351 - Hi PAAB, could you please advise what is required in terms of balancing copy for NHP products?

  • NHPs can satisfy the code fair balance requirements by either of the following (i.e. you can choose between 'a' and 'b'): a) including the indication AND the weblink destination to the product license within the body of the advertisement as described in PAAB code s2.4.3. b) including all relevant text from the TMA within the body of the advertisement (in which case a link to the TMA is not required). "All relevant text" means the medicinal ingredients, the recommended use, all cautions & warnings, all contraindications, all interactions, all known adverse reactions and the dosing information relating to the uses promoted in the APS. This approach also applies to homeopathic products and OTC products. The approach does not apply to any other category of healthcare product.