Guidance documents on the Package Leaflet, Summary of Product Characteristics and Labelling are listed below and attached for immediate reference. The documents are essentially as published by the EMEA. Since these documents are subject to regular updates interested parties are advised to consult the EMEA Quality Review of Documents (QRD) web pages as appropriate21, 22.
21www.emea.eu.int/htms/human/qrd/qrdintro.htm
22www.emea.eu.int/htms/human/qrd/qrdtemplate.htm
Guidance documents to consult include: Templates:
1. |
Annex I |
Summary of Product Characteristics (template) |
File 01…23 |
| |
Annex III |
A. Labelling (template) |
|
| |
|
B. Package Leaflet (template)
This is a Word version, which is directly usable as a template to start developing the documents. |
|
2. |
Annex I, III |
Same as 1 above, annotated. |
File 02… |
3. |
Appendix I |
Statements for use in Section 4.6 "Pregnancy and lactation" of Summary of Product Characteristics |
File 03… |
4. |
Appendix II |
MedDRA terminology to be used in Section 4.8 "Undesirable effects" of the Summary of Product Characteristics |
File 04… |
5. |
Appendix III |
New standards for required storage statements |
File 05… |
6. |
Appendix IV |
Terms for Batch number and Expiry date |
File 06… |
23 File references refer to guidance files in the subdirectory 'Ref docs App 3 - QRD'
QRD support documents:
1. |
Convention to be followed for EMEA-QRD templates |
File 10… |
2. |
Compilation of QRD decisions on the use of terms |
File 11… |
3. |
Compilation of QRD decisions on stylistic matters in product information. |
File 12… |
4. |
Tables of non-standard abbreviations |
File 13… |
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