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VO-Form Application for Authorisation / Variation human medicines . Applicant / authorisation holder (marketing company) Address for correspondence Name Street PC/Town Telephone Fax E-mail (if not identical to the authorisation holder) ...... ...... ...... ...... ...... ...... Name Street PC/Town Telephone Fax E-mail ...... ...... ...... ...... ...... ...... Legal representative (if not identical to the authorisation holder) Name ...... Street ...... PC/Town ...... Telephone ...... Fax ...... E-mail ...... Power of attorney provided to Swissmedic yes no* *If no: Power of attorney included with this application (including original signature) Name of the medicinal product ...... (or for complementary and herbal medicinal products, the basic company dossier / master dossier, if known and applicable) Authorisation No. ...... (or for complementary and herbal medicinal products, the basic company dossier / master dossier, if known and applicable) Application No. ...... (issued on initial application reception) eCTD sequence no.: ...... n/a Active pharmaceutical ingredient(s)* ...... Dosage form* ...... Indication ...... Pharmaco-therapeutic group Dosage strength(s) ATC Code ...... Sales packaging (primary packaging) IT-No. ...... Packaging (secondary packaging) (e.g. blister pack) (All packaging sizes including hospitalsize packs) ...... ...... ...... ...... ...... ...... ...... ...... ...... ...... ...... ...... ...... ...... ...... * For applications for complementary medicinal products, only if applicable Product category Complementary and herbal medicines Advanced therapy products Allergens for in vivo diagnosis or therapy Synthetic drugs Vaccines and blood products Biotechnological drugs Radiopharmaceuticals Collective application Collective applications are only permitted for variations requiring approval in accordance with Appendix 7, section 1, para. 1, section 2, para. 2 and 3, section 2 of the Medicinal Products Authorisation Ordinance (AMZV). The present form must be completed for each product within a collective application. Please list the names and authorisation nos. for the products concerned by this collective application: ..... QM-Ident: ZL000_00_003e_FO / V22 / cis / dts / 01.03.2016 1/6 Swissmedic • Hallerstrasse 7 • CH-3000 Berne 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12 VO-Form Application for Authorisation / Variation human medicines First authorisation New active pharmaceutical ingredient (NAS) Known active pharmaceutical ingredient with innovation* Known active pharmaceutical ingredient without innovation* Medicinal product for which simplified authorisation is not possible (Art. 12, para. 4,VAZV) Biosimilar New combination (Art. 6 AMZV) Parallel import (Art. 14 Abs. 2 HMG) Notification procedure / Co-marketing (Art. 32 et. seq. VAZV) Limited time authorisation (Art. 9, para. 4, TPA) Major variations in accordance with Art. 12, VAM Change of active pharmaceutical ingredient (without recombinants) Change of pharmaceutical form Change or addition of doses (=dosage strength) Change or addition of route of administration Change or addition of indication Change or addition of recommended dose Change of active pharmaceutical ingredients manufactured using recombinant technologies or procedures, incl. manufacturing procedures (Art. 12, para. 4, VAZV, Appendix 9, AMZV) Change of a genetically modified organism Other applications: Conversion of co-marketing to independent authorisation Adjustment of dispensing category Extension of the authorisation (see separate form) Answer to an approval with condition regarding quality aspects Answer to an approval with condition regarding clinical or preclinical aspects Other: ...... Variations requiring approval without scientific evaluation (Appendix 7, section 3, AMZV) Change to product information (Appendix 7, section 3, para. 1, sections 1 and 2, AMZV) Change of product name Renouncement of a dosage strength number (formerly sequence) New pack size(s) or change of pack size(s) Now only for export instead of marketing in Switzerland In addition to authorisation for export, new authorisation for marketing in Switzerland Transfer of authorisation Change to packaging material / Changes to information on the container Changes to the packaging materials in line with the provisions of the revised Ordinance on the Authorisation of Medicinal Products (AMZV) that came into force on 1 January 2013, without other changes Adjustment of the dispensing category to change on list of substances Variations requiring approval with scientific evaluation (Appendix 7, section 2, AMZV) Quality (see separate form) Product information – major evaluation (concerns more than two sections) Product information – major evaluation (safety relevant) Product information – minor evaluation (concerns 1 or 2 sections) Prolongation of the supplementary first applicant protection from 3 to 5 years *If applicable please insert: Name of the reference product and, if used, the foreign comparator product: ...... Authorisation no. of the reference product: ...... Applications for complementary medicinal products without indication only First authorisation Complementary medicinal product without indication (Art. 17, para. 2 or Art. 26, Ordinance on Complementary and Herbal Medicinal Products, KPAV) Homeopathic or anthroposophic medicinal product without indication, with reduced dossier (Art. 17, para. 1, KPAV) Variation Complementary medicinal product without indication, with reduced dossier (in accordance with the form "Variation with reduced dossier)" Modification to basic company dossier Modification to product notifications Modification to the master dossier Authorisation by the notification procedure (Art. 19 et. seq. or Art. 27 et. seq., KPAV) Extension Basic company dossier for complementary medicinal products Extension, using the HOMANT notification without