[Template for the Letter of Undertaking (commitments undertaken by the Applicant/MAH) to be
provided in MS Word format and as a signed PDF document]
(< FROM MAH ON HEADED PAPER >)
<Date>
<CHMP Chairman>
European Medicines Agency
7 Westferry Circus
Canary Wharf
London
E14 4HB
United Kingdom
Dear <Chairman>,
RE: EMEA/H/C/<product No./procedure No.>
<Product Name>, <INN>, <MAH>
<MAH> agrees to undertake the following Post-Authorisation Commitments (PACs) requested by the
CHMP and commits to submit the data listed below within the specified timeframe.
We understand that when a Commitment results in a variation, an application for a variation should be
submitted instead and in any case before the due date of the PAC. We also agree to submit any
variation application resulting from the CHMP assessment of the below mentioned data.
With respect to on-going stability programs, we also undertake that, in accordance with EU GMP
guidelines (6.32 of Vol. 4 Part I of the Rules Governing Medicinal Products in the European Union),
any confirmed out of specification result, or significant negative trend, will be reported to the
Rapporteur and the EMEA.
[Please complete or delete the table(s) below as necessary.]
[The EMEA procedure (i.e. EMEA/H/C/product No./procedure No.) from which the PAC originates
should be stated for each commitment, e.g. EMEA/H/C/132/II/0032.]
[Please give a clear and concise description of each PAC, with sufficient level of detail. This
description will be entered into EMEA’s SIAMED database. Please note that the text of the description
for Specific Obligations will be copied in Annex II.C to the Community Marketing Authorisation. The
exact same description should be used in the template cover letter when submitting the PAC data.]
[An updated Letter of Undertaking including only quality FUMs, is required at the time of the annual
submission of Quality FUMs A consolidated Letter of Undertaking including all PACs (quality, nonclinical, clinical and pharmacovigilance) is required at the time of renewal or annual reassessment, if
applicable.]
<Specific Obligations:>
Area
Description
Due Date
Quality
<Description>
<dd/mm/yyyy>
Non-clinical
Clinical
<Description>
<Description>
[Please include the protocol / study number and title, and a
brief description of the study / data to be submitted, if
applicable.
Please provide a submission timeframe / schedule when
protocols, interim and final study reports are to be
<dd/mm/yyyy>
<dd/mm/yyyy>
Pharmacovigilance
submitted]
<Description>
<dd/mm/yyyy>
<Follow-up Measures:>
Area
Quality
Non-clinical
Clinical
Pharmacovigilance
Description
<Description>
[Unless otherwise justified, all Quality FUMs should be
grouped under a single entry with a single proposed due
date for annual submission (ideally at the anniversary of
the initial marketing authorisation) in order to minimise the
number of submissions of Quality FUMs.]
<Description>
<Description>
[Please include the protocol / study number and title, and a
brief description of the study / data to be submitted, if
applicable.
Please provide a submission timeframe / schedule when
protocols, interim and final study reports are to be
submitted]
<Description>
Due Date
<dd/mm/yyyy>
<dd/mm/yyyy>
<dd/mm/yyyy>
<dd/mm/yyyy>
<Periodic Safety Update Reports and Risk Management Plan:>
[Please specify PSUR and RMP requirements if different from the normal PSUR cycle, as requested
by CHMP]
Yours sincerely,
<Name and signature of authorised contact person>
<MAH>