Document ID: chunk:federal_register_of_legislation:F2006L02853:body:0:p3
Version: federal_register_of_legislation:F2006L02853
Segment Type: other
Provision Reference: 
Character Range: 6070–9542

development; the development, preparation and supply of active ingredients for use in non-clinical testing and clinical trials; clinical trial management; bioinformatics; and biostatistical analysis, activities associated with complying with statutory requirements or standards needed for drug or device registration.

         The following activities are, for the purposes of these directions, deemed not to be pharmaceutical R&D activities:
                (a)     market research, market testing, market development or sales promotion (including consumer surveys, post-registration studies and product familiarisation programs);
                (b)     quality control related to the manufacture of finished product intended for sale;
                (c)     the making of cosmetic modifications or stylistic changes to products, processes or production methods;
                (d)     pre-production activities, such as demonstration of commercial viability, tooling-up or trial runs, which are not related to the product registration process such as with the Therapeutic Goods Administration;
                (e)     any activity related to the reproduction of a commercial product or process by a physical examination of an existing system or from plans, blueprints, detailed specifications or publicly available information;
                (f)      epidemiology studies;
                (g)     management studies or efficiency surveys;
                (h)     research in social sciences, arts or humanities;
                (i)       the making of donations;
                (j)       routine collection of information, except as part of the R&D process;
                (k)     preparation for teaching;
                (l)       activities associated with complying with statutory requirements or standards other than those needed for drug or device registration; and
                (m)   specialised routine medical care or the provision of drugs under the Special Access Scheme (SAS), except when they are a component of an investigative program with an established protocol.

       program means the Pharmaceuticals Partnerships Program, a merit-based program that is administered by the Department and is designed to increase the level of high quality eligible Australian pharmaceutical R&D activity in Australia and the development of partnerships within the pharmaceuticals industry.

       proposed portfolio of activities means all eligible Australian pharmaceutical R&D activities that are proposed to be undertaken by or on behalf of the applicant.

       recipient means an entity that is entitled to receive funding under the program pursuant to an agreement between the entity and the Commonwealth.
       revised portfolio of activities means a portfolio of activities that is proposed to replace the agreed portfolio of activities pursuant to a proposal of the kind contemplated in clause 9.
       revoked directions mean the directions revoked by clause 17.
       three year history of pharmaceutical R&D activities means the pharmaceutical R&D activities undertaken by or on behalf of an applicant in each of 2004-05, 2005-06 and 2006-07 financial years.
       (2)         In these directions,
          (a)       may is permissive and not mandatory.
          (b)       a reference to financial year means the 12 month period beginning on 1 July in one calendar year and ending on 30 June in the following calendar year.

PART 2 –