ࡱ> -0*+,] hbjbjzz /1\1\`^~^~֋֋֋֋֋T***Œd*NJzp8vl8$N֋R88RR֋֋4PPPR֋֋PRPP<O+"H0N[<VJ֋RRPRRRRRVRRRNRRRRRRRRRRRRR^~> : Guide to completing a New Medicine Application Over-the-Counter (OTC) Medicine Introduction This guide is a reference document to assist you with putting together a New Medicine Application (NMA) for an OTC medicine. For prescription medicines and related products please refer to the relevant guides for these types of medicines (ie, Guide to completing a New Medicine Application Prescription Medicine; and the Guide to completing a New Related Product Application). Not everything in this document applies to every new medicine application and the guide should only be used as a reference to completing the application form. Additional resources that you should utilise when putting together your application include: the relevant New Zealand medicines legislation international guidelines pharmacopoeias relevant sections of the  HYPERLINK "http://www.medsafe.govt.nz/regulatory/guidelines.asp" Guideline for Regulation of Therapeutic Products in New Zealand (GRTPNZ). Of particular use for OTC medicines is HYPERLINK "http://www.medsafe.govt.nz/regulatory/current-guidelines.asp"Part 2: Obtaining approval for new and changed medicines that describes the pre-market and evaluation process for OTC medicines. Appendix 3 to Part 2 describes the risk categorisation framework for OTC NMAs that defines the different OTC New Medicine Application categories, and the key application criteria. Appendix 3 should be your first point of reference in selecting the correct application category. Appendix 3 also contains a number of application selection tools that should be used to further refine your selection. Further information on these application selection tools is detailed below. NOTE: Please do not send this document to Medsafe with your application. Contents  TOC \o "1-4" \h \z \u  HYPERLINK \l "_Toc353357719" 1. Instructions for using the form for a New Medicine Application OTC Medicine  PAGEREF _Toc353357719 \h 3  HYPERLINK \l "_Toc353357720" 2. Application form for a New Medicine Application OTC Medicine  PAGEREF _Toc353357720 \h 3  HYPERLINK \l "_Toc353357721" 3. Determining the application category  PAGEREF _Toc353357721 \h 3  HYPERLINK \l "_Toc353357722" 4. Application format  PAGEREF _Toc353357722 \h 4  HYPERLINK \l "_Toc353357723" 5. Proposed product details, required for all applications  PAGEREF _Toc353357723 \h 5  HYPERLINK \l "_Toc353357724" 6. Additional information, where applicable  PAGEREF _Toc353357724 \h 7  HYPERLINK \l "_Toc353357725" 7. Applicant and sponsor details  PAGEREF _Toc353357725 \h 9  HYPERLINK \l "_Toc353357726" 8. Fees and invoice details  PAGEREF _Toc353357726 \h 9  HYPERLINK \l "_Toc353357727" 9. Product formulation  PAGEREF _Toc353357727 \h 10  HYPERLINK \l "_Toc353357728" 10. Product packaging, patient information, and storage conditions  PAGEREF _Toc353357728 \h 10  HYPERLINK \l "_Toc353357729" 11. Production  PAGEREF _Toc353357729 \h 10  HYPERLINK \l "_Toc353357730" 12. Provided information  PAGEREF _Toc353357730 \h 11  Instructions for using the form for a New Medicine Application OTC Medicine The NMA form for new OTC medicines is designed for electronic completion. All fields of the form should be completed. The macro enabled form is no longer available for use. Application form for a New Medicine Application OTC Medicine The form should be used when applying for consent to distribute a new OTC medicine. The same form should be used for medicines in all of the categories ie, N1, N3, N4, N5. Each application should also be accompanied by a completed New Medicine Application OTC Medicine Declarations and Commitments form. Determining the application category Before submitting an application, use the following application selection tools (located as Appendices to HYPERLINK "http://www.medsafe.govt.nz/regulatory/current-guidelines.asp"Part 2 of the GRTPNZ) to determine the correct application category and data requirements: Part 2 Appendices: Appendix 2: Application categorisation tool Appendix 3: OTC placement tool Appendix 4: Decision tree for umbrella branded OTC medicines Appendix 5: Additional notes on categorisation of applications for new OTC medicines Appendix 6: Summary of data requirements for new medicines applications Appendix 7: OTC dossier documents matrix. The selection of the appropriate category of application will determine the data requirements and additional information that the sponsor must supply in support of the application. Sponsors may contact Medsafe for additional clarification. Category N1An application for a clone. The clone must be identical to a previously approved parent product2 in all respects other than the product name and labelling. An application for a flavour/fragrance/colour (FFC) variant of a previously approved parent product2 where there is only a change in the content of the FFC agent(s) and where the product otherwise meets all the requirements applying to a clone. An application for an additional classification due to an additional pack size of a previously approved parent product2 and where the product otherwise meets all the requirements applying to a clone. New combination pack containing two or more currently approved parent products2; container for each