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Application for a Drug License

The manufacture, importation, prescription and sale of drugs in Uganda are governed by the National Drug Authority. The NDA classifies drugs; maintains a register of drugs; licenses Retail Pharmacies, Wholesale Pharmacies, and Pharmaceutical Manufacturers; and licenses the importation of drugs.

Operational Requirements.
Importers of pharmaceuticals must apply for an annual license, as well as submit each shipment for a specific license.  Normally, the importer is also a registered Pharmacy (or manufacturer), although it is possible for exceptions to be made.  There must be a supervising registered Pharmacist associated with the firm, as with the general licensing process.  Applicants must fill out the form “Application for an Annual Importation Licence for Pharmaceuticals.

In addition to the annual license, which authorizes the firm to import, a Verification Certificate is required for each consignment.  Importers (and exporters) must list the contents of the shipment on the “Application for Verification Certificate to Import/Export, and submit it to the NDA along with the commercial invoice for approval. The NDA will then issue its Verification Certificate to the Importer.

General requirements for all Applicants.
1.1    All applicants should collect application forms  from the following locations:
District Assistant Drug Inspector (DDI) based in the office of the DHO in every district.
Regional office located at the following locations:

  • Central Region-Premier complex Nakawa.
  • South Eastern Region-Rippon Gardens, jinja
  • Eastern Region-Kwapa Road, Tororo
  • Northern Region-Erute Road,Lira
  • Western Region- Mugwana Center,Plot30,Old Toro Road, Hoima
  • South Western Region-Kamukuzi, Mbarara
  • West Nile Region-Plot1 Mt. Wati Road Anafiyo-Arua
NDA headquarters, Plot No. 46-48. Lumumba Avenue, Kampala
PLEASE NOTE THAT ALL APPLICATION FORMS AND BANKING SLIPS ARE FREE.

1.2    In line with “Guidelines for Equitable Distribution for Drug Outlets”, no persons shall open up or transfer any drug outlet anywhere without the prior approval of the location by the National Drug Authority. An application of the location of the proposed premises should be submitted to NDA prior to any financial or legal commitment to the premises and the approval should be obtained in writing following pre-inspection.    This is to avoid loss in case of rejection of application based on these and any other guidelines.NDA shall not be obliged to licence premises opened without following these procedures and shall not be liable to any claims of resultant financial loss. This approval shall be valid for a period of 3months and, if not implemented or delay not justified in writing, thereafter shall be null and NDA may authorise a new applicant in the location.

1.3     A pharmacist shall not be allowed to supervise pharmaceutical  operations of two premises and must indicate to NDA at the time of application:
• The time and duration he/she is expected to be physically present in each premises
• The name and qualification of the Professional Auxiliary Staff (PAS) to deputize the pharmacist during the hours his/her physical absence, attending to the other pharmacy
• Premises applying for renewal of both wholesale and retail licences  are required to have at least two PAS

1.4    A drug outlet shall be considered unlicensed and should close its operations if the National Drug
Authority has not received the application for renewal of licenses by 31st Jan 2011. The premises shall be subject to closure and all operation shall cease forthwith until when licensed. Applicants are encouraged to apply to renew their licenses before the expiry of the current licenses.

1.5    Licenses will not be renewable for applicants with unsatisfactory required records of operations  or transactions.

1.6    All licensed drug outlets must have  clearly visible signpost indicating the name and the type of outlet ,namely; Drug Shop, Retail Pharmacy or Wholesale Pharmacy.

1.7    Licenses shall be cancelled where it is confirmed that:
a) Unqualified stuff have been allowed to handle drugs or have been left in charge of the drug outlet
The drug outlet has been involved in stocking and/or selling drugs beyond those prescribed by the respective license or unregistered, unauthorised, smuggled or counterfeit drugs.

1.8    In case the Pharmacist or in-charge of drug shop ceases to be responsible for the outlet before           
The expiry of the operating licence issued in his/her name. It shall be his/her responsibility to return to NDA the said license. Such a Pharmacist or in-charge shall not be issued with a new licence if he/she has not returned the valid license previously issued in his or her name.

1.9    Any drug outlet that does not renew its license for at least one year without written acceptable and prior approved reasons shall, on reapplication, be treated as a new applicant with respect to location and fees.

