NDA Uganda Guidelines

I am looking to download the Guidelines on the Registration of Pharmaceuticals for other than biological products of National Drug Authority Uganda so can you please provide me the official website of this National Drug Authority Uganda so that I can download the Guidelines on the Registration of Pharmaceuticals for other than biological products?

Hii sir, I Wants to get the Guidelines for the Drug Registration Requirements in Uganda of the National Drug Authority ?

[pooja]

As you Asking for the Guidelines for the Drug Registration Requirements in Uganda of the National Drug Authority is given below

Information on National Drug Authority

A) Brief on National Drug Authority
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.

B) 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)

Contact Details :

NATIONAL DRUG AUTHORITY
P.O. box 23096 KAMPALA
Secretariat Office, Plot 93, Buganda Road
Tel: 255665/255628/347391/2 Fax : 255758
Email: nda@imul.com