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Pharmaceutical Benefits Advisory Committee

Timing of Stages in the PBS Listing Process for 2011-2013

A table showing the timing of Stages in the PBS listing process for 2011-2013

PBAC Cycle Timeframe for 2011-2013

Abbreviations

PBAC = Pharmaceutical Benefits Advisory Committee
“responsible persons” = legal wording requirement for terminology – previously known as sponsors
PES = Pharmaceutical Evaluation Section
DUSC = Drug Utilisation Sub Committee
ESC = Evaluation Sub Committee
ATAGI = Australian Technical Advisory Group on Immunisation
RWG = Restrictions Working Group
PBPA = Pharmaceutical Benefits Pricing Authority
PSDs = Public Summary Documents

Industry

MEETING	2011/3 2-4 November		2012/1 7-9 March		2012/2 11-13 July		2012/3 7-9 November
Activity	Wk		Wk		Wk		Wk
(PBAC meeting Wed-Friday) Close for major submissions – Wednesday	0	6 July 2011	0	2 Nov 2011	0	7 March 2012	0	11 July 2012
	1		1		1		1
	2		2		2		2
	3		3		3		3
Pre submission meetings with companies	4	1-26 Aug 2011	4	28 Nov - 21 Dec 2011	4	***Additional week added 2 April – 9 May 2012 (6, 9 & 25 April PH)	4	6-31 Aug 2012
Submissions to discussants (Wednesday)	5	10 Aug 2011	5	7 Dec 2011	5	18 April 2012	5	15 Aug 2012
Close minor submissions & 1st deadline for Secretariat listings (Friday)	6	19 Aug 2011	6	16 Dec 2011	6	27 April 2012 (25 April 2012 PH)	6	24 Aug 2012
	7		7		7		7
	8		8		8		8
	9		9		9		9
Combined PES, DUSC and PBAC Secretariat commentaries to “responsible persons”. 2nd deadline for Secretariat listings to PBAC Secretariat (Wednesday)	10	14 Sept 2011	10	18 Jan 2012	10	23 May 2012	10	19 Sept 2012
“responsible persons” send Pre-Subcommittee Responses to PBAC Secretariat by midday Wednesday Publication of PBAC agenda on web Pre submission meetings with companies	11	21 Sept 2011 21 Sept 2011 19-29 Sept 2011	11	25 Jan 2012 (26 Jan PH) 25 Jan 2012 23 Jan to 2 Feb 2012	11	30 May 2012 30 May 2012 28 May – 7 June 2012	11	26 Sept 2012 26 Sept 2012 24 Sept-4 Oct 2012 (1 Oct PH)
DUSC meeting Friday	12	30 Sept 2011	12	3 Feb 2012	12	8 June 2012	12	5 Oct 2012
ESC meeting (Monday-Tuesday) Closing date for online consumer comments ATAGI meeting (Thursday - Friday) – dates are not fixed – To Be Confirmed (TBC)	13	4-5 Oct 2011 (Tues-Wed) (3 Oct PH) 5 Oct 2011 6-7 Oct 2011 (TBC)	13	6-7 Feb 2012 8 Feb 2012 9-10 Feb 2012 (TBC)	13	12-13 June 2012 (Tues-Wed) (11 June PH) 13 June 2012 14-15 June 2012 (TBC)	13	9-10 Oct 2012 (Tues-Wed) (8 Oct ACT PH) 10 Oct 2012 11-12 Oct 2012 (TBC)
Pre-PBAC RWG meeting (Tuesday)	14	11 Oct 2011	14	14 Feb 2012	14	19 June 2012	14	16 Oct 2012

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MEETING	2011/3 2-4 November		2012/1 7-9 March		2012/2 11-13 July		2012/3 7-9 November
Activity	Wk		Wk		Wk		Wk
ESC, DUSC, ATAGI & RWG advice & summary of consumer comments to “responsible persons” Wednesday	15	19 Oct 2011	15	22 Feb 2012	15	27 June 2012	15	24 Oct 2012
“responsible persons” send Pre-PBAC Responses to PBAC Secretariat by midday Wednesday Pre submission meetings with companies not relating to imminent submissions	16	26 Oct 2011 24-28 Oct 2011	16	29 Feb 2012 27 Feb-2 March 2012	16	4 July 2012 2-6 July 2012	16	31 Oct 2012 29 Oct-2 Nov 2012