1.10    Applicants must also comply with these and all other statutory and regulatory requirements.

2. Supervision Requirements.
2.1    Drug Shops
2.1.1    These may not only be supervised by one of the following professionals with an approved medical pharmaceutical or veterinary qualification.

2.1.2    Human Drug Shops
• Pharmacy Technician
• Registered or Enrolled Nurse
• Comprehensive Nurse
• Registered or Enrolled Midwife
• Public Health Dental Assistant
• Clinical Officer(Medical, Psychiatric, Orthopaedic, Dental)
• Anaesthetic assistant

2.1.3    Veterinary drug Shops
• Veterinary surgeon (BVN)
• Animal Husbandry Officer

2.1.4    Supervision must be on full time basis, i.e. throughout the entire opening hours of the shop. If the supervisor must leave the premises for any reasons, the drug shop must be closed and locked, unless the supervisor is only absent for a short period and another person who is appropriately qualified is employed to dispense or supply medicines.

2.2    Pharmacies
2.2.1    Must be supervised by a named registered pharmacist
2.2.2    A pharmacist shall be allowed to supervise pharmaceutical operations of two pharmacy premises and must indicate to NDA at the time of the application:
• The time and duration  he/she is expected to be physically present in each premises
• The name and qualification of the Professional Auxiliary Staff(PAS) to deputize the pharmacist during the hours of his/her physical absence, attending to the  other  pharmacy

• Premises applying for renewal of both Wholesale and Retail Licenses are required to have at least two PAS.

2.2.3    For wholesalers  dealing in Veterinary vaccines, a registered  named veterinary surgeon must be employed  in each premises supervised by the pharmacist

2.3           Pharmaceutical Manufacturing Facilities
2.3.1    Manufacturing must be carried out under  the direct supervision of a registered pharmacists to supervise other pharmaceutical business whether on the same or any other premises.

2.3.2    The production pharmacist must be supported by suitably qualified personnel such as pharmacists, pharmacy technicians or approved chemists.

2.3.3    Quality control of manufactured products must be supervised by a registered named quality Control Pharmacist or Chemist.

2.3.4    The quality control Pharmcist or Chemist must be supported by suitably qualified personnel such as pharmacists, pharmacy technicians or approved chemists.

2.3.5    The Pharmaceutical manufacturing operations must comply with NDA Guidelines on Good Manufacturing Practises(GMP).

3.    Licensing Requirements for Pharmacies and Drug Shops.
3.1   Applicants  for license renewal
3.1.1    All Renewing applicants should submit the following not later than 31st January 2011.
3.1.2    The completed application forms
3.1.3    Letter of acceptance from the professional in charge plus a copy of his/her relevant Registration/Enrolment Certificate.
3.1.4    The previous year’s licenses number filled in the space provided on the form for application for license
3.1.5    Pharmacies
3.1.6    In addition to the above requirements, the applicant should submit also the following:
3.1.7    A valid Certificate of Registration of the supervising pharmacist as issued by the registrar of the Pharmacy Council, Ministry of Health.
3.1.8    A letter of commitment from the supervising pharmcist.
3.1.9    For Retail/Wholesale pharmacies (human): a copy of the certificate of the dispenser or approved registered or enrolled nurse.
3.1.10    For retail/wholesale pharmacies (veterinary):a copy of the certificate of the qualified veterinary professional (Veterinary Surgeon or Animal Husbandry Officer)
3.1.11    In case of change of pharmacist, the applicant must submit a certified copy of the articles and Memorandum of association or Partnership Deed showing the Supervising Pharmacist as one of the Directors or Partners respectively.
3.1.12    In case of change of ownership, the applicant must submit evidence of the sale such as copies of the sales agreement between the seller and the buyer and the updated /current articles and memorandum of association.
3.1.13    Drug shops.
3.1.14    In addition to the general  requirements, the applicant should submit also the following:
3.1.15    Two black and white passport photos of the qualified professional in charge.
3.1.16    A copy of the certificate of the qualified medical/pharmaceutical /veterinary profession in charge .
3.1.17    Note: It is a joint responsibility of the in- charge and the applicant/owner of the drug shop to ensure that the certificate of the in-charge submitted to NDA is valid and authentic.
3.1.18    Submission of an invalid or non-authentic certificate may lead to:
• Denial  and revocation of a license
• Prosecution of the in-charge and/or the owners of the drug shop
• Blacklisting of the in-charge and/or the owners of the drug shop

