Dr Marsh answers a few fundamental questions on licence renewals, with a UK slant.
For how long is my Marketing Authorisation valid?
A Marketing Authorisation (MA) is granted for up to 5 years. You need to renew it at least 9 months before it expires.
Can I renew multiple MAs at the same time?
You can renew more than 1 MA if the products have the same:
- active ingredient
- dosage form
- periodic benefit risk evaluation report (PBRER)
- renewal date
What happens after the first renewal?
When the first renewal is granted, the MA is usually given unlimited validity but if there are safety concerns a 5-year expiry date is given.
How do I renew my licence?
You need to complete the renewal application form for MAs granted by:
- mutual recognition procedures (MRPs)
- decentralised procedures (DCPs)
For further information on this please see our blog on MRP and DCP Renewals
For MAs granted by the centralised procedure we have written separately on this – keep an eye out!
What is the arrangement for fees?
You must pay your fee before submitting your application and include proof of payment when you submit your form and supporting documents. A reduced fee structure applies if you are renewing multiple MAs in one submission.
How long does it take to process a renewal application?
It takes at least 3 months to process a renewal application, although you can continue to market your product as long as you have submitted the form with the required documents.
What if I need the MHRA to process my renewal application quickly?
There may be occasions when you need your renewal application processed quickly such as in the case of:
- a commercial need or
- where there is a safety issue
In these cases you can email the MHRA’s regulatory information service email@example.com or call on 020 3080 7400.
What documents are required?
The documents you need to include are listed on the renewal application form.
What should I do if I no longer wish to keep my licence?
You will need to cancel or withdraw your marketing authorisation if you don’t want to keep it, only removing the medicinal product from the market after you’ve done this. You must also inform the Department of Health, following their guidelines for discontinued medicines.
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