Reference Member State and Concerned Member State describe the roles of national medicines authorities in the Decentralised Procedure and the Mutual Recognition Procedure. The Reference Member State conducts or transmits the scientific assessment; the Concerned Member States review it and decide on recognition. The terms therefore describe tasks within coordinated national authorisation routes, not types of authorisations.
The role of the Reference Member State
The Reference Member State, often referred to as the RMS, is the authority on which the joint scientific assessment is based. In the Mutual Recognition Procedure, this is the Member State that has already granted a national marketing authorisation for the medicinal product. It makes its assessment of the product available to the other Member States. Its remit therefore includes the scientific appraisal of the existing dossier and the transfer of that basis into the recognition procedure.
In the Decentralised Procedure, there is no national marketing authorisation at the outset. The applicant proposes a Member State as the Reference Member State; once it agrees, it undertakes the initial assessment of the application. It prepares a draft assessment report and coordinates the scientific communication with the other Member States. The RMS is therefore neither merely an administrative recipient nor a representative of the applicant, but a competent national authority with its own assessment responsibility.
The Reference Member State forms the scientific interface, but its position is not a unilateral permission for all other Member States. It must incorporate the advice, questions and reasoned objections of the Concerned Member States into the process. A robust agreement requires that the assessment report, Summary of Product Characteristics, labelling and package leaflet are based on a shared scientific foundation.
The role of the Concerned Member States
Concerned Member States, often referred to as CMS, are, in the MRP, the Member States asked to recognise the Reference Member State’s marketing authorisation. In the DCP, they are all participating Member States except the Reference Member State. They receive the assessment, review the dossier and product information, and raise questions or objections. If the procedure concludes successfully, each of them grants a national authorisation to place on the market.
CMS therefore do not merely provide a formal countersignature. Their review is intended to ensure that the joint assessment can be adopted and that the legally required national steps are completed. If an authority cannot agree, the difference must be addressed scientifically and legally. The coordination structure is designed to prevent divergent assessments from remaining side by side without resolution.
Distinction from the centralised procedure and committee roles
RMS and CMS are roles within the Decentralised Procedure and the Mutual Recognition Procedure. In the centralised procedure, there are no Reference Member States or Concerned Member States: the EMA organises the scientific assessment, and the European Commission grants the Union-wide marketing authorisation. National authorities do contribute via committees and implementation, but not as the RMS or CMS for a dossier.
The terms are also not equivalent to rapporteur and co-rapporteur within an EMA committee. Those roles perform scientific tasks for a committee within a centralised assessment. By contrast, the Reference Member State is a national authority in the MRP or DCP. The precise role designation matters because responsibility, communication pathway and decision level depend on it.
In day-to-day project work, it is also advisable to distinguish between the authority in its RMS or CMS role and the national organisational points of contact. The applicant may propose a Reference Member State, but acceptance of the role lies with the competent authority. The number and selection of Concerned Member States also shape the scope, language management and coordination effort of an application, without changing the RMS’s assessment role.
Relevance for clinical trials
For clinical development programmes, the choice of a potential Reference Member State influences the regulatory preparation of an MRP or DCP. Dossier quality must allow a well-founded initial assessment while also withstanding review by multiple Concerned Member States. Consistent clinical study reports, tables, safety analyses and product information reduce the risk that differing questions will break the common line. Even after study completion, a traceable data provenance remains essential for responses within the procedure.
Full-service CROs such as Mediconomics support documentation planning, clinical data quality assurance, medical writing, data management and regulatory project coordination. They can structure alignment between the sponsor, investigational sites and specialist functions, and prepare the evidence so that it is available to the Reference Member State and the Concerned Member States in a transparent and consistent manner.
Frequently Asked Questions (FAQ)
Who determines the Reference Member State in the DCP?
The applicant proposes a Member State; that Member State must accept the task as Reference Member State.
Are Concerned Member States the same roles in the DCP and MRP?
Yes. In each case, they are the participating Member States other than the Reference Member State, although their specific starting position differs between the DCP and the MRP.
Does the RMS grant the marketing authorisation for all Member States?
No. It conducts or transmits the assessment. After successful coordination, each participating Member State grants its national authorisation.
Regulatory References
- Directive 2001/83/EC, Articles 28 and 29 — governs assessment, recognition and objections by the Member States.
- HMA, Medicines Approval System — defines RMS and CMS in the MRP and DCP.
- CMDh, Best Practice Guide for the Reference Member State — describes the RMS’s assessment and coordination role.