An unregistered medicine is a medicine that has not been authorized or registered by the relevant national medicines regulatory authority for lawful use in that jurisdiction.
Registration generally involves regulatory assessment of a medicine’s quality, safety, efficacy or effectiveness, manufacturing standards, labeling, and other requirements. An unregistered medicine has not gone through the applicable authorization process, although the exact legal meaning and circumstances can vary between countries.
An unregistered medicine should not automatically be assumed to be counterfeit or fake. A medicine can be genuine but unregistered in a particular country, while a falsified medicine may also be unregistered. The important issue is that its regulatory status has not been established through the appropriate national authorization process.
QUICK FACT
Unregistered does not necessarily mean fake, and registered does not mean risk-free. These terms describe regulatory status, not by themselves the quality or clinical outcome of an individual medicine.
COMMONLY CONFUSED WITH
Falsified medicine: A falsified medicine deliberately misrepresents its identity, composition, or source. An unregistered medicine refers to a medicine that lacks the required regulatory authorization in a particular jurisdiction.
SEE ALSO
- Falsified medicine
- Substandard medicine
- Medicine quality
- Antimicrobial resistance
