Marketing Authorisation Holding

A Marketing Authorisation (MA) is required before any medicinal product can be placed on the market. The format of information required for application “The Dossier” is harmonised across regions. The electronic common technical document (eCTD) is an interface and international specification for the pharmaceutical industry to agency transfer of regulatory information.

The eCTD has five modules:

Module 1

Administrative information and prescribing information. (Region specific)

Module 2

Common technical document summaries.

Module 3

Quality

Module 5

Nonclinical study reports

Module 6

Clinical study reports

Our Regulatory team can create full eCTDs for new applications as well as taking dossiers for older MA applications and variations and converting them to eCTD.

We have extensive experience in all the different routes for MA applications and can recommend and guide you in the appropriate route, which takes into account your individual circumstances, market access requirements and specific product. There are four routes to consider:

Centralised Procedure (CP)

Mutual Recognition Procedure (MRP)

National Procedure

Decentralised Procedure (DCP)

Callisto Pharma Group has offices in both the UK and EU so can act as applicant for your procedure in the UK or Europe.

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