Why should I get a CADIFA?

[@amolgaikwad9491]

Good Information

[@AshwaniKumar-xi5xq]

Thank you Ma'am... wait eagerly for the next learning. Thank you so much once again.

[@pharmasolutionpakistan7668]

Good effory

[@lorenapereira1729]

Obrigada por facilitar nossa vida, Fernanda! Parabéns!

[@FernandaWaechter]

Feliz em saber que foi útil Lorena!! :)

[@rafaelpaes7515]

Excelente! Obrigado

[@rods4920]

Parabéns! Muito didático!

[@FernandaWaechter]

Obrigada!! :)

[@rajalakku4137]

Nice Explanation

[@pharmasolutionpakistan7668]

Good effort

[@ellykourany]

Dear Fernanda, many thanks for this video. For an existing medicine with a Marketing authorizations already approved by ANVISA, is a CADIFA mandatory or optional? Many thanks for your response

[@FernandaWaechter]

Hello! If the product is already approved, transitioning to a CADIFA is optional.

[@ellykourany]

Thank you very much Fernanda. If a CADIFA is submitted, can the API section of the Marketing authorization file be withdrawn? so that the company does not need to maintain 2 API files (with the variations etc).

[@FernandaWaechter]

@@ellykourany When the API supplier is requesting a CADIFA through the MAH, the open part of the DMF needs to be included in the MAH submission as well. However if the API supplier already holds a CADIFA, there is no need to submit the DMF to Anvisa through the MAH. In this case the MAH submission will just make reference to the CADIFA, however the MAH must have access to the open part of the DMF and keep track of variations as well - since some of them may have impact for the finished product and may require a variation by the MAH as well. Hopefully this answers your question, let me know if not.

[@Lil_cut]

😮