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New Zealand Regulatory Guidelines for Medicines

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New Zealand Regulatory Guidelines for Medicines New Zealand Regulatory Guidelines for Medicines Part G: Resources Edition 6.13 March 2011 (consolidation of fifth edition and subsequent updates) Table of Contents PART G: RESOURCES Section 1: Description of Dosage Form...............................................................................2 Section 2: Routes of Administration....................................................................................4 Section 3: Shelf Life and Storage Conditions .....................................................................5 Section 4: Abbreviations.......................................................................................................6 Description of Dosage Form The dosage form description for a product should be selected from the following list: Block Granules, oral Capsule Implant, subcutaneous Capsule, combination Implant, intracranial Capsule, liquid filled Implant, intraocular Capsule, modified release Infusion, concentrate Capsule, powder filled Infusion, emulsion Capsule, powder filled, nasal inhalation Infusion, powder for Capsule, soft gelatin Infusion, powder for concentrate Cement, bone, liquid component Infusion, solution Cement, bone, powder component Inhalation, capsule, liquid filled Cement, dental Inhalation, capsule, powder filled Chewing gum Inhalation, powder Chocolate, medicated Inhalation, solution Combination Inhalation, solution, powder for Condom, medicated Inhalation, suspension Condom with spermicide Inhalation, volatile liquid Cream, rectal Inhaler, aerosol, metered Cream, topical Injection with diluent Cream, vaginal Injection, concentrate Crystals Injection, depot Dermal patch, local effect Injection, emulsion Diluent Injection, gel Dressing, medicated Injection, granules for Drops, ear Injection, powder for Drops, ear/eye Injection, solution Drops, ear/eye/nose Injection, suspension Drops, eye, powder and diluent Intrauterine contraceptive device Drops, eye, solution Irrigation Drops, eye, suspension Irrigation, eye Drops, nasal Irrigation, powder for reconstitution. Drops, oral Lacquer, nail Elixir Linctus Emulsion, oral Liniment Emulsion, topical Lotion, scalp Enema Lotion, skin Enema, powder for Lozenge Eye strip, impregnated Mouthwash, solution Foam Mouthwash, solution, powder for Gas Oil Gel, ophthalmic Oil, bath Gel, oral Oil, topical Gel, oral topical Ointment, ear/eye Gel, topical Ointment, eye Gel, vaginal Ointment, rectal Granules, effervescent Ointment, topical Granules, modified release Ointment, vaginal New Zealand Regulatory Guidelines for Medicines (Volume 1, Edition 6.131, 2011) Part G: Resources Page 2 Pad, skin wash impregnated Suppository Paste, oral Suppository, urethral Paste, topical Suspension, intratracheal Pastille Suspension, intratracheal, powder for Pessary Suspension, oral Plant material Suspension, oral, granules for Powder Suspension, oral, powder for Powder, effervescent Suspension, rectal/oral Powder, nasal Syrup Powder, topical Syrup, powder for Shampoo Tablet Skin wash Tablet for contact lens solution Soap Tablet, chewable Solution Tablet, chewable/dispersible Solution, antiseptic Tablet, coated Solution, contact lens Tablet, dispersible Solution, dialysis Tablet, effervescent Solution, dialysis, powder for Tablet, enteric coated Solution, oral Tablet, film coated Solution, oral, granules for Tablet, modified release Solution, oral, powder for Tablet, orodispersible Solution, topical Tablet, soluble Solution, topical, powder for Tablet, sublingual Solution, vaginal douche Tablet, uncoated Sponge, vaginal Tablet, vaginal Spray, contact lens solution Test kit Spray, nasal solution Test kit, pregnancy Spray, nasal suspension Toothpaste Spray, oral Transdermal gel Spray, sublingual Transdermal patch Spray, topical Transdermal patch, systemic effect Spray, topical powder Vaginal ring Stick, topical Wafer New Zealand Regulatory Guidelines for Medicines (Volume 1, Edition 6.131, 2011) Part G: Resources Page 3 Routes of Administration The description of the route of administration for a product should be selected from the following list: Conjunctival Intrasternal Cutaneous Intrauterine Dental Intrathecal Endocervical Intratracheal Endosinusial Intravenous Epidural Intravesical Extra-amniotic Irrigation Gingival Nasal Haemodialysis Implant Opthalmic Inhalation Oral Insufflation Oromucosal Intra-amniotic Otic Intra-arterial Periarticular Intra-articular Perineural Intrabursal Periodontal Intracardiac Peri-osteal Intracavernous Rectal Intracervical Subconjunctival Intracoronary Subcutaneous Intradermal Sublingual Intradiscal Submucosal Intralesional Systemic Intralymphatic Transdermal Intramuscular Transmammary transfer Intraocular Ungula Intraperitoneal Urethral