Portugal como Estado Membro de Referência

Portugal as Reference Member State


The Portuguese National Competent Authority INFARMED, I.P. participates actively in the Mutual Recognition (MRP) and Decentralised (DCP) procedures as Reference Member State (RMS), and has since the start received a high number of requests for time slots, more than the agency currently is able to accommodate.
In addition the HMA (Heads of Medicines Agencies) has agreed a common DCP RMS request form.

•  The request should be made by filling in the request form
•  This form must contain all relevant details. The applicant is requested to consider number of intended Concerned Member States and how many duplicate applications, if any, will be included in the procedure.
• The request should be sent by email only to rms.procedures@infarmed.pt. Please include the following text in the heading of the email: MRP RMS request.  INFARMED will reply to the request as soon as possible, within one month after reception of a request.

  
Request for time slot for applications via the DCP with Portugal as RMS
 
Request for DCP applications to be submitted on 2010.
DCP time slots available (last update: 19 February 2010): 70

• The request should be made by filling in the request form, available at http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Templates/MA_Application/CMDh_036_2009_Rev0_Request_Form.doc
• This form must contain all relevant details. The applicant is requested to consider number of    intended Concerned Member States and how many duplicate applications, if any, will be included in the procedure.
• The request should be sent by email only to rms.procedures@infarmed.pt. Please include the following text in the heading of the email: DCP RMS request.  INFARMED will reply to the request as soon as possible, within one month after reception of a request.
• Applicants who receive a confirmation for a time slot must be prepared to keep the submission deadline and notify the INFARMED as soon as possible in case of a delay or withdraw.

 Note: Requests for a slot for duplicates and extensions procedures can be made outside of the above mentioned procedure.

 DCP time slots that have become available
With some regularity the applicants withdraw DCP procedures after allocation of RMS with PT as RMS for which they have been assigned a time slot. It is important to both applicants and the INFARMED that these slots that have become available are rapidly filled. In case that time slots have become available, we publish this information at this page. Also, potential applicants could register for our E-mail alert for DCP time slots that have become available with PT as RMS. The request should be sent by email only to rms.procedures@infarmed.pt., with information on the email address where this alert should be sent. Please include the following text in the heading of the email: E-mail alert for DCP time slots request.

 Request for DCP application to be submitted on 2011
The applicant is asked to request the INFARMED to act as RMS approximately 6 months before planned submission, as described on the table below.

 The availability DCP timeslots is changing in result of resource improvement. The total of DCP timeslots available to 2011 will be published soon.