Summary
On 27 March 2020, Medicines Australia (MA) lodged an application for authorisation on behalf of itself and its members, and the Generic and Biosimilar Medicines Association (GBMA) and its members (together the MA/GBMA Working Group) and any future members of the MA/GBMA Working Group. MA initially sought authorisation for six months to implement a coordinated strategy in relation to the supply of essential medicines and related supplies in response to the current COVID-19 pandemic. MA also sought urgent interim authorisation, in light of the current demands on the health system and in order to assist relevant government bodies.
On 3 April 2020, the ACCC granted interim authorisation with certain conditions.
On 26 June 2020, the ACCC issued a draft determination proposing to grant authorisation with certain conditions until 27 March 2021. In its submission on the draft determination, MA requested authorisation for 12 months.
On 24 September 2020, the ACCC issued a final determination granting authorisation to MA with certain conditions until 30 September 2021. A copy of the final determination is available below.
A timetable is set out below for your information
|
Indicative date |
Stage in assessment process |
|
27 March 2020 |
Lodgement of application, including request for interim authorisation |
|
3 April 2020 |
ACCC decision on interim authorisation |
|
6 April 2020 |
Public consultation |
|
27 April 2020 |
Closing date for submissions |
|
18 May 2020 |
Applicant responds to issues raised in public consultation process |
|
26 June 2020 |
ACCC draft determination |
|
July/August 2020 |
Public consultation on the draft determination |
|
24 September 2020 |
ACCC final determination |
Applicant(s)
- Medicines Australia
Authorisation number(s)
- AA1000486-1
Applications
| Document title | Date | |
|---|---|---|
| Notice of Additional Working Group Participant ( PDF 420.6 KB ) | 14 May 2020 | |
| Notice of Additional Working Group Participant ( PDF 66.35 KB ) | 11 May 2020 | |
| Notice of Additional Working Group Participant ( PDF 62.55 KB ) | 4 May 2020 | |
| Notice of Additional Working Group Participant ( PDF 634.32 KB ) | 28 Apr 2020 | |
| Notice of Additional Working Group Participant ( PDF 104.75 KB ) | 23 Apr 2020 | |
| Notice of Additional Working Group Participant ( PDF 67.97 KB ) | 27 Apr 2020 | |
| Notice of Additional Working Group Participant ( PDF 67.03 KB ) | 23 Apr 2020 | |
| Notice Additional Working Group Participant ( PDF 722.5 KB ) | 21 Apr 2020 | |
| Notice of additional Working Group participant ( PDF 306.47 KB ) | 16 Apr 2020 | |
| Applicant - clarification of conduct ( PDF 482.41 KB ) | 2 Apr 2020 | |
| Application - further information ( PDF 1.47 MB ) | 1 Apr 2020 | |
| Application Received ( PDF 333.18 KB ) | 30 Mar 2020 | |
| Show all documents (9 more) | ||
Decisions
| Document title | Date | |
|---|---|---|
| Final Determination ( PDF 446.6 KB ) | 24 Sep 2020 | |
| Draft Determination ( PDF 422.57 KB ) | 26 Jun 2020 | |
| Interim Authorisation Decision ( PDF 262.11 KB ) | 3 Apr 2020 |
Consultations
| Document title | Date | |
|---|---|---|
| ACCC to non-primary applicants requesting update ( PDF 265.22 KB ) | 29 Apr 2020 | |
| ACCC to Interested Parties re Consultation Process ( PDF 343.01 KB ) | 6 Apr 2020 |
Reporting
Submissions - before draft decision
Submissions - after draft decision
| Document title | Date | |
|---|---|---|
| Applicant ( PDF 1.32 MB ) | 4 Sep 2020 | |
| NSW Health ( PDF 167.26 KB ) | 1 Sep 2020 | |
| Applicant ( PDF 307.25 KB ) | 31 Jul 2020 | |
| Applicant ( PDF 548.62 KB ) | 17 Jul 2020 | |
| NSW Health ( PDF 586.81 KB ) | 17 Jul 2020 | |
| Show all documents (2 more) | ||