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

More documents

Recommendations

Info

B. Recommendations for the labelingGeneral considerationsLabeling covers both outer packaging and inner packaging. Although inner packaging mayinclude a lesser set of particulars, many of the principles outlined in relation to outer packagingwill apply equally to the labeling of blister packs or other small package units.Labeling ensures that the critical information necessary for the safe use of the medicine islegible, easily accessible and that users of medicines are assisted in assimilating this informationso that confusion and error are minimized.Those involved in the design of labeling should consider the following sections prior tosubmission to the competent authority. The recommendations given in relation to the PIL(section A) may be applicable to labeling and should be borne in mind in designing and layingout the required information on labels. The particulars appearing on the label of all medicinalproducts should be printed in characters of at least 7 points (or of a size where the lower case "x"is at least 1.4 mm in height), leaving a space between lines of at least 3 mm.In particular the information presented on small packs will need careful consideration so that thetext is presented in as large a type size as possible to reduce the likelihood of medication error.1. Name of the medicineThe full name of the medicinal product, with its strength and its pharmaceutical form, and, ifappropriate, whether it is intended for babies, children or adults, should appear on the outerpackaging and on the immediate packaging to aid accurate identification of the medicinalproduct.Where the medicinal product contains up to three active ingredients, the international nonproprietaryname (INN)/common name(s) of these active ingredient(s) should be stated after thefull name on the outer packaging and the immediate packaging, unless the INN/common name(s)is part of the name. The INN should be afforded due prominence for safety reasons.Page 48 of 52
2. Strength and total contentIn some cases the packaging may need to contain information on both the quantity per unitvolume and on the total quantity per total volume. The total quantity per total volume can beparticularly important for safety reasons for injectable products and other medicines available insolution or suspension.Different strengths of the same medicinal product should be expressed in the same manner: forexample 250 mg, 500 mg, 750 mg, 1000 mg and NOT 1 g. Trailing zeros should not appear (2.5mg and NOT 2.50 mg). The use of decimal points (or comma) should be avoided where thesecan be removed (i.e. 250 mg is acceptable whereas 0.25 g is not). For safety reasons it isimportant that micrograms is spelt out in full and not abbreviated. However, in certain instanceswhere this poses a practical problem which cannot be solved by using a smaller type size thenabbreviated forms may be used, if justified and if there are no safety concerns.3. Route of administrationThis should be as registered in the summary of product characteristics (SPC) only according tothe standard terms. Negative statements should not be used: for example “Not for intravenoususe”. In principle only standard abbreviations may be acceptable (i.v., i.m., s.c.).Other nonstandard routes of administration should be spelled out in full. Some routes ofadministration will be unfamiliar to patients and may need to be explained within the PIL. This isparticularly important when medicinal products are made available for self-medication.4. Design and layoutApplicants and marketing authorization holders should make best use of the space available toensure that the important information is clearly mentioned on prime spaces on the outer andimmediate packaging, presented in a sufficiently large type size. Company logos and pictogramsmay be presented, where space permits, on the outer packaging and on immediate packaging,provided they do not interfere with the legibility of the mandatory information.Use of a large type size will be appropriate, although other factors may also be important inmaking the information legible. Consideration should be given to the line-spacing and use ofwhite space to enhance the legibility of the information provided. For some small packs it maynot be possible to present all the critical information in the same field of view. The use of anyPage 49 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: 8. Use of symbols and pictogramsThe
Page 51 and 52: Small containersWhere the labeling

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

You also want an ePaper? Increase the reach of your titles

Delete template?

Save as template?