#qiif1
| Q.II.f.1 Change in the shelf life or storage conditions of the finished product | Conditions to be fulfilled | Documentation to be supplied | Procedure type |
| (a) Reduction of the shelf life of the finished product | |||
| 1. As packaged for sale | 1, 6 | 1, 2, 3, 4 | IAIN |
| 2. After first opening | 1, 6 | 1, 2, 3, 4 | IAIN |
| 3. After dilution or reconstitution | 1, 6 | 1, 2, 3, 4 | IAIN |
| (b) Extension of the shelf life of the finished product | |||
| 1. As packaged for sale (supported by real time data, fully in line with the stability protocol) | 3, 4, 5 | 1, 2, 3 | IAIN |
| 2. After first opening (supported by real time data) | 1, 2, 3 | IB | |
| 3. After dilution or reconstitution (supported by real time data) | 1, 2, 3 | IB | |
| 4. Extension of the shelf life of the finished product based on extrapolation or stability modelling not in accordance with relevant stability guidelines | II | ||
| 5. Extension of the shelf life of the finished product based on extrapolation of stability data in accordance with relevant stability guidelines | 1, 2, 3 | IB | |
| (c) Change in storage conditions of a biological finished product | II | ||
| (d) Change in storage conditions of the finished product or the diluted/reconstituted product | 1, 2, 3 | IB | |
| (e) Change to an approved stability protocol of the finished product | 1, 2 | 1, 4 | IA |
| Conditions | |||
| 1. The change should not be the result of unexpected events arising during manufacture or because of stability concerns. | |||
| 2. The change does not concern a widening of the acceptance criteria in the parameters tested, a removal of stability indicating parameters or a reduction in the frequency of testing. | |||
| 3. Stability studies have been performed in accordance with a currently approved stability protocol. Real time data are submitted. All batches meet their pre-defined specification at all time points. No unexpected trends have been observed. | |||
| 4. Product is not a biological or herbal finished product. | |||
| 5. Product is an immediate release film-coated tablet. | |||
| 6. Product is not on the Union list of critical medicines or similar national list (where applicable). | |||
| Documentation | |||
| 1. Amendment of the relevant section(s) of the dossier (presented in the EU-CTD format). This must contain results of appropriate stability studies conducted in accordance with the relevant stability guidelines on three pilot scale batches(3) of the finished product in the authorised packaging material and/or two batches after first opening or reconstitution, as appropriate. Where applicable, results of appropriate microbiological testing should be included. | |||
| 2. Revised product information. | |||
| 3. Copy of approved end of shelf life finished product specification and where applicable, specifications after dilution/reconstitution or first opening (as annex to the application form). | |||
| 4. Justification for the proposed change(s). | |||
| (3) Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives (OJ L 354, 31.12.2008, p. 16, ELI: http://data.europa.eu/eli/reg/2008/1333/oj). | |||
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