Cmdh Slot Request Form

• Cmdh Slot Request Form Template
• Cmdh Slot Request Form Sss
• Cmdh Slot Request Forms

CMDH | RECENTLY PUBLISHED

A copy of the form should be provided to the individual and the original placed in the individual's file. If at a later time the individual wishes to reapply for the Community Supports Waiver, a new Community Supports Waiver Slot Allocation Request (Community Supports Form 30A) must be submitted according to the procedures outlined in this.

1. Requested MS to act as RMS: Intended number of CMSs (if known): Active Substance(s): ATC Code: Proposed Product Name Pharmaceutical Form(s) Strength(s) Legal basis of application: Art.8(3) Art.10(1) Art.10(3) Art.10(4) Art.10a Art.10b Art.10c Art. 16a Extension This is a duplicate of an ongoing or finalised procedure: Indicate the procedure number of the original dossier: Indicate the number.
2. 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.

Practical guidance on the implementation of the Protocol on Ireland/Northern..
added 14/12/2020

Added in December 2020 14 December 2020 NEW - Practical guidance on the..
modified 14/12/2020

Meeting 8-9 December 2020: Agenda Meeting 10-11 November 2020: Agenda -..
modified 10/12/2020

Cutaquig (human normal immunoglobulin) End of procedure: 22/10/2020 Date of..
modified 24/11/2020

Mebendazole End of procedure: 17/12/2018 Date of publication: 24/11/2020
modified 24/11/2020

Templates Variation Assessment Report
added 24/11/2020

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Meeting with Interested Parties - 11 November 2020 Agenda Presentations ..
added 20/11/2020

Requirements on submissions (number and format) for New Applications within MRP,..
added 17/11/2020

Pethidine hydrochloride End of procedure: 25/09/2020 Date of publication:..
added 10/11/2020

Retinol, cholecalciferol, alphatocopherol, ascorbic acid, thiamine,..
added 10/11/2020

List of documents published on CMDh Website(November 2020)

The CMDh started its activities in November 2005, replacing the informal Mutual Recognition Facilitation Group (MRFG), which was in operation over 10 years, to coordinate and facilitate the operation of the mutual recognition procedure.

The Co-ordination group for Mutual recognition and Decentralised procedures – human (CMDh), was set up in Directive 2004/27/EC for the examination of any question relating to marketing authorisations of a medicinal product in two or more Member States in accordance with the mutual recognition procedure or the decentralised procedure. The task of the CMDh was substantially extended in 2012 by Directive 2010/84/EU, amending Directive 2001/83/EC as regards pharmacovigilance.

This very broad scope for the CMDh is complemented by specific tasks laid down in the legislation:

• aim to solve disagreements on the grounds of potential serious risk to public health between the Member States involved in a mutual recognition or decentralised procedure;
• examination of questions related to the pharmacovigilance (Art. 107c, 107e, 107g, 107k and 107q of Directive 2001/83/EC);
• examination of questions related to variations;
• laying down, yearly, a list of medicinal products for which a harmonised summary of product characteristics should be drawn up.

To fulfil its tasks the CMDh has established several working parties/working groups, currently:

• Joint CMD/CHMP/CVMP/EMA/QWP/EDQM working group on ASMF procedures - responsible for developing work-sharing procedures for ASMF assessment;
• Joint CMD/EMA working party on variation regulation - responsible for drafting guidance documents relating to variations;
• Joint CMDh/EMA working party on paediatric regulation - responsible for helping with the coordination of work-sharing assessment of paediatric data;
• Working Party on Pharmacovigilance Procedures Work Sharing - responsible for the finalisation of the PSUR work-sharing project for purely national active substances and to develop procedures for RMPs;
• Joint CMDh/GCP Inspectors working party - responsible for preparing inspection programmes;
• Communication Tracking System (CTS) working group - responsible for maintaining and developing the MRP and DCP tracking system and the publicly available product index.

The CMDh is composed of one representative per Member State and Norway, Iceland and Liechtenstein, appointed for a renewable period of three years. Member States may appoint an alternate to the CMDh member. The list of the CMDh Members and alternates, their professional qualifications and declarations of interest are published on the CMDh and EMA websites. The European Commission participates on a regular basis as an observer. Observer status can be granted in line with the CMDh Rules of Procedure to other institutions (e.g. accession countries).

The Chairperson of the CMDh is elected for a term of three years.
According to the Rules of Procedure, the CMDh has one elected Vice-Chairperson elected for a term of three years. A second Vice-Chairperson is appointed by the Member State currently holding the Presidency of the Council of the European Union for the duration of the term of the presidency.

