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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 ...... 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 Implant, subcutaneous Capsule, combination Implant, intracranial Capsule, filled Implant, intraocular Capsule, modified release Infusion, concentrate Capsule, filled Infusion, Capsule, powder filled, nasal Infusion, powder for Capsule, soft gelatin Infusion, powder for concentrate Cement, bone, liquid component Infusion, Cement, bone, powder component Inhalation, capsule, liquid filled Cement, dental Inhalation, capsule, powder filled Inhalation, powder Chocolate, medicated Inhalation, solution Combination Inhalation, solution, powder for Condom, medicated Inhalation, Condom with spermicide Inhalation, volatile liquid , rectal , , metered Cream, topical with diluent Cream, vaginal Injection, concentrate Crystals Injection, depot , local effect Injection, emulsion Diluent Injection, 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 Linctus Emulsion, oral Emulsion, topical , scalp Lotion, skin Enema, powder for Lozenge Eye strip, impregnated , solution Foam Mouthwash, solution, powder for 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 , oral Suppository, urethral Paste, topical Suspension, intratracheal Suspension, intratracheal, powder for Suspension, oral Plant material Suspension, oral, granules for Powder Suspension, oral, powder for Powder, effervescent Suspension, rectal/oral Powder, nasal Powder, topical Syrup, powder for 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 Tablet, uncoated Sponge, vaginal Tablet, vaginal Spray, contact lens solution Test kit Spray, nasal solution Test kit, pregnancy Spray, nasal suspension Spray, oral gel Spray, sublingual 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 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 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 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 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]

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Part I Administrative/summary section of European dossier Part II & pharmaceutical section of European dossier Part III Pharmaco-toxicological section of European dossier Part IV Clinical section of European dossier Ph Eur European Pharmacopoeia PHARMAC Pharmaceutical Management Agency Ltd PMF Plasma Master File PDP Principal Display Panel PU Prescriber Update r Correlation coefficient 2 r Coefficient of determination RP Related Product SACN Self-assessable Change Notification SCOTT Standing Committee on Therapeutic Trials [an HRC committee] SMARTI System for the Management of Activities, Risks and Therapeutic Information [Medsafe database] SPC Summary of Product Characteristics t½ Elimination half-life TGA 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 United States Pharmacopoeia VSC Vaccines Subcommittee [of MAAC] WHO World Health Organisation

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