Request for MRP/RUP for Medicinal Products for Human Use
Request for MRP/RUP for Medicinal Products for Human Use
Requested MS to act as RMS:Anticipated submission date: The RMS will propose a timetable after confirmation of the MRP/RUP request
Product name(s)/
pharmaceutical form(s)/
strength(s)
One line per application if multiple applications / MRP/DCP no.
(if available): / Indicate RMS MA/identification number(s) for original dossier(s):
Active substance(s): / ATC Code:
First wave(MRP): / Yes No
Repeat use(RUP): / Yes No
If RUP, date of finalisation of last MRP/DCP:
Extension for a previously completed MRP: / Yes No
Is the product a duplicate:
Yes No
If yes, please state the name of the original product/mother license:
Indicate the CMS (if known):
Legal basis of medicinal product(s) approved:
Art.8(3) / Art.10(1) / Art.10(3) / Art.10(4) / Art.10a / Art.10b / Art. 10c / Art. 16a
Reference medicinal product is/has been authorised in all proposed CMS (abridged applications only)? Yes No
If no, please state the CMS(s) where a European Reference product will be used:
Has a Ph.Eur. certificate of suitability (CEP) been issued for the active substance? Yes No
If yes, indicate the currently approved version of the CEP*:
And/or
Will an Active Substance Master File (ASMF) be used? Yes No.
If yes, indicate the currently approved version of the ASMF*:
*If superseded by a new version, a variation has to be filed prior to the MRP/RUP
Common Renewal Date (CRD): / For bioequivalence study(-ies), when performed/CRO/ used reference medicinal product:
The study(-ies) meet(s) the current guidelines:
Yes No
If no explain in Appendix 1
I hereby confirm that the dossier complies with the current legislation/EU guideline:
Yes No
Is there any other regulatory procedure ongoing: Yes No
If yes explain in Appendix 1
Is there any other regulatory procedure foreseen until the intended MRP/RUP submission date or potentially during the MRP/RUP: Yes No
If yes explain in Appendix 1
The MAHs authorised contact person for this request. Indicate company, name, phone and E-mail address:
Company:
Authorised contact person:
Phone:
E-mail:
Other information if relevant:
The request should be accompanied by the following documents :
- Appendix 1 – Approved, pending and/or foreseen variations/renewal(s)/commitments
- If applicable - a compiled list of changes referring to variations/new data (e.g. updated stability data) made to Module 3 since approval/last MRP/RUP
- Proposed application form to be submitted to the CMS including:
-Annex 5.6/5.9 for the approved manufacturers (updated versions if more than three years have passed, even if they have not been provided before)
- For MRP only– proposedtranslations in English of the SmPC, PL and labelling in WORD-format, using the template which can be found on the EMA website
- The completed request form together with the requested annexes should be submitted via e-mail to
- Please note that an invoice of the application fee will be issued after receipt of the request form.
CMDh/337/2015, Rev.0MPA template version 2018-06-26