RegulatoryGuideline · final

MHRA updates marketing authorisation variations guidance, adding batch release site and CHM appeal details

🇬🇧 MHRA · Wed 14 Oct 2026

The UK regulator's variations page, last revised on 14 October 2026, now covers batch release site deletions, Type II refusal appeals and Type IA annual updates.

The Medicines and Healthcare products Regulatory Agency (MHRA) revised its guidance on applying for variations to marketing authorisations on 14 October 2026. The latest change adds a new item, numbered (viii), covering cases where a change involves deleting a batch release site and affects the product information.

The update follows a run of changes since September. On 5 October the MHRA added an 'Appealing to CHM' section explaining how to appeal a refusal of a Type II application. On 2 October it linked to a new guidance page on electronic Application Forms (eAFs). On 21 September it published guidance on Type IA annual update variations.

In mid and late September the agency also clarified how 120-day Type II variations for new therapeutic indications are assessed. The clarification covers Day 90 decisions and the use of a single Request for Further Information (RFI). It also confirms applicants' right to ask for a CHM review after a Type II refusal. Earlier in 2026 the page gained a section on Type II variations to add a new therapeutic indication (20 January), followed by a section on deadlines for such variations (2 July).

The guidance explains that variations are classed as Type IA, Type IB (minor) or Type II (major), and that applicants can submit single or multiple changes. It states that the procedures in Chapter IIa of Regulation (EC) No 1234/2008 continue to apply to purely national UK marketing authorisations under the Human Medicines Regulations 2012. Commission Regulation 2024/1701, which amends that framework, applies in the UK from 1 January 2025.

New guidance on procedures and categories of variations applies from 15 January 2026 to all UK variations, whatever the route of application. For variations submitted through the International Recognition Procedure (IRP) on or after that date, the new application form and categories should be used. The page says the MHRA guidance should be read alongside EMA and CMDh material, because the lead authority differs by MA type: the MHRA, the Reference Member State or the Reference Authority.

What it means for your team

  • Teams planning batch release site deletions should check whether the change affects product information, as the new item (viii) now addresses this.
  • Type II applicants should review the new CHM appeal section and the clarified Day 90 and single-RFI process for 120-day new indication variations.
  • Submissions made on or after 15 January 2026, including IRP variations, should use the new application form and variation categories.
  • Regulatory affairs teams should check which authority leads a variation and follow the matching MHRA, EMA or CMDh guidance.

Official guideline text: MHRA ↗

Article written by VigiEye from the official source (MHRA). AI-assisted; check the source before acting.

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