marketing authorisation via decentralised and mutual recognition procedures
The Decentralised and Mutual Recognition procedures are European
authorisation procedures based on the principle of recognition of
the assessment by the Reference Member State (RMS).
Mutual Recognition Procedure
In the case of the Mutual
Recognition procedure, the RMS has already issued a marketing
authorisation. The RMS's assessment report forms the basis for
requesting the other Member States' mutual recognition of the
marketing authorisation (including the Summary of Product
Characteristics (SPC), package leaflet and labelling text), unless
they have objections on the grounds of a potentially serious risk
to public health. In such situations, further discussions will be
held in the Coordination group for Mutual recognition and
Decentralised procedures
(CMD(h)).
Decentralised procedure
The Decentralised procedure
may be used to obtain a marketing authorisation in several Member
States when the applicant does not yet have a marketing
authorisation in any country.
The applicant requests one country to be the Reference Member State
(RMS) in the procedure. After 70 days the RMS circulates the first
Draft assessment report. The Concerned Member States (CMS) and
the applicant can then make their comments. On the
120th day of the assessment procedure, the RMS
circulates another Draft assessment report, including comments
on the SPC, package leaflet and labelling texts. There is also a
Mutual Recognition Procedure during the next 90 days, in which
other Member States generally adopt the RMS's assessment, unless
they have important objections on the grounds of a potentially
serious risk to public health. In such situations, further
discussions will also be held in the Coordination group for Mutual
recognition and Decentralised procedures
(CMD(h)).
Once a positive opinion on products has been taken in the Mutual
Recognition and Decentralised procedure, Dutch translations of the
SPC, package leaflet and labelling texts are submitted and a
national marketing authorisation is issued.
A summary of all the products that
have been accepted through the Decentralised and Mutual recognition
procedure is published in the European Product Index on the website
of the Heads of Medicines Agencies (HMA) (www.hma.eu/mri.html)
CMD(h)
The Coordination group for Mutual Recognition and Decentralised
procedures (CMD(h)) is the European consultative body with
responsibility for the proper functioning of the Mutual Recognition
and Decentralised procedures. CMD(h) is a group composed of the
Heads of Medicines Agencies (HMA). They can discuss any procedural
or scientific questions in the procedure. Each Member State has one
representative in the group. These representatives may be
accompanied by experts if necessary. Any products that have been
referred for discussion on the grounds of a potentially serious
risk to public health are also discussed in the CMD(h).
The HMA website www.hma.eu/cmdh.html provides further information on
CMD(h) meetings, as well as on SOPs and Guidance Documents that
have been drafted for the Decentralised and Mutual recognition
procedure.
In the case of medicinal products authorised after 30 October
2005, a public assessment report, including the approved SPC and
package leaflet, will be published on the European Product
Index.
Information on how to contact MEB or CMD(h) representatives
can be found via
Contact.
Requests for the MEB to act as a Reference
Member State (RMS)
Formal requests for the
MEB to act as RMS in the Decentralised and Mutual Recognition
procedure must be submitted to the MEB in writing. You can use the
RMS request form to send the request to the head of the relevant
Pharmaco-Therapeutic group or to the Botanicals & Novel
Foods unit. A possible time frame will then be determined in mutual
consultation.
An intention to submit a request for the MEB to act as a Reference
Member State in the Mutual Recognition procedure should preferably
be announced upon submitting the national application.
