Notes on the Enforcement of the AMG-EV, Version 5.0, of 1 Juli 2007

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1 Contents Explanatory Notes on the Enforcement of the Ordinance on the Submission of Documents within Licensing and Renewal Procedures for Medicinal Products (AMG-Submission Ordinance, AMG-Einreichungsverordnung, AMG-EV) of 21 December Version 5.0 of 1 July Explanatory Notes on the Enforcement of the Ordinance on the Submission of Documents within Licensing and Renewal Procedures for Medicinal Products (AMG-Submission Ordinance, AMG- Einreichungsverordnung, AMG-EV) of 21 December Version 5.0 of 1 July General remarks address for the electronic submission Information Hotline contact for electronic submissions in accordance with AMG-EV as well as explanatory notes on the on-line procedure electronic notification of variation Contact person for procedural and scientific questions Contact person ectd Modalities of electronic submission General Documents to be submitted... 6 Table 1 CTD-Module according to NTA Vol 2 B Supplementsl and additions New applications for marketing authorisation in accordance with Section 21ff. AMG / Request for ENR Technical specifications concerning s subject content attachments and file formats Problems with the MS-TNEF format in Outlook Zip containers Files with documents to be submitted Files with metadata Table 2 Construction of attribut.txt for procedure types Search for ENR / PNR Encryption of the container Version 5.0 of 1 July 2007 Page 1 / 38

2 5.3.7 Encryption software Encryption with the BfArM key Downloading of the BfArM key, encryption of the zip container File name convention Elements of file names for electronic submission to BfArM Table 3 Types of Document, set file names File name convention in accordance with ICH ectd Specification Checklist to monitor whether all conditions have been fulfilled Table 4 Checklist Item Verification and confirmation of s Confirmation of receipt and confirmation as to the coherence of the formal/technical properties Confirmation as to the intellectual verification of content Possible error messages regarding electronic verification of coherence of formal/technical characteristics Table 5 Error message Possible error messages regarding intellectual verification of submitted s Table 6 Error message System response What to do in the case of false-positive system responses Submission under a wrong ENR Submission of partly wrong data Important information concerning permission of exclusive submission of paper documents in accordance with Section 3 AMG-EV List of changes Table of figures: 1. Fig 1 Dialogue for download of BfArM public key Fig 2 Download subdirectory Fig 3 Import of key into key manager / Schlüsselverwaltung Fig 4 Selection and iimport of BfArM public key Fig 5 Schlüsselimport / key import dialogue Fig 6 Status message Schlüsselimport Fig 7 Display of imported key Fig 8 Fingerprint degree of trust Fig 9 Fingerprint check Fig 10 Ownertrust Fig 11 Encryption of zip container Version 5.0 of 1 July 2007 Page 2 / 38

3 12. Fig 12 Selection of BfArM key Fig 13 with attached zip container Figure 14 Cancellation of a false-positive system response Version 5.0 of 1 July 2007 Page 3 / 38

4 1 General remarks The AMG-Submission Ordinance (AMG-Einreichungsverordnung, called AMG-EV in the following) regulates the electronic submission of documents for applications for authorisation, variation or renewals in Module 1 and Module 2 of the Common Technical Documents (CTD, Within this purview, the AMG-EV as well as these Explanatory Notes override earlier regulations on the submission of documents. Divergent requirements in previous notifications are replaced by these Explanatory Notes. Aside from this, unless otherwise specified by the AMG-EV, the currently existing regulations on the submission of documents apply. This means, e.g., that if documents can or must be submitted on paper according to Sections 3 and 4 of the AMG-EV, the existing requirements for such submissions must still be observed. These Explanatory Notes override the previous explanatory notes of version 4.09 dated 01 August. 2 address for the electronic submission Attention: For test purposes, documents can be sent to the following address: Electronic submissions to the test address exclusively serve for testing for possibly existing formal errors and are not further processed by BfArM. In no case do positive test messages replace the actual submission. 3 Information 3.1 Hotline contact for electronic submissions in accordance with AMG-EV as well as explanatory notes on the on-line procedure electronic notification of variation Request for advice as to problems with electronic submission in accordance with AMG-EV should be addressed to the hotline account Contact person: Ms. Dudszus-Hentschel The hotline can be contacted by phone: / or / Attention: For enquiries about submitted documents refer to the serial number of the day (Tagesnummer) of the BfArM response mail. This number is found in the subject line (Betreffzeile) of the positive or negative response message. For further details see 6.5 System response. Questions about the application for a PNR or ENR or other frequently asked general and technical questions including system response are answered under FAQ on BfArM homepage. Version 5.0 of 1 July 2007 Page 4 / 38

