Cmdh Slot Request Form

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Request for Emergency Access to Waiver Services Prior to submitting a request for emergency access to waiver services the CSB should thoroughly explore the availability of slots at the CSB and if there are other resources that could be sought to support this individual. REQUEST FOR A RECOMMENDATION ON THE CLASSIFICATION OF AN UNFORESEEN VARIATION UNDER ARTICLE 5 OF COMMISSION REGULATION (EC) NO 1234/2008 Subject: General Author: Laurence O'Dwyer Last modified by: Ba Zsuzsanna Created Date: 8/28/2013 5:05:00 PM Company: Irish Medicines Board Other titles. Please use this form to submit your proposed member slot conversion for OneStar's review. It is recommended as a best practice to seek guidance and approval from OneStar before making significant changes to your member slot allocation.

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  • Best Practice Guide for the Decentralised and Mutual Recognition Procedures (September 2020) [Track version]
  • Best Practice Guide on the Assessment Report for Mutual Recognition and Decentralised Procedures (September 2020) [Track version]
  • Best Practice Guide on Break-out Sessions/Hearings (April 2016) [Track version]
  • Best Practice Guide for authorisation of non-prescription medicines in the Decentralised and Mutual Recognition procedures (January 2019) [Track version]
  • Recommendations on Informed Consent Applications in Mutual Recognition and Decentralised Procedures(April 2015) [Track version]
  • Recommendations on Multiple/Duplicate Applications in Mutual Recognition and Decentralised Procedures(May 2016) [Track version]
  • MSs Recommendations on Extension Applications in Mutual Recognition and Decentralised Procedures (September 2020) [Track version]
  • Position Paper concerning Applicants’ request of submission of multiple applications during ongoing DCPs or inclusion of new CMS or additional strength(s) in an already ongoing DCP(October 2017) [Track version]
  • CMDh Guidance Document for Submission of Summary of the Pharmacovigilance System(July 2015)[Track version]
  • Languages to be used for Marketing Authorisation Applications (MAAs), Variations and Renewals - National, Mutual Recognition and Decentralised applications (July 2020) [Track version]
  • Mock-ups, Specimens and Samples for new applications(October 2016) [Track version]
  • 'Blue-box' requirements (September 2020) [Track version]
  • CMDh SOP on decision-making process for new active substance status or extension of marketing protection or data exclusivity [Track version](October 2017)
  • User Guide for the electronic Application Form for a Marketing Authorisation (July 2018) [Track Version]
  • (June 2020) [Tracked version]
  • Procedural advice on Validation of MR/Repeat-use/DC Procedures (June 2019)
  • Data requested for New Applications in the MRP/DCP which are not stated in the current EU legislation and/or in Volume 2B, Presentation and format of the dossier Common Technical Document (CTD) and/or in the EEA approved Guidelines/Recommendation papers(November 2020) [Track version]
  • Member States Recommendations on the Cover Letter for New Applications submitted through MRP/DCP (January 2018) [Track version]
  • CMDh Best Practice Guide on the compilation of the dossier for New Applications submitted in Mutual Recognition and Decentralised Procedures (Febuary 2020) [Track version]

Cmdh Slot Request Form Sss

  • CMS Validation Checklist for human medicinal products in DCP(March 2020)
  • RMS Validation Checklist for human medicinal products in DCP(April 2020)

Introduction to Published Papers on Validation has been taken off the website as it was considered to be obsolete.

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.

Cmdh Slot Request Form Template

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 [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.

Cmdh slot request forms

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.