3.2      Requirements  for new applicants:
3.2.1    Pharmacies
3.2.2    All new applicants are required to secure the services of a pharmacist duly registered in Uganda before applying for pre-inspection. The request for the pre-inspection must be accompanied by the commitment letter/letter of acceptance by the Pharmacist.
3.2.3    Pharmacists applying for Pre-inspection of a premise must be eligible to supervise.
3.2.4    All new applicants for a pharmacy license must submit the following after inspection:
• A certified copy of the articles and Memorandum of association or Partnership Deed showing the supervising pharmacist as one of the directors or partners of the firm respectively
• A sketch plan of the premises taking into consideration the minimum floor area for wholesale, retail and additional storage area
• The certificates of registration of the supervising pharmacist.
• Certificate of registration of the auxiliary pharmacy staff, issued by the respective professional Councils.
• Note that the minimum floor area acceptable for pharmacies is:
– 20 square metres for retail pharmacies
– 25 square metres for wholesale pharmacies
3.2.5    Dual applications for both the wholesale and retail pharmacies will no longer be accepted for the same premise and location with effect from 2010. Applicants will have to apply for licenses to operate their wholesale or retail pharmacies only.
3.2.6    Dual applications both have wholesale and retail pharmacies with respect to premises and location may be considered for only Underserved areas. However this has to be in line with guidelines for equitable distribution of pharmaceutical outlets
3.2.7    Pharmacies that sell human medicines, but desiring to sell Veterinary medicines as well can apply for certificates of suitability of premises and operating licences for retail sale of veterinary medicines provided they meet the minimum floor required.
3.2.8    Drug shops
3.2.9    All New Applicants for a drug shop license are required to submit the following after inspection:
3.2.10    The completed application forms.
3.2.11    Two black and white passport photos of the qualified professional in charge
3.2.12    A copy of the certificate of the qualified medical/pharmaceutical/veterinary in-charge.
3.2.13    NOTE;
o    It is a joint responsibility of the in-charge and the applicant/owner of the drug shop to ensure that the certificate of the in-charge submitted to NDA is valid and authentic
o    The minimum floor area acceptable for drug shops is 16 square metres.


3.3          Medical equipment and Chemical sellers
3.3.1    All medical and diagnostic equipment sellers’ will be required to apply for  certificates of Suitability of premises
3.3.2    In addition, their activities shall be carried out under the supervision of a duly qualified professional with a medical and/or biomedical qualification.
3.3.3    Firms involved in the importation of medical/or diagnostic reagents, equipment and consumables shall be required to apply for import permits and have their imports verified and inspected by the NDA.

4.           Licensing Requirements for Pharmaceutical manufacturers
4.1           Renewal Applicants.
4.1.2      In addition to the general requirements, the applicant should submit also the following:
4.1.3      The Certificate of Registration of the supervising pharmacist as issued by the Registrar of   
the pharmacy council and Ministry of Health.
4.1.4       A certificate and letter of commitment of a qualified person to carry out Quality Control  and Quality Assurance.

4.1.5      The Certificate of the dispenser
4.1.6     A letter of commitment from the supervising pharmacist
4.1.7     A letter of commitment from the dispenser.
4.1.8     A complete list of the products to be manufactured and their registration status.
4.1.9     A complete list of all the technical staff, stating their positions, their qualifications, nationalities and registration numbers if any.
4.1.10     A complete list of all laboratory equipment.

4.2         New Applicants
4.2.1    All applicants interested in establishing new pharmaceutical manufacturing facilities are advised to contact the National Drug Authority at the above-mentioned address for guidance before embarking on any works.

