Package Insert h) Dosage and Mode/Route of Administration i) Contraindication(s), Precaution(s), Warning(s) (if applicable) j) Pregnancy and Lactation (if applicable) k) Interactions Center for Drug Regulation and Research 41
Package Insert l) Undesirable Effects m)Overdose and Treatment n) Storage Condition(s) o) Dosage Forms and Packaging Available (pack size) p) Instructions and Special Precautions for Handling and Disposal (if applicable) Center for Drug Regulation and Research 42
Package Insert q) Name and Address of Marketing Authorization Holder r) Name and Address of Manufacturer s) Caution Statement t) ADR Reporting Statement u) Registration Number Center for Drug Regulation and Research 43
Package Insert v) Date of First Authorization/Renewal of Authorization w)Date of Revision of Package Insert Center for Drug Regulation and Research 44
Patient Information Leaflet a) Product Name b) Strength of the Medicine c) Description of the Product d) What is in the Medicine? e) What is this Medicine used for? f) How much and how often should you use this Medicine? Center for Drug Regulation and Research 45
Patient Information Leaflet g) When should you not take this Medicine? h) Care that should be taken when taking this Medicine? i) Undesirable Effects j) What other medicine or food should be avoided whilst taking this Medicine? Center for Drug Regulation and Research 46
Patient Information Leaflet k) What should you do if you miss a dose? l) Signs and Symptoms of Overdosage m)What to do when you have taken more than the recommended dosage? n) How should you keep this Medicine? o) When should you consult your doctor? Center for Drug Regulation and Research 47
Patient Information Leaflet p) Name and address of MAH q) Name and address of Manufacturer r) ADR Reporting Statement s) Registration Number t) Date of First Authorization/Renewal u) Date of Revision of PIL Center for Drug Regulation and Research 48
Republic of the Philippines Department of Health Food and Drug Administration Revised Labeling Regulation VII. SPECIFIC REQUIREMENTS Center for Drug Regulation and Research 49
Product Name 1) Generic and brand name (if any) 2) Generic name – as active moiety based in INN, consistent with the dosage strength; prodrugs – INN of prodrug 3) Generic name shall appear prominently, enclosed in an outline box; prominence over other information as determined by common visual sense Center for Drug Regulation and Research 50
Product Name 4) Herbal and TM: Botanical origin or as recognized by FDA 5) Generic name shall appear above brand name; for narrative texts, the brand name shall be preceded by the generic name and shall be enclosed in parenthesis or brackets Center for Drug Regulation and Research 51
Product Name 6) Multiple APIs - all APIs shall be indicated, in order of decreasing pharmacological activity; of more or less similar activity, in decreasing potency; provided that if single approved name for FDC, single approved name shall be used; Center for Drug Regulation and Research 52
Product Name provided further if there is no single approved name but a generic class name exist, generic class name shall be used. The individual components shall be indicated under formulation Center for Drug Regulation and Research 53
Product Name 6) Multiple APIs: B A Center for Drug Regulation and Research 54
Dosage Form and Strength 1) Label shall specify: a) Dosage form (tablet vs capsule) b) Special delivery system (sustained- release vs. extended-release) c) Specific mode of administration (vaginal vs. rectal) if any and appropriate are required d) No qualifier for tablets – oral, uncoated, IR tablet Center for Drug Regulation and Research 55
Dosage Form and Strength 2) dosage strength - expressed in metric units reduced to lowest terms and in the number of the largest unit specified (e.g. 500mcg, not 0.5mg) 3) strength of certain dosage forms to be expressed as percentage Center for Drug Regulation and Research 56
Dosage Form and Strength 4) For multiple APIs: dosage strength of each API shall be stated in accordance with the arrangement of the APIs, separated by a slash sign (/); provided, that if a single approved INN of the combination drug is used, the dosage strength shall be indicated as the whole Center for Drug Regulation and Research 57
Dosage Form and Strength Center for Drug Regulation and Research 58
Pharmacologic Category As determined by FDA Center for Drug Regulation and Research 59
Formulation/Composition 1) Name and strength of all APIs present per unit dose of product in generic names, arranged in decreasing potency 2) Name of API shall be stated in full (including its salt or hydrate form, if any), and correlated with active moiety when applicable; shall be in accordance with INN or FDA approved name; for herbal/TM – in accordance with PP or FDA approved name Center for Drug Regulation and Research 60
