A Marketing Authorisation Application (MAA) that references Decentralised Manufacture (DM) (either in part or in whole of the manufacturing process) is enabled by award of a DM designation which confirms that in the view of the MHRA, the legal test for DM is justified in the context of the medicinal product. The application process for DM designation is detailed in The designation step.

The MAA should include evidence of DM designation. It should be confirmed that the information that was provided in support of the DM designation remains unchanged. Where a significant change has been made to the supporting information, a new DM designation should be sought.

Ideally, the Manufacturing Licence (MIA) for the Control Site should be appropriately scoped for DM at the point of submission. However if this process has not yet completed, this will not preclude submission and validation of a MAA. The Applicant should note that failure to provide a current and appropriately-scoped Certificate of GMP Compliance no later than the response to Request for Information may result in refusal of the MAA.

The general principles of product development, manufacture, and control continue to apply.

Process validation and/or extended characterisation information may also be required to demonstrate comparability between batches and/or manufacturing locations; the extent of data required will be more substantial for more complex or potentially variable products.

In cases where principles of Real Time Release Testing (RTRT) are proposed, information demonstrating enhanced product and process knowledge should be provided that supports this approach. Results of representative process validation for multiple batches made at a representative scale covering critical manufacturing steps should be provided in section P.3.5. The RTRT strategy should be based on a firm understanding of the manufacturing process and of the relationship between process parameters, in-process controls and finished drug product attributes. Further information about the principles of RTRT are described in the Guideline on Real Time Release Testing (formerly guideline on parametric release) and also from a GMP perspective in Eudralex Vol 4 Annex 17 on ‘RTRT and Parametric Release’.

See information about labelling.

Decentralised Manufacture: Marketing Authorisation application