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DECENTRALISED PROCEDURE - REQUESTS TO ACT AS RMS Doc. Ref.: CMDh/020/2009/Rev.19 September 2014 The Heads

DECENTRALISED PROCEDURE - REQUESTS TO ACT AS RMS

Doc. Ref.: CMDh/020/2009/Rev.19 September 2014

The Heads of Medicines Agencies’ Task Force on Resources in DCP in cooperation with CMDh has developed a common request form to be used when asking a National Competent Authority (NCA) to act as Reference Member State in a decentralised procedure. The Heads of Medicines Agencies has agreed to publish the request form on the CMDh website as well as on all national competent authorities websites.

The request form (http://www.hma.eu/219.html) should be submitted to the NCA in accordance with information provided by that NCA. Below is a list of links to the NCAs’ webpages where their recommendations for requests to act as RMS are published.

MEMBER

STATES

SUMMARY OF NATIONAL BOOKING SYSTEMS & LINKS TO NATIONAL WEBPAGES

AUSTRIA

BELGIUM

BULGARIA

Applicants wishing to apply for a marketing authorisation through the Decentralised Procedure with AT as RMS are advised to inform Austrian Medicines and Devices Agency (BASG / AGES) in advance about their intentions and agree on a date for submission with BASG / AGES. Requests for a time slot are made by using the CMDh request form. Completed forms should be sent to rms@ages.at.

DCP slot-requests and bookings, long-term and short-term, can be placed any time according to the availabilities as indicated in the matrix http://www.basg.gv.at/en/medicines/authorisation-mrpdcp/ages- slots/

For Mutual Recognition, Repeat-Use and Line Extension Procedures requests can be placed any time to rms@ages.at.

Applicants are advised to inform BASG / AGES as early as possible if an agreed application will not be submitted in due course to the slot agreed.

More detailed information can be found on the BASG / AGES website:

http://www.basg.gv.at/en/medicines/authorisation-mrpdcp/ages-slots/

The Belgian Agency gives priority to the applications for medicinal product in the following domains:

- Oncology (with special focus on treatment of cancer pain and paediatrics)

- vaccines.

For existing substances, the Belgian Agency also gives priority to those where BE has been RMS or rapporteur in previous procedures. Applicants should send the request at least 3 months before the expected date of submission of the application and will receive a response within 3 weeks. Please note that applications with BE as RMS are booked for a specific active substance, dosage form and submission date. If the applicant intends to change one of those parameters, a new request should be introduced.

Applicants are informed that there is no available timeslot in BE in 2010.

Further information are available on the fagg-afmps website:

MEMBER

 

STATES

 

SUMMARY OF NATIONAL BOOKING SYSTEMS & LINKS TO NATIONAL WEBPAGES

CROATIA

CYPRUS

 
 

DCP timeslots are allocated by the The State Institute for Drug Control for a two-year-period. This period starts as from the submission deadline.

The submission deadlines shall be 31 st March and 30 th September of a calendar year.

After the submission deadline the Institute shall allocate DCP timeslots with respect to the following criteria:

CZECH

1.free capacity of the Institute (of the assessors).

REPUBLIC

2.chronological order of requests received (according to the day of receipt and should the day of receipt be the same then according to the exact time of receipt).

The notification on an intention to submit a request in order to ask a MS to be the RMS (hereinafter referred to as “request for a DCP timeslot”) should be addressed to the following e-mail address:

A

detailed and updated specification of the process of slot allocation for applicants for marketing

authorisation via decentralised procedure with the Czech Republic as the Reference Member State can be found on the SUKL website: http://www.sukl.eu/medicines/reg-85-version-1

 

In order to best meet both applicants’ requests for specified submission dates and to optimise our own use of time and resources, future applicants are advised to request time slots for application(s), for which they wish Denmark as RMS in the decentralised procedure, within a reasonable time prior to the proposed submission date.

Time slots may be requested at any time and there are currently no restrictions on the choice of time period. However, we prefer that the requests are limited to no longer than 1½ years from the date of the request.

Time slots are allocated on a “first come first served” basis. If the requested time slot is not available, a suitable alternative will be offered.

DENMARK

Requests for a time slot are made by using the CMDh request form. The form should be sent by e-mail

to

Changes to already agreed time slots should be notified to the DHMA as soon as possible for new submission date to be scheduled/agreed.

More detailed information can be found on our website:

 

The requests for slot booking have to be sent to mrp@ravimiamet.ee

The requests can be sent at any time.

ESTONIA

For more information please visit our web-page:

http://www.ravimiamet.ee/en/dcp-estonia-rms

FINLAND

The Finnish Medicines Agency is open for RMS requests for DCP applications four times per year: in February, May, August and November. The Applicants should be prepared to submit the applications during the following 612 months. Cancelled time slots can be requested any time.

More detailed information can be found on the Fimea website: http://www.fimea.fi/

 

In

May 2011, ANSM has changed the current system of booking and allocation of timeslots for the

decentralised procedures (DCP) with France acting as the Reference Member State. ANSM opens two booking periods each year to allow submission of timeslot requests for decentralised procedures.