Formulation/Composition 3) reference monograph finished product shall be indicated, unless non-official; for multiple API, it shall be indicated after the first API Center for Drug Regulation and Research 61
Formulation/Composition Center for Drug Regulation and Research 62
Formulation/Composition 4) Alcohol must be expressed as percentage; alcohol without qualification - ethanol 5) Excipients that may cause hypersensitivity shall be indicated, and/or other adverse reactions shall also be indicated, with the amount expressed in the same manner as the API 6) Preservative/antimicrobial agents shall be indicated, with the amount expressed in the same manner as the API Center for Drug Regulation and Research 63
Indication Only FDA approved clinical use Center for Drug Regulation and Research 64
Dosage and Mode of Administration 1) Recommended dosage, where applicable: a) Initial/loading dose b) Optimal use or usual dose c) Frequency interval d) Duration of treatment e) Dosage adjustment Center for Drug Regulation and Research 65
Dosage and Mode of Administration 2) Dilution/reconstitution/preparation instructions in all labeling materials; description of the reconstituted preparation; description of reconstituted solution is also required 3) Dosage for special populations, adults and children ; if not for children, “adult dose” or any statement to that effect Center for Drug Regulation and Research 66
Contraindication(s), Precaution(s), Warning(s) 1) Full information on contraindication, as well as the precautions to be observed 2) Special warnings should be included as required and specified by FDA 3) For products are to be used on one occasion only, “ single use only ”, “ single dose ” Center for Drug Regulation and Research 67
Interactions 1) Drug-Drug 2) Drug-Food 3) Drug-Laboratory test 4) Other relevant Center for Drug Regulation and Research 68
Undesirable Effects Shall include known ADE/ADRs for the drug product Center for Drug Regulation and Research 69
Overdose and Treatment 1) Signs and Symptoms of Overdose 2) Treatment for overdose Center for Drug Regulation and Research 70
Storage Condition 1) Appropriate storage conditions and special instructions for handling (e.g. cold chain) 2) Special labelling instructions: Center for Drug Regulation and Research 71
Net Content/Pack Size 1) Unit carton – pack size expressed in terms of the number of units or the volume of each unit; for reconstitution products, the reconstituted volume 100 Tablets 10 Blister Packs x 10 Tablets 12 Sachets x 5g 60mL 12 vials x 5mL Center for Drug Regulation and Research 72
Net Content/Pack Size 2) Primary label (except blisters and foil strips) – net content stating the total amount/quantity of dosage form in a given container 100 Tablets 5g 60mL 5mL Center for Drug Regulation and Research 73
MAH Name and address of MAH Market Authorization Holder: Pavenus Ltd Mother Ignacia cor. Sgt. Esguerra St., Diliman Quezon City Center for Drug Regulation and Research 74
Manufacturer Name and specific manufacturing site address of manufacturer below the MAH Market Authorization Holder: Pavenus Ltd Mother Ignacia cor. Sgt. Esguerra St., Diliman Quezon City Manufacturer: Will Del Una Intl Rm. 128, 1 st Flr Main Building, Alabang, Muntinlupa Center for Drug Regulation and Research 75
Rx Symbol and Caution Statement 1) Required for prescription products; allowed to be over-printed or superimposed 2) Caution Statement – unit carton, primary label except blister pack, foil strip, and small containers, and package insert: Center for Drug Regulation and Research 76
Rx Symbol and Caution Statement Foods, Drugs, Devices, and Cosmetics Act prohibits dispensing without prescription. For Dangerous drugs, additional caution statement as specified by PDEA Center for Drug Regulation and Research 77
ADR Reporting Statement 1) For the unit carton and primary label (except blister pack, foil strip, and small containers) For suspected adverse drug reaction, report to the FDA: www.fda.gov.ph ” Center for Drug Regulation and Research 78
ADR Reporting Statement 2) For product information sheet, statement instructing the patient to seek medical attention immediately MAH may also include reporting statement for their own PV system Center for Drug Regulation and Research 79
Registration Number Registration number assigned by FDA Center for Drug Regulation and Research 80
Batch and Lot Number 1) Batch number if marketed by one drug establishment 2) If divided into lots marketed by different establishments, lot and batch number Center for Drug Regulation and Research 81
Expiration/Manufacturing Date 1) Month and year is required; if stated in numbers alone, year is stated completely; if day is specified, month is spelled out a) June 2007 b) 07/2007 c) 03 June 2007 or 03 Jun 2007 Center for Drug Regulation and Research 82