5 Questions about the use or functionality of compression tools are principally not answered by BfArM. Information about the on-line procedure electronic notification of variation : Submissions via the procedure electronic notification of variation need not be additionally made to the a.m. address. However, the AMG-EV conventions, especially for the file format (rtf for SPC and PIL/Fach- and Gebrauchsinformation), remain valid unchanged. You will find further information on "Electronic notification of variation" on the BfArM homepage or PharmNet homepage: 3.2 Contact person for procedural and scientific questions Procedural and scientific questions concerning ongoing procedures are answered by the responsible project management. Please contact the address 3.3 Contact person ectd The AMG-EV for electronic submission does not interfere with the ectd submission procedure. Web addresses of ectd specifications are: ectd contact persons are General questions: Dr. Menges, phone: oder 0228/ , Technical questions: Mr. Kunz, phone: or 0228/ , 4 Modalities of electronic submission 4.1 General Electronic submission of documents is to be made to the address < >. At the same time the written version (paper) is to be sent to the regular mailing addresses depending on which procedure is used. For electronic submission of documents in accordance with Section 1 sub-section 2 of the AMG- EV only the web-technology is to be used. Thus, transfer of data via disk or CD is impossible. For more information please refer to the reasoning of the Federal Council of Germany (Bundesrat) on the AMG-EV of 10 November 2000 (BR-Drs/resolution 745/2000). The same applies to supplements, insofar as they are included in Section 2 sub-section 1 of the AMG-EV. Version 5.0 of 1 July 2007 Page 5 / 38

6 4.2 Documents to be submitted All documents listed in Section 2 sub-section 1 AMG-EV are to be submitted electronically, i.e. drafts for Labelling in accordance with Section 10 AMG Patient information in accordance with Section 11 AMG Expert information ("Fachinformation") in accordance with Section 11a AMG Expert Reports in accordance with Section 24 sub-section 1 numbers 1-3 AMG. In accordance with Commission Directive 2003/63/EC of 26 June 2003 and the "Hinweise zum Einreichen von Zulassungsanträgen im CTD-Format beim Bundesinstitut für Arzneimittel und Medizinprodukte" (Instructions on Submitting Applications for Marketing Authorisation in CTD Format to the Federal Institute for Drugs and Medical Devices) of 2 July 2003, use of the CTD format is mandatory as of 1 November 2003 (apart from the exceptions permitted in the a.m. instructions). Therefore, as of 1 November 2003 the term "Expert Report in accordance with Section 24 sub-section 1 numbers 1-3 AMG" is considered to mean the corresponding documents according to the Notice to Applicants, Vol 2 B, edition July 2003 as presented in the following comparison: Table 1 CTD-Module according to NTA Vol 2 B NTA NTA Vol 2 B, edition 1998 EU CTD (NTA Vol 2 B, edition 2005) CTD IC Expert Reports IC1 rsp. Section 24 (1) Expert Report on the chemical, pharmaceutical and biological documentation no. 1 AMG IC1 Product profile Introduction 2.2 IC1 Critical Assessment Quality Overall Summary Quality Expert Statement 2.3 IC1* Signature, Information on the expert* Information about the experts* 1.4* IC1 Appendix 1: Tabular Formats - - IC1 Appendix 2: Written Summary - - IC 2 rsp. Section 24 (1) no. 2 AMG Expert Report on the toxico-pharmacological documentation IC2 Product profile Introduction 2.2 IC2 Critical Assessment Nonclinical Overview 2.4 Nonclinical Expert Statement IC2* Signature, Information on the expert* Information about the experts* 1.4* IC2 Appendix 1: Tabular Formats Nonclinical Summary Pharmacology Tabulated Summary Pharmacokinetics Tabulated Summary Toxicology Tabulated Summary IC2 Appendix 2: Written Summary (Pharmacology) Nonclinical Summary Pharmacology Written Summary Pharmacokinetics Written Summary IC3 rsp. Expert Report on the clinical documentation Section 24 (1) no. 3 AMG IC3 Product profile Introduction 2.2 IC3 Critical Assessment Clinical Overview Clinical Expert Statement Version 5.0 of 1 July 2007 Page 6 / 38

