Your CDMO Doesn’t Handle UK Release – Now What?

1. Regulatory Impasse

If your CDMO is not equipped to handle batch release, this means:

• The batch cannot be released in the UK due to lack of a UK-based Qualified Person (QP).
• You cannot legally place the product on the UK market until the batch is certified by a QP holding an MHRA-authorised Manufacturing and Import Authorisation (MIA) or MIA(IMP), depending on product type.

2. Supply Chain Disruption

If manufacturing is performed in third countries (outside the EU and EEA), the product cannot be released for commercial supply in the UK without UK QP certification under MIA. This leads to regulatory delays, logistical challenges, and potential financial impact.

MHRA Oversight and QP Requirements

The MHRA, the UK’s competent authority for medicines, mandates that a Qualified Person (QP) responsible for batch release must be resident in the UK and named on an MHRA MIA/MIA(IMP) licence.

From 1 January 2025, additional MHRA rules require:

• All medicines intended for the UK market must carry a clear label stating “UK Only.”
• Any EU FMD barcodes that appear on packs must not be functional or should be securely covered before release in the UK.
• QPs and Responsible Persons for Import must comply with the new Windsor Framework-related labelling/import rules.

Compliance Standards

The facility must adhere to EU or UK GMP standards, maintain quality systems, and enable audits, especially if relying on external testing for UK release.

1. Use a UK-Based QP with MIA/MIA(IMP)

You can outsource the Importation and release step to a UK-based CDMO or QP service provider with the necessary MHRA licences. They perform final certification and ensure UK batch release compliance.

2. Import via UK Responsible Person (RPi)

If your CDMO imports into the UK from EU, you can appoint a UK-based Responsible Person for Import (RPi) to oversee regulatory compliance, including QP release under an MIA license. However, the RPi must be UK-based and comply with MHRA rules.

3. Split Services: Manufacture Abroad, Release in UK

Keep development and manufacturing with your original CDMO, but arrange to have batches shipped to a UK facility for sampling, testing, QP certification, and release. This can be cost-effective if arrangements and transfer protocols are well managed.

4. Engage a Full-Service UK CDMO

Working with a UK CDMO that handles end-to-end services like Sciom Limited, including analytical testing, stability, QC, regulatory support, and UK batch release, removes complexity and streamlines operations.

MHRA-Approved, UK-Resident QP Release

Sciom Ltd, established in 2023, operates from an MHRA-approved facility in the UK and offers comprehensive services including batch testing & release, with resident Qualified Persons and full compliance capabilities.

Broad CDMO & Support Services

Sciom offers a comprehensive, one-stop solution designed to support pharmaceutical companies throughout the product lifecycle. Its services include:

• Development, analytical and method validation, technology transfer, and stability testing, ensuring robust product quality from early development to commercial supply.
• Batch release testing and certification, carried out under MHRA approval with Qualified Person (QP) oversight for full compliance with UK regulatory requirements.
• Regulatory services, including eCTD document preparation, dossier compilation, and scientific writing to streamline submissions and approvals.
• Pharmacovigilance and ongoing safety monitoring, enabling continuous evaluation of product safety throughout its market presence.
• A strong quality culture with strict GMP alignment, ensuring every step meets international standards for safety and efficacy.

Simplified Path to UK Market

Working with Sciom ensures:

• Smooth UK QP batch release
• Compliance with MHRA’s "UK Only" labeling and regulatory roadmap
• Reduced operational fragmentation by consolidating testing, release, and regulatory support in one MHRA-licensed partner