Template for the Cover Letter to Submit Data on Post-Authorisation Commitments

Template for the Cover Letter to Submit Data on Post-Authorisation Commitments

[Template for the Cover Letter to submit data on Post-Authorisation Commitments]

(< FROM MARKETING AUTHORISATION HOLDER ON HEADED PAPER >)

<Date>

Central Information Group (CIG)

F.A.O. H-PACS

European Medicines Agency

Loading Dock

Ontario Way

CanaryWharf

London

E14 4HB

United Kingdom

General Information
Applicant / <Marketing Authorisation Holder>
Application number / EMEA/H/C/<product No.>/<related variation, e.g. II-12, R-025>
Product name / <Product Name> / ATC / <ATC>
INN / <INN>
Submission Type / Post-authorisation commitments (PAC)–FUM / SO / PSUR / RMP
Submission Description / <Follow-Up Measure / Specific Obligation No. <SIAMED PAC No.; e.g. FUM/FU2/SOB/ANN-xxx (can be requested from the EMEA if unknown)>
<Periodic Safety Update Report No. <PSUR No.; e.g. PSU-xxx>
<Risk Management Plan No. <RMP No.>
eCTD Sequence / <eCTD sequence No.> / Related Sequence / <Related sequence No.>
Data security/ Virus scan / <name and version of virus checker>
Contact persons / For questions regarding the content of the submission
Name: <name>
Telephone: <telephone No.>
e-mail: <e-mail>
For technical questions
Name: <name>
Telephone: <telephone No.>
e-mail: <e-mail>

Dear <PTL/PTM-Quality Name>,

Please find herewith enclosed our <response to the following Follow-up Measure(s) / Specific Obligation(s)> <Periodic Safety Update Report> <Risk management Plan>.

[Complete or delete the table(s) below as necessary.]

[Mention the EMEA’s SIAMED database PAC No as provided by the EMEA after agreement of the Letter of Undertaking, e.g. Follow-Up Measure (FUM) - FUM/012, Follow-on of a previous FUM - FU2/003, Specific Obligation(SO) - SOB/008, Periodic Safety Update Report (PSUR) - PSUR/006, Risk Management Plan (RMP) - RMP/002. The FUM/FU2/SOB/ANN No can be requested from the EMEA if unknown.]

[Provide the exact same description for all PACs and due date as in the Letter of Undertaking, where applicable.]

<Specific Obligations:>

Area / Description / Due Date
Quality / <SO No. + Description> / <dd/mm/yyyy>
Non-clinical / <SO No. + Description> / <dd/mm/yyyy>
Clinical / <SO No. + Description> / <dd/mm/yyyy>
Pharmacovigilance / <SO No. + Description> / <dd/mm/yyyy>

<Follow-up Measures:>

Area / Description / Due Date
Quality / <FUM No. + Description> / <dd/mm/yyyy>
Non-clinical / <FUM No. + Description> / <dd/mm/yyyy>
Clinical / <FUM No. + Description> / <dd/mm/yyyy>
Pharmacovigilance / <FUM No. + Description> / <dd/mm/yyyy>

<Periodic Safety Update Reports:>

Description / Due Date
<PSUR No. - Period covered - Description> / <dd/mm/yyyy>

<Risk Management Plans:>

Description / Due Date
<RMP No. - RMP Version No. - Description and/or summary of the changes from the previous RMP> / <dd/mm/yyyy>

[MAH’s own text and further explanation.]

[Requests for extension of the due date of a specific FUM / SO PSUR / RMP should be made herewith and a justification provided]

I herewith confirm that the above data does not require an update of the Product Information.

Yours sincerely,

<Signature of authorised contact person>

<MAH>

cc:

<Rapporteur>

<Co-Rapporteur>

CHMP members

Encl(s)

<CD-ROM(s) / DVD(s)>

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