KBL Container material if the container is a N 2, 7, 10 & 15 9D(3) – blister pack, the goods are a solid dosage form (e.g. tablet) and the change is of a type listed in assurance 15 KOT Container material other than in A - 9D(3) – changes KBT, KGL or KBL [This might result in a making the goods separate and distinct under S16(1)(g)] KCL Closure N 2, 10 9D(3) KSL Tamper-resistant seal addition O - – (including label notice to alert consumers to presence of seal) KSX Tamper-resistant seal removal O - – (including removal of label notice re seal) KWA Inert wadding material addition, O - – substitution or removal where stability is not affected by the action KDA Desiccant inclusion in container A - 9D(3) – KDX Desiccant removal from container A - 9D(3) – KPP Specifications of primary pack (other O - than labelling) KSP Introduction of a measuring device (e.g. N 2, L 9D(3) spoon, cylinder) or applicator (e.g. finger cot); this change can include graphical representation of the device on the label (copy of current and proposed label must be supplied if label is changed) KMD Changes to existing measuring device N 2, L 9D(3) (e.g. cylinder) or applicator supplied with the goods, or removal of a measuring device or applicator, where other means of accurately measuring or applying the dose are readily available KPA Introduction of a primary pack (no new N 2, 11 9D(3) text or graphics)
KBL Container material – if the container is a blister pack, the goods are a solid dosage form (e.g. tablet) and the change is of a type listed in assurance 15 N 2, 7, 10 & 15 9D(3) KOT Container material – other than in changes KBT, KGL or KBL [This might result in a making the goods separate and distinct under S16(1)(g)] A - 9D(3) KCL Closure N 2, 10 9D(3) KSL Tamper-resistant seal – addition (including label notice to alert consumers to presence of seal) O - KSX Tamper-resistant seal – removal (including removal of label notice re seal) O - KWA Inert wadding material – addition, substitution or removal where stability is not affected by the action O - KDA Desiccant – inclusion in container A - 9D(3) KDX Desiccant – removal from container A - 9D(3) KPP Specifications of primary pack (other than labelling) O - KSP Introduction of a measuring device (e.g. spoon, cylinder) or applicator (e.g. finger cot); this change can include graphical representation of the device on the label (copy of current and proposed label must be supplied if label is changed) N 2, L 9D(3) KMD Changes to existing measuring device (e.g. cylinder) or applicator supplied with the goods, or removal of a measuring device or applicator, where other means of accurately measuring or applying the dose are readily available N 2, L 9D(3) KPA Introduction of a primary pack (no new text or graphics) N 2, 11 9D(3)
consult-cm-argcm-partd-130624-1.docx