New Zealand Regulatory Guidelines for Medicines

Part G:
Resources

Edition 6.14
July 2011
(consolidation of fifth edition and subsequent updates)

Table of Contents
PART G: RESOURCES Edition 6.14 1 July 2011 1 Description of Dosage Form........................................................................................................1 Routes of Administration .............................................................................................................3 Shelf Life and Storage Conditions...............................................................................................4 Abbreviations.................................................................................................................................5

Description of Dosage Form

The dosage form description for a product should be selected from the following list: Block Capsule Capsule, combination Capsule, liquid filled Capsule, modified release Capsule, powder filled Capsule, powder filled, nasal inhalation Capsule, soft gelatin Cement, bone, liquid component Cement, bone, powder component Cement, dental Chewing gum Chocolate, medicated Combination Condom, medicated Condom with spermicide Cream, rectal Cream, topical Cream, vaginal Crystals Dermal patch, local effect Diluent Dressing, medicated Drops, ear Drops, ear/eye Drops, ear/eye/nose Drops, eye, powder and diluent Drops, eye, solution Drops, eye, suspension Drops, nasal Drops, oral Elixir Emulsion, oral Emulsion, topical Enema Enema, powder for Eye strip, impregnated Foam Gas Gel, ophthalmic Gel, oral Gel, oral topical Gel, topical Gel, vaginal Granules, effervescent Granules, modified release Granules, oral Implant, subcutaneous Implant, intracranial Implant, intraocular Infusion, concentrate Infusion, emulsion Infusion, powder for Infusion, powder for concentrate Infusion, solution Inhalation, capsule, liquid filled Inhalation, capsule, powder filled Inhalation, powder Inhalation, solution Inhalation, solution, powder for Inhalation, suspension Inhalation, volatile liquid Inhaler, aerosol, metered Injection with diluent Injection, concentrate Injection, depot Injection, emulsion Injection, gel Injection, granules for Injection, powder for Injection, solution Injection, suspension Intrauterine contraceptive device Irrigation Irrigation, eye Irrigation, powder for reconstitution. Lacquer, nail Linctus Liniment Lotion, scalp Lotion, skin Lozenge Mouthwash, solution Mouthwash, solution, powder for Oil Oil, bath Oil, topical Ointment, ear/eye Ointment, eye Ointment, rectal Ointment, topical Ointment, vaginal

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Pad, skin wash impregnated Paste, oral Paste, topical Pastille Pessary Plant material Powder Powder, effervescent Powder, nasal Powder, topical Shampoo Skin wash Soap Solution Solution, antiseptic Solution, contact lens Solution, dialysis Solution, dialysis, powder for Solution, oral Solution, oral, granules for Solution, oral, powder for Solution, topical Solution, topical, powder for Solution, vaginal douche Sponge, vaginal Spray, contact lens solution Spray, nasal solution Spray, nasal suspension Spray, oral Spray, sublingual Spray, topical Spray, topical powder Stick, topical

Suppository Suppository, urethral Suspension, intratracheal Suspension, intratracheal, powder for Suspension, oral Suspension, oral, granules for Suspension, oral, powder for Suspension, rectal/oral Syrup Syrup, powder for Tablet Tablet for contact lens solution Tablet, chewable Tablet, chewable/dispersible Tablet, coated Tablet, dispersible Tablet, effervescent Tablet, enteric coated Tablet, film coated Tablet, modified release Tablet, orodispersible Tablet, soluble Tablet, sublingual Tablet, uncoated Tablet, vaginal Test kit Test kit, pregnancy Toothpaste Transdermal gel Transdermal patch Transdermal patch, systemic effect Vaginal ring Wafer

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Routes of Administration
The description of the route of administration for a product should be selected from the following list: Conjunctival Cutaneous Dental Endocervical Endosinusial Epidural Extra-amniotic Gingival Haemodialysis Implant Inhalation Insufflation Intra-amniotic Intra-arterial Intra-articular Intrabursal Intracardiac Intracavernous Intracervical Intracoronary Intradermal Intradiscal Intralesional Intralymphatic Intramuscular Intraocular Intraperitoneal Intrapleural Intrasternal Intrauterine Intrathecal Intratracheal Intravenous Intravesical Irrigation Nasal Opthalmic Oral Oromucosal Otic Periarticular Perineural Periodontal Peri-osteal Rectal Subconjunctival Subcutaneous Sublingual Submucosal Systemic Transdermal Transmammary transfer Ungula Urethral Vaginal

