What is DCP in regulatory?
The Decentralised Procedure is one of three routes available to applicants to gain multinational marketing authorisation within the European Economic Area (EEA) on the basis of a single application.
What is European marketing authorization?
The European Medicines Agency (EMA) is responsible for the scientific evaluation of centralised marketing authorisation applications (MAA). Once granted by the European Commission, the centralised marketing authorisation is valid in all European Union (EU) Member States, Iceland, Norway and Liechtenstein.
What is mutual recognition procedure?
A procedure through which an authorisation of a medicine in one European Union Member State is recognised by another Member State.
What are the procedure for approval of drug in EU?
National authorisation procedures
- mutual-recognition procedure, whereby a marketing authorisation granted in one Member State can be recognised in other EU countries;
- decentralised procedure, whereby a medicine that has not yet been authorised in the EU can be simultaneously authorised in several EU Member States.
Who is market authorization holder?
A Marketing Authorisation Holder (MAH) is a company, firm or non-profit organisation that has been granted a marketing authorisation. The marketing authorisation allows the holder to market a specific medicinal product, in one or more EU member states.
What is centralised and 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.
Who can be a marketing authorisation holder?
What is a MA holder?
MA Holder means the entity that holds the Marketing Approval for a product in a given country.
How many days after the start of the DCP assessment step I does the reference member state have to supply the draft labeling to the concerned member states and applicant?
120 days
The reference Member State shall prepare these draft documents within 120 days after receipt of a valid application and shall send them to the concerned Member States and to the applicant.”
How long does MAA approval take?
How long does it take? Upon submission of a valid application, the evaluation takes up to 210 days, at the end of which the Committee for Medicinal Products for Human Use (CHMP) must issue a scientific opinion on whether the medicine may be authorised or not.
How much time before MAA submission centralized process should the sponsor submit a letter of intent?
A letter of intent, analogous to an FDA meeting request, and briefing package must be submitted by the sponsor either three weeks (when seeking scientific advice without a meeting) or approximately seven weeks (when requesting a pre-submission meeting) prior to the intended start of the scientific advice procedure.
What is Volume 9a pharmacovigilance?
Volume 9 of “The rules governing medicinal products in the European Union” contains Pharmacovigilance guidelines for medicinal products for both human and veterinary use.
