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

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6.6 Special precautions for disposal − Include practical instructions for preparation and handling of the product, whereapplicable, including disposal of the medicinal product, and waste materials derivedfrom the used medicinal product.− If applicable, e.g. for cytotoxics, the following standard statement should be included,‘Any unused product or waste material should be disposed of in accordance with localrequirements.’− If there are no special use or handling instructions for the pharmacist or other healthcareprofessionals, the following standard statement should be included:7. Marketing authorisation holder{Name and address}8. Marketing authorisation number(s)9. Date of first Authorisation/ renewal of the authorisation 10. Date of revision of the text{MM/YYYY}Page 28 of 52
11. − For radiopharmaceuticals, full details of internal radiation dosimetry.12. − − For radiopharmaceuticals, additional detailed instructions for extemporaneouspreparation and quality control of such preparation and, where appropriate, maximumstorage time during which any intermediate preparation such as an eluate or the readyto-usepharmaceutical will conform to its specifications.Page 29 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 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

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