7 NTA NTA Vol 2 B, edition 1998 EU CTD (NTA Vol 2 B, edition 2005) CTD IC3* Signature, Information on the expert1 * Information about the experts* 1.4* IC3 Appendix 1: Tabular Formats Synopsis of individual studies IC3 Appendix 2: Written Summary Clinical Summary Notice to Applicants Vol. 2A, 2B and 2 C is found on the EUDRALEX website: Notice to Applicants, Vol. 2B - Common Technical Document (CTD), June 2006, on: Notice to Applicants, Vol. 2B Electronic Common Technical Document (ectd), December 2006, on: The complete list of types of document to be submitted (cf. Point Elements of file names) applies to all applications for marketing authorisation, renewals of marketing authorisation in accordance with Section 31 and/or 105 AMG, and variations in accordance with Section 29 AMG. In order to accelerate all mutual recognition and decentralised procedures (RMS and CMS procedures) it is recommended to submit all informative texts during the procedure in coordination with the responsible project management. On completion of a procedure, the final version of the product information texts are to be submitted in accordance with the regulations of the AMG-EV and these Explanatory Notes. Registration procedures in accordance with Section 38 AMG and centralised European Procedures are not subject to the purview of Section 1 AMG-EV. Electronic submission for registration and/ or re-registration of homeopathic medicines 2 are not prescribed by law, however, in the interest of accelerating the procedure it is urgently recommended. The documentation according to Sections 10, 11, 11a as well as the Expert Reports according to Section 24 AMG must be submitted electronically as separate files (i.e. no summary of drafts of labelling and wording in accordance with Sections 10, 11 and 11a in one file). Furthermore, all links to other files in the respective file must be removed prior to saving. Any type of document must only be saved in one single file. Aside from this, splitting the types of documents (cf. Point Elements of file names) into individual files in the style of the ectd is only permissible in the following exceptions. Exception: In the case of Modules 2.3, 2.6 and 2.7 a splitting as in the ectd is possible. When doing this, the type of document is always to be provided with a 3-digit sequential number (cf Elements of file names). This sequential number is also to be assigned if only one file is submitted. * Until introduction of the electronic signature, these documents must be submitted on paper. However, in addition, they can also be submitted electronically (e.g. as a.pdf file). 2 Homeopathic medicines without specified indications are covered by the procedural type of registration or post-marketing registration. Version 5.0 of 1 July 2007 Page 7 / 38

8 Example: qos-001.rtf For a transitional period, submission of the documents CTD 2.2, 2.3, 2.4, 2.5, 2.6 and 2.7, instead of the Expert Report in accordance with Section 24 AMG, is considered to be sufficient to fulfil the AMG-EV. For each application (= processing number of the medicinal product = ENR hier ergänzen, s. folg. Hinweis ) a separate is to be sent to BfArM. Attention: If, for one ENR, one and the same type of document occurs repeatedly within an , this is rejected; exception cf. 5.4 File name convention. 4.3 Supplementsl and additions After 1 January 2001, electronic submission is required also for supplements or additional documents concerning drafts for Labelling (Section 10 AMG) Patient information leaflet (Section 11 AMG) Expert information ("Fachinformation") (Section 11a AMG) Expert Reports (Section 24 AMG sub-section 1, numbers 1-3, corresponding to Section 2 subsection 1 AMG-EV). This also applies to applications filed prior to 1 January Attention: With supplements take care that the dates stated in attribut.txt are identical with the date of application in the paper version, otherwise the reference might get lost. 4.4 New applications for marketing authorisation in accordance with Section 21ff. AMG / Request for ENR If the pharmaceutical company intends a new authorisation procedure, the BfArM is first to be informed of this in writing under the mailing address: Bundesinstitut für Arzneimittel und Medizinprodukte Z Antragseingang / Fachregistratur Kurt-Georg-Kiesinger-Allee Bonn, preferably via telefax no.:+49 (0)228/ , stating the name of the medicinal product and the pharmaceutical form. As a response to this informal letter, the applicant will receive a processing number (ENR) reserved for this procedure. In the case that the pharmaceutical company, as the applicant, has commissioned a consultant to apply for the ENR on the applicant s behalf, the PNR of the pharmaceutical company (applicant) must always be stated. Enclose a power of attorney unless already available at BfArM. Once received, the processing number should always be stated throughout the documents for application as well as in the dossier (e.g. in the corresponding field of the application forms). Version 5.0 of 1 July 2007 Page 8 / 38

