How to renew your marketing authorisation (MA) to have the option to continue to market your medicinal product.

A marketing authorisation (MA) is granted for up to 5 years. You need to renew it at least 9 months before it expires. You can renew more than 1 MA if the products have the same active ingredient, dosage form, indications, periodic benefit risk evaluation report (PBRER) and renewal date. A reduced fee structure applies.

On first renewal, MAs are usually given unlimited validity, but if there are safety concerns a 5-year expiry date is given.

Apply to renew your MA

For MAs granted by national, mutual recognition and decentralised procedures you need to complete the renewal application form following best practice guidelines.

If you’re a UK applicant, submit your application and documents to the Medicines and Healthcare Products Regulatory Agency, on the MHRA portal (you’ll need to sign up if you haven’t already).

If your MA was granted under the decentralised or mutual recognition procedures submit your application and documents to all countries at the same time.

For MAs granted by the centralised procedure you need to complete the European application form on the European Medicines Agency website, following the EMA guidelines for applying.

Since January 2016 it has become mandatory for new marketing authorisation, renewal and variation application submissions to be made using electronic application forms (eAFs). This will apply to all procedure types, including national procedures. If you are making a submission using the portal, you will have to submit using the portal forms as well as submitting the eAF. If you are submitting your application through CESP you will only need to submit the eAF.

For the latest eAF updates please refer to the EMA website

You must pay your fee before submitting your application and include proof of payment when you submit your form and supporting documents.

You can now submit your application via the Central European System Platform (CESP).

Submissions through the Common European Submission Portal (CESP)

This system is available from the Heads of Medicines Agencies (HMA) and provides a simple and secure mechanism for exchange of information between applicants and regulatory agencies.

The purpose of the system is to:

  • provide a secure method of communicating with regulatory agencies via one platform
  • allow submission of an application once to reach all required agencies
  • reduce the burden for both industry and regulators of submitting/handling applications on CD-ROM and DVD

If you are a first time CESP user and wish to setup up an organisation/university or trust to manage multiple users on the system, register with CESP here.

If you are a standalone user and wish to upload for Non Commercial Use on your own behalf, register with CESP here.

Once registered you will receive credentials to access the portal to your registered email address.

Please view MHRA clinical trials guidelines here.

General CESP training is available to all registered users via CESP’s training menu once logged into the system. Training on demand videos are available and you can also sign up to our free online weekly live demonstrations. CESP encourage all users to attend training before using the system. View FAQs here.

Application process

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.

If you’ve applied to MHRA and need us to process your application quickly because of a commercial need or where there is a safety issue email the regulatory information service variationqueries@mhra.gsi.gov.uk or call 020 3080 7400.

Required documents

The documents you need to include are listed on the renewal application form.

For a fuller explanation of the required documents, see the EMA’s guidelines on renewals

You will also need to attach a proof of payment of the renewal fee.

Fees

See the fees for renewal applications.

Make a payment to MHRA before submitting your application.

Not renewing your MA

You must 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.

Contact

Email the pharmacovigilance service mailto:Area4-RENEW-PSUR-PIQ-BROMI-submission-queries@mhra.gsi.gov.uk if you have any queries.