What is a Decentralised procedure?

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 does CHMP mean?

Committee for Medicinal Products for Human Use
The Committee for Medicinal Products for Human Use (CHMP) is the European Medicines Agency’s (EMA) committee responsible for human medicines.

What is DLP in PSUR?

The data lock point (DLP) is defined as the cut-off date for data to be included in a PSUR. It may be set according to the European birth date (EBD) or international birth date (IBD) of the medicinal product.

What is a type 1b 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. For more information, see type IB variations: questions and answers. About us.

What is CHMP approval?

The Committee for Medicinal Products for Human Use (CHMP) is the European Medicines Agency’s (EMA) committee responsible for human medicines. The CHMP replaced the former Committee for Proprietary Medicinal Products (CPMP) in May 2004.

What is the decentralised procedure?

The decentralised procedure is a European authorisation procedures based on the principle of recognition of the assessment by the Reference Member State (RMS).

What fees are included in Apr finance charges?

Fees Included in APR Finance Charges: 203K Permits 203K Consultant Fee 203K Inspection Fee (Lender Makes These Inspections) 203K Supplemental Document Fee 203K Supplemental Origination Fee Administrative Fee Amortization Schedule Application Fee (if only sometimes charged) Appraisal Review (Review by Lender) Assignment Fee Assumption Fee

How does the mutual recognition and decentralisation procedure work?

When all Member States involved decide on a positive opinion on products in the mutual recognition and decentralised procedure, Dutch translations of the SmPC, package leaflet, labelling texts and mock-ups are submitted and a national marketing authorisation is issued.

What is a decentralised marketing authorisation?

The decentralised procedure should be used to obtain a marketing authorisation in several Member States when the applicant does not yet have a marketing authorisation in any country. The applicant requests one country to be the Reference Member State (RMS) in the procedure.

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