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

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2. Minimum particulars to appear on blisters or stripsa. Name of the medicinal product{(Invented) name strength pharmaceutical form}{Active substance(s)}b. Name of the marketing authorisation holder{Name}c. Manufacturing and Expiry datesDates should be expressed with the month given as 2 digits or 3 characters and the year as 4digits. e.g.: 02/2010, Feb 2010.d. Batch number {number}e. Other[Space permitting, any other information necessary for the correct use and administrationof the product can be included here, e.g. calendar days.]Page 8 of 52
3. Minimum particulars to appear on small immediate packaging unitsSmall immediate packaging units are defined as containers sized up to and including 10 ml.On a case-by-case basis the minimum particulars could also be considered for othercontainers where it is not be feasible to include all the information. Such exceptional caseshave to be justified, discussed and agreed upon with the GCC.a. Name of the medicinal product and route(s) of administration{(Invented) name strength pharmaceutical form}{Active substance(s)}{Route of administration}b. Method of administrationMethod of administration: directions for proper use of the medicinal product, e.g. “Do notswallow”, “Do not chew”, “Shake well before use”. If full details cannot be included onthe immediate packaging itself, a reference to the patient information leaflet should bemade, e.g. “Read the patient information leaflet before use”.c. 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.d. Batch number {number}e. Contents by weight, by volume or by unitPage 9 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: j. Special precautions for disposal
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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