What is a Type 2 variation?
A major change to a marketing authorisation 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.
How long does a type 1b variation take?
For type-IB variations affecting the annexes to the Commission decision, the Commission decision will generally be updated within one year, unless the type-IB variation concerns any of the changes listed in Article 23.1a(a), for which the Commission decision will be updated within two months.
What is a variation dossier?
A variation is a change in the dossier of an authorised product. There are four different types of variations: Type IA, Type IB, Type II and Line extension. The definitions of these variations are available in: The Regulations of the European Commission: Regulation (EC) 1234/2008 en Regulation (EU) 712/2012.
What is meant by implementation for Type IA variations?
Meaning of implementation for type-IA variations For product information, it is when the company internally approves the revised product information. The revised product information will then be used in the next packaging run.
What are types of variation?
|Continuous variation||Discontinuous variation|
|Weight||Hand used to write with|
|Arm span||Eye colour|
|Head circumference at birth||Ability to roll tongue|
What is a Type Ib variation?
A minor change to a marketing authorisation that the marketing-authorisation holder must notify to the regulatory authority before implementation, but which does not require formal approval.
What is variation in pharma?
Variation means any amendment to the terms of the decision granting the marketing authorisation as well as any change to the summary of product characteristics and the documents forming the basis for an authorisation to market a medicinal product.
How many batches data are required for submission in Europe?
Data on a minimum of 3 production scale batches should be submitted unless otherwise justified.
What is variation in regulatory affairs?