Here’s your weekly must-read update from RosaPharma. This week’s edition comes all the way from an extremely windy and soggy Lisbon ⛈️🌪️

 

Contact us with any questions or feedback.

 

This proposal will be available for public consultation for 45 days and is structured into 4 annexes:

1. New Ingredients with Specifications Approved by Anvisa: A list of ingredient names along with their approved parameters for identification, purity and composition (disclosing the respective names of the applicant companies) will be available;
2. New ingredients with Compendial Specifications: This section will include all compendial specifications references. Contributions to additional compendial specifications can be suggested during the public consultation.
3. New Ingredients with Proprietary Specifications: Only the names of the ingredients and the respective proprietary companies will be disclosed. The specification parameters will remain unpublished.
4. New Ingredients with Specifications Approved under Specific Standards.

 

Furthermore, new requirements will be implemented for requests for approval of new ingredients, based on parity of specifications. These requests will only apply to New Ingredients that hold specifications already approved or recognized by ANVISA (corresponding to Annexes 1 and 2 above).

 

Although no specific date has been shared for when the public consultation will begin, it is expected to be announced very soon.

 

This is a developing narrative. We will keep you briefed as new information becomes available.