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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 protect from moisture below -20C (Deep freeze) below -5C (Freeze) at 2 to 8C (Refrigerate, do not freeze) at 8 to 15C (Cool) at 15 to 25C (Controlled room temperature) at or below 25C below 30C Use immediately

Note that in New Zealand below 25C means room temperature, whereas in Australia below 25C refers to air-conditioned facilities and below 30C 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

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Abbreviations

AAN ADR Ae API AUC

Australian Approved Name Adverse drug reaction Cumulative urinary recovery Analysis of variance Active pharmaceutical ingredient Area under the concentration vs. time curve extrapolated to

ADEC Australian Drug Evaluation Committee

ANOVA

ARTG Australian Register of Therapeutic Goods AUC AUC up to the last quantifiable concentration plus additional area infinity, calculated using kel AUCt

Area under the concentration vs. time curve (AUC) measured to the last quantifiable concentration AUC measured over one dose interval (T) at steady state MR product Ratio of AUC over the dosing interval to the total AUC

AUCTCSS AUCTS/AUC BAN BNF BP Cav CFC CMI Cmin CMN CoS Cpd

AUCTS AUC over the dosing interval (T) following a single dose of the British Approved Name British National Formulary British Pharmacopoeia Average concentration Chlorofluorocarbon Consumer Medicine Information Minimum observed concentration Changed Medicine Notification Certificate of Suitability (European Pharmacopoeial Commission) Pre-dose concentration determined immediately pre-dose

CARM Centre for Adverse Reactions Monitoring

Cmax Maximum observed concentration

CHMP Committee for Medicinal Products for Human Use (formerly known as CPMP Committee for Proprietary Medicinal Products) [Europe] CPP Ct CTD DF DMF EC EP Certificate of a Pharmaceutical Product The last quantifiable concentration Common Technical Document (ICH format) Degree of fluctuation = (Cmax - Cmin)/ (AUCT/T) x 100% Drug Master File European Community; or European Commission; or Enteric-coated [See Ph Eur] CRPN Changed Related Product Notification

EMEA European Medicines Evaluation Agency

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ERMA Environmental Risk Management Authority EU FDA FEV1 GC GMP GSC HRC ICH IMM INN European Union Food and Drug Administration [USA] Forced expiry volume in 1 second Gas chromatography Good Manufacturing Practice Generics Subcommittee of MAAC Health Research Council International Conference on Harmonisation Interchangeable Multi-source Medicine International Non-proprietary Name

GCRP Good Clinical Research Practice

HPLC High pressure (or performance) liquid chromatography HSNO Hazardous Substances and New Organisms Act

IMMP Intensive Medicines Monitoring Programme kel Terminal elimination rate constant MAAC Medicines Assessment Advisory Committee MARC Medicines Adverse Reactions Committee MCA MCC MOH MoH MoU MQC MR MRC MRT NBE NCE NF NMA Medicines Control Agency [UK]; or Medicines Control Advisor Medicines Classification Committee Medical Officer of Health Ministry of Health Memorandum of Understanding Minimum quantifiable concentration Modified release Medicines Review Committee Mean residence time New Biological Entity New Chemical Entity National Formulary [USA] 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 New Zealand Regulatory Guidelines for Medicines NZRGM OIA OTC

NZRP New Zealand Reference Product Official Information Act Over The Counter [i.e. nonprescription products]

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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 of European Ph Eur European Pharmacopoeia PHARMAC PMF PDP PU r r
2

dossier Ltd

Pharmaceutical Management Agency

Plasma Master File Principal Display Panel Prescriber Update Correlation coefficient Coefficient of determination Related Product

RP

SACN Self-assessable Change Notification SCOTTStanding Committee on Therapeutic Trials [an HRC committee] SMARTI SPC t TGA System for the Management of Activities, Risks and Therapeutic Information [Medsafe database] Characteristics

Summary of Product Elimination half-life

Therapeutic Goods Administration [Australia]

Tmax Observed time at which Cmax occurred TPDR Therapeutic Product Database Report [from SMARTI] TSE Transmissible spongiform encephalopathy USAN United States Approved Name USNF [see NF] USP VSC United States Pharmacopoeia Vaccines Subcommittee [of MAAC]

WHO World Health Organisation

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