The Provider of Services must attach a copy of this form to the current month's billing for each change in the status of a patient. Staple all CRCF-01 forms together for each patient. Mailing address for 18th of month claims: Medicaid Claims Receipt- OSS Claims Section Post Office Box 100122 Columbia, SC OSS Slot Reservation Request. 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.
- Cmdh Slot Request Forms
- Cmdh Slot Request Form Sss
- Cmdh Slot Request Form 9465
- Cmdh Slot Request Form Template
- The word based application forms (AF) have been replaced by electronic application forms (eAF), with new possibilities like electronic data import/export, data population within the form, online access to standardised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.
- Time Slot Request Form Thank you for your interest in cablecasting your 28- or 58-minute program on one of MNN's channels! Please submit this form if you have a completed program that you would like to have scheduled on one of MNN's channels.
- Request for RMS in a decentralised procedure, medicinal products for human use Request for RMS DCP, medicininal products for human use CMDh/036/2009, Rev.1, June 2016 Page 1/1.
A New System of DCP Slots Allocation with SÚKL as the RMS
SÚKL informs about a new system of slots allocation within the scope of decentralised procedures (DCP) with SÚKL as the Reference Member State (RMS), effective as of 1 January 2018. DCP slots are newly allocated on a continuous basis, with a monthly publication of free capacities.
A DCP slot is a time interval in which it is possible to submit an application for marketing authorisation of a medicinal product within a DCP to SÚKL as the RMS and to the agencies of the Concerned Member States.
SÚKL allocates DCP slots to applications for marketing authorisation of a medicinal product with all types of legal basis 2 years in advance.
Requests for DCP slots allocation
It is advisable to ask for a DCP slot at least two months Best free poker app for iphone. prior to the planned submission of the marketing authorisation application with SÚKL as the RMS, taking into account the free capacities specified in the table of free capacities below. This table specifies currently available free capacities for DCP slots on a monthly basis for the next 12 months; nevertheless, it is possible to apply for a DCP slot allocation as long as 2 years in advance.
Furthermore, it is necessary to apply for a DCP slot in case of applications for marketing authorisation through line extensions and so-called duplicates.
Free capacities for DCP slot allocation:
2020
DCP slot dates in 2020 | No. of free slots in the respective month | DCP slot dates in 2020 | No. of free slots in the respective month |
January | 1 | February | 1 |
March | 1 | April | 0 |
May | 0 | June | 0 |
July | 0 | August | 0 |
September | 0 | October | 0 |
November | 0 | December | 2 |
2021
DCP slot dates in 2021 | No. of free slots in the respective month | DCP slot dates in 2021 | No. of free slots in the respective month |
January | 0 | February | 1 |
March | 1 | April | 2 |
May | 5 | June | 5 |
July | 5 | August | 5 |
September | 5 | October | 5 |
November | 5 | December | 5 |
Requests for DCP slots are to be submitted using a fully completedCMDh Request Form. The preferred timeline for submission of the marketing authorisation application has to be specified in themonth and yearformat (rather than the quarter and years format).
The request submitted on the CMDh Request Form has to be sent to the following e-mail address: DCP.slot@suklcz.
The request should be sent at least 2 months before the planned date of submission of the marketing authorisation application.
Concurrently, applicants are invited to wait for the reply regarding DCP slot allocation from SÚKL prior to submitting a request for a DCP slot in another EU medicines agency.
Procedure for DCP slots allocation
The applicant will be informed about the allocated slot within 2 weeks of sending the fully completed request for a DCP slot. In case it is not possible to accept the DCP slot date proposed by the applicant, SÚKL shall propose an alternative one.
Thereafter, within one week of receiving the information on DCP slot allocation (or an alternative date, if applicable), the applicant has to confirm whether they accept the DCP slot date or not. Should SÚKL fail to receive any confirmation within a week of having sent the information on the allocated DCP slot date, the slot shall be considered free again.
Changes to allocated DCP slots
DCP slot postponement: The applicant shall apply for a DCP slot postponement as soon as practicable; the request shall be sent by e-mail to the following e-mail address: DCP.slot@suklcz. The applicant shall be informed about the postponement within 2 weeks of sending the request.
DCP slot cancellation: The applicant should inform SÚKL about the cancellation of the DCP slot as soon as practicable.
Change to a DCP slot: In case a change to an existing slot (such as a change of the active substance, legal basis, pharmaceutical form) occurs, the applicant shall apply for a new DCP slot allocation. The allocation procedure is the same as described above. Concurrently, it is necessary to inform about the cancellation of the originally allocated DCP slot.
