Portugal as Reference Member State

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Infarmed was the 3rd Member State to start procedures as Reference Member State in 2018

Strengthening Portugal's position in the regulatory system is one of the strategic objectives of Infarmed and includes the active participation in the European medicines evaluation network through Mutual Recognition and Decentralised procedures, in particular through the number of marketing authorisation applications initiated by Portugal as Reference Member State.

In 2018, Infarmed reached the top 3 of the Member States that most contribute to the European evaluation system. The work carried out by Infarmed in the last 10 years, along with Brexit, has made it possible for Infarmed to integrate the European group of agencies with a greater active role in the evaluation of medicines.

The technical and scientific capacities in different therapeutic areas, recognised experience in the authorisation assessment and the availability are some of the aspects that are recognized and valued.

 

Portugal as Reference Member State

The Portuguese National Competent Authority, INFARMED, I.P., participates actively in the Mutual Recognition (MR) and Decentralised (DC) procedures as Reference Member State (RMS). Since the beginning it has been receiving a high number of requests for time slots, more than the agency is currently able to accommodate.

In addition the HMA (Heads of Medicines Agencies) has agreed a common DCP RMS request form.
 

Request for applications via the MRP/RUP with Portugal as RMS

The request should be made by filling in the request form. This is also applicable for applications via the Repeat Use Procedure (RUP).

This form must contain all relevant details. The applicant is requested to consider the 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.

The intended date of submission - in Portugal only - refers to the date in which the application is submitted to the RMS only.

Request form for applications via the MRP with Portugal RMS

Request form for applications via the MRP with Portugal RMS [following CMDh recommendation adopted in October 2015]

The  Appendix 1 of the request must be filled and submitted along with the Request form.
 

Request for time slot for applications via the DCP with Portugal as RMS

The request should be made by filling in the request form, available at: http://www.hma.eu/

This form must contain all relevant details. The applicant is requested to consider the number of intended Concerned Member States and how many duplicate applications, if any, will be included in the procedure. As per CMDh recommendation, only one RMS should be approached for a slot application.

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 + active substance + intended submission date. 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 acknowledge it and be prepared to fulfill the submission deadline. In cases of intended delay or withdrawal, Infarmed must be approached at least 15 days in advance.

 

Submission of DCP, MRP and RUP 

DCP:

There is an electronic portal for management of medicinal products for human use for pre-submission of Marketing Authorization Application (SMUH-AIM).

The payment of fees applicable to MAA is integrated into the SMUH-AIM portal and should be made via ATM reference issued in the portal by the applicant. The issuing of the payment form with the reference for payment is performed using automatic calculation rules applied to the information in the online form, therefore applicants should consider the need to fill the form appropriately.

Any doubt about the scientific filling must be addressed to rms.procedures@infarmed.pt, identifying the procedure number (PT/H/...), before finishing this submission.

After electronic pre-submission of the MAA and confirmation of valid payment of fee in the portal, the applicant must submit the MAA dossier exclusively via CESP (Common European Submission Portal). It's recommended the sending of an email containing the subject : "PT/H/xxxx/xxx/xx - INN+Applicant - Initial submission" to rms.procedures@infarmed.pt. This email should contain information about CESP number and Dispatch list of the submission in the CMSs.

The validation step will start immediately after these 3 requirements are fulfilled.

 

MRP/RUP:

There is an electronic portal for management of medicinal products for human use for pre-submission of Marketing Authorization Application (SMUH-AIM), including pre submission of MR or Repeated Use procedures where Portugal acts as Reference Member State (for which preparation of assessment report is required previously to the European procedure). All details about the medicine should be available and confirmed by the Applicant.

The medicine should be available at the portal and all the relevant approved details are displayed. As with DCP, the payment of fees applicable to MAA is integrated into the SMUH-AIM portal and should be made via ATM reference issued in the portal by the applicant The issuing of the payment form with the reference for payment is performed using automatic calculation rules applied to the information in the online form, therefore applicants should consider the need to fill the form appropriately.

Any doubt about the filling must be addressed to rms.procedures@infarmed.pt, identifying the procedure number (PT/H/...), before finishing this submission.

After electronic pre-submission of the MAA and confirmation of valid payment of fee in the portal, the applicant must submit the MAA dossier exclusively via CESP (Common European Submission Portal). It's recommended the sending of an email containing the subject : "PT/H/xxxx/xxx/xx - INN+Applicant - Initial submission" to rms.procedures@infarmed.pt. This email should contain information about CESP number. s.

The validation step will start immediately after these 3 requirements are fulfilled.