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

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FAMILIARISATIONSITTING COMFORTABLYFront seatsHead restraint heightiOther functions available...Table position for the frontpassenger seat (SW).Storing driving positions (driver'selectric seat).Heated seats.Front armrestSteering wheel adjustmentLumbar1. Unlocking the control.2. Adjustment for height and reach.3. Locking the control.!As a safety precaution, theseoperations must only be carriedout when stationary.For your comfort, the height andlongitudinal position of the front armrestcan be adjusted.It also has a storage compartment.12 65 77 106APp-308BB_01_2010_anglais_cag_pd12 12 04/11/2010 16:27:17
III. Patient Information Leaflet (PIL)A separate patient information leaflet should be provided per strength and per pharmaceuticalform. However, applicants may present patient information leaflets for different strengths in onedocument during the evaluation process, clearly indicating the strength or presentation to whichalternative text elements refer. Where applicants consider to also market a combined packageleaflet, a detailed justification for such a combined patient information leaflet should be providedin the application at submission.The following items must appear in the patient information leaflet as required by this guidance.In exceptional cases, alternative headings may be acceptable, especially for those headingscontaining or where a different wording would be more appropriate for the productconcerned e.g. to better reflect the user of the product. This should not in any case impact on thecontent required for the section concerned. Applicants should justify the use of alternativeheadings (e.g. by reference to user testing results). For certain medicinal products not all itemsmay be relevant, in this case the corresponding heading should not be included.It is important that the PIL can easily be tracked for updates and review. Each PIL should begiven a reference number along with the date the leaflet was issued and a suitable review date.Each PIL should be reviewed every 5 years or when necessary.Bracketing convention:{text}: Information to be filled in.: Text to be selected or deleted as appropriate.Page 11 of 52
Page 1 and 2: Executive Board of the Health Minis
Page 3 and 4: ContentsI. Introduction 4II. Labeli
Page 5 and 6: II. LabelingThe data should be pres
Page 7 and 8: j. Special precautions for disposal
Page 9: 3. Minimum particulars to appear on
Page 13 and 14: 1. What {product name} is and what
Page 15 and 16: 3. How to {product name} − You
Page 18 and 19: d. This leaflet was last approved i
Page 20 and 21: − In case of tablets designed wit
Page 22 and 23: − In the overall assessment, all
Page 24 and 25: these are not available, results ob
Page 26 and 27: 6. Pharmaceutical particulars6.1 Li
Page 28 and 29: 6.6 Special precautions for disposa
Page 30 and 31: Appendix 1: Recommended labeling st
Page 32 and 33: Appendix 3: Pregnancy statements1.-
Page 34 and 35: 8.- Well-conducted epidemiological
Page 37 and 38: Appendix 5: Additional information
Page 39 and 40: ماهوإسم المستحضر <
Page 41 and 42: ملاحظة:‏يجب أن تكو
Page 43 and 44: A. Recommendations for the PILGener
Page 45 and 46: 4. Print colorAccessibility is not
Page 47 and 48: 8. Use of symbols and pictogramsThe
Page 49 and 50: 2. Strength and total contentIn som
Page 51 and 52: Small containersWhere the labeling

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

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