Application for an Amendment to an Approved Package Insert

MRF 4

MEDICINES CONTROL COUNCIL

APPLICATION FORM FOR AMENDMENTS TO APPROVED PACKAGE INSERTS

APPLICATION FORM FOR AMENDMENT TO A PACKAGE INSERT OF REGISTERED ORTHODOX MEDICINES

DETAILS OF PRODUCT:
PROPRIETARY NAME: ......
REGISTRATION NUMBER: ...... /

INCOMPLETE APPLICATIONS AND APPLICATIONS WHICH DO NOT COMPLY TO THE PRESCRIBED FORMAT WILL RESULT IN THE APPLICATION BEING RETURNED TO THE APPLICANT FOR CORRECTION.

The submission should be presented as follows:

I.  three (3) suitably bound copies of the following documents submitted in the order:

(i) covering letter reflecting ALL proposed changes and a motivation for the changes;

(ii)  Proposed cross – referenced package insert typed in double spacing and in black print only;

(iii) Approved package insert (unmarked);

(iv) Package insert/SPC approved with other regulatory authority, whenever listed as a reference;

2. two (2) copies of supporting data or references suitably bound. A copy of the covering letter should be bound into each set of the supporting data or references.

Note:

(a) Each copy referred to in 1 and 2 above should be bound separately.

(b)  Bound copies should not be bigger than A4 size.

(c)  Back – to – back printing is not acceptable.

Tick the appropriate box / Yes (Y) No (N) /
Are all additions in the proposed package insert indicated by underlining with a solid line? /   /
Are all deletions in the proposed package insert indicated by bolded square brackets? /   /
Are all rephrasing in the proposed package insert denoted by a broken line? /   /
Are all proposed amendments in the package insert properly cross referenced to the relevant substantiating data? /   /
Are three (3) unmarked copies of the current approved package insert included? /   /
Are three (3) copies of the proposed package insert included? /   /
Are two (2) bound copies of supporting data / references submitted? /   /
Type of amendment
1) Does this amendment include a new indication ?
2) Does this amendment include an amendment to a current indication?
3) Does this amendment include a new dosage instruction?
4)Does this amendment include an amendment to a current dosage instruction?
5) Does this submission contain a complete safety update? /  
 
 
 
  /
Has the proposed package insert been checked for grammatical and typographical errors? /   /

I declare that the application has been checked and that the information supplied herewith

is complete and complies to the prescribed requirements.

......

Name in block letters Signature

......

Designation Date

6.03 MRF4 May03 v1.doc May 2003 Page 3 of 3