ABSTRACT
Definition: A combination product includes • a product comprising two or more regulated components, i.e., drug/device, biological/device, drug/biological, or drug/device/biological, that are physically, chemically, or otherwise combined or mixed and produced as a single entity • two or more separate products packaged together in a single package or as a unit and comprising drug and device products, device and biological products, or biological and drug products • a drug, device or biological product packaged separately that according to its investigational plan or proposed labeling is intended for use only with an approved individually specified drug, device, or biological product where both are required to achieve the intended use, indication, or effect and where upon approval of the proposed product the labeling of the approved product would need to be changed, e.g., to reflect a change in intended use, dosage form, strength, route of administration, or significant change in dose • any investigational drug, device, or biological product packaged separately that according to its proposed labeling is for use only with another individually specified investigational drug, device, or biological product where both are required to achieve the intended use, indication, or effectFor combination products, both the National Pharmaceutical Control Bureau and the Medical Device Authority will evaluate the relevant sections.
