Guidance

Types of application (legal basis)

You must include the appropriate legal basis for your application when you apply to MHRA for a marketing authorisation.

• From: Medicines and Healthcare products Regulatory Agency
• Published: 30 March 2021
• Last updated: 31 March 2021 — See all updates

The appropriate legal basis will depend the type of application you are making. The legal bases are:

• full application - Regulation 50 (previously Article 8(3) of Directive 2001/83/EC)
• generic application – Regulation 51 (application for UKMA(NI); regulation 51A (application for UKMA(GB)); regulation 51B (application for UKMA(UK)) (previously Article 10.1 of Directive 2001/83/EC)
• hybrid application – Regulation 52 (application for UKMA(NI)); regulation 52A (application for UKMA(GB)); regulation 52B (application for UKMA(UK)) (previously Article 10.3 of Directive 2001/83/EC)
• similar biological application – Regulation 53 (application for UKMA(NI)); regulation 53A (application for UKMA(GB)); regulation 53B (application for UKMA(UK)) (previously Article 10.4 of Directive 2001/83/EC)
• well-established use application – Regulation 54 (previously Article 10a of Directive 2001/83/EC)
• fixed-combination application – Regulation 55 (previously Article 10b of Directive 2001/83/EC)
• informed consent application - Regulation 56 (previously Article 10c of Directive 2001/83/EC)
• traditional herbal registrations - Regulation 127 (previously Article 16a of Directive 2001/83/EC)
• certificate of homeopathic medicinal products - (called Simplified Registration scheme) - Regulation 103 (previously Article 14(1) of Directive 2001/83/EC)
• national homeopathic products (called the National Rules Scheme) - Regulation 50(6)(g) and Schedule 10 (previously Article 16(2) of Directive 2001/83/EC)

Find out more

The legal basis for all types of application is set out in the Statutory Instruments:

You can read about The Rules Governing Medicinal Products – Notice to Applicants Volume 2A (chapter 1).

You can find out about changes to the reference medicinal products for new generic medicines or other abridged marketing authorisation applications.

We have guidance on making applications to MHRA for orphan designation products.

If you have any questions about the legal basis for your submission you can email [email protected].

Published 30 March 2021
Last updated 31 March 2021 + show all updates

1. 31 March 2021

   Regulations 51 to 53 have been updated to reflect the different types of application.

2. 30 March 2021

   First published.