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i. An authorisation or clearance may be given.ii. A query may arise whereby the consignment may be held pending further investigations.iii. An outright rejection of the consignment pending re-export or destruction at owners’ expensemay be issued.GUIDANCE ON VERIFICATION OF SPECIAL DRUG IMPORTS1. EligibilityPharmacies (retail or wholesale)Hospitals (Government or NGO)Government and Private institutions involved in providing healthcare and/or researchMedical or Veterinary NGOsIndividual patients or their representatives** For a named patient supported with a valid prescription2. Criteriaa. Drugs which are on the Essential Drugs List for Uganda (EDLU/EVDLU) for which there are no registeredequivalentsb. Life-saving drugs for which there are no registered equivalentsc. Other drugs the registered equivalents of which are currently unavailable on the market (as verified by NDA orany other reasonable method)d. Drugs registered by other stringent Drug regulatory authorities as approved by NDA after written request andjustification.- Preferred sources of the unregistered drugs shall be those with other products on the Drugs Register, whoseGMP status has been approved by NDA.- Other drug sources may be approved by NDA under exceptional circumstances on presentation of sufficientjustification, such as, but not limited to, approval of registration and/or current GMP status by a stringentDrug Regulatory Authority or approval of GMP status by NDA.No product shall be approved under these provisions if its registration has been voluntarilywithdrawn and/or denied or revoked for safety, efficacy and quality reasons, including, but notlimited to, failure to comply with current GMP.3. ProcedureA form for application for special drug import must be completed for each drug product applied for(obtainable at NDA).Save the above criteria, the normal procedure for processing applications for verification shall apply.Exemption:A letter authorizing the import of drugs for personal use shall be granted after submission of an applicationtogether with a valid prescription up to six months.GUIDANCE FOR APPLICATION OF VERIFICATION FEES1. Applicabilitya) A Pro-forma Invoice Verification Fee of 2.0% of the Free On Board (FOB) value of the PFI will be chargedon all imports subject to NDA import regulation with the exception of those listed in section 2 below.b) Verification fees are payable by the importer.c) Free goods accompanying similar commercial goods shall be subject to 2.0% PFI-VF and shall beassumed to be priced similarly to the accompanying commercial goods for the purpose of calculation ofPFI-VF.3

d) Donations and Medical supplies with no declared commercial value procured by community-based NGOsas identified and duly authorised by the NDA will be subject to a flat verification fee of UGX 50,000 perPFI (this is in addition to the provisional import permit fee of UGX 100,000).e) Donations to commercial entities like private clinics, pharmacies and hospitals must declare the actualvalue and shall attract a PFI-VF of 2.0%.f) The PFI-VF of 2.0% for donations to Government ministries, Institutions or projects by identified reliefagencies, which are exempted by International/National laws/agreements from paying fees shall be paidby the recipient ministry, institution of project.2. ExemptionsThe following categories of medicinal items will not be subject to PFI-VF:a) Vaccines and related supplies for public goodb) Veterinary Vaccines and related supplies categorised by the Director of Animal Resources, Ministry ofAgriculture, Animal Industry and Fisheries (MAAIF), as for the public goodc) Pharmaceutical raw materials and packaging materials imported by licensed pharmaceuticalmanufacturersd) Any item ordered in non-commercial quantities for a named patient on the basis of a valid prescriptione) Other items or importers exempted by the NDA from time to time after written request and justification.3. Payment termsa) Payment shall be in full at the time of application for verification of the PFI. Verification of a PFI may notbe authorised until and unless full payment of the fee has been made.b) All payments of PFI-VF shall be paid through the bank based on an invoice issued by the accountssection of NDA.c) Evidence of payment of PFI-VF in form of an authentic banking slip must be presented to accountssection of NDA shall issue a corresponding receipt to the payer/importer.d) Note: In the case of MOH (and related institutions/Programmes/Projects), NMS, JMS and any otherimporter approved by NDA, each application shall be invoiced but payments may be made on the basisof one month credit line or any other arrangement approved by NDA.e) A receipt or invoice in the case of importer using a credit line shall be attached to the application for aVerification Certificate as the only acceptable evidence of payment or commitment to pay the PFI-VF Annual import permit…………………………………..shs.300,000 Provisional import/export permit……………………...shs.100,000 A booklet of applications for verification……………….shs.10,000 Verification fees………………………………………2% FOB valueRE-EXPORT OF REJECTED CONSIGNMENTS1. Drugs rejected for quality reasons must be re-exported to the supplier in the country of export within astipulated period of one month after receiving a rejection report.2. Drugs rejected due to being unregistered in Uganda or neutral labelling may be re-exported to a thirdcountry on special request with special clearance from the authorities of the importing country.4

RE-EXPORT PROCEDURE1. Application for verification is lodged in by intending exporter, accompanied by the relevant invoice anddocuments related to the rejection indicating also the exact point of destination.2. Re-inspection is carried out by an inspector of drugs to confirm that the consignment is still intact, beforea provisional re-export permit is issued by NDA on payment of the appropriate fee.3. A customs or NDA official must witness loading for re-export.4. Copies of the re-export documents stamped at exit ports must be submitted to NDA as proof of RE-EXPORT.REGULAR EXPORT OF DRUGSThis can only be done by licensed pharmacies or manufacturers of drugs in accordance with section 45 of NDP/AAct Cap 2006. Where the exporter has no annual export permit a provisional export permit is issued perconsignment after:I. Presentation of the following documents;a) Order from importerb) Copy of the authority given to importer by competent authority in country of importc) 3 copies of a proforma invoice prepared by exporter showing batch numbers, registration status ofthe products to be exported and quantities of drugs to be exported.d) Application for both a provisional export permit, where applicable, and verification certificate.II. Payment of the appropriate fees.III. NDA may from time to time decide which consignment is to be inspected before re-export.The word drug in these guidelines refers to all human and veterinary medicines, biologicals, syringes, medicalsundries, laboratory reagents and other diagnostic equipments.These guidelines also apply in the importation of public health chemicals, condoms, mosquito nets and any othersubstance as the authority may deem necessary.Note:a) Mandatory analysis is conducted on every batch of condoms imported into the country.b) For drug donations see further guidance on guidelines for drug donationsc) National Drug Authority reserves the right to approve or reject any application for importation or exportation of adrug in line with its mandate.5