types of licences issued and the names of the issuing authorities:

LI2.1: Are the conditions for issuing the different licences published and known by the applicants?

Yes
No

LI3 Is the submission of an inspection report one of the requirements for issuing a licence to engage in pharmaceutical business?

Yes
No

LI3.1 Is such an inspection report also a requirement for renewal of licences?

Yes
No

Human resources

LI4: What is the number and level of qualification of the staff working in the licensing unit?

Financing

LI5: Is there a specific budget for the licensing unit/body?

Yes
No

LI5.1: If yes, what was the budget of the licensing unit/body during each of the last five years (US$):

LI5.2: If yes, what was the source of the budget in the last five years (answer yes/no)?

LI5.3: If the answer to LI5 is no, indicate the estimated expenditure of the licensing authority in each of the last five years:

LI6: If fees are collected, indicate the different fees charged for the various licensing services:

Activities

LI7: How many licences have been issued, renewed, suspended or revoked in the last five years?

LI8: Indicate, in the table below the total number of licensed drug establishments in the country. If a licence is not required by law, indicate the type of drug establishments that are not required to be licensed by law.

LI9: Are there unlicensed/illegal establishments engaged in the manufacture of pharmaceutical products?

Yes
No

LI9.1: If yes, what is their estimated number?

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LI10: Are there unlicensed/illegal establishments engaged in the importation of drugs?

Yes
No

LI10.1: If yes, what is their estimated number?

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LI11: Are there unlicensed wholesalers of pharmaceutical products?

Yes
No

LI11.1: If yes, what is their estimated number?

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LI12: Are there unlicensed drug outlets dispensing or selling pharmaceutical products?

Yes
No

LI12.1: If yes, what is their estimated number?

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LI13: Are there persons engaged in dispensing/selling pharmaceutical products outside licensed premises (peddlers/hawkers)?

Yes
No

LI13.1: If yes, what is their estimated number?

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LI14: What is the legally required professional qualification to obtain a licence to engage in or operate the following activities/establishments?

LI15: Are lists of licensed premises/establishments and persons published and distributed to interested parties?

Yes
No

LI15.1: If yes, collect copies of the lists.

LI16: Is an import permit required to bring consignments of the following types of drug products into the country?

LI17: Can one company import a product registered by another company into the country?

Yes
No

LI17.1: If yes, which is responsible for the recall of defective products?

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LI18: What mechanisms does the country use to prevent illegal importation/smuggling of pharmaceutical products into the country? Explain.

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LI19: Are export licences issued for exported pharmaceutical products?

Yes
No

LI19.1: If yes, do they differ from licences issued for imported products?

Yes
No

Monitoring and evaluation

LI20: Is there a process for the monitoring and evaluation of the licensing system?

Yes
No

LI20.1: If yes, collect a copy of the latest report.

LI20.2: If yes, what are the main constraints, weaknesses or problems and the strengths of the licensing system?

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