Definitions for the purposes of this Regulation
3The following definitions apply in this Regulation.
“Act” means the Prescription and Catastrophic Drug Insurance Act.(Loi)
“actual acquisition cost” means the unit price of a drug to a participating provider, based on reasonable and customary purchasing practices, which is calculated by deducting from the total amount paid or payable to purchase the drug, excluding franchise fees and shipping charges, the value of any price reduction.(coût d’achat réel)
“brand name product” means the drug for which the first notice of compliance has been issued in respect of a particular active ingredient or combination of particular active ingredients, the drug’s strength and the drug’s dosage form.(produit de marque)
“controlled drug” means a controlled drug as defined in Part G of the Food and Drug Regulations under the Food and Drugs Act (Canada).(médicament contrôlé)
“extemporaneous preparation” means a drug compounded by a provider that does not duplicate the formulation of a manufactured drug.(préparation extemporanée)
“manufacturer’s list price” means the unit price of a drug as provided by a manufacturer to the Minister and published by the Minister, excluding any markup for distribution and the value of any price reduction.(prix courant du fabricant)
“maximum allowable price” means the unit price of a drug determined by the Minister in accordance with subsection 30(1) of the Act.(prix maximal autorisé)
“narcotic” means a narcotic as defined in the Narcotic Control Regulations under the Controlled Drugs and Substances Act (Canada).(stupéfiant)
“original product” means a drug that
(produit original)
(a)
is the brand name product, and
(b)
is or was marketed in Canada by the drug’s innovator or a person acting under a licence granted by the drug’s innovator before the issuance of any subsequent notice of compliance for another drug having the same active ingredient or combination of active ingredients.
“pharmaceutical alternative” means a drug that contains the same therapeutic moiety as another drug but
(substitut pharmaceutique)
(a)
different salts, esters or complexes of that moiety, or
(b)
in a different dosage form or strength.
“pharmaceutical equivalent” means a drug that contains identical amounts of identical medicinal ingredients as another drug in a similar dosage form.(équivalent pharmaceutique)
“price reduction” means a rebate, an allowance, a refund, free goods or any other similar advantage granted to a participating provider by a manufacturer or pharmaceutical distributor in respect of the purchase of a drug and includes
(réduction de prix)
(a)
a discount, unless the discount is for prompt payment that is made within 30 days after the drug is delivered to the participating provider and that does not exceed 2% of the net purchase price, and
(b)
a delayed payment, unless the payment is made within 120 days after the drug is delivered to the participating provider, in which case the delayed payment is deemed to be a profit of 1.5% of the net purchase price per month.
“reasonable and customary purchasing practices” means purchasing sufficient quantities to satisfy anticipated sales of a drug and maintenance of appropriate inventory levels based on generally accepted business principles.(pratiques d’achat raisonnables et courantes)
“targeted substance” means a targeted substance as defined in the Benzodiazepines and Other Targeted Substances Regulations under the Controlled Drugs and Substances Act (Canada).(substance ciblée)