BROMI Renewal Letter Template

Information Processing Unit

Area 4 - Renewals

Medicines and Healthcare Products Regulatory Agency

151 Bucking Palace Road

Victoria

LONDON

SW1W 9SZDate:

Dear Sir / Madam

Re:Application for Renewal under BROMI

PRODUCT NAMEPL xxxxxx/yyyy

MA Holder:

Please find enclosed a renewal application for <Product Name>, which is due to expire dd/mm/yyyy.

The following documents have been submitted in EU-CTD format:

Cover letter and application form

Quality Overview (quality expert statement), together with the CV of the expert

Clinical Overview (clinical expert statement), together with the CV of the expert

Reports of post marketing experience (PSURs)

Amended SPC, labelling and package leaflet (see Annex) (delete if no amendments are proposed)

The following documents have been omitted:

Module 1 / Tick As Appropriate
Details of contact Persons
We confirm these are unchanged and the same as previously advised
Chronological list of variations submitted since grant of authorisation.
We confirm that the record on RAMA has been checked and is correct
The current SPC, labelling and leaflets
We confirm that no changes are proposed to the currently approved documents.
These documents were last approved on the following dates:
SPC:
Label(s):
Leaflet:
Authorisations/GMP Certificates for Manufacturing sites listed in the authorisation(s).
We confirm that the product is manufactured in accordance with GMP at the registered sites
Declaration from a QP that the active ingredient(s) is manufactured in accordance with GMP.
We confirm that the active ingredient is manufactured in accordance with GMP at the registered sites

We confirm that the licence details held on RAMA-XL have been checked and are correct. The information provided above and in the annex to this letter is correct. No other changes have been made to the product particulars other than those that have been approved.

Checklist

1 / Is the product currently marketed in the UK? / Yes/No
2 / If the answer to (1) is No – please give date product was last marketed.
3 / Does the PSUR provided with the application include any happenings of significance that would affect the company core date sheet or the SPC?
Please provide brief details: / Yes/No
4 / Are any changes proposed to the SPC?
List sections to be changed/updated: / Yes/No
5 / Are there any changes proposed to the label and PIL?
a)to incorporate proposed SPC changes
b)updates to comply with Article 59 of Directive 2001/83/EC as amended.
c)Other changes (please give brief details) / Yes/No

Yours faithfully

Company Contact Name

Position in Company