GOV.

UK

Home Marketing authorisations, variations and licensing guidance

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
(/government/organisations/medicines-and-healthcare-products-regulatory-agency)

Published
30 March 2021
Last updated
31 March 2021 —

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)
(http://ec.europa.eu/enterprise/sectors/pharmaceuticals/documents/eudralex/vol-
2/index_en.htm).

You can find out about changes to the reference medicinal products for new
generic medicines or other abridged marketing authorisation applications
(https://www.gov.uk/guidance/reference-medicinal-products-rmps-from-1-january-
2021).

We have guidance on making applications to MHRA for orphan designation

products (https://www.gov.uk/guidance/how-the-mhra-will-manage-orphan-
medicinal-products-from-1-january-2021-in-great-britain-gb).

If you have any questions about the legal basis for your submission you can
email RIS.NA@mhra.gov.uk.
Published 30 March 2021
Last updated 31 March 2021 + show all updates

Related content

Reference Medicinal Products (RMPs) (/guidance/reference-medicinal-products-

rmps)

Marketing Authorisation Application submission dates for 150-days national and

European Commission decision reliance procedures (/guidance/marketing-
authorisation-application-submission-dates-for-150-days-national-and-european-
commission-decision-reliance-procedures)
Comparator products in Bioequivalence/Therapeutic Equivalence studies
(/guidance/comparator-products-in-bioequivalencetherapeutic-equivalence-studies)

Electronic Application Form and Cover Letter Tool

(/government/publications/electronic-application-form-and-cover-letter-tool)

Variations to Marketing Authorisations (MAs) (/guidance/variations-to-marketing-

authorisations-mas)

Collection

Licensing: how to apply (/government/collections/licencing-how-to-apply)

Explore the topic

Marketing authorisations, variations and licensing guidance (/topic/medicines-

medical-devices-blood/marketing-authorisations-variations-licensing)

All content is available under the Open Government

Licence v3.0, except where otherwise stated © Crown copyright