Outline of the system
For the import of general medicine, a license must be obtained from the Namibian Medicine Regulatory Council for all medicines. Licenses are only granted to registered wholesalers and distributors. Once a license is issued, the import of general medicine can be undertaken without an import permit. However, special import permits are required for the import of narcotics and psychotropic substances.
The permit system applies specifically to all medicines, narcotics and psychotropic substances.
Nature of licensing
If Automatic, administrative purpose
If Non-Automatic, description of the notified Non-Automatic Licensing regime
Products under restriction as to the quantity or value of imports
The import permit system is intended to control the import of medicines import, to ensure that medicines imported comply with Namibian laws and regulations as well as for statistical purposes.
Questions for products under restriction as to the quantity or value of imports
The system applies to products originating from which country?
The system is non-country specific.
Expected duration of licensing procedure
Is the licensing statutorily required?
Medicines and Related Substances Control Act, 2003 (Act 13 of 2003).
Does the legislation leave designation of products to be subject to licensing to administrative discretion?
Is it possible for the government to abolish the system without legislative approval?
It is not possible to abolish the system without legislative approval.
Eligibility of applicants
Is there a system of registration of persons or firms permitted to engage in importation?
What persons or firms are eligible to apply for a licence?
Special permit applications are only considered from registered distributors and wholesalers with a licence.
Is there a registration fee?
Is there a published list of authorized importers?
Contact point for information on eligibility
Submission of an application
Administrative body(ies) for submission of an application
What information is required in applications?
Quantity, name of the medicine, country of origin, date of import information is required for the special permit. The information required for the import license relates to contact information of
the importer and the business address from which the medicine will be distributed.
What documents is the importer required to supply with the application?
Window of submission of an application
How far in advance of importation must application for a licence be made?
At least three days in advance of importation. The application and approval process for a license can be completed within one month.
Are there any limitations as to the period of the year during which application for licence can be made? If so, explain
Issuing the license
Can a licence be granted immediately on request?
A special permit must be submitted at least one week prior to importation.
Can licences be obtained within a shorter time-limit or for goods arriving at the port without a licence
For special permits for the import of narcotics and psychotropic substances, the application has to be submitted at least three days in advance and the approval process can be completed within a week.
Which administrative body is responsible for approving application of licences?
Special permits and licenses for the importation of medicines are all issued by the Namibian Medicine Regulatory Council.
Must the applications be passed on to other organs for visa, note or approval?
Are there any other conditions attached to the issue of a licence?
The importer must comply with the provisions of the Medicine and Related Substances Control Act.
Fees and other administrative charges
Is there any licensing fee or administrative charge?
Special permits are granted for free. However, license applicants for the import of general medicine have to pay a fee.
What is the amount of the fee or charge?
License applicants for the import of general medicine have to pay a fee of N$1000.
Is there any deposit or advance payment required associated with the issue of licences?
Amount or rate?
Is it refundable?
What is the period of retention?
What is the purpose of this requirement?
Refusal of an application
Under what circumstances may an application for a licence be refused other than failure to meet the ordinary criteria?
Special permit applications may not be granted if the permit applicant does not have a requisite license to import, i.e. not a distributor or wholesaler.
Are the reasons for any refusal given to applicants?
Have applicants a right of appeal in the event of refusal to issue a licence?
If so, to what bodies and under what procedures?
Are there any limitations as to the period of year during which importation may be made?
What documents are required upon actual importation?
The importer must furnish the customs officials with the special import permit issued in the case of narcotics and psychotropic substances.
Are there any other administrative procedures, apart from import licensing and similar administrative procedures, required prior to importation?
Conditions of licensing
What is the period of validity of a licence? Can the validity be extended? How?
The permit is valid for three months while the import license is valid for one calendar year.
Is there any penalty for the non-utilization of a licence or a portion of a licence?
No, but the permit fee is non-refundable.
Are licences transferable between importers? If so, are any limitations or conditions attached to such transfer?
Licences are non-transferable between importers.
Is foreign exchange automatically provided by the banking authorities for goods to be imported?
The provision of foreign exchange for import is subject to the requirements of the financial institution.