South African GCP has the following definition for an Investigational Product (which is synonymous with Study Product, and termed Investigational Medicinal Product (IMP) in Europe):
A pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial, including a product with a marketing authorisation when used or assembled (formulated or packaged) in a way different from the approved form, or when used for an unapproved indication, or when used to gain further information about an approved use.
Trials using Investigational Products must adhere to South African Good Clinical Practice (GCP) and Good Pharmacy Practice (GPP), both of which reference South African Good Manufacturing Practice (GMP).
If the Investigational Product is not pre-packaged by the Sponsor, and uses anything other than a simple dilution or reconstitution, please talk to the CRC for advice about whether you must adhere with the onerous full GMP requirements.
Whoever compounds and/or dispenses Investigational Product must be legally authorized to do. Currently this situation is unclear, however, it appears to be that, for clinical trials, a registered nurse is not allowed to dispense.
Currently researchers conducting clinical trials using medical devices do not have to apply to the Medicines Control Council unless the device contains a medicinal product. However, this situation will change; The Minister of Health, in consultation with the Medicines Control Council, in terms of section 35 of the Medicines and Related Substances Act, 1965 (Act No. 101 of 1965), intends to make regulations in the Schedule regarding the conduct of device clinical trials. This is likely to include a submission and approval system similar to investigational medicinal products.
If you would like advice on, or services for, pharmacy-related issues for your clinical research study please contact us. We will also be continually updating the CRC website with various resources.