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MVG introduction Types of variation application Some differences between AVG & MVG Scope Timeline Additional notes Fee Changes leading to new product registration References Implementation 1 Types of

  1. MVG introduction  Types of variation application  Some differences between AVG & MVG  Scope  Timeline  Additional notes  Fee  Changes leading to new product registration  References  Implementation 1

  2. Types of Variation application  17 Major Variation (MaV) - Prior approval (tell and do) - Significantly and/or directly affects safety, efficacy, quality - Does not fall into MiV or new registration  36 Minor Variation Prior Approval (MiV-PA) - Prior approval (tell and do) - minimal / no significant impact on safety, efficacy, quality  11 Minor Variation Notification (MiV-N) - Notification (do and tell) - Administrative changes with no impact on safety, efficacy, quality 2

  3. Some differences between AVG & MVG  No change in the categorization of variation but minor adjustment to conditions and supporting documents.  Currently NPCB does not allow multiple site for the same manufacturing step of finished product (MaV-5, MaV- 6, MiV-PA4, MiV-PA30, MiV-N8)  Added: MaV-4: Major change of manufacturing process for DS a) (where CEP is not available) MiV-PA3: Change of PIL b) MiV-N2: Change of importer and store address c) 3

  4. Scope of current MVG  Pharmaceutical products for human use (NCEs, prescription, non prescription X-full products) 4

  5. Timeline – Minor Variation Notification (MiV-N) Variation type MiV- N (do and tell) Procedure If the notification fulfils the requirements (conditions and supporting documents) as per described under MiV-N, product registration holder must notify NPCB. NPCB shall acknowledge receipt of a notification. Timeline for Within 20 working days following receipt of a NPCB to notification. acknowledge notification  A MiV-N application may be rejected with the consequence that the PRH must cease to apply the already implemented variation.  PRH must ensure validity of the manufacturer’s license prior to implementation of MiV-N. 5

  6. Timeline – Minor Variation Prior Approval (MiV-PA) & Major Variation (MaV) Variation type MiV-PA MaV Approval or • Approval or first correspondence • Approval or first correspondence correspondence shall be issued to product shall be issued to product registration holder within 45 registration holder within 60 working days, provided all working days, provided all conditions conditions and supporting and supporting documents are documents are fulfilled. fulfilled. • Subsequent correspondences which • Subsequent correspondences which fulfill the requirements will be fulfill the requirements will be granted approval within 20 working granted approval within 30 working days. days. • After third correspondence, • After third correspondence, application may be rejected if still application may be rejected if still does not fulfill requirements. does not fulfill requirements. Timeline for Within 20 working days failing which Within 30 working days failing which product application will be rejected. Auto- application will be rejected. Auto- registration reminder will be sent 10 working days reminder will be sent 15 working days holder to reply before the deadline. before the deadline. 6

  7. Timeline – Minor Variation Prior Approval (MiV-PA) & Major Variation (MaV) Product Registration Holder NPCB MiV-PA 0 0 MaV 45 / 60 working days to issue approval or first correspondence 20 / 30 working days for first correspondence 20 / 30 working days to issue approval or second correspondence 20 / 30 working days for second correspondence 20 / 30 working days to issue approval or third correspondence 20 / 30 working days for third correspondence 20 / 30 working days to know the 20 / 30 working days to issue approval or final status rejection 7

  8. Timeline – Implementation of variation (MiV-PA & MaV)  Within 6 months after the PRH has been informed of the approved variations. 8

  9. Additional Notes  Re-categorization: May have to withdraw & resubmit  Revised PI & labeling subject to current requirement: DRGD a) Circulars b) What is registered in the system (includes c) administrative data of Part I)  NPCB’s right: Re-categorize a) Ask for additional information b) Reject application if incomplete c) 9

  10. Proposed variation fee per variation type per product Type of Application Full evaluation Abridge evaluation (A, X) (N, T) MiV-N No fee No fee MiV-PA RM150 RM50 MaV RM300 RM100 Additional indication RM1000 Not applicable 10

  11. Fee for change of manufacturing site per product Type of Application Pharmaceutical Traditional (A, X, N) (T) I RM500 RM100 II, III, IV, V RM1000 RM500 11

  12. Changes leading to new product registration  Changes to the Active Pharmaceutical Ingredient (API). Change of the API to a different API including change in the salt or • isomer form of the API. Inclusion of an additional API to a multicomponent product. • Removal of one API from a multicomponent product. • Change in the strength of one or more APIs. • Increase in overage. •  Changes to the pharmaceutical form/dosage form.  Changes in the route of administration (exception for parenteral route).  Changes in the manufacturing site of drug product. • Addition of a new manufacturing site to the currently approved site for the same manufacturing process. • Change from a currently approved contract manufacturer or own plant to another contract manufacturer not under crisis situation. 12

  13. Others  Lead compendium refers to British Pharmacopeia (BP), European Pharmacopeia (EP), Japan Pharmacopoeia (JP) and United States Pharmacopeia (USP).  This list of variations is not exhaustive and will be amended from time to time as and when the need arises. Any variations not yet listed in this guideline should be justified and decided by NPCB.  Appropriate reference can be made to:  ASEAN Variation Guideline for Pharmaceutical Products 2012  EMA Classification Guidance On Minor Variations of Type IA, Minor Variations of Type IB And Major Variations of Type II.  SUPAC-IR: Immediate-Release Solid Oral Dosage Forms: Scale-Up And Post- Approval Changes: Chemistry, Manufacturing And Controls, In Vitro Dissolution Testing, And In Vivo Bioequivalence Documentation.  SUPAC-MR: Modified Release Solid, Oral Dosage Forms, Scale-Up and Post approval Changes: Chemistry, Manufacturing, and Controls; In Vitro Dissolution Testing and In Vivo Bioequivalence Documentation.  WHO Guidance On Variations To A Prequalified Product Dossier. 13

  14. MVG implementation in Malaysia  1 July 2013 – Minor Variation Notification (MiV- N) including MiV-N timeline  1 January 2014 – a) Conditions & documentations for MaV & MiV- PA b) grace period for implementation by PRH after approval of variation  Payment for variation, timeline for MaV & MiV-PA – with Quest 3+  Type I COS & additional indication payment via manual route after approval of proposed fee by Bahagian Kewangan 14

  15. Moving on from here  Submission mode: a) Products registered in Quest 2: online b) Products registered in Quest 3: manual - In your cover letter, pls leave your contact details eg. e-mail, phone no.) - Table of comparison of the current and propose data  Types of variation for the interim period: a) Starting 1 July 2013 : MiV-N replaces Type I variation. PRH required to fill up MiV-N form. b) Variations that are not listed under MiV-N becomes a Type II variation. c) Starting 1 January 2014 : Conditions & documentations according to MVG. The processing timeline for MaV and MiV-PA is the same for the interim period. 15

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