What you need to tell your health authority and when?
We can advise you on the key documents you will need to send your national health authority for each of the regulatory pathways you may need to use and in most cases we can give you an indication of how long you should expect it to take to receive approval.
If your patient’s scenario means a health authority approval is not required in advance, we will let you know of any additional responsibilities you may have.
For example, you may need to send a notification on receipt of the product. And if there is an urgent medical need, we can talk you through your health authority’s ‘fast track’ mechanism step-by-step.