Legal Pathways for Marketing Authorisation Applications in the United Kingdom

1. Regulatory background

In the United Kingdom, applications for a marketing authorisation (MA) for medicinal products must be submitted under a defined legal basis, which determines the type and extent of data that must be provided. These legal bases are set out in UK medicines legislation and are applied by the Medicines and Healthcare products Regulatory Agency (MHRA). They are largely aligned with former EU frameworks but now operate independently under UK law. Source: Types of application (legal basis)

2. Full (stand-alone) application

A full application is used when the applicant relies entirely on its own pre-clinical and clinical data to demonstrate the quality, safety, and efficacy of the medicinal product. This route is typically chosen for:

• New active substances
• Products with novel indications or formulations where no relevant reference product can be relied upon

Applicants must submit a complete Common Technical Document (CTD), including full quality, non-clinical, and clinical modules. Source: Types of application (legal basis)

3. Generic (abridged) application

A generic application allows the applicant to rely on a reference medicinal product that has already been authorised, provided that:

• The generic product has the same qualitative and quantitative composition in active substances
• The same pharmaceutical form is used
• Bioequivalence with the reference product is demonstrated

This pathway significantly reduces the need for new clinical and non-clinical studies. Source: Types of application (legal basis)

4. Hybrid application

A hybrid application is used when the product does not fully meet the definition of a generic product, for example due to:

• Differences in strength, pharmaceutical form, route of administration, or indication

In such cases, the applicant may rely partly on the reference product’s data but must also submit additional non-clinical and/or clinical data to support the differences. Source: Types of application (legal basis)

5. Bibliographic application (well-established use)

Under a bibliographic application, the applicant demonstrates safety and efficacy based on published scientific literature, rather than new studies. To qualify, the active substance must have:

• A well-established medicinal use within the UK or EU
• Recognised efficacy and an acceptable level of safety, typically supported by at least 10 years of clinical use

This route is often used for long-established substances with extensive literature. Source: Types of application (legal basis)

6. Informed consent application

An informed consent application allows an applicant to use data from another authorised marketing authorisation holder, provided that:

• The original authorisation holder gives explicit written consent
• The products are essentially the same in terms of quality, safety, and efficacy

This pathway is commonly used within corporate groups or licensing arrangements. Source: Types of application (legal basis)

7. Choosing the appropriate legal basis

Selecting the correct legal basis is a strategic regulatory decision. Applicants should consider:

• The nature of the product and its development history
• Availability of reference products or published literature
• The scope of indications and formulation differences

Early scientific advice or regulatory consultation with the MHRA can help determine the most appropriate application type and reduce regulatory risk. Source: Types of application (legal basis)