9 Attention: Please do not reserve processing numbers as so-called "variables". The application should be submitted within four weeks after reservation of a processing number. As before, only actual submission of the application is relevant for the date of receipt of the application and not the advance assignment of the processing number. 5 Technical specifications concerning s More than one electronic submissions for one and the same ENR are possible. Since the system allocates serial number of the day, previous submissions do not get overwritten. The files to be sent with the submitted document should be compressed with the help of a compression program (e.g. zip or tar-formats) (cf Zip container). Attention: The following examples use zip containers, but they also apply to tar containers subject Only the 7-digit processing number (ENR) which is intended for the submission is to be stated in the subject line of the . The validation program checks whether the subject line exclusively states the processing number (ENR), if not, the is rejected. The is likewise rejected if the subject line is empty. The sender is not informed of this fact as the is considered spam mail content The text ( content ) of the is optional and is not evaluated by BfArM but is returned as an attachment to the confirmation of receipt. Therefore, the text can be used for in-company purposes attachments and file formats Every contains a zip container attachment with the files of the documents to be submitted including the attribut.txt with its metadata. If necessary, the zip container can be encrypted (cf Checklist) Problems with the MS-TNEF format in Outlook The use of MS outlook (MS-TNEF format) may cause problems because MS-TNEF chabges the file name: it packs the zip container in a winmail.dat thus blocking the electronic submission; the sender will wait in vain for a system response. For this reason, deactivate MS-TNEF in Outlook. Deactivation of MS-TNEF-formats: Select format in the index card/in der Registerkarte -Format auswählen Change to text only in format selection/formateinstellung auf Nur Text ändern Save the changes and re-write the . Version 5.0 of 1 July 2007 Page 9 / 38

10 5.3.2 Zip containers Exactly one zip container shall be provided with every . The name of the zip container shall be as follows: <7-digit ENR>. zip Example: zip Websites for information about data compression (Freeware-Download-Portal) &modus=suche&such=winzip&dtt_filter= Files with documents to be submitted Currently, the only file format readable by the BfArM with a justifiable effort in accordance with Section 1 sub-section 2 AMG-EV is the Rich Text Format (*.rtf) (cf. BR-Drs./resolution 745/00, p. 5). Use of the.pdf format (*.pdf) is permissible for complete documents if the text contained therein is additionally submitted separately as an.rtf file with identical name (cf. 5.4 File name convention). Furthermore, it is allowed to submit Module 2.3 Quality Overall Summary (also for Quality Expert Statement) exclusively as a.pdf file. However, the.pdf files must not contain any restricted or scanned documents. Modules ixq = Information about the Expert - Quality Expert; ixn = Information about the Expert -Non-Clinical Expert; ixc = Information about the Expert -Clinical Expert) are currently not part of the electronic submission. In any case they are to be submitted in paper and can additionally be submitted as.pdf files. Due to the possibility of transmitting macro viruses, files in MS Word format are excluded from processing. Furthermore, the use of text fields in the actual text is not permitted for safety reasons (with the exception of headers and footers). Attention: The files must be saved with MS Word as.rtf files. It is not sufficient to change the file extension to ".rtf". Version 5.0 of 1 July 2007 Page 10 / 38

