17Clinical Evaluation Packages (“Samples”)

17.1General PrinciplesAdd to favorites¹
xLe présent chapitre s’applique aux échantillons, comme ils sont définis dans la Loi sur les aliments et drogues de Santé Canada. En plus des échantillons physiques directs aux professionnels de la santé, l’utilisation d’échantillons électroniques est également en conformité avec la définition du MEC. Dans ce cas, le produit est dispensé aux patients par l’intermédiaire des pharmacies à la présentation d’une ordonnance et d’un bon.

17.1.1 Members believe that the timely distribution of Clinical Evaluation Packages (CEPs) to Health Care Professionals as authorized by Health Canada, following the rules set out by the Food and Drugs Act and Regulations regarding samples, provides benefits to both patients and Health Care Professionals. When used appropriately members believe CEPs are an important tool for Health Care Professionals and provide benefit to patient health outcomes.
17.1.2 CEPs must be dispensed by Health Care Professionals only. Their main use is to, when appropriate; determine a patient’s clinical response to drug therapy before a full course of therapy is prescribed.

17.2.1 For the purpose of this Code, a “Clinical Evaluation Package” (CEP) is: a package containing a limited quantity of a pharmaceutical product sufficient to evaluate clinical response; distributed to authorized Health Care Professionals through different methods of distribution, free of charge, for patient treatment.
17.2.2 In addition to the Food and Drugs Act and Regulations governing the manufacture, packaging, storage, and distribution of CEPs, hospital and/or institutional regulations may apply.

17.3.1 CEPs shall only be given to authorized Health Care Professionals who have signed an order for the CEP. The order for the CEP must be completed by the Health Care Professional before being passed on to authorized company personnel (such as the Member’s Sales Representative or another authorized agent of the Member or third party).
17.3.2 An essential part of the CEP service involves providing the Health Care Professionals with prescribing information. This information is to be shared with his/her patient. Members should also provide full prescribing information on the CEP for a minimum of two years following the introduction of a product to the Canadian market. A shorter version of the disclosure may be provided two years after the product is first introduced.
17.3.3 CEPs given to a Health Care Professional as part of an order must be included on the invoice. If no order is made when the CEPs are supplied, the goods must be documented on a separate “NO CHARGE” invoice. CEPs should be labeled “Not for resale”.
17.3.4 Giving out CEPs at convention/clinic displays, business meeting and event or at learning programs is prohibited.
17.3.5 Members should ensure they have a policy in place to comply with all applicable requirements set out in the Food and Drugs Act and Regulations. Prior to distribution, Members must take reasonable measures to prevent the theft, sale and/or inappropriate distribution of CEPs.

17.4.1 Prior to distribution, CEPs must be stored in locked cabinets, storage areas, or rooms which are only accessible to Member Sales Representatives or other authorized personnel, and must be stored in conditions that will maintain their stability, integrity and effectiveness.

17.5.1 Members are responsible for ensuring that all excess and/or expired CEPs of their own products are returned to the Member’ storehouse or head office, or an authorized third party, for appropriate disposal.

17.6.1 Members should have adequate systems of control and accountability for CEPs provided to Health Care Professionals and must ensure that a complete and accurate inventory of all CEPs held by Member Representatives or other authorized personnel is conducted on an annual basis by an appropriate individual assigned by the Member, and not by the representative who holds the CEPs.