5.           Payment of license fees
5.1    All applicants for licenses to operate pharmacies and drug shops should pay the relevant fees through any branch of Stanbic within their area using NDA bank slips. The details of the account number and bank branch are pre-printed on the customized bank slips. No license fee should be paid to the DADI or any other inspector. NDA shall not be responsible for any money paid to any inspector or any other official.
5.2     The NDA banking slips (in quadruplicate) should be collected from any of the following offices  nearest to you:
5.3    District Assistant Drug Inspector (DADI) based in the office of the DHO in every district.
5.4     Regional office located at the following locations:
• Central Region-Premier complex Nakawa.
• South Eastern Region-Rippon Gardens, jinja
• Eastern Region-Kwapa Road, Tororo
• Northern Region-Erute Road,Lira
• Western Region- Mugwana Center,Plot30,Old Toro Road, Hoima
• South Western Region-Kamukuzi, Mbarara
• West Nile Region-Plot1 Mt. Wati Road Anafiyo-Arua
5.5    NDA headquarters, Plot No. 46-48. Lumumba Avenue, Kampala
5.6    During payment, the banking slip should be filled in quadruplicate and should clearly show the name of the drug shop of pharmacy and the amount paid. Each of the 4 copies shall be originally signed and stamped by the bank.
5.7    The yellow copy shall be retained by the bank to be used to send returns directly to NDA>
5.8    The white, blue and pink copies shall be returned to the payee/applicant who shall attach the blue and pink copies onto the application forms and handover the set to the inspector/DADI. The white copy shall be retained by the applicant as evidence of payment.
5.9    The inspector/DADI shall deliver the blue copy to the regional office to be issued with a receipt in exchange. this should be done promptly to facilitate bank reconciliation. NDA shall issue a receipt only on receipt of a blue copy originally endorsed by the Bank. The applicant shall make good any deficit charges found during bank reconciliations.
5.10    The inspector, DDI shall promptly forward the receipt to the applicant.
For further information on these and any other drug regulatory issues contact NDA officials at the above addresses (Sections1.1 and 6.2)

Fees:
Herewith listed are NDA fees applicable for the licenses for the year 2010 until further notice. Please note that there has been change in fees for Local Pharmaceutical Manufacturers only. The rest of the license fees remain unchanged.
Note: All fees are in Uganda shillings except where stated otherwise.
1)     Drug Shop

2)    Retail PHARMACIES(outside Kampala District)

3)    Wholesale Pharmacies (outside Kampala District)

4)     Wholesale pharmacies (Kampala District)

5)    Retail Pharmacies (Kampala district)

 

Application Process.
The application process is essentially the same for the three classifications of retail pharmacy, wholesale pharmacy, and pharmaceutical manufacturer. Initially, the prospective investor should present his plans to NDA in a letter.  The contents of this letter are not prescribed, and are not expected to be detailed, but should indicate the type of activity and prospective products. The NDA will then issue a letter in support of the project to UIA, in the event that the investor is seeking an investment license or incentives.  UIA will require this letter from NDA prior to issuing an investment license.

The next step is to submit the “Application for a Certificate of Suitability of Premises for Operating a Wholesale Pharmacy” (or Retail Pharmacy or Pharmaceutical Manufacturing) to the NDA on the prescribed form.   The application must be accompanied by a detailed set of plans for the premises, and the application fee.  The NDA evaluates the plans according to criteria detailed in the Regulations, as shown under the model inspection report.  Upon approval, the Authority issues a Certificate of Suitability of Premises.  Prior to operation, businesses in the sector must obtain an operating license from the NDA.  Firms must submit the “Application for a Licence to Operate a Wholesale Pharmacy” (or retail pharmacy or pharmaceutical manufacturing operation).  The Certificate of Suitability of Premises must accompany this form, along with the license fee.  This form must indicate that there is a registered pharmacist associated with the project, either as a partner or director, and operationally in a supervisory position.  The application must also include an attestation from the registered pharmacist.  Upon approval, the NDA issues the “Licence to Operate a Wholesale Pharmacy” (or retail pharmacy or pharmaceutical manufacturing operation). Firms conducting more than one type of business, i.e. wholesale and retail, must apply for both types of certificates and licenses.

For detailed guidelines for registration please visit: http://www.nda.or.ug/drug-reg.php

The Executive Secretary/ Registrar
National Drug Authority
Plot 46/48 Lumumba Avenue
P.O. Box 23096
Kampala, Uganda
Tel. 256-41-347391/2
Fax: 256-41-255758
Email: ndaug@nda.or.ugThis e-mail address is being protected from spambots. You need JavaScript enabled to view it
Web site: www.nda.or.ug