11 5.3.4 Files with metadata Each zip container (attached to each submission mail) includes a file with metadata (attribut.txt), as already stated in 5.3 attachments and file formats. The file format is text (.txt), the standard file name is: attribut.txt The file contains the following describing attributes: Table 2 Construction of attribut.txt for procedure types authorisation: renewal: post-approval: zulassung verlaengerung nachzulassung Note: a. m. types of procedure apply likewise to the authorisation of homeopathic medicines with specified indication/s. Content of attribut.txt for the authorisation procedure for homeopathic medicines without specified indication/s: Registration registrierung Post-registration nachregistrierung Variation: aenderung pnr = pharmaceutical manufacturer number enr = entry number verf = type of procedure edat = dd.mm.yyyy (date of submission identical with the date of cover letter of paper version submission) Example attribut.txt: pnr = enr = verf = authorisation edat = pnr = pharmaceutical manufacturer number enr = entry number verf = variation aend = dd.mm.yyyy (date of submission identical with the date of cover letter of paper version submission) Example attribut.txt: pnr = enr = verf = variation aend = Attention: As in the above examples the following notation is preferred: lower case letters for the field names, blanks before and after the equals signs, lower case letters for the value list date format (dd.mm.yyyy). pnr (number for pharmaceutical company) always 7-digit, if necessary, leading zeros. enr (processing number) always 7-digit. Version 5.0 of 1 July 2007 Page 11 / 38

12 5.3.5 Search for ENR / PNR ENR and PNR can be searched for at in AMIS Public Section (chargeable part of the DIMDI database offer) Encryption of the container Optionally, the zip container can be encrypted. The encryption software will automatically add to the file name of the container.pgp or.gpg, depending on the software used, so the file name is either <7-digit ENR>. zip.pgp or <7-digit ENR>. zip.gpg Only entire zip or tar containers should be encrypted. Individual files of a zip container shall not be encrypted Encryption software Exclusively the PGP (Pretty Good Privacy) program or a product compatible with OpenPGP are to be used for encryption. Other encryption methods cannot be processed or used without an unjustifiable effort. The free program GnuPG and information on its use can be found on the internet under or The product is called, e.g., Windows Privacy Tray (WinPT Tray released). Depending on the version of the program, German is not used continuously. Example: Windows Privacy Tray, Version 07.96rc1 ( ). The following is a description of the necessary steps for downloading the encryption software: 1. Download of "gnupp-1.1-de-installer.exe" to a specified directory (e.g. C:\Programs\GnuPP) and installation of the program. 2. The programme Windows Privacy Tray is started from the start menu (Start -> Programs -> GnuPP -> Windows Privacy Tray); it is then constantly available in the taskbar Encryption with the BfArM key You will find the respective valid public key of the BfArM in the file: nnn=true. You can download the key (file BfArM-OpenPGP-AS-Key.asc) for encryption in the course of submissions in accordance with the AMG-EV and save as BfArM-OpenPGP-AS-Key-asc.txt in your computer. The public key is replaced by a new one every six months on 2 January and 1 July. This serves to increase the safety of both parties. Use of an expired key generates an error message Downloading of the BfArM key, encryption of the zip container The following is a description (Figures 1 to 11) of the necessary steps for downloading the public BfArM key and encrypting the zip container (Fig. 13 shows an prepared for an electronic submission plus attachment with encrypted zip container): Version 5.0 of 1 July 2007 Page 12 / 38

13 1. Fig 1 Dialogue for download of BfArM public key 2. Fig 2 Download subdirectory The file with the key is stored in your system in a download subdirectory you create yourself. Version 5.0 of 1 July 2007 Page 13 / 38

14 3. Fig 3 Import of key into key manager / Schlüsselverwaltung The BfArM public key is integrated via the menu option "Schlüsselverwaltung"/ key manager of the Windows Privacy Tray. Click on "Import" in the "Schlüssel"/ key menu. 4. Fig 4 Selection and iimport of BfArM public key The downloaded BfArM key file is selected and then imported. Version 5.0 of 1 July 2007 Page 14 / 38

15 5. Fig 5 Schlüsselimport / key import dialogue Click on "Öffnen" to open the "Schlüsselimport" dialogue. Click on "Import" to receive status message as in Fig Fig 6 Status message Schlüsselimport 7. Fig 7 Display of imported key Click on "OK" as in Fig. 6 to display the imported key in Schlüsselverwaltung / key manager. If the key is not displayed immediately close the Schlüsselverwaltung / key manager and reopen. Version 5.0 of 1 July 2007 Page 15 / 38

