Complaints procedure
Source: gov.uk (2025-12-11)

How to make a complaint about a service provided by the Medicines and Healthcare products Regulatory Agency.

1. Before you make a complaint

You can make a complaint if you are dissatisfied with the service provided by MHRA, for example if:
- mistakes have been made
- there were unreasonable delays
- you feel you’ve been treated poorly
We will not investigate complaints:
- about the service or care provided by hospitals, GPs practices, NHS services and other social care services, see feedback about complaints and NHS services (https://www.england.nhs.uk/contact-us/feedback-and-complaints/complaint/)
- about government policy or law
- about regulatory decisions
- that have already been investigated or are currently being investigated by Parliamentary and Health Service Ombudsman
- that are, or have been, subject to legal proceedings, including legal settlements
If your complaint is about something else, such as regulatory matters, it will still receive a response in line with our correspondence handling process.

2. Making a complaint

You should submit your complaint no later than 3 months after the incident has happened unless there are exceptional circumstances.

Please email the Customer Experience Centre (mailto:xxx@xxx.xx) explaining why you are unhappy with our service and how you believe we can put things right.

If your complaint is about our service, it will be allocated to someone within the team responsible for the issues about which you have complained. They will aim to investigate and respond to you within 20 working days and will advise if they need longer.

3. If you are not satisfied with our response

If you’re not happy with the first complaint response you received, you can ask for the Administrative Complaints Officer to review your case. The Administrative Complaints Officer will aim to respond within 20 working days and will contact you if she needs longer than this.

4. Wait for our final response

You will receive a final response from our Administrative Complaints Officer by email and this will contain details of how to contact the Parliamentary and Health Service Ombudsman if you remain dissatisfied.

Complaints made under the Freedom of Information Act 2000

Separate procedures cover complaints made under the Freedom of Information Act. If we cannot give you the information you have asked for, or have to charge for that information, we will explain the reasons why.

If you’re dissatisfied with the agency’s reply to your FOI request, or the decision to impose a charge, you can request a formal internal review. The response we send to you will tell you who to contact to request such a review, which will be done by a senior member of the agency who was not involved in the original decision.

Complaints made regarding the processing of personal data

When we process your information we will keep to the law, including the UK General Data Protection Regulation and the Data Protection Act 2018. Through appropriate management and strict controls, we will follow the 7 principles of data protection (https://eur01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fico.org.uk%2Ffor-organisations%2Fuk-gdpr-guidance-and-resources%2Fdata-protection-principles%2Fa-guide-to-the-data-protection-principles%2F&data=05%7C02%7CLorraine.Shuttleworth%40mhra.gov.uk%7C1ce41adade0b4684156008de37ef51a1%7Ce527ea5c62584cd2a27f8bd237ec4c26%7C0%7C0%7C639009698173774274%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=F2zmEgQDMZJufEYXpdakhKdYBJK4SOJIgPQNKJ28LVE%3D&reserved=0) described in the act.

If you have any queries about how the agency protects and uses your personal data or are dissatisfied with how your personal information has been managed, please contact xxx@xxx.xx (mailto:xxx@xxx.xx) in the first instance. You may also contact the DHSC Data Protection Officer at xxx@xxx.xx (mailto:xxx@xxx.xx).

Alternatively, you can contact us in writing:

Data Protection Officer MHRA 10 South Colonnade London E14 4PU

Or

Data Protection Officer DHSC 39 Victoria Street London SW1H 0EU

For independent advice about data protection, privacy and data sharing issues you can contact the independent Information Commissioner’s Office (https://eur01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fico.org.uk%2F&data=05%7C02%7CLorraine.Shuttleworth%40mhra.gov.uk%7C1ce41adade0b4684156008de37ef51a1%7Ce527ea5c62584cd2a27f8bd237ec4c26%7C0%7C0%7C639009698173807671%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=vCwi0dd%2FDvkLKkVVdrRm9xNZRVMaUjRC39OxLAdG5Zo%3D&reserved=0) at:

Wycliffe House Water Lane Wilmslow Cheshire SK9 5AF

Tel: xx-xxxx-xxxx

Whistleblower referrals

Contact the whistleblowing section if you are reporting on issues as an employee, ex-employee or third-party employee of the company or organisation in question.

Email xxx@xxx.xx (mailto:xxx@xxx.xx) or phone xx-xxxx-xxxx.

All other queries about potential illegal dealings should go to Medicines enforcement (https://www.gov.uk/guidance/contact-mhra#medicines-enforcement).