Intrapleural Vaginal New Zealand Regulatory Guidelines for Medicines (Volume 1, Edition 6.131, 2011) Part G: Resources Page 4 Shelf Life and Storage Conditions The claimed shelf life must be supported by stability studies. Such studies should meet the requirements of the ICH guidelines for stability testing. If specific storage conditions are required, the storage conditions statement should be selected or compounded using elements from the following list (or words of similar meanings): protect from light at 8° to 15°C (Cool) protect from moisture at 15° to 25°C (Controlled room temperature) below -20°C (Deep freeze) at or below 25°C below -5°C (Freeze) below 30°C at 2° to 8°C (Refrigerate, do not freeze) Use immediately Note that in New Zealand “below 25°C” means room temperature, whereas in Australia “below 25°C” refers to air-conditioned facilities and “below 30°C” refers to room temperature. Summary of Special Requirements [Also add matrix to show a list of medicines that need specific labelling requirements and warnings for data sheets. Example:] Medicine or Ingredient Labelling Requirements Data Sheet Requirement New Zealand Regulatory Guidelines for Medicines (Volume 1, Edition 6.131, 2011) Part G: Resources Page 5 Abbreviations AAN Australian Approved Name ADEC Australian Drug Evaluation Committee ADR Adverse drug reaction Ae Cumulative urinary recovery ANOVA Analysis of variance API Active pharmaceutical ingredient ARTG Australian Register of Therapeutic Goods AUC Area under the concentration vs. time curve AUC∞ AUC up to the last quantifiable concentration plus additional area extrapolated to infinity, calculated using kel AUCt Area under the concentration vs. time curve (AUC) measured to the last quantifiable concentration AUCTCSS AUC measured over one dose interval (T) at steady state AUCTS AUC over the dosing interval (T) following a single dose of the MR product AUCTS/AUC∞ Ratio of AUC over the dosing interval to the total AUC BAN British Approved Name BNF British National Formulary BP British Pharmacopoeia CARM Centre for Adverse Reactions Monitoring Cav Average concentration CFC Chlorofluorocarbon Cmax Maximum observed concentration CMI Consumer Medicine Information Cmin Minimum observed concentration CMN Changed Medicine Notification CoS Certificate of Suitability (European Pharmacopoeial Commission) Cpd Pre-dose concentration determined immediately pre-dose CHMP Committee for Medicinal Products for Human Use (formerly known as CPMP Committee for Proprietary Medicinal Products) [Europe] CPP Certificate of a Pharmaceutical Product CRPN Changed Related Product Notification Ct The last quantifiable concentration CTD Common Technical Document (ICH format) DF Degree of fluctuation = (Cmax - Cmin)/ (AUCT/T) x 100% DMF Drug Master File EC European Community; or European Commission; or Enteric-coated EMEA European Medicines Evaluation Agency EP [See Ph Eur] New Zealand Regulatory Guidelines for Medicines (Volume 1, Edition 6.131, 2011) Part G: Resources Page 6 ERMA Environmental Risk Management Authority EU European Union FDA Food and Drug Administration [USA] FEV1 Forced expiry volume in 1 second GC Gas chromatography GCRP Good Clinical Research Practice GMP Good Manufacturing Practice GSC Generics Subcommittee of MAAC HPLC High pressure (or performance) liquid chromatography HRC Health Research Council HSNO Hazardous Substances and New Organisms Act ICH International Conference on Harmonisation IMM Interchangeable Multi-source Medicine IMMP Intensive Medicines Monitoring Programme INN International Non-proprietary Name kel Terminal elimination rate constant MAAC Medicines Assessment Advisory Committee MARC Medicines Adverse Reactions Committee MCA Medicines Control Agency [UK]; or Medicines Control Advisor MCC Medicines Classification Committee MOH Medical Officer of Health MoH Ministry of Health MoU Memorandum of Understanding MQC Minimum quantifiable concentration MR Modified release MRC Medicines Review Committee MRT Mean residence time NBE New Biological Entity NCE New Chemical Entity NF National Formulary [USA] NMA New Medicine Application NMA-H New higher-risk medicine application NMA-I New intermediate-risk medicine application NMA-L New lower-risk medicine application NRL National Radiation Laboratory NRPA New Related Product Application NSAID Non-Steroidal Anti-Inflammatory Drug NZ New Zealand NZRGM New Zealand Regulatory Guidelines for Medicines NZRP New Zealand Reference Product OIA Official Information Act OTC Over The Counter [i.e. non- prescription products] New Zealand Regulatory Guidelines for Medicines (Volume 1, Edition 6.131, 2011) Part G: Resources Page 7 Part I Administrative/summary section of European dossier Part II Chemistry & pharmaceutical section of European dossier Part III Pharmaco-toxicological section of European dossier Part IV Clinical section
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