|
| |
|
Case Study 1
Example of experience of the use of the Decentralised Procedure.
The following is an actual example of the type of application for which staff at Ivowen have been responsible.
A large Decentralised Procedure (DCP) involving eleven separate independent customers, many of whom had multiple sites of manufacture/distribution, etc., in different member states. There were 15 separate Concerned Member states (CMSs) - with multiple applications in many of the CMSs.
The regulatory strategy was developed by taking patent expiry dates, data exclusivity dates, SmPC differences in different member states and the customers’ needs including their requirements for packaging, batch release and distribution into consideration.
Of primary importance during the procedure was meeting the needs of the customers in a timely fashion and working in a positive and co-operative way with the RMS.
This example is one of many DCPs for which we have been responsible.
Brief description of the project:
Product: |
Generic oncology tablet, 1 strength
|
Reference Member State: |
UK/NL
|
Concerned Member States: |
BE, BG, CZ, DE, EE, HU, IE, LU, LT, LV, PL, PT, RO, SI, SK
|
No. of Duplicate licences in RMS: |
7/2, resulting in 7/2 parallel MRPs
|
No. of individual customers involved in CMSs: |
11
|
Outcome: |
DCP completed successfully in all CMSs
|
Total number of licences issued for the product: |
Approx. 30
|
|
| |
Case Study 2
Example of experience of the use of the Mutual Recognition Procedure.
The following is an actual example of the type of application for which staff at Ivowen have been responsible.
A large Mutual Recognition Procedure (MRP) involving seven separate independent customers, many of whom had multiple sites of manufacture/distribution, etc., in different member states. There were 10 separate Concerned Member states (CMSs) - with multiple applications in many of the CMSs. In addition to the MRP there were also multiple national applications in the Reference Member State (RMS).
The regulatory strategy was developed by taking patent expiry dates, data exclusivity dates, SmPC differences in different member states and the customers needs including their requirements for packaging, batch release and distribution into consideration.
Of primary importance during the procedure was meeting the needs of the customers in a timely fashion and working in a positive and co-operative way with the RMS.
This example is one of many MRPs for which we have been responsible, although it was the largest and most complex.
Brief description of the project:
Product: |
Generic beta-blocker tablet, 2 strengths |
Reference Member State: |
NL |
Concerned Member States: |
AT, BE, DE, ES, FR, FI, IE, LU, SE, UK |
No. of Duplicate licences in RMS: |
9, resulting in 9 parallel MRPs |
No. of individual customers involved in CMSs: |
7 |
Outcome: |
MRP completed successfully in all CMSs |
Total number of licences issued for the product: |
Approx. 96 |
|
|
