Drug Registration In Uganda
A drug is any chemical substance that causes a change in an organism’s physiology or psychology when consumed. Drugs are typically distinguished from food and substances that provide nutritional support.
It has been defined as: “a system that subjects all pharmaceutical products (under the scope of the NRA) to pre-marketing evaluation, marketing authorization (registration), and post-marketing review to ensure that they conform to required standards of quality, safety and efficacy established by NRA” (4).
Owners or operators of places of business (also called establishments or facilities) that are involved in the production and distribution of medical devices intended for use in Uganda are required to register annually with the FDA. This process is known as establishment registration.
Brief Of National Drug Authority On Drug Registration In Uganda
Uganda did not have an elaborate drug policy until 1993. The National Drug Authority (NDA) was established under the National Drug Policy & Authority Statute. 1993 & is the sole organ of government charged with over seeing the implementation of the policy through its Secretariat. The NDA has been mandated with a reasonable degree of financial & administrative autonomy. The NDA is the legal & institutional framework for the drug regulatory body of Uganda.
The NDP (1993) that is to be implemented by NDA is to
a) ensure that essential, safe, efficacious & cost effective drugs are made available to the entire population of Uganda to provide a satisfactory healthcare;
b) make a continuous review of the needs, knowledge & resources of essential drugs;
c) promote rational use of drugs both in the public & private sector;
d) improve government regulation & control on manufacture, production, importation, exportation & marketing & use of drugs:
e) provide systematic public information, professional training & retraining of health W workers,
f) improve the registration of drugs & licensing of pharmaceutical premises:
g) intensify research in all types of drugs including the conventions on narcotic drugs & psychotropic substances; &
h) fight drug & substance abuse.
Process Of Registration of Drugs in Uganda
All drugs to be manufactured or imported into Uganda have to be registered with the National Drug Authority, Uganda This is application only to drug formulations, surgical disposables & other items do not require to be registered.
The registration process involves –
– NDA inspection & approval of the manufacturing facility (audit fee is USD 4,000/- per facility)
– Submission of dossier (as per NDA format & samples & payment of registration fee of USD 500/- per product)
Note: The audit may take place once or twice in a year depending on the number of application & NDA resources.
Registration period is anywhere between 3-6 months or sometimes even more, depending on factors like backlog of applications, data submitted, etc.
Chronology of Regulations
– Registration process started in the year 1996.
– The first list of drugs on the “Provisional Drug Register” was issued/released in February 1997.
– Audit/Inspection of Mfg. facilities in India, Kenya & Pakistan started from April 1997 in a phased manner. Companies failing the audit were withdrawn from the Provisional Drug Register.
– The “National Drug Register” came into effect in May/June 1998 Products from those companies that passed NDA audit were included on the register. However, companies from other countries, which had not been audited by NDA, still had their products on the Drug Register.
– Companies which failed NDA audit were given a chance of re-inspection at the cost of the Mfr.
– In the 2nd phase, NDA carried out audit of mfg. facilities in Europe, China & other countries towards end of 1999.
– The National Drug Register, as of date, has 2540 human drugs & 320 veterinary drugs.
– The total no. of companies approved by NDA are 220 out of which around 80 are from India. The rest are from Europe, China, Pakistan, Kenya & other African countries (in that order).
Circular No. 3/2001
In order to improve NDA drug regulatory efficiency and effectiveness, to strengthen the capacity to test drugs being imported into the country, and to increase pharmaco-vigilance in view of the liberalized procurement of drugs by the district authorities, NDA is obliged to begin charging for certain services and documents which have hitherto been provided for free. NDA therefore wishes to advise of the following new fees and charges, effective from the date of this circular:
I. Verification of proforma invoices
A fee of Ushs 50,000/- or 1% of the total proforma invoice value, whichever is $ greater, will be charged per proforma invoice verified by NDA.
Note: Logal manufactures importing raw materials for pharmaceutical production will be exempted from this fee.
2. cGMP Inspections
a) Foreign companies : a fee of UGX 15364968.00 pharmaceutical manufacturing factories in Asia and UGX 7682484.00 for pharmaceutical factories in East Africa will be charged for each cGMP inspection irrespective of whether it is a new inspection or a re-inspection. Fees for factories in other locations will be worked out as, and when required and will be communicated to you at that time.
b) Local companies: the fee will be: Small-scale manufacturers Ushs 50,000
Large-scale manufacturers Ushs 100,000
3. Quality Control Testing
– Mandatory Analysis: NDA will expand the range of products to undergo mandatory analysis and will meet the cost of 5 batches of a product in a particular consignment. For any batch of the product tested in excess of these, an analysis fee of Ushs 100, 000 per batch will be charged. Details of products to be placed
– Requested Analysis: any analysis requested by an importer will be charged a fee covering the full costs involved.
