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i. An authorisation or clearance may be given.ii. A query may arise whereby <strong>the</strong> consignment may be held pending fur<strong>the</strong>r investigations.iii. An outright rejection of <strong>the</strong> 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 <strong>the</strong>ir representatives** For a named patient supported with a valid prescription2. Criteriaa. <strong>Drug</strong>s which are on <strong>the</strong> Essential <strong>Drug</strong>s List for Uganda (EDLU/EVDLU) for which <strong>the</strong>re are no registeredequivalentsb. Life-saving drugs for which <strong>the</strong>re are no registered equivalentsc. O<strong>the</strong>r drugs <strong>the</strong> registered equivalents of which are currently unavailable on <strong>the</strong> market (as verified by NDA orany o<strong>the</strong>r reasonable method)d. <strong>Drug</strong>s registered by o<strong>the</strong>r stringent <strong>Drug</strong> regula<strong>to</strong>ry authorities as approved by NDA after written request andjustification.- Preferred sources of <strong>the</strong> unregistered drugs shall be those with o<strong>the</strong>r products on <strong>the</strong> <strong>Drug</strong>s Register, whoseGMP status has been approved by NDA.- O<strong>the</strong>r drug sources may be approved by NDA under exceptional circumstances on presentation of sufficientjustification, such as, but not limited <strong>to</strong>, approval of registration and/or current GMP status by a stringent<strong>Drug</strong> Regula<strong>to</strong>ry <strong>Authority</strong> or approval of GMP status by NDA.No product shall be approved under <strong>the</strong>se provisions if its registration has been voluntarilywithdrawn and/or denied or revoked for safety, efficacy and quality reasons, including, but notlimited <strong>to</strong>, failure <strong>to</strong> 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 <strong>the</strong> above criteria, <strong>the</strong> normal procedure for processing applications for verification shall apply.Exemption:A letter authorizing <strong>the</strong> import of drugs for personal use shall be granted after submission of an application<strong>to</strong>ge<strong>the</strong>r with a valid prescription up <strong>to</strong> six months.GUIDANCE FOR APPLICATION OF VERIFICATION FEES1. Applicabilitya) A Pro-forma Invoice Verification Fee of 2.0% of <strong>the</strong> Free On Board (FOB) value of <strong>the</strong> PFI will be chargedon all imports subject <strong>to</strong> NDA import regulation with <strong>the</strong> exception of those listed in section 2 below.b) Verification fees are payable by <strong>the</strong> importer.c) Free goods accompanying similar commercial goods shall be subject <strong>to</strong> 2.0% PFI-VF and shall beassumed <strong>to</strong> be priced similarly <strong>to</strong> <strong>the</strong> accompanying commercial goods for <strong>the</strong> 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 <strong>the</strong> NDA will be subject <strong>to</strong> a flat verification fee of UGX 50,000 perPFI (this is in addition <strong>to</strong> <strong>the</strong> provisional import permit fee of UGX 100,000).e) Donations <strong>to</strong> commercial entities like private clinics, pharmacies and hospitals must declare <strong>the</strong> actualvalue and shall attract a PFI-VF of 2.0%.f) The PFI-VF of 2.0% for donations <strong>to</strong> Government ministries, Institutions or projects by identified reliefagencies, which are exempted by International/<strong>National</strong> laws/agreements from paying fees shall be paidby <strong>the</strong> recipient ministry, institution of project.2. ExemptionsThe following categories of medicinal items will not be subject <strong>to</strong> PFI-VF:a) Vaccines and related supplies for public goodb) Veterinary Vaccines and related supplies categorised by <strong>the</strong> Direc<strong>to</strong>r of Animal Resources, Ministry ofAgriculture, Animal Industry and Fisheries (MAAIF), as for <strong>the</strong> public goodc) Pharmaceutical raw materials and packaging materials imported by licensed pharmaceuticalmanufacturersd) Any item ordered in non-commercial quantities for a named patient on <strong>the</strong> basis of a valid prescriptione) O<strong>the</strong>r items or importers exempted by <strong>the</strong> NDA