Project

General

Profile

Feature #2536

NA Introduce amendments

Added by Oleksii Kurasov about 8 years ago. Updated over 7 years ago.

Status:
Closed
Priority:
Normal
Assignee:
Oleksii Kurasov
Start date:
09/12/2017
Due date:
10/11/2017
% Done:

100%

Estimated time:
200.00 h (Total: 294.00 h)

Description

Receive list of possible amendments and analyse impact to a product information.
Design requirement for programming

Subtasks

Feature #2659: Implement amendment Change in the name and/or address of a manufacturer of the API whether or not a European Pharmacopoeia certificate of suitability is availableClosedOleksii Kurasov

Feature #2660: Implement amendment Change product owner (applicant name and address)ClosedOleksii Kurasov

Feature #2661: Implement amendment Change of contact person on applicant /agentRejectedOleksii Kurasov

Feature #2662: Implement amendment Change product nameClosedOleksii Kurasov

Feature #2663: Implement amendment Change batch numbering systemClosedOleksii Kurasov

Feature #2664: Implement amendment Withdrawal/deletion of manufacturer (drug substance, drug product, packer or batch releaser)ClosedOleksii Kurasov

Feature #2665: Implement amendment Change to appearance/description (excluding scoring for dosage claim and shape of tablets) restricted to shape, imprinting/embossing and printingClosedOleksii Kurasov

Feature #2666: Implement amendment Replacement an IPI with a comparable* IPI with the same functional characteristics, resulting in no change in the dissolution profile for solid oral dosage forms. The final product specifications should remain unchanged.ClosedOleksii Kurasov

Feature #2667: Implement amendment Addition of one or more IPIsClosedOleksii Kurasov

Feature #2668: Implement amendment REMOVAL IPI from the (Addition or removal or increasing or decreasing any release controlling ingredient (IPI))ClosedOleksii Kurasov

Feature #2669: Implement amendment Replacement of an IPClosedOleksii Kurasov

Feature #2670: Implement amendment Change/additional source of API to a different company (route of synthesis stated to be the same, specifications the same)ClosedOleksii Kurasov

Feature #2671: Implement amendment Shelf-life extension (final product)ClosedOleksii Kurasov

Feature #2672: Implement amendment Change in the API to a different APIClosedOleksii Kurasov

Feature #2673: Implement amendment Inclusion or removal of an API(s) from a multi-component product unless specifically required by CouncilClosedOleksii Kurasov

Feature #2674: Implement amendment Change in the quantity of the API(s), per dosage unit excluding overages and/or potency adjustmentsClosedOleksii Kurasov

Feature #2675: Implement amendment Change in the dosage form including, change from an immediate release product to modified-release dosage form or vice versa and change from liquid to powder for reconstitution, or vice versaClosedOleksii Kurasov

Feature #2676: Implement amendment Change in the route of administrationClosedOleksii Kurasov

Feature #2680: Implement non database changes amendmentClosedOleksii Kurasov

History

#1 Updated by Oleksii Kurasov about 8 years ago

  • Parent task deleted (#2530)

#2 Updated by Oleksii Kurasov about 8 years ago

  • Due date changed from 03/13/2017 to 03/15/2017

#3 Updated by Oleksii Kurasov about 8 years ago

  • Due date changed from 03/15/2017 to 03/20/2017

#4 Updated by Oleksii Kurasov about 8 years ago

  • Due date changed from 03/20/2017 to 03/22/2017
  • Status changed from New to In Progress

a) Applicant transfers and applicant name and address changes;
b) Changes of the manufacturer, packer and testing laboratories
c) Proprietary name changes in consultation
d) Pharmaceutical changes or amendments to the registration dossier; and
e) Cancellations of registered medicines and withdrawal of applications for the registration of
medicines

#5 Updated by Oleksii Kurasov about 8 years ago

  • Due date changed from 03/22/2017 to 03/23/2017

#6 Updated by Oleksii Kurasov about 8 years ago

  • Due date changed from 03/23/2017 to 03/29/2017

#7 Updated by Oleksii Kurasov about 8 years ago

  • % Done changed from 0 to 10
  • Estimated time set to 32.00

#8 Updated by Oleksii Kurasov about 8 years ago

  • Project changed from Finalization Pharmadex for Mozambique, Bangladesh, Namibia, Ethiopia to Finalization Pharmadex for Namibia

#9 Updated by Oleksii Kurasov about 8 years ago

  • Due date changed from 03/29/2017 to 04/11/2017

#10 Updated by Oleksii Kurasov about 8 years ago

  • Due date changed from 04/11/2017 to 04/28/2017

#11 Updated by Oleksii Kurasov about 8 years ago

  • % Done changed from 10 to 30

#12 Updated by Oleksii Kurasov almost 8 years ago

  • Due date changed from 04/28/2017 to 05/11/2017

#13 Updated by Oleksii Kurasov almost 8 years ago

  • Due date changed from 05/11/2017 to 05/18/2017

#14 Updated by Oleksii Kurasov almost 8 years ago

  • Due date changed from 05/18/2017 to 05/17/2017

#15 Updated by Oleksii Kurasov almost 8 years ago

  • Due date changed from 05/17/2017 to 06/14/2017

#16 Updated by Oleksii Kurasov almost 8 years ago

  • Due date changed from 06/14/2017 to 06/21/2017

#17 Updated by Oleksii Kurasov almost 8 years ago

  • Due date changed from 06/21/2017 to 07/13/2017

#18 Updated by Oleksii Kurasov over 7 years ago

  • Due date changed from 07/13/2017 to 09/30/2017
  • Estimated time changed from 32.00 to 200.00

#19 Updated by Oleksii Kurasov over 7 years ago

  • Status changed from In Progress to Resolved

#20 Updated by Oleksii Kurasov over 7 years ago

  • Status changed from Resolved to Closed

Also available in: Atom PDF