What is EMA template?
The European Medicines Agency’s (EMA) Working Group on Quality Review of Documents (QRD) develops, reviews and updates templates for product information for use by applicants and marketing authorisation holders for human medicines. The information contained in these documents is non-exhaustive.
What is a line extension EMA?
A line extension is a marketing authorisation in the name of the same marketing authorisation holder, for example if the pharmaceutical form and/or strength of the product differs from one or more other veterinary medicinal products for which this marketing authorisation holder already has a marketing authorisation.
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 a Type Ia variation?
A minor change to a marketing authorisation that has a minimal or no impact on the quality, safety or efficacy of the medicine and does not require prior approval before implementation by the marketing authorisation holder.
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 a Type Ib variation EMA?
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.
Do all Type II variations require a formal approval?
Type II variations require a formal approval. For more information, see type II variations: questions and answers. Product emergency hotline outside working hours About Who we are Human regulatory Veterinary regulatory
Does the variations classification guideline apply to all variations?
Until further notice the variations classification guideline, which is a fundamental component of the operation of the variations system, will continue to apply to all types of variations.
What information about the clinical expert is required for Type II variations?
Module 1.4.3 – Information about the clinical expert (signed and dated expert statement + CV) is mandatory for all type II variations including or referring to clinical data and/or applications including an updated version of the Risk Management Plan (RMP).