The GCC Guidance for Presenting the SPC, PIL and Labeling ...

6. Pharmaceutical particulars6.1 List of excipients− A list should be given of the excipients, expressed qualitatively only. All excipients, whichare present in the product, should be included, even those present in small amounts, suchas printing inks.− Each to be listed on a separate line according to the different parts of the product.6.2 Incompatibilities− Information on physical and chemical incompatibilities of the medicinal product withother products with which it is likely to be mixed or co-administered should be stated.− Statements concerning compatibility of the product with other medicinal products ordevices should not be included in this section but in section 6.6. Statements concerningpharmacological incompatibilities with food should be included in section 4.5.− If appropriate, the standard statement, ‘Not applicable’, should be included.− For certain pharmaceutical forms, e.g. parenterals, either of the following standardstatements should be included as appropriate:6.3 Shelf life− Information on the finished product shelf life and on the in-use stability after 1 st openingand/or reconstitution/dilution should appear here. Only one overall shelf life for thefinished product is to be given even if different components of the product may have adifferent shelf life (e.g. powder & solvent). Page 26 of 52