FACTS ON VARIATION FILING IN EUROPEAN UNION

29th July, 2014 - Posted by Rahul Agarwal - No Comments

FACTS ON VARIATION FILING IN EUROPEAN UNION

The regulatory authorities generally demand continuous up gradation of quality, indication, safety of

the drug products. To achieve this they have framed variation guidelines which cover minor to major variations.

The guidelines are also useful for registering minor administrative changes.

How variations are classified in EU and who reviews the same

Type1A (Minor variation )Type IAIN – Minor  variation which should be notified immediately after implementation

Type1B (variation which are neither major nor minor)

Type II (Major variation)

The variations are reviewed by National authorities (For drugs market under national procedure or Mutual reorganization procedure) or by EMA if the drug is marketed under DCP or centralized procedure.

What is Type 1A variation and Type 1 B variation?

How the same are submitted and reviewed?

Type 1A variations which has minimal impact, or no impact at all on the quality, safety or efficacy of the medicinal product concerned.Type IB is a variation which neither minor nor major.

The submission procedure and  review procedure is as per follows::

The details on variation should be submitted within 12 months following implementation. Such variations are never fully full assessed. They are only check for the presence of the required documentation and compliance. The official review period is  0-30 days

What happens if  one or more of the conditions for a Type IA/1B change are not met

Under such incidence type 1A/1B  variation becomes  Type 2

What is Type II variation? How they are reviewed?

Type II Variation is the variation which may have significant impact on the Quality, Safety or Efficacy of a medicinal product.Such variations require approval before implementation.

The normal assessment time is 60 to 90 days.  This may be reduced to a 30 days

 

What is meant by Extension of Marketing Authorization?

It is an extension of Marketing Authorization for new route new pharmaceutical form; new strength or new salt of active substance; administration.An extension application is evaluated in accordance with the same procedure applied to the granting of the initial marketing authorization to which it relates Regulation

 

What is Work sharing

Under this procedure reference member state examines the variation application on behalf of the other concerned states.

 

What information is to be supplied in variation form

 

 

Type of the drug (Human/Veterinary)Name of the procedure under which the applicant is aiming to file variation i.e. National/MRP/DCP/ Central Procedure

Type of variation i.e. Type 1A, Type 1Ain, Type 1B, Type 1B unforeseen, Type 2 ,Single variation/Grouping of variations/ Line extensions

Specific variation category e.g.  indication, Pediatric requirements, Safety, Urgent Safety Restriction ,Quality and other

Description and background of all the proposed changes.

 

 

 

 

 

 

 

 

 

 

 

Posted on: July 29, 2014

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