Modifications to guidance document "Formal requirements" and Modifications to the table "Documents to be submitted"


Update Guidance document for formal requirements:

  • Section 2.1 "Summary of submission formats" table adapted in respect of the "Bioequivalence trials" form and the number of copies of draft information for healthcare professionals/patient information texts
  • Section 2.1 New note stating that published documentation cited in paper-based applications can be submitted exclusively by electronic means
  • Section A. Note stating the "Bioequivalence trials" form no longer needs to be submitted as a Word document
  • Section A. Requirement extended ("forms" replaced by "documents")
  • Section A. Additional information for applications for parallel import supplemented and consecutive numbering of the subsections corrected
  • Section A. If no submission / authorisation for the relevant preparation exists in other countries, there is no need to submit the "Status abroad" form
  • Section 2.5.2 Consecutive numbering of subsections corrected
  • Section 3.1 Scientific Advice meeting / Section 3.2 Pre-Submission meeting: Specify the address of the requesting company and the exception for procedure with prior notification has been deleted.
  • Chapter A. Explanatory statement that, for applications under Art. 13 TPA, the Assessment Report of the Restricted Part, the LoQ and the company's answers to the Restricted Part must be submitted by the DMF holder.
  • Section 3.12 end / Section 3.13 end: The documentation for collective applications in paper format does not need to be submitted separately for each authorisation, but only once (original/copy).
  • New section 3.24.6: Additional specific requirements added for section A. Applications for parallel import.

Update to the table "Documents to be submitted"

  • Divider sheet “Extension+discon.”: a cover letter does not need to be submitted for an extension or a for a "no extension"
  • Divider sheet “Var. req. app.+maj. var.”, column “Var. req. notif.”: for Var. req. notif. Form Manufacturer information, Form Full declaration / packaging elements where applicable should be submitted; column “Var req. app/no sc. ass. auth CH/FL-> abroad only“: packaging elements, patient information und extract from the Registry of Trade are not necessary
  • Divider sheet “ NA+maj. var.“, column “NA Parallel import“: Cover letter, Form Full declaration must be submitted for both HUM and VET

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