What is unforeseen variation?
A variation is considered ‘unforeseen’ when the proposed variation is not considered a minor variation of Type IB following the Commission classification Guideline, or has not been classified as a Type IB variation in an Article 5 recommendation.
What is variation submission?
“Variaton Submission” enables pharmaceutical companies both to create national and european variations using the data stored with the Competent Authorities(CAs) and also to submit these generated variations directly to the CAs.
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.
How do I apply for the deletion of more than one manufacturing site?
How to apply for the deletion of more than one manufacturing site? In case more than one manufacturer in one MA has to be deleted a single variation of type IA under classification category A. 7 to delete all manufacturing sites may be submitted.
What is the anticipated implementation time limit for Type II variations in EU?
Upon receipt of a favourable CHMP opinion which requires amendments to the decision granting the marketing authorisation, the Commission shall amend the marketing authorisation to reflect the variation within 2 months, for the variations listed under Article 23(1a)(a) or within one year for the other type II variations …
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.
What is a variation in pharma?
How is an EMA application procedure number attributed?
4.7 How is an EMA application/procedure number attributed? On receipt of a submission, details of the product/procedure are entered into a tracking database which attributes product and procedure numbers.
What is a Type 1 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.
What is a Decentralised procedure?
The procedure for authorising medicines in more than one European Union Member State in parallel. It can be used for medicines that do not need to be authorised via the centralised procedure and have not already been authorised in any Member State.
What are basic 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 an extension under the variations regulation?
Extensions Annex I of the Variations Regulation sets out a list of changes to be considered as extensions. As established in Article 19 of the Variations Regulation, such applications will be evaluated in accordance with the same procedure as for the granting of the initial marketing authorisation to which it relates.
Which variation is an extension of the marketing authorisation?
One of the variations in the group is an extension of the marketing authorisation. One of the variations in the group is a major variation of type II; all other variations in the group are variations which are consequential to this major variation of type II.
When can the approved major variation (s) be implemented?
The approved major variation (s) of Type II requiring amendment of the Commission decision granting the marketing authorisation within 2 months may only be implemented once the holder has been informed by the Commission accordingly.
What is the variations regulation for medicinal products?
Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products ( 1) (‘the Variations Regulation’) governs the procedure for the variation of marketing authorisations.