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Public Assessment Report Decentralized ProcedureDiclofenac Plaster (Diclofenac examine)Applicant: MEAT S.p.A. Italian Marketing Authorization Number: 045953 European procedure number: IT/H/0560/001/Diclofenac

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How to fill out decentralised procedure

01

Obtain a Letter of Intent (LoI) from the Reference Member State (RMS).

02

Prepare the application in electronic Common Technical Document (eCTD) format.

03

Submit the application to the RMS, who will distribute it to Concerned Member States (CMS).

04

Address any questions or concerns raised by the CMS during the procedure.

05

Obtain approval from all concerned Member States.

06

Implement the approved procedure and update product information accordingly.

Who needs decentralised procedure?

01

Companies looking to market a medicinal product in multiple European countries at the same time.

02

Companies looking to streamline the regulatory approval process for their medicinal products.

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What is decentralised procedure?

Decentralised procedure is a regulatory process where the marketing authorisation for a medicinal product is approved by multiple countries through a single application.

Who is required to file decentralised procedure?

Any pharmaceutical company wanting to market a medicinal product in multiple EU countries is required to file a decentralised procedure.

How to fill out decentralised procedure?

Decentralised procedure can be filled out by submitting a single application to one member state, known as the reference member state, who will then distribute the application to the concerned member states.

What is the purpose of decentralised procedure?

The purpose of decentralised procedure is to facilitate the marketing authorisation of medicinal products in multiple EU countries by allowing for a streamlined regulatory process.

What information must be reported on decentralised procedure?

The decentralised procedure application must include information on the quality, safety, and efficacy of the medicinal product.

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