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. CMDh BPGs for the submission and processing of Variations in the MRP CMDh/094/2003/Rev17, O 2012 Page 4/55 Page 4/55 If reference is made to all strengths and/or pharmaceutical forms of a medicinal product the following.
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 [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
Cmdh Slot Request Form 9465
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.
The word based application forms (AF) have been replaced by electronic application forms (eAF), with new possibilities like electronic data import/export, data population within the form, online access to standardised catalogue terms, built in business rule validation, and support for validation of form, etc. Implementation of mandatory use of the eAF is part of the HMA eSubmission roadmap.
The electronic forms and supporting technical documentation are available below.
News
Previous news can be found here.
02-12-2020
eAF issues with webservices fixed
The issue affecting the ‘Substance Type' field in both, human and veterinary MAA forms has now been fixed and all the previously available substance types are now again available.
For any issues with the eAFs, please raise a call via the EMA service desk.
01-12-2020
eAF issues with webservices - Update
An issue relating to the eAF webservice update which affected availability of terms in the ‘Pharmaceutical Form' field in all 4 forms has been fixed (Monday 30th November). All pharmaceutical forms should now be again in the eAFs. Please note that as this issue affected the webservices to the form, not the forms themselves so there is no need to change the form, just ‘update lists' if the terms are not yet visible.
Additionally, another issue affecting the ‘Substance Type' field in both, human and veterinary MAA forms has been detected and we are working on a further fix to solve this issue as soon as possible.
For any issues with the eAFs, please raise a call via the EMA service desk.
26-11-2020
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eAF issue with webservices
An issue relating to the eAF webservice update has affected availability of terms in the ‘Pharmaceutical Form' field in all 4 forms. We have released a fix that has partially solved the issue; however, we are aware that there are still many combined pharmaceutical forms that are currently unavailable in the eAFs. Please note that as this issue affects the webservices to the form, not the form itself, also previous versions of the form are affected.
We are working on a further fix to solve this issue as soon as possible.
For any issues with the eAFs, please raise a call via the EMA service desk.
27-10-2020
eAF v1.24.0.0 important note to users
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
Cmdh Slot Request Form 9465
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.
The word based application forms (AF) have been replaced by electronic application forms (eAF), with new possibilities like electronic data import/export, data population within the form, online access to standardised catalogue terms, built in business rule validation, and support for validation of form, etc. Implementation of mandatory use of the eAF is part of the HMA eSubmission roadmap.
The electronic forms and supporting technical documentation are available below.
News
Previous news can be found here.
02-12-2020
eAF issues with webservices fixed
The issue affecting the ‘Substance Type' field in both, human and veterinary MAA forms has now been fixed and all the previously available substance types are now again available.
For any issues with the eAFs, please raise a call via the EMA service desk.
01-12-2020
eAF issues with webservices - Update
An issue relating to the eAF webservice update which affected availability of terms in the ‘Pharmaceutical Form' field in all 4 forms has been fixed (Monday 30th November). All pharmaceutical forms should now be again in the eAFs. Please note that as this issue affected the webservices to the form, not the forms themselves so there is no need to change the form, just ‘update lists' if the terms are not yet visible.
Additionally, another issue affecting the ‘Substance Type' field in both, human and veterinary MAA forms has been detected and we are working on a further fix to solve this issue as soon as possible.
For any issues with the eAFs, please raise a call via the EMA service desk.
26-11-2020
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eAF issue with webservices
An issue relating to the eAF webservice update has affected availability of terms in the ‘Pharmaceutical Form' field in all 4 forms. We have released a fix that has partially solved the issue; however, we are aware that there are still many combined pharmaceutical forms that are currently unavailable in the eAFs. Please note that as this issue affects the webservices to the form, not the form itself, also previous versions of the form are affected.
We are working on a further fix to solve this issue as soon as possible.
For any issues with the eAFs, please raise a call via the EMA service desk.
