FUNCTION:
Assessing pharmaceutical products by evaluating documentary evidence in order to assure that the product meets its intended purpose Once a pharmaceutical product has been assessed and found to meet its intended purpose, it is included on a list of authorized drugs for use in Uganda.
The list of authorized drugs is often referred to as the National Drug Register (or the National Formulary) and the drugs are said to be registered (sometimes it is said that marketing authorization has been granted).
PURPOSE:
To ensure that all pharmaceutical products
intended for use in Uganda meet their intended purpose and the requirements laid down by the NDA.
ACTIVITIES:
I. Produce and update regularly a National register
II. Collaborate with relevant national institutions on registration matters
III. Collaborate with relevant international bodies in drug registration matters
IV. Organize and coordinate GMP audit of foreign manufacturing facilities of applicants
V. Participate in cGMP audits/ Quality Assurance inspections for both local and foreign manufacturing facilities.
VI. Evaluate dossiers
OBJECTIVES AND STRATEGIES
Objectives:
To ensure effective control over the quality, safety and efficacy of all human and veterinary medicines in the country so as to protect the end-user.
Strategies:
i) Strengthen registration of human and veterinary medicines.
ii) Establish a system of regulating and controlling the commercial manufacture and distribution of traditional medicines.
Who are involved in the drug registration process?
i) NDA, the competent Drug Regulatory agency in Uganda
ii) The manufacturer, who generates the information and therefore owns the information submitted to NDA.
iii) The importer in Uganda or the exporter in country of manufacture
How to apply: Any of the following can apply:
- Principal/patent holder
- Manufacturer
- Legally authorized agent/distributor acting on behalf of the manufacturer and or patent holder (discoverer).
What Information is required by NDA to assess a pharmaceutical product?
A stipulated application form should be completely and accurately filled in. used.
This form is divided into sections:
- Administrative information (i.e. particulars of applicant, particulars of the manufacturer etc.)
- Particulars of the product being applied (e.g. brand name, INN name, pack size, strength etc.)
- Authorized local Technical representative in Uganda, which should be a body corporate duly licensed to handle drugs in Uganda.
- Specifications of packaging materials and the composition of the product.
- Chemistry and Pharmaceutical information of the product
- Registration status of the product in other countries
- Pharmacology and toxicology of the product
- General information on the product (information on the product published in recognized international books, journal etc)
Application forms are available from NDA head quarters. An applicant may take as many applications as required at a nominal fee of US$ 10.00 per application. A copy of guidelines as to how the application form should be filled accompanies the application forms
RECEIPT OF APPLICATION
The application is received in NDA with all its addenda:
- Appropriate Application fee:
Product manufactured outside Uganda .......................... US$ 500
Product manufactured in Uganda .................................. US$ 200
Product manufactured outside Uganda but packaged in Uganda .... US$ 300
- Samples (Minimum two<2>) of each formulation pack intended for use in Uganda
- Dossier ( completed as laid out in the application form )
REGISTRATION OF DRUGS STARTED IN 1995 AND THE FOLLOWING ARE REGISTERED.
- Drugs for Human use.
- Drugs for Veterinary.
The following are notified
- Traditional Medicines
- Food/Dietary Supplements
Future notifications
Public chemicals
Notifications are completed on the stipulated forms. A notification fee of US $ 20 per product is levied
SUMMARY OF THE PROCESSES OF REGISTRATION
- Receipt of application
- entering of data on Siamed Program
- Storing/ Retrieval of applications and samples
- Evaluation of dossiers
- Presentation of applications to the Committee on the National Formulary (CNF) and The Authority
- Communication to applicants
Other activities involved in the registration process:
- Processing of amendments
- Deletion of products from the National Drug Register
RESOURCES
Technical Staff - Pharmacists, drug analysts.
Standard Literature - Pharmacopoeias, National Formularies etc.
Software - Siamed
