European (EU) Variation Requirements

What is Variation :

Variation means any amendment to the terms of the decision granting the marketing authorization as well as any change to the summary of product characteristics and the documents forming the basis for an authorization to market a medicinal product.

European Commission has classified the variation type as   type IA/IAIN, type IB and type II.

Type IA/IAIN (do and tell) :

Changes that fall under this category are commonly referred to as “do and tell” variations because the applicant is required to implement the change and then notify the agency of the details.

This level of variation is reserved for administrative changes that are anticipated to have no impact on the quality, safety or efficacy of a product.

Variations that can be submitted as Type IA must be implemented and then the required submission made within 12 month of the implementation date.

 For changes that are categorized as Type IAIN the applicant must notify the agency within 14 days of implementation and for a single product multiples variations can be made at the same time, as long as all of them fall within the required submission deadline.

Type IB (tell, wait and do) :

Minor variations that require assessment of supporting data and are anticipated to potentially have an impact on product quality, safety or efficacy are classified as Type IB and these are also referred to as “tell, wait and do” variations.

Type IB variations are minor variations, which are neither a type IA variation, a type II variation nor an extension.

The applicant must make the submission, including all required supporting data, and await agency approval before implementing the change.

The process follows a defined assessment period of 30 days, but with agency questions it can often take up to 03 months.

Type II  :

A major change to a marketing authorization that may have a significant impact on the quality, safety or efficacy of a medicine, but does not involve a change to the active substance, its strength or the route of administration. Type II variations require a formal approval. 

They require considerable supporting documentation and must be assessed and signed off by an appropriately qualified expert in their respected field before being submitted.

Anticipated implementation time of Type II is Up to 6 months after submission.

What is Major Changes :

Where notable alterations to product registration are required, these are expected to have an impact on a product’s quality and efficacy and as such are tightly controlled, requiring in-depth assessment and review.

The Marketing authorization Holder (MAH) must demonstrate that the product will retain the same level of quality and efficacy. Comparative data is a significant requirement for such changes and must reliably show the proposed changes do not impair product quality and Assessment times for such variations are often much longer, as agencies carefully review submissions and frequently make requests for additional data and answers to questions and concerns.

What is Line Extensions:

Certain changes which affect the fundamentals of the terms of the authorization cannot be granted via a variation and are submitted as an “extension application”:

Example: changes to the active substance(s); changes to strength, pharmaceutical form and route of administration. The invented name will remain the same for the “extension”.

VariationTypeAnticipated implementation dateGuideline approval timeline
AdminType IAIN & IA14 days before implementation and up to 1 year before submissionNot applicable
MinorType IBUp to 3 months after submission30 days
MajorType IIUp to 6 months after submission60 days
Europe Variation

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