FRANCE

Applicants wishing to apply for a marketing authorisation through the decentralised procedure with FR acting as RMS are advised to inform ANSM at an early stage about their intentions and propose a date of submission. The request form completed should be sent by email during these two booking periods to the following address: slot.france@ansm.sante.fr

MEMBER

 

STATES

 

SUMMARY OF NATIONAL BOOKING SYSTEMS & LINKS TO NATIONAL WEBPAGES

 

The timeslot request has to be confirmed by the applicant 6 months before the submission date agreed by ANSM.

A

timeslot is allocated for a medicinal product with an agreed submission date. Neither the medicinal

product nor the submission date can be changed.

Further details are published on the ANSM website:

 

Generally, new DCP applications with the BfArM as proposed RMS may be submitted without prior

slot allocation/request and will be started immediately after positive validation. Start dates do not need

to

be agreed upon.

For some ATC codes, however, a slot allocation remain necessary. Such slot requests have to be

submitted prior to the intended submission by using the CMDh request form (http://www.hma.eu/219.html). They should be sent to slotrequest-DCP@bfarm.de. Information on the excepted ATC-Codes as well as on further details for the slot requests can be found on the BfArM

 

website:

GERMANY

Applicants are advised to inform BfArM as early as possible if an agreed application will not be submitted in due course to the slot agreed.

To facilitate the allocation of resources BfArM kindly requests early information on the planned submission of a DCP application for which no slot booking is necessary. This information should be directed to slotrequest-DCP@bfarm.de using the usual slot request form by the HMA (http://www.hma.eu/219.html). All procedures will be started after positive validation, start dates do not need to be agreed upon.

Special note for (traditional) herbal products without HMPC monographs or list positions as well as in case of homeopathic registrations: BfArM recommends a bilateral agreement on regulatory and scientific issues with the responsible licensing unit in advance of DCP application submissions.

GREECE

Under development

 

A

letter of intent has to be submitted according to the template ("letter of intent" Error! Hyperlink

reference not valid.) to which the completed form of Request for RMS in a decentralised procedure

published by the CMDh has to be attached as well (http://www.hma.eu/219.html).

The request will only be assessed after receiving the above mentioned information.

Slot requests have to be submitted from 1st January to 1st May every year and can only contain requests for the next year. HU does not give slots for more than one year in advance.

The planning period is from 1st January to 30th June. All the applicants will be informed about the decision of HU on their requests until 30th June.

HUNGARY

the Hungarian National Institute of Pharmacy accepts the RMS request the applicant is asked to submit the Module 1 on a CD/DVD one month before the proposed day-14.

If

Neither the slot-time nor the product can be changed once the slot has been accepted.

The validation criteria for the submission are the following:

 

1. electronic documentation (CD/DVD) in editable format (word or pdf)

2. product information and readability test in word format

3. the files have to be created according to CTD structure

4. originally signed cover letter in paper format

ICELAND

http://www.ima.is/licences/marketing_authorisations/RMS_Requests/

MEMBER

   

STATES

SUMMARY OF NATIONAL BOOKING SYSTEMS & LINKS TO NATIONAL WEBPAGES

IRELAND

The Irish Medicines Board (IMB) would welcome requests for Ireland to act as RMS in a DCP procedure at any time (no longer limited to certain time periods). Applicants are requested to submit their request for Ireland to act as RMS as early as possible and not later than 3 months prior to the planned submission of the application. The ‘Common request form for RMS’ published on the CMDh website should be used and the completed form should be submitted to rmsrequests@imb.ie

 

Applicants wishing to apply for a marketing authorisation through the Decentralised Procedure or Mutual Recognition, Repeat-Use and Line Extension Procedures with IT as RMS are advised to follow the procedure in the AIFA website at the following addresshttp://www.agenziafarmaco.gov.it/sites/default/files/how_submit_request_RMS_procedure.pdf

ITALY

Applicants are advised to inform AIFA as early as possible if an agreed application will not be submitted in due course to the slot agreed.

More

detailed

information

can

be

found

on

the

AIFA

website,

section Assessment

and

 
 

Applicants wishing to apply for a marketing authorisation through the Decentralised Procedure (DCP) with Latvia (SAM) as RMS need to inform the SAM in advance.

The requests for DCP with Latvia as RMS should be sent by e-mail to rms-lv@zva.gov.lv

 

LATVIA

This e-mail shall be accompanied with the completed (so far as possible) "Common request form" as published on the CMDh website (http://www.hma.eu/219.html) together with the preferred submission date.

The applicants will be informed whether a time slot has been booked for their submission or not. SAM should be notified of any changes in agreed submission dates as early as possible. The next slots for decentralised procedures are available for 2012 Q4.

 

LIECHTENSTEIN

 
 

Applicants wishing to apply for a marketing authorisation through the Decentralised Procedure (DCP) with Lithuania as RMS are advised to inform State Medicines Control Agency (SMCA) of Lithuania in advance about their intentions and agree on a date for submission with SMCA.

Requests for a time slot are made by using the CMDh request form (http://www.hma.eu/219.html).

