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Tuesday, July 15, 2025 2:38:42 PM
You could not be more wrong IMO. Respectfully.
Understanding MHRA Variations During the Application Process
Types of Variations
The MHRA recognizes several types of variations that can be submitted during the application process:
Variation Type Description
Type IA Minor administrative changes, such as company name or address updates. These can be implemented before notifying the MHRA.
Type IAIN Immediate notification for minor changes that affect supervision, requiring notification within 2 weeks.
Type IB Changes that may affect product quality or characteristics, requiring prior approval before implementation.
Type II Major changes that significantly impact the product, such as changes in manufacturing processes or sites.
https://www.gov.uk/guidance/medicines-apply-for-a-variation-to-your-marketing-authorisation
Understanding MHRA Variations During the Application Process
Types of Variations
The MHRA recognizes several types of variations that can be submitted during the application process:
Variation Type Description
Type IA Minor administrative changes, such as company name or address updates. These can be implemented before notifying the MHRA.
Type IAIN Immediate notification for minor changes that affect supervision, requiring notification within 2 weeks.
Type IB Changes that may affect product quality or characteristics, requiring prior approval before implementation.
Type II Major changes that significantly impact the product, such as changes in manufacturing processes or sites.
https://www.gov.uk/guidance/medicines-apply-for-a-variation-to-your-marketing-authorisation
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