For certain formulations and circumstances, equivalence between two pharmaceutical products may be considered self-evident with no further requirement for documentation. Examples include:

(a) When multisource pharmaceutical products are to be administered parenterally (e.g., intravenous, intramuscular, subcutaneous, intrathecal administration) as aqueous solutions and contain the same active substance(s) in the same concentration and the same excipients in comparable concentrations;

(b) When multisource pharmaceutical products are solutions for oral use, contain the active substance in the same concentration, and do not contain an excipient that is known or suspected to affect gastro-intestinal transit or absorption of the active substance;

(c) When multisource pharmaceutical products are a gas;

(d) When the multisource pharmaceutical products are powders for reconstitution as a solution and the solution meets either criterion (a) or criterion (b) above;

(e) When multisource pharmaceutical products are otic or ophthalmic products prepared as aqueous solutions and contain the same active substance(s) in the same concentration and essentially the same excipients in comparable concentrations;

(f) When multisource pharmaceutical products are topical products prepared as aqueous solutions and contain the same active substance(s) in the same concentration and essentially the same excipients in comparable concentrations;

(g) When multisource pharmaceutical products are inhalation products or nasal sprays, tested to be administered with or without essentially the same device, prepared as aqueous solutions, and contain the same active substance(s) in the same concentration and essentially the same excipients in comparable concentrations. Special in vitro testing should be required to document comparable device performance of the multisource inhalation product.

For elements (e), (f) and (g) above, it is incumbent upon the applicant to demonstrate that the excipients in the multisource product are essentially the same and in comparable concentrations as those in the reference product. In the event this information about the reference product cannot be provided by the applicant and the drug regulatory authority does not have access to these data, in vivo studies should be performed.