Variation filing in Europe

Types of variation filing in Europe

 

Here i have tried to explain variation filing procedures in Europe market as simple as possible in self explanatory question answer format so that it can be understood easily by even freshers in regulatory field. 

 

What is variation application?

In Europe, marketing authorization holder/manufacturer is foremost responsible for quality, safety and efficacy of medicinal product throughout the life of medicinal product.

During the life of a medicinal product, if any change or amendment is required due to any technical and scientific progress that may or may not impact the quality safety and efficacy of that medicinal product. In such cases marketing authorization holder (MAH) should notify the Regulatory Agency about these amendments or changes to implement to a medicinal product and these are called variation application.

 

How variations are classified in EU?

Depending on the level of risk to public or animal health and the impact on the quality, safety and efficacy of the medicinal product concerned

 

Variation applications are categorized in to:

  1. Major variations (Type-II variation)
  2. Minor variation (Notification-Type-IA and Type-IAIN)
  3. Minor variation (Prior approval- Type-IB)

 

 

Type-II variation (Major variations):

These are major variations and are not an extension.

Type-II variation may have significant impact on quality, safety and efficacy of the medicinal product.

Such variations require approval before implementation.

The normal assessment time for these major variations is 60 to 90 days; this may be reducing to 30 days.

 

Type-I variation (Minor variation):

These are minor variations and have minimal impact, or no impact on the quality, safety and efficacy of the medicinal product concerned.

These variations do not require prior approval.

These variations are also called “DO and tell procedures”

Type-I variations are further classified in to Type-IA and Type-IA (IN) and Type-IB variations.

Type-IA variations:

These variations do not require immediate notification after implementation.

These variations can be submitted within 12 months after implementation.

These variations allow annual reporting to regulatory agencies.

 

Type-IA (IN) variations:

These variations require immediate notification after implementation.

 

Type-IB variations:

Type-IB variations are neither minor (Type-IA) nor major (Type-II), these are also not an extensions.

These variations are also called as “Tell wait and do procedures”

These variations must be notifies to competent regulatory authorities or EMEA before implementation; however these variations do not require formal approval.

Process Flow:

Notified to agency –> Acknowledged by agency–> waits for 30 days–> Implement the change

 

How these variations are submitted and reviewed?

Each variation should require a separate submission and have different review procedures.

The variations are reviewed by National authorities (if the drug is marketed under national procedure or mutual recognition procedure) or by EMEA if the drug is marketed under decentralize (DCP) or centralize procedure.

Minor variations (Type-IA and Type-IB) are never fully assessed; they are only check for the presence of the required documentation and compliance. The official review period is 0-30 days.

Type-II variations are reviewed and assessed by competent authority and require approval before implementation.

The normal assessment time for type-II variation is 60 to 90 days. This may be reduces to 30 days.

July 21, 2015

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