vdilawri
commented
8 years ago - DO Step 2: Rename section titles as follows: a. STEP 2a – Dossier Information b. STEP 2b – Drug Product Formulation Information: i. Note: Please fix typo (Formulation, not Formation)
- DO Step 2b: Please fix all typos in Formulation button labels (Formulation, not Formation)
- DO Step 2b: Formulation repeating group header – Remove the word ‘Information’
- DO Step 2a & 2b: expand / collapse feature: a. Make the Part 2a and Part2b sections fully collapsible / expandable – with a feature to ‘collapse ALL / expand ALL’ if possible.
- DO Step 2b – Formulation tab redesign: a. Change to 4 tabs as follows: i. Tab 1: Pharmaceutical Information ii. Tab 2: Medicinal (Active) Ingredient(s) iii. Tab 3: Non-Medicinal Ingredient(s) iv. Tab 4: Animal and/or Human Sourced Material(s) v. REMOVE tab: Route of Administration – fields in this tab will be moved to other tabs – see below items. b. Shrink / the tab size – with the shorter Tab descriptions (above), shrink the tab size c. Change colour of selected tab to compliant colour (Blue background, not orange)
- DO Step 2b: Pharmaceutical Information Tab a. Move ‘Dosage Form’ field from Animal and/or Human Sourced Material(s) tab b. Move ‘Therapeutic /Pharmacological Classification’ field from ‘Animal and/or Human Sourced Material(s) tab c. Move ‘Route of Administration’ field from Route of Administration Tab [note: still needs to be repeatable] d. Move ‘ Drug Use’ section boxes from Route of Administration Tab i. Make the section horizontal list [versus vertical list currently] e. Move ‘Is this a Non-Prescription drug to which one or more Schedule A claims apply?’ field and [YES/No] from Route of Administration Tab i. This question should be very last question (below container type fields)
- DO Step 2b: Medicinal (Active) Ingredient(s) Tab
a. Can the repeating group header be replaced with the ‘Active Ingredient Name’ after it has been entered? – discuss with Chi
b. Med. Ingredients: field placements redesign:
i. Strength / Units / Per / Calculated as Base? – all should be on One line (same line)
ii. Animal / Human Source? Move 2 third line
- When ‘Yes’ selected, the ‘Appendix 4’ header is removed.
- When ‘Yes’ selected: Selection Box appears for: “Sourced from - Animal / Human” a. Human selected - Only Section 1 appears b. Animal selected – Section 1-3 appear
- DO Step 2b: Non-Medicinal Ingredient(s) a. Same as (a) above b. Same as (b) above c. Change label from ‘Active Ingredient Name’ to ‘Non-medicinal Ingredient name’
- DO Step 2b: Animal and/or Sourced Material(s) tab a. Move from tab title as a description within the tab: i. ‘Used at any stage in the manufacture of the drug’
- DO Step 2b: Route of Administration Tab: a. Remove the Tab i. Remove the ‘Drug Product’ selection list ii. Remove the Proposed Indication / Use field iii. Remove the Proposed Dosage field iv. Remove the Draft of proposed Canadian Labels (inner and outer) enclosed? Field v. Remove the Package Insert enclosed? Field
- RA Step 2: Dossier Id field a. Change text to ’HC6-24-‘ in the first text box b. Redesign: make the 2 text boxes display as adjoining boxes, or box-within-box
- RA Step 2: ‘I confirm that this administrative submission type is NOT a LASA submission’ a. Place the label on one line b. Change the ‘I Attest’ label to ‘I Confirm’
- RA Step 2: ‘Will the subm. Be signed/ filed by a third party …’ a. Yes/No selection box to be shortened b. The ‘If YES, pleas upload Authorization letter:’ field should be hidden i. When YES selected, then this dialogue becomes visible c. Button Label change: Change to ‘Select File’
- RA Step 2: Related Regulatory Activity a. Change ‘File. No.’ label to ‘Dossier ID (Previously File No.)’
- RA Step 2: Regulatory Activity Contact [for THIS Regulatory Activity] a. REMOVE from RA template and MOVE to RT Template: This whole section will be moved to RT Template b. Move below the LCM table in RT Template c. If this is an initial submission – this section is MANDATORY d. Add question in header: Same Reg. Activity Contact for this transaction? [YES/NO] i. If Yes, make the fields visible and editable ii. If NO – leave as visible only @MartinBernard @kpaschakis @cqpham @ralphbolo