Module 2 Summaries
The files in this module should be provided as PDF text with the exception of a few embedded images, when needed. The name of the folder for module 2 should be m2. The folders in module 2 should be named as follows.
The name of the folder for module 1 should be m1.
This module contains administrative information that is unique for each region. Regional guidance will provide the specific instructions on how to provide the administrative forms and detailed prescribing information.
Country In the centralised procedure, there should only be one envelope with the entry ‘emea’. For MRP/DCP, each country in the procedure needs to have a separate envelope entry. Common must not be used as a country identifier in the envelope.
Application number The application number should be the centralised procedure/application number (EMEA/H/C/…), MRP/DCP procedure number (e.g. SE/H/1234…) or other national application or licence number as required by NCAs. Multiple entries are possible. The full application number including the regulatory activity identifier should be used if known.
|Attribute value||Meaning||Attribute previous file|
|new||The file has no relationship with files submitted previously.|
|append||There is an existing file in a previous submission to which this new file should be associated||current and appended|
|replace||The existing file will be replaced by a new file||replaced|
|delete||File in the specific folder is not longer relevant. The file is deleted in the current submission but not in the pervious version||No longer relevant to the review|
The name of the folder for module 5 should be m5.
In cases where the application includes multiple therapeutic indications, the reports should be organized in a separate Section m535 for each indication. In such cases, if a clinical efficacy study is relevant to only one of the indications included in the application, it should be included in the appropriate section in m5 (eg m5\53-clin-stud-rep\535-rep-effic-safety-stud\anxiety\5351-stud-rep-contr). If a clinical efficacy study is relevant to multiple indications, the study report should be included in the most appropriate subsection of m535 and referenced as necessary in the equivalent section under the different indication.