unchanged. Combination products must be in a fully labelled outer carton; and the product must otherwise meet all the requirements applying to a clone. Note: the product name cannot include an umbrella segment categorised as requiring a higher category of assessment1.Category N2Note: category not currently applicable to New Zealand. This category of NMA may be implemented in New Zealand following trial in Australia.Category N3New application for a generic medicine other than those generic applications in categories N1, N2 or N4. Note: the product name cannot include an umbrella segment categorised as requiring a higher category of assessment1.Category N4An application for a generic medicine where the medicine: includes an umbrella branded product name where the umbrella segment is categorised as requiring a higher category of assessment 1 and/or requires supporting safety and/or efficacy (clinical / toxicological) data or a justification for not providing such data.Category N5An application for a new product that is an extension to a Generic category product including: new therapeutic indications new strengths new dosage forms new directions new combination products different patient population. An application for a product containing a new chemical entity as an active ingredient. 1Refer to the Decision tree for umbrella branded OTC medicines in Appendix 4 of Part 2 of the GRTPNZ for determination of the correct application category for umbrella branded medicines 2Parent product must have been previously approved for safety, efficacy and quality and must comply with current standards, including the Medsafe Labelling Statements Database. Application format Applications must be submitted in the CTD format in accordance with the OTC dossier documents matrix in HYPERLINK "http://www.medsafe.govt.nz/regulatory/guidelines.asp"Appendix 7 of Part 2 of the GRTPNZ. The only allowable exemption to the requirement for CTD format is for responses to RFIs, but only when the additional information or data is limited in volume. It is important for all RFI responses that the additional information or data be cross-referenced to the outstanding questions/issues in the RFI letter in numerical order. The minimum requirement is that Module 1 must be submitted with the application in hardcopy. It is acceptable to submit the rest of the dossier electronically, and two copies must be provided on CD. One copy of the application form must be completed for each separate product this means that any variation in the name, dose form, strength, classification, or identifier (eg. different flavour) will require a separate form. Proposed product details, required for all applications Type of application Select the type that best describes your application. The fee will be calculated from this information and one of the following should be entered: Category N1 clone Category N1 additional classification Category N1 new combination pack Category N1 new flavour/fragrance/colour variant Category N3 Category N4 Category N5 Justification for selection This is a brief description of how the application meets the application category criteria. Proposed trade name: This is the proposed name under which the product will be marketed in New Zealand. Identifier: If the proposed product is an extension of an existing product range, or the trade name is the drug substance name, the point of difference between the proposed and existing products should be stated (eg, manufacturer, flavour, strength, sugar free). Drug substance: This is the active ingredient in the proposed product. If the medicine contains multiple active ingredients, separate these by commas. Dose form: Select 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, intestinal 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 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 Topical Transdermal gel Transdermal patch Transdermal patch, systemic effect Vaginal ring Wafer Strength: The strength should be as stated on the labelling for each presentation of the product. New Zealand classification: New Zealand schedule of classifications can be found at the  HYPERLINK "http://www.medsafe.govt.nz/profs/class/classintro.asp" Medsafe website. Enter the name of the drug substance and click search. Route of administration: Select from the following list Conjunctival Cutaneous Dental Endocervical Endosinusial Enteral Epidural Extra-amniotic Gingival Haemodialysis Implant Inhalation Insufflation Intra-amniotic Intra-arterial Intra-articular Intrabursal Intracardiac Intracavernous Intracervical Intracoronary Intradermal Intradiscal Intragastric 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 Ungual Urethral Vaginal ATC classification: The ATC classification system can be accessed at the  HYPERLINK "http://www.whocc.no/atc_ddd_index/" WHO website. Search for the drug substance in the product field and enter the found description and the code into the Application Form field. Proposed indications and/or label claims: Proposed indications or label claims should be listed for all products. If the application is for a generic product, highlight any differences from the innovator. If the product is required to have a data sheet and the indication(s) is lengthy, reference may be made to refer to the data sheet. New Zealand