 

The applicants will be informed within 1 month whether a time slot has been booked for their submission or not.

LITHUANIA

Applicants are advised to inform SMCA as early as possible if an agreed application will not be submitted in due course to the slot agreed.

Time slots may be requested at any time and there are currently no restrictions on the choice of time period.

More detailed information can be found on the SMCA website:

 
 
 

LUXEMBOURG

 

MALTA

Applicants wishing to book slots with Malta as Reference Member State in the Decentralised procedure can do so at any time. The Common Request form is to be sent to the Medicines Authority electronically on prelicensing.mru@gov.mt, at least 2 months before planned submission date. More information can be found on http://www.medicinesauthority.gov.mt/news-details?id=F591.

 

If

you wish to request a time slot for a decentralised procedure (DCP) with the Netherlands as

Reference Member State (RMS) you need to use the MEB’s Planning tool to support application for time slots for DCP (NL=RMS) (http://reservations.cbgmeb.entopic.com/). This tool shows you

THE

NETHERLANDS

immediately how many time slots are available per month and per FT group for a period of approximately 2 years.

If you open the Planning tool to support application for time slots for DCP (NL=RMS), you can click on

a time slot of your choice and a digital form will appear. You will then attach a completed and signed

MEMBER

 

STATES

SUMMARY OF NATIONAL BOOKING SYSTEMS & LINKS TO NATIONAL WEBPAGES

 

Request for RMS in a decentralised procedure form and fill in a number of contact details.

After submission you will receive an automatic confirmation of receipt via e-mail. The MEB will then inform you within three weeks after submission whether the time slot will be assigned or not.

If you wish to know which PT group your request should be sent to you can consult the overview on the MEB’s website: about MEB > organisation > organisation structure > PT groups.

As soon as an allocated time slot is withdrawn for whatever reason, it is shown in the planning tool.

 

The Norwegian Medicines Agency (NoMA) is open for RMS requests at any time (no longer limited to certain time periods). Requests should be submitted at least three months prior to the planned submission of the Marketing Authorisation Application (MAA). Applicants will receive a response to their request within three weeks upon confirmed receipt.

NORWAY

For more detailed information, please visit the NoMA website:

POLAND

The list for request of time slots for 2014 is closed. Requests for time slots in 2015 should be submitted up to 31st May 2014 only. For time slots DCP-Poland RMS in 2015, the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products will contact applicants in July 2014.

 

To apply for a marketing authorisation through the Decentralised Procedure with PT as RMS, the Applicants need to inform INFARMED, IP and agree on a date for submission. Time slots should be requested about 6 months in advance of submission of the application, in accordance with the booking system available at INFARMED´s website.

PORTUGAL

Requests for a slot for duplicates and extensions can be made outside of the booking system established.

More detailed information on the booking system can be found on the INFARMED website:

ROMANIA

SLOVAK

REPUBLIC

SLOVENIA

Applicants wishing to apply for a marketing authorisation through the Decentralised Procedure with Slovenia as RMS need to inform the Agency for Medicinal Products and Medical devices of the Republic of Slovenia (JAZMP) at an early stage of their intentions and agree a date for submission. The JAZMP is open for RMS requests at any time (no longer limited to certain time periods). Requests for a time slot are made by using the CMDh request form. The request form should be sent to the following address: mrp_dcp@jazmp.si. More detailed information can be found on the JAZMP website: http://www.jazmp.si/en/human_medicines/marketing_authorisation/mrp_and_dcp/

 

Applicants wishing to apply for ES to act as RMS are requested to send via e-mail the common EU request form available in the CMDh website (http://www.hma.eu/219.html) to the institutional mailbox:

es_emr@aemps.es. Requests can be sent at any time as no time-window system is placed by the Spanish Agency.

SPAIN

The AEMPS final decision on the request is notified within a 30-days period. Applicants are requested to confirm the booking of the agreed slot by paying the correspondent fee (which will be deduced from the MAA fee)

Applicants are advised to inform AEMPS as early as possible if an agreed application can not be submitted in due course.

Further information are available on the AEMPS website:

MEMBER

 

STATES

SUMMARY OF NATIONAL BOOKING SYSTEMS & LINKS TO NATIONAL WEBPAGES

 

SWEDEN

Applicants wishing to apply for a marketing authorisation through the Decentralised Procedure with SE as RMS should submit a request to the Medical Products Agency (MPA). The request can be submitted to the MPA at any time (no longer limited to certain time periods) but should be submitted at least 3 months before planned submission of the application. It is also possible to sign up for a mailing list to receive information through email when the MPA has available slots due to e.g. cancellations. Since we accept requests 3 months before planned submission this would only apply to slots being available with short notice. More detailed information can be found on the MPA website:

 

Applicants can request a decentralised procedure submission date with the Medicines and Healthcare products Regulatory Agency (MHRA) as RMS by using our Do IT Online booking system

UNITED

KINGDOM

Applications can be accepted at any time, and often at short notice. The MHRA will reply to your request within 24 hours of receipt

More detailed information can be found on the MHRA website: