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

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d. Pharmaceutical form and contentsContents by weight, by volume or by number of doses or number of units ofadministration of the medicinal product (e.g. 28 tablets, 100 mL, ...)e. Method and route(s) of administrationMethod of administration: directions for proper use of the medicinal product, e.g. “Donot swallow”, “Do not chew”, “Shake well before use”. In all cases, and especially iffull details cannot be included on the outer packaging itself, a reference to the patientinformation leaflet must be made:Read the patient information leaflet before use.f. Special warning that the medicinal product must be stored out of the reach and sight ofchildrenKeep out of the reach and sight of children.g. Other special warning(s), if necessaryh. Manufacturing and Expiry datesDates should be expressed with the month given as 2 digits or 3 characters and the yearas 4 digits. e.g.: 02/2010, Feb 2010.Where applicable, the shelf life after reconstitution, dilution or after first opening thecontainer should be included.i. Special storage conditions[For recommended labeling statements see Appendix 1]• Note: Storage conditions in Arabic language should be added.Page 6 of 52
j. Special precautions for disposal of unused medicinal products or waste materials derivedfrom such medicinal products, if appropriate[E.g. radiopharmaceuticals, cytostatics.][A reference to any appropriate collection system in place should be included on theouter packaging.]k. Name and address of the marketing authorisation holder{Name and Address}l. Marketing authorisation number(s)m. Batch number {number}n. General classification for supplyo. PricePage 7 of 52
Page 1 and 2: Executive Board of the Health Minis
Page 3 and 4: ContentsI. Introduction 4II. Labeli
Page 5: II. LabelingThe data should be pres
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 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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