– Re-analysis: when this is requested by an importer, there will be the choice of local testing by NDQCL at a fee of UGX 3841242.00 per item or testing and administrative costs.
4. NDA Documents and Publications
a) Sets of application forms for suitability/licensing of premises:
Drug shop 2,000
Retail pharmacy 5,000
Wholesale pharmacy 10,000
Small-scale manufacturer 20.000
Large-scale manufacturer 30,000
b) Other publications:
Application form for unregistered drugs 1,000
Guidelines for drug donations 5,000
What is National Drug Authority (N.D.A.)
The National Drug Authority is an autonomous body set up by Government by Statute No. 13 of 1993, to implement the National Drug Policy based on the concept of Essential Drugs. The Authority consists of a Chairman and 19 members drawn from various disciplines and sectors with special relevance and interest in proper administration and management of drugs.
The staff of National Drug Authority include highly trained pharmacists, and administrators whose task is to examine, inspect and recommend granting licences to set up manufacturing plants, pharmacies and drug shops. They inspect all imported drugs to ensure efficacy and quality before use by the public.
How are the drugs controlled?
Importation of a drug requires submission of a request to National Drug Authority which is examined and verified before permission to import is granted. On arrival at specified ports of entry the drugs are checked for Quality Assurance. Where need arises samples are taken for analysis Quality Control Laboratories locally or abroad.
Drugs in Uganda are classified into three major categories:
Class A – Narcotics
Class B – Restricted drugs – Prescription only drugs /medicines + pharmacy only medicines.
Class C – Over-the-counter (OTC) drugs/medicines
Class A and B are drugs which must be dispensed only on prescription By a Registered Medical Practitioner. Dental Surgeon and Veterinary Surgeon. Always ensure that you buy your prescription – only – drugs from Registered Pharmacies not drug vendor. Avoid self-medication and purchase of antibiotics from unauthorized persons. Some of these may be fake or expired drugs! You should always follow the instructions for taking any medicine and ask your pharmacist, doctor or dispenser for advice if you don’t understand the directions or are unsure about whether you should be taking it.
The Role of N.D. A.
N.D.A. has embarked on Registration of drug products for use in the country after full details about the product and the research that has been carried out on it to assess its safety, efficiency and quality is studied. The N.D.A. examines all the research and test results in detail before a decision is made on whether the product should be granted a registration in Uganda.
This task started in July 1995 and is expected to last about two years and then become an on-going exercise. This process will weed out substandard products and reduce the number of drugs circulating in the country to a manageable number which can .be monitored effectively
Monitoring of Medicines
Even after medicines have been imported into the country or granted licence to be manufactured in the country, N.D.A. through its inspectors, monitors them while they are being used. We are instructing record books for pharmacies and drug shops in the private sector and patient registers for Hospitals and Health centres in the public sector.
Inspection and Enforcement
As a new body in a country recovering from socio-economic and political turmoil our philosophy has been to give information, educate and persuade persons handling drugs to stick to the Statute which set up the N.D.A. Where repeated persuasion has failed we resort we call in law enforcement agencies
Our inspectors carry out regular inspections of manufacturing plants, pharmacies and drug shops District Assistant Drug Inspectors (DADI’S) based in the District Medical offices, inspect public health units and shops scattered all over the country, to ensure that the required standards are maintained.
Over 90% of Uganda’s drug needs is imported Oregorous medicines control is a key issue in protecting public health in Uganda, to ensure that the medicines we take for granted are sufficiently safe, of high quality and that they work as they are supposed to. It is the responsibility of N.D.A. to ensure that the stringent standards we expect are maintained and that drugs are used rationally. Drugs are vital chemicals for curing various ailments but if misused, mishandled and irrationally used can prove very dangerous.
If you would like to know more about the work of National Authority please visit us on write to us on this address:
N.D.A. aims to ensure that medicines on the Ugandan Market meet acceptable standards of:
1. SAFETY: they are sufficiently safe to take
2. EFFUCACT: they work as they are supposed to
3. QUALITY: they are made to the highest possible standards
REQUIREMENTS AND PROCEDURES TO BE FOLLOWED BY AN INVESTOR SETTING UP A PHARMACEUTICAL OPEPRATION IN THE COUNTRY
1.1 To avoid congestion and ensure equitable distribution of the services to the people National Drug Authority advises investors about the location of premises.
