What is a Centralised procedure?

The centralised procedure is a European authorisation route resulting in a centrally authorised product with a single Marketing Authorisation. If a product has been authorised using the centralised procedure it has been assessed on an EU wide basis and approved by the European Commission.

What is Type 2 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.

How long does a type II variation take?

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 a Type 2 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.

How long does centralised procedure take?

Following a CHMP opinion the European Commission takes usually its decision, a legally binding authorisation, after 67 days. With prior agreement, these timelines can, under some circumstances, be accelerated and for more information about this please see our website.

What is Type 1a 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. For more information, see type IA variations: questions and answers.

What is type 1b variation?

type-1b variation. “T” type-1b variation. Guideline or reference source EMA Glossary of terms Definition. 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 in 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 type 1b variation?

What is Type Ia variation?

What happens after CHMP positive?

The CHMP will give a positive or negative opinion on the medicine based on this scientific assessment. If the medicine receives a positive opinion, the EMA will send a recommendation to the European Commission (EC) to approve the medicine.