| 100000000048 |
Substances considered as not falling within the scope of Regulation (EC) No. 470/2009
|
"Out of scope list" |
Current
|
| 100000111473 |
oct01
|
01 |
Nullified
|
| 100000111433 |
IC test 28/09 - add IV
|
1 |
Non-Current
|
| 100000111273 |
IC test 20/09 - add
|
1111 |
Non-Current
|
| 100000111413 |
IC test 27/09 - add
|
1111 |
Non-Current
|
| 100000152890 |
1A-01 Change in name and/or address of MAH
|
1A.1 |
Non-Current
|
| 100000152891 |
1A-11-a Change in batch size of active substance or intermediate
|
1A.11A |
Non-Current
|
| 100000152892 |
1A-012-a Change in the specification of an active substance or starting material used in MP
|
1A.12A |
Non-Current
|
| 100000152893 |
1A-13-a Change in test procedure for active substance or starting material-minor changes test procedure
|
1A.13A |
Non-Current
|
| 100000152894 |
1A-15-a Submission of new or updated Eu. Ph. certificate of suitability active substance
|
1A.15A |
Non-Current
|
| 100000152895 |
1A-15-b-2 Submission new or updated Eu. Ph. cert suitability active substance
|
1A.15B2 |
Non-Current
|
| 100000152896 |
1A-19-a Change in specification of an excipient-tightening of specification limits
|
1A.19A |
Non-Current
|
| 100000152897 |
1A-20-a Change in test procedure for an excipient-minor changes to approved test procedure
|
1A.20A |
Non-Current
|
| 100000152898 |
1A-22-a Submission of a new or updated TSE Eu. Ph. certificate of suitability for an excipient
|
1A.22A |
Non-Current
|
| 100000152899 |
1A-23-b Change in source of excipient or reagent from TSE risk to vegetable or synthetic material
|
1A.23B |
Non-Current
|
| 100000152900 |
1A-25-b-1 Change to comply with Eu. Ph. or with the national pharmacopoeia of a Member State
|
1A.25B1 |
Non-Current
|
| 100000152901 |
1A-25-b-2 Change to comply with Eu. Ph. or with the national pharmacopoeia of a Member State
|
1A.25B2 |
Non-Current
|
| 100000152902 |
1A-27a-Change to a test procedure of the immediate packaging of the finished product
|
1A.27A |
Non-Current
|
| 100000152903 |
1A-28 Change in any part of the (primary) packaging material not in contact with finished product
|
1A.28 |
Non-Current
|
| 100000152904 |
1A-03 Change in name of active substance
|
1A.3 |
Non-Current
|