Medicines Terminology: See the  HYPERLINK "http://www.nzulm.org.nz/search" New Zealand Universal List of Medicines for more information. A New Zealand Medicines Terminology Listing Certificate should be provided as part of the NMA process. Additional information, where applicable All products: Please list the details of the overseas approvals or submissions - country name, regulatory agency, and approval or submission date should be specified. Separate multiple entries by commas. Application where Module 5 contains bioequivalence studies: Information about the biostudy reference product should be provided. Applications based on a parent product: A parent product is a previously approved product where the safety, efficacy and quality of the medicine have been acceptably demonstrated, and that complies with current standards (including the  HYPERLINK "http://www.medsafe.govt.nz/regulatory/labelling.asp" Medsafe Labelling Statements Database). Category N1 All new OTC medicine applications submitted via category N1 require identification of the parent product, detailed information as to the selection of category N1 (ie, clone, classification difference, flavour/fragrance/colour differences, new combination pack) and detailed identification of the differences between the proposed and parent product as this assists with invoicing (see below). Categories N3 For category N3 the quality (CTD Module 3) data will always be evaluated in full, except, in the circumstance where all quality aspects of the product are identical to a product which has been previously approved by Medsafe. In this case the sponsor may provide an abbreviated Module 3 dossier (see HYPERLINK "http://www.medsafe.govt.nz/regulatory/guidelines.asp"Section 3.7 of Part 2 of the GRTPNZ ). For these abbreviated N3 applications the parent product should be clearly identified, and the differences between the proposed and parent product clearly detailed (see below). Categories N4 and N5 For categories N4 and N5 the CTD-formatted dossier must always be submitted in full. However, there may be some benefits to identifying any parent product as this may facilitate the evaluation process. Applications for additional name, strength, classification, flavour/fragrance/sweetener, dose form and combination pack: Under the current Medsafe fee schedule sponsors may submit applications for additional name, strength, classification, flavour/fragrance/sweetener, dose form and combination pack. These applications also require identification of a parent product. For ease of selection the OTC NMA categories have been mapped against the application type: Application categoryApplication TypeDifference from parent productN1* Additional name - Grade 1 new name to be used in addition to existing name all other details identical to parent product except for labelling new label displays new name, but all other information on the label is essentially the same as on the parent product label (even if layout is different) N1* Additional name - Grade 2 new name to be used in addition to existing name all other details identical to parent product except for labelling new label displays new name layout of label may be different from that of parent product some other information on the label is different from that on the parent product labelN1* Additional classification new classification to be used in addition to existing classification (with or without a new name) all other details identical to parent product except for labelling new label displays new classification (and new name, pack size, indications, dosage instructions, all required warnings if applicable)N1* Additional flavour or fragrance or type of sweetening new and parent products have the same dose form new product has a flavour or type of sweetening different from the parent product all other details identical to parent product except for labelling (if applicable)and specificationsN1* New combination pack new combination pack containing two or more currently approved drug products container for each component unchanged, or any change does not affect stability/shelf-life no change to indications or dosage of either componentN3+ Additional strength - Grade 1 new and parent products have the same dose form new product is a direct scale of parent product, or uses same excipient matrix all other details identical to parent product except for labelling and specificationsN3+ Additional strength - Grade 2 new and parent products have the same dose form new product is not a direct scale of parent product bioequivalence study not required all other details identical to parent product except for labelling and specificationsN3+ Additional strength - Grade 3 new and parent products have the same dose form new product is not a direct scale of parent product bioequivalence study not required other details different from parent productN3+ Additional dose form - Grade 1 new and parent products have different dose forms and the same or different strengths bioequivalence not relevant to new dose formN5 Additional dose form - Grade 2 new and parent products have different dose forms and the same or different strengths bioequivalence study or clinical data included* would be N3 if submitted with an N3 parent product; N4 if submitted with a N4 parent product; N5 if