1.2 The actual premises/building must have all the appropriate compartments, decorations and facilities for which a “Certufucate of Suitability of Premise” is issued by the National Drug Authority after inspection and recommendation by the Drug Inspectorate.
2.1 It is both a legal and professional requirement that all pharmacies and pharmaceutical industries must engage the services of a qualified pharmacist. Pharmaceutical industries may require more than one pharmacist.
2.2 The pharmacist must be registered and resident in Uganda, in case of a body cooperate or partnership at least one of the directors must be a pharmacist resident at Uganda.
3.1 Application forms can be obtained from National Drug Authority offices at Plot 93. Buganda road or from DDH’s office in the district. The actual licences are obtained from the Secretary, National Drug Authority.
3.2 The licences that can be applied for
– Licence to operate a pharmaceutical manufacturing business.
– Licence to operate wholesale pharmacy
– Licence to operate a retail pharmacy
– Certificate of Suitability of premises (Manufacturing business)
– Import/Export permit
– Legally incorporate a pharmacist as director in case of a body corporate or as a partner in case of partnership.
– Engage a supervising pharmacist. Locate a premise and consult the drug Inspector who will advise accordingly
– Prepare the premises for the pharmaceutical operations and apply for inspection and certificate of suitability of premises.
– Apply for licenses from the National Drug Authority.
– On approval and issuance of license by National Drug Authority, operation may begin.
5 Import / Export
5.1 An Import/Export permit
5.2 (Annual/Temporary) must be obtained from National Drug Authority.
At least 3 copies of the proforma invoices are presented to the verification committee of the National Drug Authority for verification and endorsement.
Note: an importer must obtain the proforma invoice and apply for verification before dispatch of drugs from supplier.
Only drugs registered and verified by National Drug Authority will be allowed entry into the country.
5.3 On arrival of the drugs in the country, inspection must be carried out at the port of entry and a National Drug authority authorization/rejection report is issued by an Inspector of Drugs or Assistant Inspector of Drugs.
6. Drug Registration and Product Licence:
6.1 All pharmaceuticals to be imported or manufactured in Uganda must first be registered with the National Drug Authority.
6.2 All manufacturers of pharmaceuticals in Uganda are required to apply for product licence from National Drug Authority.
7. National Drug Authority Statute 1993 and Regulations:
7.1 The National Drug Policy relates to the regulation of the importation, production, distribution, marketing, exportation, and use of pharmaceuticals in the public as well as in the private sector and to any matter related to the above.
National Drug Authority is charged with the implementation of the National Drug Policy.
All statutory requirements are contained in :
1. The National Drug Policy and Authority Statute, 1993.
2. The National Drug Policy and Authority (issue of licences i Regulations, 1993.
3. The National Drug Policy and Authority (Certificate of Suitability of Premises)Regulations, 1995.
4. A number of guidelines and sops these can be obtained from National Drug Authority, Head Office or from DDHS’s offices in the district.
1. All documents to be submitted in EN’GLISH type written, where originals are in another language copies shall be presented together with certified English translation.
2. Each complete application must contain a complex index to the various appendices and each page of the application dossier must be numbered.
3. Each complete application form shall be accompanied by the appropriate application fee i.e. US$ 500 for product manufactured outside Uganda and US$ 200 for product manufactured in Uganda. Subsequent applications to amend any part of the application shall be accompanied by US$ 50.00 per change.
4. Registration procedure shall commence only if Form N.D.A. R1 or N.D.A. R2 (which ever is applicable) with its appendices have been properly completed. Only the information required in the appendices should be furnished.
5. All documents shall be addressed to:
7. Payment can be made by Bank Transfer to National Drug Authority account No.: 0240060034201 Stanbic Bank Uganda Ltd, Kampala or by Bank draft in favour of National Drug Authority.
8. All pharmaceutical proudcts except medical sundries are registrable.
Application for the registration of a drug shall be made only by:
The principal/patent holder
An authorized Agent/Distributor
PARTICULARS OF THE PRODUCT
Proprietary name means the name, which is unique to a particular drug and by which it is generally, identified (and by which it is registered in country of manufacture).
Approval name/INN/Generic in relation to a drug means the internationally recognized name of such a drug or such other name as the ND A may determine.
Strength shall be given per unit dosage form eg. Mg/tab, mg/mi, mg/gm
Pharmaceutical Form shall mean the form in which the drug is presented e.g. solution, suspension, eye drops, emulsion, ointment, suppository, tablet, capsule, etc. And for injections it shall further be stated whether it’s presented in vials; ampoules, dental cartridges, etc. and so shall the contents thereof e.g. powder, solution, etc.