PBAC meeting Wednesday-Friday (Close for major submissions on Wednesday)	17	2-4 Nov 2011	17	7-9 Mar 2012	17	11-13 July 2012	17	7-9 Nov 2012
POST PBAC PROCEDURES:	18		18		18		18
	19		19		19		19
Short Minutes to “responsible persons” Friday	20	25 Nov 2011	20	30 March 2012	20	3 August 2012	20	30 Nov 2012
	21		21	***Additional week added	21		21
	22		22		22		22
Date of PBPA meeting (TBC - To Be Confirmed) Posting of recommendations on website following “responsible persons” comments	23	14 Dec 2011 16 Dec 2011	23	24 April 2012 (Tuesday TBC) (25 April PH) 27 April 2012	23	22 August 2012 (TBC) 24 August 2012	23	19 Dec 2012 (TBC) 21 Dec 2012
Deadline for Independent Review requests for reconsideration at next meeting but one	24	23 Dec 2011	24	4 May 2012	24	31 August 2012	24	4 Jan 2013
	25		25		25		25
	26		26		26		26
Draft PSDs & Draft Minutes to “responsible persons”	27	20 Jan 2012	27	25 May 2012	27	21 Sept 2012	27	25 Jan 2013
	28		28		28		28
	29		29		29		29
Comments on PSDs due back to Secretariat by midday (Wednesday)	30	8 Feb 2012	30	13 June 2012	30	10 Oct 2012 (8 Oct ACT PH)	30	13 Feb 2013
	31		31		31		31
Finalisation of PSDs (Friday)	32	24 Feb 2012	32	29 June 2012	32	26 Oct 2012	32	1 March 2013
PSDs published on web site (all except for the 1st time rejections)	33	2 March 2012	33	6 July 2012	33	2 Nov 2012	33	8 March 2013
	0		0		0		0
PSDs published on web site (1st time rejections)	1	16 March 2012	1	20 July 2012	1	16 Nov 2012	1	22 March 2013

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Suitable Dates for Sponsors to meet with the Pharmaceutical Evaluation Branch (PEB)

It is quite routine for sponsors to meet with relevant officers in the PEB prior to submitting to the PBAC, however, the available opportunities for these meetings is limited by busy periods within the PBAC meeting cycle when key personnel have other priorities.

The Branch has identified the following weeks in the cycles as being suitable for PEB-Sponsor meetings:

November 2011 Meeting Cycle

• Weeks 4-7 (1 August to 26 August 2011)
• Weeks 11-12 (19 September to 29 September 2011)
• Week 16 (where meetings do not relate to imminent submissions) (24 October to 28 October 2011).

March 2012 Meeting Cycle

• Weeks 4-7 (28 November 2011 to 21 December 2011)
• Weeks 11-12 (23 January 2012 to 2 February 2012)
• Week 16 (where meetings do not relate to imminent submissions) (27 February to 2 March 2012).

July 2012 Meeting Cycle

• Weeks 4-7 (2 April to 9 May 2012)
• Weeks 11-12 (28 May to 7 June 2012)
• Week 16 (where meetings do not relate to imminent submissions) (2 July to 6 July 2012).

November 2012 Meeting Cycle

• Weeks 4-7 (6 August to 31 August 2012)
• Weeks 11-12 (24 September to 4 October 2012)
• Week 16 (where meetings do not relate to imminent submissions) (29 October to 2 November 2012).

Please note that on occasion, due to other commitments various Departmental officers may not be able to attend meetings, but alternative members of the relevant PEB section will substitute, subject to their availability. Please contact the PBAC Secretariat by email at: pbac@health.gov.au, in the first instance to make arrangements for these meetings.
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