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PHARMACEUTICAL REGULATIONS IN UGANDA

(a) Licensing of premises in which pharmacies and drug shops are operated;

The Operating License is issued in the name of the pharmacist supervising the operations of the pharmacy. He/she must be registered in Uganda and must be one of the directors if none of the other directors is a pharmacist. This is the person legally responsible for any pharmaceutical transactions of the business. Import and export licenses for drugs can only be issued in the names of the pharmacist. The same procedure is followed in the case of drug shops, which sell drugs of the class known as “C”. These shops require for their operation, a person with approved basic medical qualification, who is not necessarily a pharmacist. They go through similar processes of inspection before licenses are granted

(b) Licensing of Pharmaceutical Manufacturers

The Inspectorate Department also does inspection of the premises and operations of pharmaceutical manufacturers, who fall into two main categories, large scale, with multi-million dollar operations, and small scale and medium manufacturers, producing a small range of mixtures and medicines.

(c) Surveillance in the Control of Counterfeit/Substandard/Expired Drugs

The NDA is mandated by the statute to prevent the circulation of drugs which are unfit for use. These could be counterfeit, substandard and not conforming to standards as laid down by the law or expired. A drug or medicine becoming expired means that it has passed its expected useful life as determined during the process of manufacturing. The expiry date of a drug is written on the container. This means that the drug must not be used beyond this date.

For More Information click on this link: www.nda.or.ug