from time <strong>to</strong> time after written request and justification.3. Payment termsa) Payment shall be in full at <strong>the</strong> time of application for verification of <strong>the</strong> PFI. Verification of a PFI may notbe authorised until and unless full payment of <strong>the</strong> fee has been made.b) All payments of PFI-VF shall be paid through <strong>the</strong> bank based on an invoice issued by <strong>the</strong> accountssection of NDA.c) Evidence of payment of PFI-VF in form of an au<strong>the</strong>ntic banking slip must be presented <strong>to</strong> accountssection of NDA shall issue a corresponding receipt <strong>to</strong> <strong>the</strong> payer/importer.d) Note: In <strong>the</strong> case of MOH (and related institutions/Programmes/Projects), NMS, JMS and any o<strong>the</strong>rimporter approved by NDA, each application shall be invoiced but payments may be made on <strong>the</strong> basisof one month credit line or any o<strong>the</strong>r arrangement approved by NDA.e) A receipt or invoice in <strong>the</strong> case of importer using a credit line shall be attached <strong>to</strong> <strong>the</strong> application for aVerification Certificate as <strong>the</strong> only acceptable evidence of payment or commitment <strong>to</strong> pay <strong>the</strong> 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. <strong>Drug</strong>s rejected for quality reasons must be re-exported <strong>to</strong> <strong>the</strong> supplier in <strong>the</strong> country of export within astipulated period of one month after receiving a rejection report.2. <strong>Drug</strong>s rejected due <strong>to</strong> being unregistered in Uganda or neutral labelling may be re-exported <strong>to</strong> a thirdcountry on special request with special clearance from <strong>the</strong> authorities of <strong>the</strong> importing country.4
RE-EXPORT PROCEDURE1. Application for verification is lodged in by intending exporter, accompanied by <strong>the</strong> relevant invoice anddocuments related <strong>to</strong> <strong>the</strong> rejection indicating also <strong>the</strong> exact point of destination.2. Re-inspection is carried out by an inspec<strong>to</strong>r of drugs <strong>to</strong> confirm that <strong>the</strong> consignment is still intact, beforea provisional re-export permit is issued by NDA on payment of <strong>the</strong> appropriate fee.3. A cus<strong>to</strong>ms or NDA official must witness loading for re-export.4. Copies of <strong>the</strong> re-export documents stamped at exit ports must be submitted <strong>to</strong> 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 <strong>the</strong> exporter has no annual export permit a provisional export permit is issued perconsignment after:I. Presentation of <strong>the</strong> following documents;a) Order from importerb) Copy of <strong>the</strong> authority given <strong>to</strong> importer by competent authority in country of importc) 3 copies of a proforma invoice prepared by exporter showing batch numbers, registration status of<strong>the</strong> products <strong>to</strong> be exported and quantities of drugs <strong>to</strong> be exported.d) Application for both a provisional export permit, where applicable, and verification certificate.II. Payment of <strong>the</strong> appropriate fees.III. NDA may from time <strong>to</strong> time decide which consignment is <strong>to</strong> be inspected before re-export.The word drug in <strong>the</strong>se guidelines refers <strong>to</strong> all human and veterinary medicines, biologicals, syringes, medicalsundries, labora<strong>to</strong>ry reagents and o<strong>the</strong>r diagnostic equipments.These guidelines also apply in <strong>the</strong> importation of public health chemicals, condoms, mosqui<strong>to</strong> nets and any o<strong>the</strong>rsubstance as <strong>the</strong> authority may deem necessary.Note:a) Manda<strong>to</strong>ry analysis is conducted on every batch of condoms imported in<strong>to</strong> <strong>the</strong> country.b) For drug donations see fur<strong>the</strong>r guidance on guidelines for drug donationsc) <strong>National</strong> <strong>Drug</strong> <strong>Authority</strong> reserves <strong>the</strong> right <strong>to</strong> approve or reject any application for importation or exportation of adrug in line with its mandate.5