Annex 5 WHO good distribution practices for pharmaceutical products

5.2 The distributor or the organization to which the distributor belongs shouldbe an entity that is appropriately authorized in terms of applicable legislationto perform the function(s) that it intends to perform. The distributor or theorganization to which it belongs should be held accountable for the activitiesthat it performs which relate to the distribution of pharmaceutical products.5.3 Only persons or entities which are authorized to do so and/orwhich hold the appropriate licence should be entitled to import or exportpharmaceutical products.5.4 Distributors or their agents may only distribute a pharmaceuticalproduct within or to a country or territory if a marketing authorizationor similar authorization has been granted, which allows the use of thatpharmaceutical product in that country or territory.5.5 Holders of an authorization to distribute pharmaceutical productsshould obtain their supplies of pharmaceutical products only from personsor entities which are in possession of the applicable authorization to sell orsupply such products to a distributor.5.6 Distributors or their agents should supply pharmaceutical productsonly to persons or entities which are themselves authorized to acquire suchproducts either in terms of an authorization to act as a distributor or to sellor supply products directly to a patient or to his or her agent.5.7 Some duties and responsibilities may be delegated or contracted outto suitably designated persons or entities as authorized and as necessary.Duties and responsibilities may only be delegated to entities whichare suitably authorized in line with the national legislation. Duties andresponsibilities should be specified in a written agreement. There shouldbe no gaps or unexplained overlaps with regard to the application of GDP.These delegated and contracted out activities should be documented inagreements or contracts. There should be a periodic audit of such activitieswith regard to application of GDP.5.8 If a distributor or his or her agent subcontracts an activity to anotherentity, the person or entity to whom the activity is subcontracted must beappropriately authorized to perform the subcontracted activity and shoulduphold the same standards as the distributor.5.9 The sale of pharmaceutical products via the Internet should be limited toregistered and authorized mail-order pharmacies or other authorized entities.6. Organization and management6.1 There should be an adequate organizational structure for each entitydefined with the aid of an organizational chart. The responsibility, authorityand interrelationships of all personnel should be clearly indicated.244