The CMDh holds monthly meetings at the European Medicines Agency which usually have a duration of 3 days. The European Medicines Agency provides the secretariat of the CMDh.

Cmdh Slot Request Form Template

Press releases with statistics, guidance documents, Q&As and information on applications referred to the CMDh are published monthly on the CMDh website.

The CMDh also publishes, on a yearly basis, a summary of the activities carried out by the CMDh and yearly statistics for new applications in the mutual recognition and decentralised procedures and for the applications referred to the CMDh.

There is regular co-operation and exchanges of information on matters of mutual interest to both human and veterinary Co-ordination Groups, with regards to the mutual recognition and decentralised procedures.

August 2016

Decentralised Procedure (DCP) / Mutual Recognition Procedure (MRP)

Cmdh Slot Request Form Sss

At present there are two different procedures to apply for a marketing authorisation for the same medicinal product in the EU/EEA in more than one Member State:

• the Decentralised Procedure (DCP)
• the Mutual Recognition Procedure (MRP).

Both, MRP and DCP, are open for all applications for marketing authorisation which do not fall within thet mandatory scope of the Centralised Procedures. The MRP has to be chosen in the case a marketing authorisation for the same medicinal product has already been granted by a Member State of the EU/EEA, whereas the DCP is applicable if no marketing authorisation exists

In general, one Member State will be selected by the Applicant to carry out the procedure (Reference Member State, RMS) for both types of procedure. The application is based on the identical dossier submitted to all CMS. Apart from leading the administrative procedure, the RMS is responsible for preparing an Assessment Report (AR) which summarises the dossier presented by the applicant. The AR characterises and critically evaluates the medicinal product concerned with regard to its quality, safety and efficacy . This AR will be made available to all Concerned Member States (CMS) by the RMS and forms the basis for the evaluation by CMS. The Applicant also receives a copy of the AR, however without confidential information MS concerned by either the MRP or the DCP will have 90 days to accept the AR (MRP) or the draft AR (DCP) of the RMS and to issue a marketing authorisation. Further documents may have to be submitted by the applicant to clarify open questions and outstanding issues.

In the case a Member State concerned by the procedure is unable to accept the AR or draft AR on the basis of a 'potential serious risk to public health' as defined in Article 29(1) of Directive 2001/83/EC as amended, and further elaborated in the Commission Communication (Official Journal C 133, 8/6/2006 p. 5 - 7) and the Annex to this Commission Communication ('Notice to Applicants, Volume 2 C - Regulatory ' ), the application will be forwarded for further discussion to the Coordination Group for Mutual Recognition and Decentralised Procedures (CMD(h)). If the CMD(h) is unable to resolve the issue within 60 days, the application will be sent to the CHMP for arbitration.

Notes on applying for a Decentralised Procedures (DCP):

A DCP must be requested in wirting. Please note the Guide to the Submission of Applications for Marketing Authorisation of Medicinal Products as well as the Guide to Submission of Applications for Marketing Authorisations of the Decentralised Procedure (DCP) (according to Art. 28(3) of Directive 2001/83/EC).

The Coordination Group for Mutual Recognition and Decentralised Procedures (CMDh) develops and publishes corresponding guidelines on the DCP on its website, where further information on the procedure can be found, e.g.

Note on submission of draft responses

If deficiencies are identified during the first assessment phase, the applicant shall be given the opportunity to amend his dossier (clock stop). Texas holdem flush probability chart. In the case of many and/or serious deficiencies, the submission of draft responses for preliminary assessment by the RMS is recommended. Draft response documents submitted for pre-assessment when Germany is acting as RMS cannot be accepted via CESP. These should be submitted directly to the responsible case manager via e-mail or EudraLink.

See also Using the COMMON EU SUBMISSION PLATFORM (CESP) for electronic submissions to the BfArM

Notes on applying for a Mutual Recognition Procedures (MRP) and ‘Repeat Use' Procedures (RUP):

A Marketing Authorisation Holder (MAH) can use the Mutual Recognition Procedure (MRP) for the same authorisation more than once after completion of a first MRP or a Decentralised Procedure (DCP) for the recognition of a marketing authorisation by other Member States (MS). This procedure is known as 'Repeat Use' (RUP).

The MAH should send a written request for MRP or RUP to the BfArM including the completed forms as published on the CMDh website:

• Request for MRP/RUP for Medicinal Products for Human Use
• Appendix 1 to Request for MRP/RUP for Medicinal Products for Human Use
• Update Assessment report for Repeat use procedures

In this context, please also note the general information of the BfArM on the Submission of Applications for Marketing Authorisation of Medicinal Products.