Cmdh Slot Request Forms
Applications for the conduct of a MRP/RUP with SÚKL as the RMS
SÚKL asks marketing authorisation holders to inform about their intention to submit an application for the conduct of a Mutual Recognition Procedure (MRP/RUP) with SÚKL as the RMS at least one month prior to the submission of the application.
The maximum capacity of MRP / RUP applications with SÚKL as RMS is 3 applications per month.
Cmdh Slot Request Form Sss
Requirements for submission of applications for conduct of a MRP/RUP with SÚKL as RMS are available here.
Marketing Authorisation Branch
4 December 2017
updated 26.8.2020
In order to view some of the documents on this website you need Acrobat Reader
(click here to download)
- 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]
Cmdh Slot Request Form 9465
- 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 Slot Request Form Template
- CMDh Best Practice Guide on the compilation of the dossier for New Applications submitted in Mutual Recognition and Decentralised Procedures (Febuary 2020) [Track version]
- CMS Validation Checklist for human medicinal products in DCP(March 2020)
- RMS Validation Checklist for human medicinal products in DCP(April 2020)
DCP slot dates in 2020 | No. of free slots in the respective month | DCP slot dates in 2020 | No. of free slots in the respective month |
January | 1 | February | 1 |
March | 1 | April | 0 |
May | 0 | June | 0 |
July | 0 | August | 0 |
September | 0 | October | 0 |
November | 0 | December | 2 |
2021
DCP slot dates in 2021 | No. of free slots in the respective month | DCP slot dates in 2021 | No. of free slots in the respective month |
January | 0 | February | 1 |
March | 1 | April | 2 |
May | 5 | June | 5 |
July | 5 | August | 5 |
September | 5 | October | 5 |
November | 5 | December | 5 |
Requests for DCP slots are to be submitted using a fully completedCMDh Request Form. The preferred timeline for submission of the marketing authorisation application has to be specified in themonth and yearformat (rather than the quarter and years format).
The request submitted on the CMDh Request Form has to be sent to the following e-mail address: DCP.slot@suklcz.
The request should be sent at least 2 months before the planned date of submission of the marketing authorisation application.
Concurrently, applicants are invited to wait for the reply regarding DCP slot allocation from SÚKL prior to submitting a request for a DCP slot in another EU medicines agency.
Procedure for DCP slots allocation
The applicant will be informed about the allocated slot within 2 weeks of sending the fully completed request for a DCP slot. In case it is not possible to accept the DCP slot date proposed by the applicant, SÚKL shall propose an alternative one.
Thereafter, within one week of receiving the information on DCP slot allocation (or an alternative date, if applicable), the applicant has to confirm whether they accept the DCP slot date or not. Should SÚKL fail to receive any confirmation within a week of having sent the information on the allocated DCP slot date, the slot shall be considered free again.
Changes to allocated DCP slots
DCP slot postponement: The applicant shall apply for a DCP slot postponement as soon as practicable; the request shall be sent by e-mail to the following e-mail address: DCP.slot@suklcz. The applicant shall be informed about the postponement within 2 weeks of sending the request.
DCP slot cancellation: The applicant should inform SÚKL about the cancellation of the DCP slot as soon as practicable.
Change to a DCP slot: In case a change to an existing slot (such as a change of the active substance, legal basis, pharmaceutical form) occurs, the applicant shall apply for a new DCP slot allocation. The allocation procedure is the same as described above. Concurrently, it is necessary to inform about the cancellation of the originally allocated DCP slot.
Cmdh Slot Request Forms
Applications for the conduct of a MRP/RUP with SÚKL as the RMS
SÚKL asks marketing authorisation holders to inform about their intention to submit an application for the conduct of a Mutual Recognition Procedure (MRP/RUP) with SÚKL as the RMS at least one month prior to the submission of the application.
The maximum capacity of MRP / RUP applications with SÚKL as RMS is 3 applications per month.
Cmdh Slot Request Form Sss
Requirements for submission of applications for conduct of a MRP/RUP with SÚKL as RMS are available here.
Marketing Authorisation Branch
4 December 2017
updated 26.8.2020
In order to view some of the documents on this website you need Acrobat Reader
(click here to download)
- 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]
Cmdh Slot Request Form 9465
- 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 Slot Request Form Template
- CMDh Best Practice Guide on the compilation of the dossier for New Applications submitted in Mutual Recognition and Decentralised Procedures (Febuary 2020) [Track version]
- 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.
