new drug submission form - Trinidad & Tobago

Requirements for the label of a Herbal Medicine:The label of a package of a Herbal Medicine shall carry -(a) on the main panel of both the inner and the outer labels -(i)(ii)the name (Proper or Common), dosageform and the standard, if any, under which the herbalmedicine was manufactured;a correct statement of the net contents in termsof weight, measure or number;(b) on both the inner and outer labels -(i)(ii)(iii)the name of the manufacturer or distributor ofthe herbal medicine;the address of the manufacturer or distributor,except that where the immediate containercontains five milliliters or less, this statementneed not be made on the inner label;in the case of a herbal medicine which consistsof more than one ingredient, a quantitative listof the active ingredients;The Botanical Name of the plant(s)used and part(s) thereof, shall be declared.the common or vernacular name of plant(s) usedmay be declared.(iv)(v)(vi)(vii)(viii)dosage regimen and adequate directions for use in theEnglish Language;the expiry date;directions as to the type of storage necessaryto maintain the potency, efficacy, safety orproperties of the herbal medicine;a declaration of any warnings or contraindications,if applicable;the declaration;CAUTION: “Keep out of the reach of children”.“If pregnant or breast feeding ask ahealth care professional before use”.(c) on any panel, including the panel at the bottom of the package –(i)(ii)the batch or lot number; andany registration number, if applicable.8