Traduction de «Customized medicine » (Anglais → Français) :

records should be kept either in the form of purchase/sales invoices or on computer, or in any other form for any transaction in medicinal products brokered and should contain at least the following information: date; name of the medicinal product; quantity brokered; name and address of the supplier and the customer; and batch number at least for products bearing the safety features.

The distribution records should be readily accessible to the person(s) responsible for the recall, and should contain sufficient information on distributors and directly supplied customers (with addresses, phone and/or fax numbers inside and outside working hours, batch numbers at least for medicinal products bearing safety features as required by legislation and quantities delivered), including those for exported products and medicinal product samples.

Selection of a container and packaging should be based on the storage and transportation requirements of the medicinal products; the space required for the amount of medicines; the anticipated external temperature extremes; the estimated maximum time for transportation including transit storage at customs; the qualification status of the packaging and the validation status of the shipping containers.

medicinal products returned from a customer not holding a wholesale distribution authorisation or from pharmacies authorised to supply medicinal products to the public should only be returned to saleable stock if they are returned within an acceptable time limit, for example 10 days.

Records must include at least the following information: date; name of the medicinal product; quantity received, supplied or brokered; name and address of the supplier, customer, broker or consignee, as appropriate; and batch number at least for medicinal product bearing the safety features

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