16 8. Fig 8 Fingerprint degree of trust In the "Schlüssel" menu option "Eigenschaften" you can check the fingerprint and adjust the degree of trust. 9. Fig 9 Fingerprint check For verification of key identity compare the fingerprint of the imported key with the published fingerprint. Version 5.0 of 1 July 2007 Page 16 / 38

17 10. Fig 10 Ownertrust 11. Fig 11 Encryption of zip container Open the file to be encrypted. Open Datei /file in the Dateimanager /file manager and click on Verschlüsseln to encrypt the.zip-file. Version 5.0 of 1 July 2007 Page 17 / 38

18 12. Fig 12 Selection of BfArM key Select the BfArM key in the "Datei verschlüsseln"/encrypt file dialogue. The status in the file manager states that the file has been encrypted. This is also apparent from the automatically added extension ".gpg". The file with the double extension "~.zip.gpg" is the encrypted zip file to be sent to the BfArM. 13. Fig 13 with attached zip container Now the mail is ready for electronic submission and can be sent. The encrypted zip container, e.g zip.gpg, is attached. Version 5.0 of 1 July 2007 Page 18 / 38

19 5.4 File name convention In accordance with the AMG-EV, the applicant must name the files in a zip container of an electronic submission pursuant to a harmonised file name convention: The minimum designation for the BfArM (cf Elements of file name, Table 3 - type of document, file name requirements) shall precede any company term. Attention: The following types of document have been newly adopted: palen for patient information leaflets in English (while document type pal has ceased to exist) palde for patient information leaflets in German (while document type pal has ceased to exist) phvsis for parmacovigilance system and qualified person riskmp for risk management action plan. Type of document (possibly with a respective sequential number which is added after a hyphen) and company term are separated by a hyphen. The hyphen after type of document is only necessary if a company term is added. Further hyphens can be included within this designation. The file name convention of the ICH ectd Specification V 3.0 of 8 October 2002 shall be observed (cf file name convention). As a rule, only one file of one type of document may be sent per mail. For several types of document, submission of multiple files per type is permitted. In this case the files are to be named with the corresponding type of document and a sequential 3-digit number. The numbering is an inherent part of the file name and must also be assigned if only a single file is submitted. Thus, the following file name would result, e.g., for "labelling (inner pack)": labip-001.rtf labip-002.rtf etc It is permitted and even encouraged that the files be submitted, possibly with the text corrections automatically made by MS Word highlighted. However, the identification of such files in the name of the file is not required. Further versions of this file (e.g. without the markings (clean version)) shall not be submitted. If a document contains diagrams or pictures, handling can be simplified as follows: a) in the.rtf format, diagrams and pictures are omitted b) in addition to the.rtf file, a.pdf file shall be submitted with the same file name which contains the complete text including diagrams and pictures. Example: labip-001.rtf and labip-001.pdf Version 5.0 of 1 July 2007 Page 19 / 38

20 Attention: The pdf file must not contain any restrictions. The submission is also rejected if only the pdf file is submitted without the corresponding rtf file. The sole exception is the type of document Quality Overall Summary, which can be submitted either as.rtf file or as pdf file (cf , Table 3 under qos-001). The types of document ixq, ixn and ixc are to be submitted in paper and can additionally be submitted as.pdf files. Hyperlinks are not permissible Elements of file names for electronic submission to BfArM Only those types of document stated in the list below shall be submitted electronically. The required file names are arranged in column 1 (left). See also our example zip container zip published on our homepage. Example: palde.rtf qos-001.rtf In accordance with the file name convention (cf ), you can make optional name extensions by hyphens. Example: qos-001-optional-extension.rtf It is recommended that the file name be structured: <document-><enr>-<procedure>-<yyyy-mm-dd> (yyyy-mm-dd is identical with the date of application in paper) Example: palen verl rtf Please remember that in additional submissions of pdf-documents, rtf file name and pdf file name are identical. Example: palen verl rtf palen verl pdf For files with diagrams and pictures: <Type of document according to the list below>[-<optional>].extension. Attention: The brackets are not part of the file name. They specify the part that can be inserted optionally. Of course, the limitations stated in Point with regard to use of upper and lower case and characters are also to be observed for this part. Example: labbl verl rtf Observe the notes following Table 3. Version 5.0 of 1 July 2007 Page 20 / 38

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