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UK MHRA Guidance: Applying for a Variation to a Marketing Authorisation

Yesterday (22 April 2024) the UK Medicines and Healthcare products Regulatory Agency (MHRA) updated its guidance "Medicines: apply for a variation to your marketing authorization" which details how to apply for changes to your marketing authorisation, including minor variations type IA and IB, major variations type II and extensions.

A variation is a change to the terms of a marketing authorisation that may impact the product's quality, safety, or efficacy. Variations are either:

  • an administrative change such as a change of company name and/or address

  • a change to the characteristics of a product that can affect its quality, such as a change to its composition

  • a change to the safety, efficacy or pharmacovigilance of the product

Changes are classed as major (type II) or minor. Minor changes are either type 1A or 1B and can be applied for:

  • a single change to one marketing authorisation (MA)

  • multiple changes to one or more products and/or MAs

Types of Variation Applications

  • Type IA: Minor changes that have little or no impact on the product's quality, safety, or efficacy and are typically approved within 30 days.

    • Type IAIN change (immediate notification) Type IAIN is a sub-type of type IA and is also classed as a ‘do-and-tell’ procedure where MHRA requires ‘immediate notification’ within 2 weeks of the change being implemented. A minor change would usually be type IAIN if it interferes with MHRA’s ability to continuously supervise the product.

  • Type IB: Changes that are not classified as Type IA or Type II and are typically approved within 60 days.

  • Type II: Major changes that may impact the product's quality, safety, or efficacy and require a comprehensive assessment by the MHRA.

Although extensions are still considered a type of variation, their impact on a product is so significant that you will need to follow the application process to apply for a new MA. Extensions can be:

  • changes to the active substance(s), including the salt/ester, isomer or biological active substance

  • changes to strength, pharmaceutical form or route of administration

The applicant can apply multiple changes to a single product using the ‘grouping’ format, as long as the changes are directly related and the type of procedure (type IA, IB, II) is determined by the extent of the change. Please refer to Annex III of the Variations Regulation and Schedule 10A of the Human Medicines Regulations for more information.

Check out this guidance for more detailed information by clicking this LINK.

Also, MHRA updated the guidance "Guidance Apply for a licence to market a medicine in the UK" which gives an overview of the process including submitting or fast-tracking an application, naming your medicine, and paying fees.


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