You must then resend the entire submission with the errors corrected. Home Human Companies - human medicinal products Marketing authorisation application Mutual recognition and Decentralised procedure Search within English part of Medicines Evaluation Board Search Marketing authorisation application via the Mutual recognition and Decentralised procedure The Mutual recognition and Decentralised procedures are European authorisation procedures based on the principle of recognition of the assessment by the Reference Member State RMS.
It should be one of: The application process takes up to 90 days, excluding time taken to provide further information or data required. You will not be charged if your submission is rejected for technical reasons. After opening the planning tool, you can select a time slot of your choice; a digital form will appear.
An expedited process may be available if you only want to add Iceland, Malta or Cyprus and your product has already been licensed through mutual recognition with UK as RMS. The RMS's assessment report forms the basis for requesting the other Member States' mutual recognition of the slots safari authorisation including the Summary of Product Characteristics SmPCpackage leaflet and labelling textunless they have objections on the grounds of a potentially serious risk to public health.
The MEB will inform you within three weeks following submission, whether the time slot mhra dcp slot request assigned or not.
For more information about fast tracking your marketing authorisation email RIS. Fast track your marketing authorisation Applications can be fast tracked if there is compelling evidence to show that the product would provide a major breakthrough in the treatment of certain conditions.
On the th day of the assessment procedure, the RMS circulates another draft assessment report on the basis of the answers given by the company to the questions posed by the RMS and other Concerned Member States CMSincluding comments on the SmPC, package leaflet and labelling texts. Centralised licences are granted by the EMA.
Withdrawing an application is only possible when this is done in all Member States involved. We can accept applications at any time. For full details see MHRA fees.
Withdrawing an application in the RMS is not possible. If agreement is not reached, this procedure will be referred to the CHMP. Types of application legal basis You must include the appropriate legal basis for your application when you apply to MHRA for a marketing authorisation: We will normally reply within 24 hours to confirm your booking and issue your product licence PL number and DCP number.
The principle is that the countries you wish to add recognise the national licence s already granted.
If you have any questions about the legal basis for your submission you should email RIS. We do, however, have a mailing list and companies can sign up to receive information through email when the MPA has available slots due to e.
If the application is approved, MHRA and each CMS will issue a national licence for the product within 30 days of the approval being granted. This is in order to agree upon the necessary steps e. If an application is withdrawn in one or more Concerned Member States during the Mutual recognition procedure as a consequence of a potential serious risk to public health, it is always discussed in the CMDh via the days procedure.
The process for repeat use is identical to the first mutual recognition procedure.