The Medicines and Healthcare Products Regulatory Agency (MHRA) has published updated guidance "Applying for a Licence to Market a Medicine in the UK" for pharmaceutical companies seeking to obtain a licence to market a medicine in the UK. The guidance includes an overview of the application process, naming considerations, fast-track options, fees, and more. The latest update, dated 11 December 2024, reflects enhanced clarity and the removal of outdated territorial information.
A marketing authorisation (MA) is required to place any medicinal product on the UK market. This process ensures that medicines meet stringent safety, efficacy, and quality standards. This guidance is applicable across the United Kingdom (England, Scotland, Wales, and Northern Ireland) and aligns with post-Brexit regulatory frameworks.
The application process involves the following steps:
Submission of the Application: Applicants must submit a completed dossier through the MHRA Submissions Portal.
Scientific Evaluation: The MHRA assesses the quality, safety, and efficacy of the medicinal product.
Required Documentation:
Common Technical Document (CTD), including modules for administrative, clinical, and non-clinical data.
Details about manufacturing processes and pharmacovigilance systems.
Post-Brexit Considerations: For Northern Ireland, additional requirements may apply under the Windsor Framework.
The MHRA considers each application for a product name to ensure that the proposed name will allow the medicine to be taken safely and correctly. Applicants can find out more in guidance: Naming human medicines - GOV.UK
For medicines addressing urgent public health needs, the MHRA offers expedited processes:
Accelerated Assessment: Reduces the evaluation timeline from the standard 210 days.
Rolling Review: Allows data submission in modules as it becomes available, facilitating quicker access to innovative medicines.
An application may be rejected if:
The dossier is incomplete or contains inadequate data.
The medicine does not meet the required safety, quality, or efficacy standards.
There are issues with the proposed name or labelling.
Applicants are encouraged to engage with the MHRA for scientific advice during the application process to mitigate the risk of rejection. Also the fee depends on:
The type of application (e.g., full application, abridged application, or generic medicine).
The product's complexity.
By offering detailed instructions on the application process, naming requirements, and fast-track options, the guidance ensures that companies can efficiently navigate regulatory requirements while maintaining the highest standards of safety and efficacy.
The latest version of this guidance includes:
Section numbers for easier navigation.
Updated links to relevant supplementary guidance documents.
Removal of outdated information, ensuring alignment with the UK’s regulatory environment post-Brexit.
For detailed information, visit the full guidance on the MHRA website.
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