submitted with a N5 parent product. Would also need to comply with all other requirements for applicable category as outlined in Part 2 of the GRTPNZ. + would be N4 if submitted with a N4 parent product; N5 if submitted with a N5 parent product. Would also need to comply with all other requirements for applicable category as outlined in Part 2 of the GRTPNZ. Note: the product name cannot include an umbrella segment categorised as requiring a higher category of assessment. Refer to the Decision tree for umbrella branded OTC medicines in Appendix 4 of Part 2 of the GRTPNZ for determination of the correct application category for umbrella branded medicines. General requirements for applications based on a parent product: The name and TT50 number of the parent product should be provided, if known. If the parent product is part of the same application, the details should be as on the first (parent) application form. The relationship between the two products should also be detailed in the cover letter. Full access rights to the parent product must be provided. The differences between the parent product and new product must be selected as this is used in conjunction with the type of application to calculate the fee. Applicant and sponsor details New Zealand Sponsor: Details, including the street address, of the licence holder (entity responsible for the product on the New Zealand market) should be provided. Applicant: Details of the company or individual responsible for submitting the application and for responding to all correspondence should be provided. Fees and invoice details The fee will be calculated from the application type and application based on a parent product information. All fees are GST inclusive. A space is included for comments relevant to invoicing. On receipt of the application, a tax invoice and acknowledgement letter will be sent to the applicant. The invoice will be made out to the New Zealand Sponsor as this is the entity legally responsible for the application. A customer reference can be quoted on the invoice, if required. Product formulation Formulation details should be entered as provided in Module 3 of the dossier. Appropriate quality standards and units should be specified for each ingredient. The salt form of the drug substance should be entered into the table and the amount of free base should be included in brackets beside the salt form. The details of the proprietary ingredients should be supplied. If the ingredient has been previously registered with Medsafe, include the name and reference number. If the ingredient has not been previously registered with Medsafe, include in the dossier or arrange for the supplier to provide Medsafe with details of the unique company identifier (name, number), quality specifications, quantitative and qualitative formulation, and quality standards of individual ingredients issued by the suppliers. The formulation table should only include the proprietary ingredient name, content, and quality standard. Product packaging, patient information, and storage conditions Primary packaging refers to the packaging directly in contact with the drug product. Secondary packaging refers to the first component opened by the consumer, and any additional wallets, pouches, blister lidding, etc. All should be briefly described. All pack sizes proposed with the application should be listed. All applicable shelf life and storage conditions should be entered using only the provided dropdown lists. Any package types that are not applicable should have Not applicable entered. Production Manufacturers: The address of the actual site of manufacture should be provided. GMP certification should be issued by a recognised authority as listed in the  HYPERLINK "http://www.medsafe.govt.nz/regulatory/guidelines.asp" GRTPNZ. If a manufacturing step is not applicable to the application type Not applicable should be entered in the name section. DMF/Certificate of Suitability: The DMF number refers to the number assigned to the DMF by Medsafe. If the DMF number is not known, this field should be left blank. If supplying certificates of analysis as evidence of drug substance quality, this section should be left blank. Site responsible for batch release: This should be the site holding documentation for batches released onto the New Zealand market and is not necessarily the testing site. If the medicine is manufactured and packed overseas, the company should advise the name and address of the company who is importing the medicine into New Zealand. This site is termed the New Zealand site of batch release and is responsible for undertaking the duties described in section 42 of the Medicines Act 1981. Biostudy/clinical site: This is the site responsible for the clinical phase of the bioequivalence study. Bioanalytical testing site: This is the site responsible for testing the samples generated from biostudy subjects. Provided information Please indicate the number of volumes provided for each section and page numbers where the specified documents can be found, so the administration staff and the evaluators can quickly locate pertinent information in the dossier. It is very helpful to the evaluators when the entire dossier is re-paginated as one document.      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