Country and address of manufacturer shall mean the full physical address of the premises where the business of manufacture takes place including telephone, fax and E-mail.
Description of the drug shall mean visual description of the drug such as colour, size, shape and such other features as shall apply e.g. Black and rd gelatin capsule with marks “Amp – 250”. Pink film coated tablets with word “PAN” embossed.
Current Patent: If product is under patent it shall be stated quoting the patent holder, patent number and country where the patent is registered e.g. Holder-Govt Parma No: UG/001/D
PARTICULARS OF THE MANUFACTURER(s) AND ACTIVITY:
Where different activities of manufacture of a given product are carried out at different manufacturing sites, details of name, address and activity carried out at the particular site shall be stated e.g.
|Uga Pharma||Plot 4 City Rd. KampalaX P.O. Box 5445 Kampala – Uganda Tel: 222207||Granulation|
|T.M. Pharmaceuticals||Plot 73 Government Avenue Nairobi P.O. Box 3459 Nairobi, Kenya Tel: 2222 18||Compression Coating|
|Goodman Limited||GLN, 13LT London, UK Tel : 235898491||Packing|
AUTHORISED REPRESENTATIVE IN UGANDA
A body corporate (company), licensed to handle pharmaceuticals, shall be the manufacturers local representative in Uganda with legal authorization to take full responsibility for the product on behalf of the manufacturer, and will be answerable to NDA. A copy of the Authority given to the representative or agent shall be enclosed.
The signatory shall be a pharmacist working for and / or authorized by the manufacturer/applicant His/Her designation and quail be stated.
SPECIFICATIONS OF THE PACKAGING MATERIAL:–
Primary (inner) container:
This is a container in immediate contact with the drug. Detailed specifications of the type, nature, size and grade of the primary container shall be given including the methods of closure. Specifications for glass containers for parenteral products, aqueous solutions and rubber closures for containers for parenteral products are as per Ph. Eur. Specifications.
Where applicable, the same requirements as above shall apply to the outlet packaging.
COMPOSITION OF THE PRODUCT:–
The approved name(s) (INN/Generic) and the chemical name(s) of the substances (active and inactive) shall be given, and in the absence of a chemical name, the chemical nature of the substance shall be described. Trade names shall not be used.
Quantities shall be given in terms on dosage unit; e.g. mg/tablet, mg/ml etc.
Specifications or reference text shall be precisely stated, e.g. BP 93 Page 101
The reason for inclusion of each inactive ingredient in the formulation shall be stated, and raw materials used, although not in final dosage form, shall also be mentioned.
1. Raw material specifications and details of their analytical methods should be given. Where references to specifications and analytical methods are given full photocopies of those references should be supplied.
2. Comprehensive procedures of manufacture, detailing various stages of manufacture including packaging (e.g. description of the type of equipment, duration of treatment etc.) shall be given. The name and address of each pharmaceutical manufacturing facility which carries out any of the manufacturing or packaging procedures, as well as full particulars of such procedures shall be mentioned.
3. Analytical, microbiological and other in-process control procedures and the frequency plus sequence in which they are carried out during the manufacturing process shall be stated.
4. Summarised specifications of the final product shall be given i.e. the acceptable limits of all the physical, chemical and where applicable microbiological parameters. Full description of analytical and other control procedures carried out to ascertain the final products specifications stated above shall be given. In the case of veterinary vaccines, final product specifications and analysis results should include potency.
Where analytical procedures in various parts of the application coincide, these procedures may be reflected in one part and may be subsequently referred to, provided that the relevant page and paragraph are clearly identified. Reference only to standard books of reference shall not be acceptable.
5. Stability data
The following information shall be required;
– The normal degradation patterns of active ingredients (where known) through solvolysis, photolysis, temperature and other factors
– Identity of known degradation products
– Storage conditions currently in force to preserve product integrity
– Tabulated experimental details (results) of stability testing carried out on final product (minimum 2 batches) i.e. stability results obtained in respect 9 of all the specifications given in 4 above. These results should indicate
both chemical and physical stability of the product.
– Full details of the environmental conditions (temperature, humidity, light, etc.) used in shelf life study.
– Confirmation that packaging used is the same as that one given in Appendix I.
– The date of manufacture and batch Nos. of the samples used in stability testing.
– Where applicable, results of the qualitative and quantitative tests carried out in the determination of degradation products
– Interpretation of the above results and the description of the basis on which shelf life is inferred.
