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Alternatively rich text (formatted) can be used by editing the text in word or outlook in rtf format 
and copy pasting the formatted text in to the present and proposed fields. 
Complex table as part of the present and proposed section in the variation eAF cannot be included. Where 
a table is needed in the present and proposed section of the eAF you are able to include the information in 
separate annex included in folder 1.2 of the eCTD structure for Human applications or in the “1a-admin-
info” folder of the VNeeS structure for Veterinary applications. The annex should be attached as a 
separate PDF document, clearly named (for example ‘ema-form-annex-presentandproposed’) in the folder 
1.2 or folder “1a-admin-info” for VNeeS submissions. 
Text such as 'See Annex Present and Proposed' should be entered into the mandatory present and 
proposed fields of the eAF. 
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4a  Type II variations – new indications – orphan medicinal product information 
This section will only appear if variation type II has been selected. The section can be flagged out, if not 
applicable 
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Version 1.0 – July 2015
4b  Type II variations – Paediatric Requirements 
This section will only appear if variation type II has been selected. The section can be flagged out, if not 
applicable 
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Version 1.0 – July 2015
4c  Type II variations – Extended data exclusivity/market protection 
This section will only appear if variation type II has been selected. The section can be flagged out, if not 
applicable 
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ANNEXED DOCUMENTS (WHERE APPROPRIATE) 
DECLARATION OF THE APPLICANT 
SIGNATURE 
This section need to be completed in the same way as in other forms. You may refer to the respective 
section above. 
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RENEWAL FORM 
On the following pages technical information in regard to the renewal form is 
provided.  
1.  APPLICATION FORM FOR RENEWAL OF A MARKETING AUTHORISATION 
This form is applicable to both domains and you have to make a selection at first (indicated with arrows in 
the figure below): 
Another difference to the previous form is the indication whether the product is marketed or not (squared 
box), but all other details need to be completed as know from the MAA form or the variation form.  
Again  you  have  the  option  to  populate  the  product  details  in  section  ”Qualitative  and  quantitative 
composition” (section 3. 
Further product characteristics have to be provided: 
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In case of selecting “Veterinary” this section will be adapted to add the target species and it is expected 
that the ATC vet code and respective group are chosen (although not explicitly mentioned): 
Name and address of the Marketing Authorisation Holder will be handled in the same way as in other 
forms. Details provided here
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2.  APPROVED MANUFACTURERS 
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