Module 12 2019

Current process for an administrative change

Pre-define Manufacturer used as bulk manufacturer and packager changes it ´ s name. Same manufacturer is used by 5 different MAHs.

MAH performs following process: •

Initiates change control process to evaluate change and determine plan for implementation Creates documentation (cover letter, variation application form, copy of the variation guideline) Plans variations

• •

Supplier 1

Supplier 1

Supplier 1

Supplier 1

Supplier 1

MAH 1

MAH 2

MAH 3

MAH 4

MAH 5

Creates eCTD submission Creates CESP delivery file Uploads submission to CESP

• • • • • •

100 products 100 CLs 100 eAF 100 eCTDs

10 products 10 CLs 10 eAFs 10 eCTDs

20 products 20 CLs 20 eAF 20 eCTDs

50 products 50 CLs 50 eAFs 50 eCTDs

80 products 80 CLs 80 eAFs 80 eCTDs

Informs RMS about submission dates Tracks variation implementation Updates Regulatory Information Management system

NCA performs following process: •

Receiving and sorting (CESP and non CESP)

Technical validation

• • • • •

Case creation

10 variations

100 variations

20 variations

50 variations

80 variations

Fees (if applicable)

CTS and content validation National implementation

NCA 30

NCA 1

NCA 2

NCA 3

NCA 4

NCA 5

NCA ..

The Organisation for Professionals in Regulatory Affairs