indication procedure, of complementary medicinal products Product notifications for complementary medicinal products without indication without indication Other applications Master dossier for homeopathic or anthroposophic medicinal Change to the HAS list products without indication Support case, HOMANT software Sample quality documentation for an Asian medicinal product Other: ...... without indication QM-Ident: ZL000_00_003e_FO / V22 / cis / dts / 01.03.2016 2/6 Swissmedic • Hallerstrasse 7 • CH-3000 Berne 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12 VO-Form Application for Authorisation / Variation human medicines Other information Is any TSE risk material used for the manufacture of the drug? Are other materials of animal origin used for the manufacture of the drug? Is human material used for the manufacture of the drug? Are blood or blood components used for the manufacture of the drug? Does the medicinal product consist of active pharmaceutical ingredients or excipients that contain, or could contain, a fraction manufactured from GMO? Does the drug contain synthetic nanoparticles 2? if yes: Which component of the medicinal product contains nanoparticles 2? Active substance(s): ..... see Module(s): ..... Excipient(s): ..... see Module(s): ..... Other: ..... see Module(s): ..... Does the preparation contain a narcotic ingredient? If yes, the narcotic ingredient is classified as list a Is a Drug Master File used? Is a Site Master File for foreign manufacturing sites used for vaccines and blood products? Orphan Drug granted on: b yes1 yes1 yes1 yes no no no no yes1 yes no no yes c yes1 yes1 no d no no ...... (Separate application for Orphan Drug Status necessary if status not yet granted.) Does a decision on the part of a foreign authority exist for this application, or has the application been submitted to a foreign authority? Yes: the form Status of authorisation applications abroad is provided. No: this application has neither been submitted abroad, nor does a decision on the part of a foreign authority exist for this application. In accordance with the Table of documents to be submitted, the submission of the form Status of authorisation applications abroad is not required for this application. An application for the test results by foreign authorities to be taken into account (Art. 13, TPA) is submitted simultaneously to this application. yes3 no An application to view the assessment report disclosed to the applicant when the decision is opened is submitted simultaneously with this application 4: 1 2 3 4 yes no If yes, please provide the corresponding forms / documents; for applications for variation, however, only submit these if they are relevant for the application in question, i.e. if the currently authorised status has changed in any way. The particles have at least one dimension on the nanoscale (1-1000nm) plus a function and / or mode of action based on nanotechnology characteristics. If yes, please include the checklist formal control application authorisation human medicines Art. 13, TPA. Only applies to application types for which Swissmedic prepares evaluation reports (generally first authorisations and major variations). For changes to the product information We confirm that all changes, including those that are still pending with Swissmedic, are clearly marked as such. Changes that are still pending are marked in a different colour, and include the submission date of the application. The rest of the text corresponds to the current status in accordance with the last approved version of the text dated (day/month/year). Any changes requiring notification that have been submitted to Swissmedic and to which it has made no objection are taken into consideration in the attached product information texts. yes n/a Packaging material / laser printout We hereby explicitly confirm that the appended laser printout of the above-mentioned product is completely identical in terms of text and graphics with the original printout of the packaging material. yes n/a eDok confirmation of identical documentation We confirm that the electronic copy and the paper documentation are complete and identical. We hereby confirm our agreement for the review by Swissmedic to be carried out using the electronic documents only. yes n/a QM-Ident: ZL000_00_003e_FO / V22 / cis / dts / 01.03.2016 3/6 Swissmedic • Hallerstrasse 7 • CH-3000 Berne 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12 VO-Form Application for Authorisation / Variation human medicines Documents submitted: Other documents for Module 1 If not stated in the appended checklist or if no checklist is appended, if yes, insert list here: .................................................. Non-CTD format Section I Section II Section III Section IV Number of folders Number of CD/DVDs CTD-format Module 1 Module 2 Module 3 Module 4 Module 5 Number of folders Number of CD/DVDs ...... ...... yes no ...... ...... For new applications and major variations: Meetings with companies Presubmission meeting Scientific advice meeting Date: ...... Date: ...... Procedures Fast-track authorisation application approved on: ...... with prior notification approved on: ...... Dispensing category A Single dispensing on medical prescription B Dispensing on medical prescription C Dispensing after expert consultation by medical personnel D Dispensing after expert consultation E Dispensing without expert consultation Market introduction Intended for introduction onto the Swiss market Intended for distribution abroad only Information exchange with partner authorities of the Consortium The authorisation holder permits Swissmedic to exchange the evaluation reports that it draws up on these medicinal products within the framework of collaboration with partner authorities of the International Regulators Consortiums (Therapeutic Goods Administration of Australia, Health Products and Food Branch of Canada and Health Sciences Authority of Singapore), based on the existing agreements for the purposes of information exchange and as support for forming opinions. Swissmedic is thus authorised to provide its evaluation reports to partner authorities on request 1. The decision regarding an authorisation is made independently of any information exchange with Swissmedic. Swissmedic informs the authorisation holder in writing if an exchange of evaluation reports takes place. 