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• (2) In the case of a medicine for human use that contains a controlled substance as defined in the Controlled Drugs and Substances Act or a substance listed or described in Schedule C or D to the Food and Drugs Act or that is a prescription drug as defined in section A.01.010 of the Food and Drug Regulations, the information referred to in subsection (1) shall be provided

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• (3) In the case of a medicine for human use that does not contain a controlled substance as defined in the Controlled Drugs and Substances Act or a substance listed or described in Schedule C or D to the Food and Drugs Act or that is not a prescription drug as defined in section A.01.010 of the Food and Drug Regulations or in the case of a medicine for veterinary use, the information referred to in subsection (1), for each six-month period beginning on January 1 and July 1 of each year, shall be provided to the Board within 30 days after the day on which the Board sends a request in response to a complaint respecting the price of the medicine and, during the two years following the request, within 30 days after the end of each six-month period.

• (4) For the purposes of subparagraph (1)(f)(i),

  • (a) in calculating the average price per package of medicine, the actual price after any reduction given as a promotion or in the form of rebates, discounts, refunds, free goods, free services, gifts or any other benefit of a like nature and after the deduction of the federal sales tax shall be used; and

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• (8) For the purposes of this section, the Income Tax Act, as that Act read on December 1, 1987, applies, with any modifications that the circumstances require, in determining whether a patentee or former patentee is dealing at arm’s length with another person.

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• (3) Despite subsection (2), in each of the following cases, the information referred to in subsection (1), for each six-month period beginning on January 1 and July 1 of each year, shall be provided within 30 days after the day on which the Board sends a request for the rights holder to provide that information and, during the two years following the request, within 30 days after the end of each six-month period:

  • (a) the medicine is not a prescription drugas defined in section A.01.010 of the Food and Drug Regulations and is not a drug described in Schedule D to the Food and Drugs Act;

  • (b) the medicine contains a controlled substanceas defined in subsection 2(1) of the Controlled Drugs and Substances Act, the sale or provision of which does not require a prescription under that Act;

• (4) For the purposes of subparagraph (1)(f)(i),

  • (a) in calculating the average price per package of medicine, the actual price after any reduction given as a promotion or in the form of rebates, discounts, refunds, free goods, free services, gifts or any other benefit of a like nature and after the deduction of the federal sales tax shall be used; and

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• (8) For the purposes of this section, the Income Tax Act, as that Act read on December 1, 1987, applies, with any modifications that the circumstances require, in determining whether a rights holder or former rights holder is dealing at arm’s length with another person.

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• (3.1) Despite subsection (3), in each of the following cases, the information referred to in subsection (1) shall be provided within 30 days after the day on which the Board sends a request for the rights holder to provide that information:

  • (a) the medicine is not a prescription drugas defined in section A.01.010 of the Food and Drug Regulations and is not a drug described in Schedule D to the Food and Drugs Act;

  • (b) the medicine contains a controlled substanceas defined in subsection 2(1) of the Controlled Drugs and Substances Act, the sale or provision of which does not require a prescription under that Act;

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6 For the purposes of subsection 88(1) of the Act, the expression research and development means those activities for which expenditures qualify, or would qualify if the expenditures were made by a taxpayer in Canada, for an investment tax credit in respect of scientific research and experimental development under the Income Tax Actas that Act read on December 1, 1987.