Global Regulatory Affairs

We are in a position to manage your entire Marketing Authorisation Application (MAA) and to execute any of the following procedures:

Centralised

Centralised Procedure (CAP) – Under the relevant Regulation and Directive, a CAP results in a single marketing authorisation that is valid in all Member States (MSs) of the European Union (EU), as well as in Iceland, Liechtenstein and Norway.

This procedure is compulsory for some type of medicines (tratment of HIV / AIDS, cancer, diabetes…) and optional for the rest.

Decentralised

​Decentralised Procedure (DCP) – With this procedure companies may apply for simultaneous authorisation in one or more EU country for products that have not yet been authorised in any EU country and that do not fall within the mandatory scope of the CAP.

National

National Procedure (NP) – Each EU Member State (MS) has its own procedures for the authorisation of medicines which fall outside the scope of the CAP.

Mutual Recognition

​Mutual Recognition Procedure (MRP) – When a medicine has been approved for the first time in a MS following a NP of that State, another authorisation may be requested through an MRP.

The provisions to implement this procedure are established by the relevant Directive, adopted by all MSs.

Since 1 January 1998, a MRP is compulsory for all medicinal products marketed in a MS other than that in which they were first authorised.

Business Cases

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If you are interested in our service please contact us for more information.

Telephone+353 125 44033
Email: marketing@arriello.com

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