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

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d. This leaflet was last approved in {MM/YYYY}; version number { }e. To report any side effect(s):• Saudi Arabia:− National Pharmacovigilance Center (NPC)o Fax: +966-1-210-7398o E-mail: npc.drug@sfda.gov.sao Website: www.sfda.gov.sa/npc• Other GCC States:− Please contact the relevant competent authority.f. Council of Arab Health MinistersThe following statements issued by the Council of Arab Health Ministers should beprinted in the PIL.This is a Medicament− Medicament is a product which affects your health and its consumption contrary toinstructions is dangerous for you.− Follow strictly the doctor’s prescription, the method of use and the instructions of thepharmacist who sold the medicament.− The doctor and the pharmacist are the experts in medicines, their benefits and risks.− Do not by yourself interrupt the period of treatment prescribed for you.− Do not repeat the same prescription without consulting your doctor.− Keep all medicaments out of reach of children.Council of Arab Health MinistersUnion of Arab PharmacistsPage 18 of 52
IV. Summary of Product Characteristics (SPC)During the evaluation process, applicants may present SPCs for different strengths in onedocument, clearly indicating with grey-shaded titles the strength or presentation to whichalternative text elements refer. However, a separate SPC per strength and per pharmaceuticalform, containing all pack-sizes related to the strength and pharmaceutical form concerned willhave to be provided by the applicant.Bracketing convention:{text}: Information to be filled in.: Text to be selected or deleted as appropriate.1. Name of the medicinal productThe name should be followed by both the strength and the pharmaceutical form.{(Invented) name strength pharmaceutical form}2. Qualitative and quantitative composition− Full details of the qualitative and quantitative composition in terms of the activesubstance(s) and excipients.− A standard statement should be included at the end of the section, i.e. ‘For a full list ofexcipients, see section 6.1.3. Pharmaceutical form− Full description of the pharmaceutical form should be provided.− It is recommended that a visual description of the appearance of the product (color,markings, etc.) is given, including information on pH and osmolarity as required e.g.:‘Tablet White, circular flat bevelled-edge tablets marked ‘100’ on one side’.Page 19 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 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

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