Practical guidance on the application form for centralised ...

1 Official address Domenico Scarlattilaan 6 1083 HS Amsterdam The Netherlands An agency of the European Union Address for visits and deliveries Refer to Send us a question Go to Telephone +31 (0)88 781 6000 25 February 2021 EMA/233564/ 2014 - Rev. 3 Procedure Management and Business Support Division European Medicines Agency Practical guidance on the application form for centralised type IA and IB variations This document is intended as guidance to facilitate the completion of the latest version of the application form for type IA and IB variations to be submitted in the centralised Procedure and should be read in conjunction with Changes introduced in of the variation form - guidance for applicants.

2 This document in not exhaustive; therefore, in case certain aspects are not covered, applicants may wish to contact the EMA Service desk, using the Question option. The Type of question to be selected is Post-authorisation queries , followed by the relevant sub-option Variation IA or Variation IB . If you do not have an EMA Account, you may create one via the EMA Account Management portal. European Medicines Agency Practical guidance on the application form for centralised type IA and IB variations EMA/233564/ 2014 Page 2/19 European Medicines Agency Practical guidance on the application form for centralised type IA and IB variations EMA/233564/ 2014 Page 3/19 European Medicines Agency Practical guidance on the application form for centralised type IA and IB variations EMA/233564/ 2014 Page 4/19 Selections made in section 1 Type of application will directly affect section 3 of the form.

3 Only relevant scopes will be available in section 3. In case of a single variation, only one scope can be selected. In case of a grouping of variations, a validation error will be raised if a single scope is selected. Please leave blank. The procedure number will be assigned by the Agency upon receipt of the application All applicable options should be indicated by ticking the appropriate boxes European Medicines Agency Practical guidance on the application form for centralised type IA and IB variations EMA/233564/ 2014 Page 5/19 Contact details of the authorised contact person registered with the Agency should be up to date. If they need to be modified, the change in contact person form should be sent to EMA Service desk by choosing from the Type of question drop down list HUMAN - Change of contact Post Auth and attaching the filled-in template on company headed paper.

4 European Medicines Agency Practical guidance on the application form for centralised type IA and IB variations EMA/233564/ 2014 Page 6/19 Only the presentation(s) (EU number(s)) affected by the change(s) should be listed. Please do not include by default the latest Annex A with the list of all approved presentations. For applications relating solely to the addition of new presentation(s), only the new presentation(s) should be indicated (EU number(s) confirmed with the Agency prior to submission).

5 If different changes apply to different presentations, all affected presentations should be listed in the table and a detailed description of the changes, together with an explanation of which change(s) apply/ies to which presentation(s), should be included in the 'Precise scope' section of the application Form. European Medicines Agency Practical guidance on the application form for centralised type IA and IB variations EMA/233564/ 2014 Page 7/19 Selection of scopes in section 3 is done by using dropdown menus to display available scopes based on the selection made in section 1. Please note that any changes in Type of application in section 1 will delete any selected variations!

6 Implementation date for Type IA/IAIN variations should be included here. Where relevant, tickbox for Art 5 will be automatically ticked. Tick the select tick box in order to select the applicable scope. If this box is not ticked and changes are made in the dropdown menu, the selected options will be deleted. When grouping is selected in section 1, and different procedure types have been selected in section 1, you will need to manually select the procedure type. Use the different drop-down menus to select the scope. European Medicines Agency Practical guidance on the application form for centralised type IA and IB variations EMA/233564/ 2014 Page 8/19 Make sure the applicable procedure type is selected.

7 In the note field, it is highly recommended to include the location (eCTD section) and name of the supportive documents under the relevant requirement. European Medicines Agency Practical guidance on the application form for centralised type IA and IB variations EMA/233564/ 2014 Page 9/19 The applicant is advised to add any relevant clarification/explanation as these can speed up the validation of the procedure. If one or several of the conditions are not met or not applicable, a justification should be provided in the free text field. European Medicines Agency Practical guidance on the application form for centralised type IA and IB variations EMA/233564/ 2014 Page 10/19 The applicant is advised to list the EUDRAGMDP reference numbers where a MIA or GMP certificate is a necessary document.

8 For EU sites, a valid MIA should be provided in order to avoid issues during validation. European Medicines Agency Practical guidance on the application form for centralised type IA and IB variations EMA/233564/ 2014 Page 11/19 To add another scope and display the different drop-down menus, use Show Variation Lists . To show previously selected scopes, use Show Selected Variation . Always ensure that you have selected the scope and ensure that the details are shown in the summary box before moving on. For IG applications (1 or >1 Type IA/IAIN variations affecting >1 product of the same MAH) or WS applications (a (group of) Type IB and/or Type II and/or Type IA/IAIN variations affecting >1 product of the same MAH), the same scope(s) (change(s)) must be applied to all products concerned by the application .

9 The scope(s) applied for should not be repeated for each product as this will incur unnecessary fees being invoiced. For variations concerning a single product, identical scope(s) (change(s)) should be repeated as many times as needed. + and buttons, as well as clone button are available to duplicate scopes you have already selected. European Medicines Agency Practical guidance on the application form for centralised type IA and IB variations EMA/233564/ 2014 Page 12/19 The precise scope should be clear, detailed and all individual changes should be listed separately as shown above. A ' guidance for applicants for the preparation of the 'precise scope' section of the variation application form' has been prepared to support marketing authorisation holders in completing this section.

10 When there is a grouped procedure, all individual changes should be listed with their corresponding description in the 'Precise scope' section and should correspond to the 'Present and proposed' table. Any proposed editorial changes (should also be listed and included in the 'Present and proposed' table. The editorial changes proposed should only affect the same part of the dossier concerned by the variation procedure fourth level of the eCTD dossier ( or ). For Type IB grouped applications a justification for grouping should be provided. This justification is not needed for IA grouped applications. If the product information is updated, the sections of the SmPC should be specified along with a description of the change.)