27-10-2020
eAF v1.24.0.0 important note to users
An updated version of the variation eAF v1.24.0.0 is now available. This release which does not change the form version number, provides a fix to the Adobe backwards compatibility issue and it should solve the issues some users have experienced with the scope selection dropdown list in section 3. This version also includes a change in the form validation rules for grouping of Type IA or Type IAIN variations.
Please ensure that upon opening the eAF you ‘trust' the form by clicking the small exclamation mark at the top of the left-hand adobe pane and then selecting the trust option from the yellow banner which will open across the top of the forms. The drop-down menu's will not work if the form has not been trusted.
The Presentations for applicants and NCAs on the release v1.24.0.0 have been updated and are available below.
For any issues with the eAFs, for example reporting missing scopes, please raise a call via the EMA service desk.
08-10-2020
eAF v1.24.0.0 important note to users
The variation form can only be used with Adobe Reader version DC. The functionalities in variation selection drop down list in section 3 will not work with older versions (e.g. reader 2017, X or XI).
Please ensure that if you have Adobe Acrobat or Acrobat Pro2017, X or XI installed, you close all documents that have been opened using Acrobat/Acrobat Pro or documents that contain Adobe sign signature before opening the eAF using reader DC as these may prevent the drop down list of scopes in section 3 working as expected.
Please note that we are working hard to find a solution to this cross-interference issue as soon as possible.
Please ensure that upon opening the eAF you ‘trust' the form by clicking the small exclamation mark at the top of the left-hand adobe pane and then selecting the trust option from the yellow banner which will open across the top of the forms. The drop-down menu's will not work if the form has not been trusted.
The presentation on the release v1.24.0.0 has been updated and is available below.
For any issues with the eAFs, for example reporting missing scopes, please raise a call via the EMA service desk.
15-09-2020
Version 1.24.0.0 of all four electronic Application Forms (eAFs) is now available. The release v1.24.0.0 provides a major change in section 3 of the variation form by further integrating with RMS from SPOR (scopes and conditions and documentation). Some defects have been fixed in MAA human, MAA vet and renewal (H&V forms.
The new version is implemented with 3 months transitional period. Mandatory use of v1.24.0.0 will start on 16th December 2020.
More details can be found in the release notes and the updated Practical user guide for electronic Application Forms as well as the presentation on changes.
Please note that due to the major change in the variation form, data imports from older versions of the variation form will not work.
Applicants are reminded that the version of the form should not be changed during an ongoing procedure.
Forms
Please note that applicants should use Adobe Reader or Adobe Reader DC for locking the forms. Adobe Acrobat or Acrobat Pro DC should not be used for filling and locking the forms as this may cause issues when the locked forms are opened/viewed by the recipient who may be using Adobe Reader/Adobe Reader DC.
Currently accepted version of forms :
Cmdh Slot Request Forms
As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period.
Version 1.24.0.0, available for use from 15th of September, Mandatory use from 16th of December 2020
| Form | Notice to Applicant Revision | Electronic Forms version | Release Notes version |
MAA-Human | Revision 13 | MAA-Human Form 1.24.0.0 (15-09-2020) New | MAA-H Release Notes 1.24.0.0 (15-09-2020) New |
| Variation | Revision February 2018 | Variation Form 1.24.0.0 (26`0-2020)Updated | Variation Release Notes 1.24.0.0 (15-09-2020) New |
| Renewal | Revision February 2018 | Renewal Form 1.24.0.0 (15-09-2020) New | Renewal Release Notes 1.24.0.0 (15-09-2020) New |
MAA-Vet | Revision 8 | MAA-Vet Form 1.24.0.0 (15-09-2020) New | MAA-Vet Release Notes 1.24.0.0 (15-09-2020) New |
| Summary of eAF changes in current release | Summary of changes 1.24.0.0 (15-09-2020) New |
Version 1.23.1.3 and 1.23.1.4, available for use until 15th December 2020
