Anvisa informs that the new subject codes for secondary application for registration and post-registration of synthetic drugs are already available. Therefore, the old codes will be deleted from the electronic petition system.

The documents from the virtual seminar held on 7/5 on the new publication flow for synthetic medicines, including the text that brings together the main questions and answers on the subject. The materials are gathered in this link. It is important to note that the questions and answers will be updated periodically. The receipt of contributions can be done using specific form. >

Check the changes below:</ span>




Old Codes< span data-ccp-props=”{“201341983″:0,”335559740″:259}”>

New codes

11627 GENERIC – Registration Documentation Information Form (FIDR) or Company Technical Analysis Opinion (Pate)</span >

12107 GENERIC – Registration Documentation Information Form (FIDR) – Quality Analysis Registration


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