CMDH | RECENTLY PUBLISHED

A copy of the form should be provided to the individual and the original placed in the individual's file. If at a later time the individual wishes to reapply for the Community Supports Waiver, a new Community Supports Waiver Slot Allocation Request (Community Supports Form 30A) must be submitted according to the procedures outlined in this.

1. Requested MS to act as RMS: Intended number of CMSs (if known): Active Substance(s): ATC Code: Proposed Product Name Pharmaceutical Form(s) Strength(s) Legal basis of application: Art.8(3) Art.10(1) Art.10(3) Art.10(4) Art.10a Art.10b Art.10c Art. 16a Extension This is a duplicate of an ongoing or finalised procedure: Indicate the procedure number of the original dossier: Indicate the number.
2. 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.

Practical guidance on the implementation of the Protocol on Ireland/Northern..
added 14/12/2020

Added in December 2020 14 December 2020 NEW - Practical guidance on the..
modified 14/12/2020

Meeting 8-9 December 2020: Agenda Meeting 10-11 November 2020: Agenda -..
modified 10/12/2020

Cutaquig (human normal immunoglobulin) End of procedure: 22/10/2020 Date of..
modified 24/11/2020

Mebendazole End of procedure: 17/12/2018 Date of publication: 24/11/2020
modified 24/11/2020

Templates Variation Assessment Report
added 24/11/2020

Salle de spectacle casino de montreal. The page will give you Salle De Spectacle Casino Montreal all the information you need, including details about alternative payment methods. $25 No Deposit Bonus.

Meeting with Interested Parties - 11 November 2020 Agenda Presentations ..
added 20/11/2020

Requirements on submissions (number and format) for New Applications within MRP,..
added 17/11/2020

Pethidine hydrochloride End of procedure: 25/09/2020 Date of publication:..
added 10/11/2020

Retinol, cholecalciferol, alphatocopherol, ascorbic acid, thiamine,..
added 10/11/2020

List of documents published on CMDh Website(November 2020)

The CMDh started its activities in November 2005, replacing the informal Mutual Recognition Facilitation Group (MRFG), which was in operation over 10 years, to coordinate and facilitate the operation of the mutual recognition procedure.

The Co-ordination group for Mutual recognition and Decentralised procedures – human (CMDh), was set up in Directive 2004/27/EC for the examination of any question relating to marketing authorisations of a medicinal product in two or more Member States in accordance with the mutual recognition procedure or the decentralised procedure. The task of the CMDh was substantially extended in 2012 by Directive 2010/84/EU, amending Directive 2001/83/EC as regards pharmacovigilance.

This very broad scope for the CMDh is complemented by specific tasks laid down in the legislation:

• aim to solve disagreements on the grounds of potential serious risk to public health between the Member States involved in a mutual recognition or decentralised procedure;
• examination of questions related to the pharmacovigilance (Art. 107c, 107e, 107g, 107k and 107q of Directive 2001/83/EC);
• examination of questions related to variations;
• laying down, yearly, a list of medicinal products for which a harmonised summary of product characteristics should be drawn up.

To fulfil its tasks the CMDh has established several working parties/working groups, currently:

• Joint CMD/CHMP/CVMP/EMA/QWP/EDQM working group on ASMF procedures - responsible for developing work-sharing procedures for ASMF assessment;
• Joint CMD/EMA working party on variation regulation - responsible for drafting guidance documents relating to variations;
• Joint CMDh/EMA working party on paediatric regulation - responsible for helping with the coordination of work-sharing assessment of paediatric data;
• Working Party on Pharmacovigilance Procedures Work Sharing - responsible for the finalisation of the PSUR work-sharing project for purely national active substances and to develop procedures for RMPs;
• Joint CMDh/GCP Inspectors working party - responsible for preparing inspection programmes;
• Communication Tracking System (CTS) working group - responsible for maintaining and developing the MRP and DCP tracking system and the publicly available product index.

The CMDh is composed of one representative per Member State and Norway, Iceland and Liechtenstein, appointed for a renewable period of three years. Member States may appoint an alternate to the CMDh member. The list of the CMDh Members and alternates, their professional qualifications and declarations of interest are published on the CMDh and EMA websites. The European Commission participates on a regular basis as an observer. Observer status can be granted in line with the CMDh Rules of Procedure to other institutions (e.g. accession countries).

The Chairperson of the CMDh is elected for a term of three years.
According to the Rules of Procedure, the CMDh has one elected Vice-Chairperson elected for a term of three years. A second Vice-Chairperson is appointed by the Member State currently holding the Presidency of the Council of the European Union for the duration of the term of the presidency.

The CMDh holds monthly meetings at the European Medicines Agency which usually have a duration of 3 days. The European Medicines Agency provides the secretariat of the CMDh.

