You can ask for scientific advice from the Medicines and Healthcare products Regulatory Agency (MHRA) at any stage of the initial development of your medicine, before you have submitted your application for a marketing authorisation (MA) (product licence) and during the pre-submission period for a variation to an existing MA.
Meetings can also be held with the MHRA to discuss:
- proposals to change labelling or package leaflets
- post-authorisation regulatory advice relating to a product range
You can request a broader scope scientific advice. This would cover broader issues and would not relate to only 1 development programme or product.
You can also have a joint meeting with MHRA and National Institute for Clinical Excellence (NICE)…