What is type II variation?
A type II variation means a major variation which is not an extension and which may have a significant impact on the quality, safety and/or efficacy of the medicinal product concerned. Implementation of type IB variations and type II variations requires prior approval by the Danish Medicines Agency.
What is type II variation EMA?
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.
What is a Type 2 variation?
What is CMDH EMA?
Coordination Group for Mutual Recognition and Decentralised Procedures – Human: the group responsible for the examination and coordination of questions relating to the marketing authorisation of human medicines in two or more Member States in accordance with the mutual recognition or decentralised procedure.
What is a type II variation?
Type II 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. Type II variations require a formal approval.
How long does it take for a type II variation?
The majority of type II variation procedures following a 30-day timetable (e.g. urgent safety issues) will most commonly follow the monthly start timetable. This is because they are likely to require Commission Decision within two months from CHMP Opinion and discussion during the CHMP plenary meeting.
What is the reduced timescale for Type II variations?
4.1 Type II variations are normally processed according to a 60 day timescale; however, the Regulation additionally specifies a reduced (30 day) or extended (90 day) timescale. 4.2 The reduced timescale is intended for variations concerning safety issues.
What is the assessment deadline for a type II variation application?
The assessment timetable and hence the submission deadline applicable to a type II variation application depends on the committees involved in the assessment, the amount of assessment needed and whether the CHMP Opinion will be followed by an amendment of the Commission Decision granting the Marketing Authorisation within two months.