2.2.1 Size of submission Note: All Category 3 applications should be formatted according to the Common Technical Document (CTD) format. Only a single copy of any supporting data is required. In addition to the hard copy, an electronic copy is required. Module Number of Volumes Double Sided? Electronic copy attached? Yes No Yes No Yes No 2.2.2 Submission details Please provide an overview of the data submitted in support of the proposed variation, including an overview of the proposed variation with cross-references to Module 3 sections, if relevant. 2.3 Other information 2.3.1 Drug Master File (DMF), Plasma Master File (PMF) and Certificate of Suitability of Monographs of the European Pharmacopoeia (CEP) Will your request make reference to any of the following: Drug Master File Yes No TGA file number: Plasma Master File Yes No Name of PMF: TGA file number: Certificate of Suitability of Monographs of the European Pharmacopoeia Yes No
2.2.1 Size of submission Note: All Category 3 applications should be formatted according to the Common Technical Document (CTD) format. Only a single copy of any supporting data is required. In addition to the hard copy, an electronic copy is required. Module Number of Volumes Double Sided? Electronic copy attached? Yes No Yes No Yes No 2.2.2 Submission details Please provide an overview of the data submitted in support of the proposed variation, including an overview of the proposed variation with cross-references to Module 3 sections, if relevant. 2.3 Other information 2.3.1 Drug Master File (DMF), Plasma Master File (PMF) and Certificate of Suitability of Monographs of the European Pharmacopoeia (CEP) Will your request make reference to any of the following: Drug Master File Yes No TGA file number: Plasma Master File Yes No Name of PMF: TGA file number: Certificate of Suitability of Monographs of the European Pharmacopoeia Yes No
pm-forms-section9d-9d3-cat3-141117.docx