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Filing Variations in the European Union

Whenever the European Union requires a drug manufacturer to make changes into the product be they minor, substantial or major; there are rules within the European Union about how to report these changes. These changes could be in relation to the quality of the drug, its safety or to its indications. These are what are called filing variations in the European Union, because the manufacturer has to file for these variations.

What are the types of variations?

The EU classifies filing variations under the following types:

Type 1A:This represents minor variation, and has to be brought to the notice of the EU authorities on filing variations immediately after it is implemented

Type 1B:This classification of filing variations in the European Union is when the variation is considered neither big nor small, but is of a rather general nature

Type II:This variation is considered major.

Who reviews these filing variations?

Reviews for filing variations in the European Union are carried out in this method:

  1. By respective national authorities in the case of drugs marketed under what is called national procedure, or under Mutual Reorganization Procedure (MRP)
  2. By the European Medicines Agency (EMA) if the drug is marketed under the Decentralized Procedure (DCP) or Centralized Procedure (CP).

What are the timeframes for submission of filing variations?

Filing variations in the European Union have the following timeframes:

  • In the case of Type 1A and Type 1B variation, all the details pertaining to variations have to be submitted within 12 months of the implementation of such variations. In the initial 30 days, the concerned agencies or authorities check only compliance with the required documents. When a medical manufacturer fails to meet one or more requirements of Type 1A or Type 1B; the variation automatically becomes a Type 2 variation
  • In the case of Type II variation, rules on filing variations in the European Union require companies to take approval before these variations are implemented. The timeframe is usually between 30 and 90 days.
What should go into a variation form?

Filing variation in the European Union should be accompanied by details relating to the background and description as to the particular variation category, such as:

  • Safety
  • Quality
  • Indication
  • Urgent Safety Restriction
  • Pediatric requirements

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