22Manufacturer’s declaration

22 Manufacturer’s declaration

The application must contain, or be accompanied by, a declaration by or on behalf of each manufacturer for the product, to the effect that, as between the original product and the repacked product: (a) the sites of manufacture will be the same (including that the equipment used will be the same); and (b) the formulation information will be the same (the same ingredients of the same standards at the same concentrations); and (c) the manufacturing processes will be the same (including quality assurance and test procedures); and (d) the formulation type or dose form, physico-chemical properties (including pH, particle size, crystal form and, where applicable, dissolution profile, payout rate and payout period), and product specifications (release and expiry limits and test methods) will be the same; and (e) the containers will be the same (including packaging materials and closure systems) and that there is no additional pack size.