Cmdh Slot Request Form Template

Press releases with statistics, guidance documents, Q&As and information on applications referred to the CMDh are published monthly on the CMDh website.

The CMDh also publishes, on a yearly basis, a summary of the activities carried out by the CMDh and yearly statistics for new applications in the mutual recognition and decentralised procedures and for the applications referred to the CMDh.

There is regular co-operation and exchanges of information on matters of mutual interest to both human and veterinary Co-ordination Groups, with regards to the mutual recognition and decentralised procedures.

August 2016

Decentralised Procedure (DCP) / Mutual Recognition Procedure (MRP)

Cmdh Slot Request Form Sss

At present there are two different procedures to apply for a marketing authorisation for the same medicinal product in the EU/EEA in more than one Member State:

• the Decentralised Procedure (DCP)
• the Mutual Recognition Procedure (MRP).

Both, MRP and DCP, are open for all applications for marketing authorisation which do not fall within thet mandatory scope of the Centralised Procedures. The MRP has to be chosen in the case a marketing authorisation for the same medicinal product has already been granted by a Member State of the EU/EEA, whereas the DCP is applicable if no marketing authorisation exists

In general, one Member State will be selected by the Applicant to carry out the procedure (Reference Member State, RMS) for both types of procedure. The application is based on the identical dossier submitted to all CMS. Apart from leading the administrative procedure, the RMS is responsible for preparing an Assessment Report (AR) which summarises the dossier presented by the applicant. The AR characterises and critically evaluates the medicinal product concerned with regard to its quality, safety and efficacy . This AR will be made available to all Concerned Member States (CMS) by the RMS and forms the basis for the evaluation by CMS. The Applicant also receives a copy of the AR, however without confidential information MS concerned by either the MRP or the DCP will have 90 days to accept the AR (MRP) or the draft AR (DCP) of the RMS and to issue a marketing authorisation. Further documents may have to be submitted by the applicant to clarify open questions and outstanding issues.

In the case a Member State concerned by the procedure is unable to accept the AR or draft AR on the basis of a 'potential serious risk to public health' as defined in Article 29(1) of Directive 2001/83/EC as amended, and further elaborated in the Commission Communication (Official Journal C 133, 8/6/2006 p. 5 - 7) and the Annex to this Commission Communication ('Notice to Applicants, Volume 2 C - Regulatory ' ), the application will be forwarded for further discussion to the Coordination Group for Mutual Recognition and Decentralised Procedures (CMD(h)). If the CMD(h) is unable to resolve the issue within 60 days, the application will be sent to the CHMP for arbitration.

Notes on applying for a Decentralised Procedures (DCP):

A DCP must be requested in wirting. Please note the Guide to the Submission of Applications for Marketing Authorisation of Medicinal Products as well as the Guide to Submission of Applications for Marketing Authorisations of the Decentralised Procedure (DCP) (according to Art. 28(3) of Directive 2001/83/EC).

The Coordination Group for Mutual Recognition and Decentralised Procedures (CMDh) develops and publishes corresponding guidelines on the DCP on its website, where further information on the procedure can be found, e.g.

Note on submission of draft responses

If deficiencies are identified during the first assessment phase, the applicant shall be given the opportunity to amend his dossier (clock stop). Texas holdem flush probability chart. In the case of many and/or serious deficiencies, the submission of draft responses for preliminary assessment by the RMS is recommended. Draft response documents submitted for pre-assessment when Germany is acting as RMS cannot be accepted via CESP. These should be submitted directly to the responsible case manager via e-mail or EudraLink.

See also Using the COMMON EU SUBMISSION PLATFORM (CESP) for electronic submissions to the BfArM

Notes on applying for a Mutual Recognition Procedures (MRP) and ‘Repeat Use' Procedures (RUP):

A Marketing Authorisation Holder (MAH) can use the Mutual Recognition Procedure (MRP) for the same authorisation more than once after completion of a first MRP or a Decentralised Procedure (DCP) for the recognition of a marketing authorisation by other Member States (MS). This procedure is known as 'Repeat Use' (RUP).

The MAH should send a written request for MRP or RUP to the BfArM including the completed forms as published on the CMDh website:

• Request for MRP/RUP for Medicinal Products for Human Use
• Appendix 1 to Request for MRP/RUP for Medicinal Products for Human Use
• Update Assessment report for Repeat use procedures

In this context, please also note the general information of the BfArM on the Submission of Applications for Marketing Authorisation of Medicinal Products.

Cmdh Slot Request Forms

The Coordination Group for Mutual Recognition and Decentralised Procedures (CMDh) develops and publishes corresponding guidelines on the MRP and RUP on its website, where further information on the procedures can be found, e.g.