1 These evaluation reports may contain, among other aspects, confidential data such as personal data, business secrets and both positive and negative evaluations with regard to the assessment of an authorisation. yes QM-Ident: ZL000_00_003e_FO / V22 / cis / dts / 01.03.2016 no 4/6 Swissmedic • Hallerstrasse 7 • CH-3000 Berne 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12 VO-Form Application for Authorisation / Variation human medicines Evidence of notification of the use of a genetic resource or related traditional knowledge in accordance with the Nagoya Ordinance According to Art. 3 para. 1bis of the Ordinance on Therapeutic Products (TPO; SR 812.212.21), a new application for authorisation of a medicinal product whose development is based on the use of genetic resources or related traditional knowledge must include the registration number pursuant to Art. 4 para. 3 or 8 para. 5 of the Nagoya Ordinance (NagO, SR 451.61). The registration number serves as evidence that the obligation to notify pursuant to Art. 4, 5 or 8 of the NagO is satisfied, and is a prerequisite for authorisation according to Art. 7 para. 1 bis of the TPO. The obligation to notify according to Art. 4 NagO must be complied with if access to the genetic resource was gained after 12 October 2014 (see Art. 25d of the Federal Act on the Protection of Nature and Cultural Heritage (NCHA]; SR 451). If the use of traditional knowledge relating to genetic resources pursuant to Article 23p NCHA is involved, the obligation to notify according to Art. 4 NagO is similarly applicable. If the use of a genetic resource from Switzerland pursuant to Art. 8 NagO is involved, evidence that the obligation to notify has been met is to be provided once Art. 8 NagO has taken effect from 1 January 2017. Additional information on the requirements can be found in the guidance document Formal requirements. Is the new application for authorisation subject to the obligation to notify pursuant to Art. 4, 5 or 8 of the NagO? yes no n/a If yes, the registration number issued by the FOEN as evidence that the obligation to notify has been met is as follows: ..... QM-Ident: ZL000_00_003e_FO / V22 / cis / dts / 01.03.2016 5/6 Swissmedic • Hallerstrasse 7 • CH-3000 Berne 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12 VO-Form Application for Authorisation / Variation human medicines This page must always be completed We hereby confirm that all existing data that is relevant for the quality, safety and efficacy of the medicinal product has been submitted as required. The information provided herewith is certified to be accurate and complete. (Official stamp of the applicant / authorisation holder (marketing company)) Compulsory Optional (other signature) Place, date ...... Place, date ...... Signature ………………………………………….. Signature ......................................................... Person responsible Surname ...... First name ...... Job title ...... Telephone ...... E-mail ...... Other person Surname First name Job title ...... ...... ...... The application must be sent to Swissmedic, Swiss Agency for Therapeutic Products P.O. Box, Hallerstrasse 7, 3000 Berne 9 For inquiries contact Telephone +41 58 462 02 11 Fax +41 58 462 02 12 QM-Ident: ZL000_00_003e_FO / V22 / cis / dts / 01.03.2016 6/6 Swissmedic • Hallerstrasse 7 • CH-3000 Berne 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12 VO-Form Application for Authorisation / Variation human medicines Change history Version Valid and binding as of: Modified without version change Description, comments (by author) Author’s initials 25.10.16 Initials in footer corrected and date modified in the change history. tsj 08.08.16 Chapter structure modified. fua 20.05.16 Page 3: Language “view the assessment report disclosed to the applicant” has been corrected. cis 07.03.16 22 01.03.16 07.01.16 The passage regarding Nagoya has been moved to the chapter „New applications and major variations” Page 4: New passage “Evidence of notification of the use of a genetic resource or related traditional knowledge in accordance with the Nagoya Ordinance” cis dts The by mistake deleted “eDok confirmation of identical documentation” has been inserted again. cis 21 01.01.16 There is no need to supply an additional hard copy of entirely paper-based submissions. dts 20 30.11.15 Modification of the procedure for applications to change the name and domicile of the authorisation holder and for transferring authorisation cis 19 01.07.15 Page 3: Option to apply to view the public evaluation report added; Reference to submission of form ZL000_00_009e_FO_Human_blood_components deleted apk 18 01.01.15 Applicants will no longer be required to confirm that they are Swissmedic Portal users, either on the form Application for authorisation / variation or in correspondence. er The telephone and fax numbers within the document have been updated in line with those in the footer. sel Page 1: Extension of the time limit for uploading the medicinal product information to the Swissmedic portal, from 5 to 7 calendar days; eCTD sequence no. now included; eDok confirmation of identical documentation; Page 3: Clarification provided regarding documents to be submitted; text confirmation in the case of additional text correction rounds deleted: this confirmation must be submitted separately. er 13.10.14 17 01.09.14 QM-Ident: ZL000_00_003e_FO Swissmedic • Hallerstrasse 7 • CH-3000 Berne 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