Expiration/Manufacturing Date 2) understood to be the last day of the month if no day specified 3) For reconstituted products or can be administered multiple times, the label shall include the period of guaranteed safety and efficacy after first opening at a given storage condition Center for Drug Regulation and Research 83
Republic of the Philippines Department of Health Food and Drug Administration Revised Labeling Regulation VIII. SPECIAL LABELLING INSTRUCTIONS Center for Drug Regulation and Research 84
Parenterals 1) All labeling materials: excipients and amounts - formulation 2) “intravenous”, “intramuscular” or “subcutaneous” 3) For concentrated solution – direction not to administer the solution undiluted and direction to dilute w/ specified diluent Center for Drug Regulation and Research 85
Fluid Replacement and Dialysis Solution Products 1) follow standard formulations contained in official compendium, the nomenclature used in the official compendium shall be adopted as the generic class name; 2) Non-official solutions – FDA shall determine generic class name Center for Drug Regulation and Research 86
Fluid Replacement and Dialysis Solution Products 3) directly below the generic class name but still inside the generic outline box – individual components w/ corresponding mEq/L or mmol/L enumerated in the order of decreasing pharmacologic activity 4) amino acids and/or proteins - total amount of nitrogen 5) Nominal osmolality and nominal pH range Center for Drug Regulation and Research 87
For External Use Rendered in all capital letters and red background or red font Ex. Center for Drug Regulation and Research 88
Multivitamin/Mineral/Herbal Products with Standard Formulations and Non- vitamin/mineral/herbal Components 1) Generic class name - Multivitamins and Minerals for multi-vitamin and multi-mineral containing products 2) For multi-vitamin/mineral containing products with additional herbal ingredients (at least 3) – generic class name shall be herbs Center for Drug Regulation and Research 89
Multivitamin/Mineral/Herbal Products with Standard Formulations and Non- vitamin/mineral/herbal Components 3) For multi-vitamin products with individual non-vitamin components (i.e. mineral or herbal ingredient), or multi-mineral products with individual non-mineral components (vitamin or herbal ingredient), the term “Multivitamins” or “Minerals” shall first be stated, followed by additional individual components Center for Drug Regulation and Research 90
Multivitamin/Mineral/Herbal Products with Standard Formulations and Non- vitamin/mineral/herbal Components Center for Drug Regulation and Research 91
Multivitamin/Mineral/Herbal Products with Standard Formulations and Non- vitamin/mineral/herbal Components content of each vitamin present shall no longer be required to be indicated in the generic box, but shall appear in the Formulation Center for Drug Regulation and Research 92
MDRP On the label of the minimum pack for drugs listed under Section 1 of E.O. No. 821: Center for Drug Regulation and Research 93
Unique Global Product Identification Number The existing rules and regulations for GTIN shall be followed Center for Drug Regulation and Research 94
Reproductive Health Products PIL as product information Shall be writeen in English and Filipino, and/or local dialect Center for Drug Regulation and Research 95
Generic Drug Products with Proven Interchangeability This product has the same therapeutic efficacy as any other generic product of the same name This product has the same therepaeutic efficacy as the innovaor product of the same generic name Center for Drug Regulation and Research 96
Republic of the Philippines Department of Health Food and Drug Administration Revised Labeling Regulation EXEMPTIONS Center for Drug Regulation and Research 97
Exemptions 1) Drug products manufactured for export; 2) Veterinary drug products; 3) The container or primary pack containing the product is enclosed in a transparent covering and the particulars which are required to be set on the label on the container or primary pack are clearly visible through transparent covering, the transparent covering is exempted; 4) Products that are compounded by a pharmacist in accordance with the individual prescription of a medical practitioner or dentist for immediate use; Center for Drug Regulation and Research 98
Exemptions 5) Investigational drugs, i.e. new chemical or structural modification of a tried and tested or established drug proposed to be used for a specific therapeutic indication(s); 6) Foreign donated pharmaceutical products; 7) Products that require special handling (pre-filled syringes, cold chain); and 8) Low volume of importation Center for Drug Regulation and Research 99
Exemptions 1) GLE application – submitted with registration application 2) Approval – GLE Certificate w/ validity and number 3) Registration Number shall be reflected on the label Center for Drug Regulation and Research 100
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