– Description of analytical procedures used to determine stability and the
reason for assuming that these methods are stability indicating (if these analytical products are identical to that provided in 4 above a statement to this effect shall suffice.
– Accelerated studies shall be accepted for new products only.
– Where accelerated studies are used a programme whereby stability testing would be monitored to confirm the inferred shelf life.
– For products that are reconstituted before use stability studies for the reconstituted product must be conducted and a short-term shelf life established
– Terms like room temperature, cool and dry place should be accompanied by real values.
– A shelf life of more than 24 months cannot be granted on the basis of accelerated stability studies.
6. Batch records
Copies of original documents used in the manufacture of one complete batch i.e. from release of raw materials to release of final product for marketing shall be submitted including QC reports. Batch records should include manufacturer’s certificates of analysis of raw materials, processing records, packaging records and certificates of analysis of the finished product, all for one particular batch. In the case of veterinary vaccines, a certified copy of a State Batch Release Certificate for the batch, including information on purity potency, and efficacy testing shall be provided.
1. If the drug has been registered in another country, the conditions of registration and copy of the registration certificate shall be submitted. If no such registration has been authorized, all relevant particulars with regards to the progress already made concerning the registration of the drug being applied for shall be furnished.
2. If product is not registered in country of manufacture valid explanation must be given.
3. Under the W.H.O. certification scheme on the quality of pharmaceutical products moving in international commerce, a “Certificate of a Pharmaceutical Product” shall be submitted, where the exporting country shall be the country of manufacture and importing (requesting country) shall be the Republic of Uganda.
1. Particulars of tests and their conclusions performed to demonstrate all aspects of toxicity of the drug, and to prove the safety of its use with special reference to,
– Acute toxicity, including average lethal dose
– Teratogenecity studies
– Carcinogenicity studies
– Other tests to substantiate the safety of the drug shall be provided.
2. In the case of veterinary drugs, details of residue studies to ascertain the claimed withdrawal periods details of studies on safety to the user and the environment shall be provided.
For well-known active substances N.D.A. may grant exemption from the submission of some of the above information on request. However, photocopies of references to such studies performed elsewhere shall be provided.
Details of tests performed on human beings/animals with regard to the safety of the use of the drug with special reference to the particular dosage, routes of administration used and the side effects shall be given. In the case of veterinary vaccines, field safety studies to ascertain safety under field conditions shall be provided.
3. Particulars of clinical tests conducted with reference to the efficacy of the use of the drug shall be provided, with a description of the nature of the tests, by whom conducted and where, results etc. and this shall be proof of the claims in 2 above.
4. In the case of veterinary drugs, guidelines for clinical trials of different types of veterinary drugs shall be followed.
5. Experimental details and results of tests carried out on the drug to confirm its biological availability shall be submitted. The applicant shall state whether any correlation exists between in vivo data and the in vitro data obtained by the methods used.
Guidelines for the conduct of bioequivalence studies shall be followed. For acaricides, applicants must show proof of field trails conducted in Uganda. For veterinary vaccines, vaccination – challenge studies and/or field efficacy studies shall be required.
The applicant shall confirm that data given have been obtained with the drug for which registration is being applied. Full details of the reference products used as the standard for reference purposes, shall be supplied (proprietary name, Batch No. etc.).
Applicant may request partial or total exemption from the requirements of this appendix if the drug being applied for is well documented in international literature acceptable to N.D.A Copies of such literature shall be provided.
1. References to literature shall be precise, quoting year of publication and pages(s) (photocopies of relevant literature may be attached).
2. 20 copies of package inserts as they appear in the packaging being applied for shall be submitted. Samples of labels and packaging material also tobe provided.
3. Particulars and samples of proposed advertising and promotion material shall be furnished stating clearly for whom these materials are intended.
4. A minimum of two samples of product for each package size being applied, as it shall appear on the market must be provided.
Office Location For Drug Registration In Uganda
NATIONAL DRUG AUTHORITY
P.O. box 23096 KAMPALA
Secretariat Office, Plot 93, Buganda Road
Tel: 255665/255628/347391/2 Fax : 255758
Our Ref: 0885/SR/NDA/7/2001 Date : 2 July 2001
All Pharmaceutical Importers
All Retail and Wholesale Pharmacies
All Pharmaceutical Manufacturers
GUIDELINES FOR ESTABLISHMENT OF PHARMACEUTICAL
For further information contact:
The Executive Secretary / Registrar
National Drug Authority
P.O. Box 23096
E-mail : firstname.lastname@example.org
Tel : 255665 / 255628 / 347391/ 2
Fax : 255758
Physical Address : Plot 93
Buganda Road, Kampala