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

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innovative technique in packaging design to aid in the identification and selection of themedicinal product is encouraged. It is also encouraged where space is at a premium.Colors should be chosen to ensure a good contrast between the text and the background to assuremaximum legibility and accessibility of the information. Highly glossy, metallic or reflectivepackaging should be avoided, as this affects the legibility of the information. Different colors inthe name of the product are discouraged since they may negatively impact on the correctidentification of the product name. The use of different colors to distinguish different strengths isstrongly recommended.Similarity in packaging which contributes to medication error can be reduced by the judicioususe of color on the pack. The number of colors used on packs will need careful consideration astoo many colors could confuse. Where color is used on the outer pack it is recommended that itis carried onto primary packaging to aid identification of the medicine.Where a multi-lingual outer and/or immediate packaging is proposed there should be a cleardemarcation between different languages where space permits.5. Blister pack presentationsFor blister pack presentations it is important that the particulars remain available to the user up tothe point at which the last dose is removed. Often it will not be possible to apply all theinformation over each blister pocket, consequently where a random display of the information isproposed it should frequently appear across the pack. In all cases it will be acceptable to applythe batch number, manufacturing and expiry dates to the end of the blister strip. If technicallypossible, applying this information to both ends of each strip should be considered. Where a unitdoseblister presentation is proposed all the information required for blister packs must appear oneach unit dose presentation.In addition, blister foils should be printed to ensure maximum legibility of the information usinga sufficiently large font.Color for the text and the font style, should be chosen carefully as the legibility of the text on thefoil is already impaired due to the nature of the material. Where possible, non-reflective materialor colored foils should be considered to enhance the readability of the information presented andthe correct identification of the medicine.Page 50 of 52
Small containersWhere the labeling particulars cannot be applied in full to the labeling of small containers, theminimum particulars could be considered. Other factors may need to be taken into account suchas the amount of information which has to be included and the font size necessary to ensure thelegibility of the information.The criteria for small container status would normally apply to containers of nominal capacity of10 ml or less.Innovative pack design is encouraged where space is at a premium (e.g. the use of wraparound orconcertina labels). Paper labels are recommended to increase the legibility of the informationapplied to, for example, ampoules.Page 51 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 and 10: 3. Minimum particulars to appear on
Page 11 and 12: III. Patient Information Leaflet (P
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: 2. Strength and total contentIn som

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

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