Appendix 4: Routines for orders, receipt and deviations

Rules for purchases/call-off orders  

Hospital trusts and regional supply centres place call-off orders to the supplier for goods under contract.

Purchase orders, order replies and invoices must be sent electronically in accordance with the relevant electronic coordination agreement with the health regions, if not otherwise specifically agreed with the supplier.

The purchase order must comply with the same message requirements and include an estimated delivery date for any back ordered goods.

The purchase order from the hospital trust or supply centre must, at minimum, include the supplier’s item number, unit, quantity delivered, quantity back ordered, price and delivery date.  

Delays in order delivery  

The contact placing the purchase order must immediately be notified of any delays. This also applies if the supplier becomes aware of events that may impact future deliveries.

The notification must include information about the cause of the non-conformity, which measures have and will be implemented, estimated delivery date and quantities for each item.

The back order and replacement order form must be used if disruptions in the supply of goods under contract are expected. The regional forms can be found [here] 

Delayed pharmaceuticals  

Pharmaceuticals shall follow the same procedure as purchase orders. If a delay leads to a shortage, a written notice shall also be issued immediately to the regional supply centre affected, the Norwegian Medical Products Agency and contract management in Sykehusinnkjøp HF.

Rush orders  

Rush orders, i.e. deliveries faster than what has been agreed in the regular delivery schedule or purchase agreement, may be agreed separately between the supplier and the customer.  

Special supply centre purchases  

Where relevant, the regional supply centres may place special purchases with the suppliers. Examples include special orders or sterile goods without transport packaging, as described in Appendix 2, Chapter 2.  

Signature upon arrival  

The recipient at the hospital trust or supply centre shall sign the waybill upon arrival. Before signing, the contact shall verify that the quantity to packages received corresponds with the waybill.

Any visible non-conformities shall be recorded on the waybill or otherwise documented as a basis for a complaint to the supplier  

Delivery to supply centre

The date and time of reception shall be recorded.

The agreed date and time of delivery, according to the delivery schedule, shall form the basis for measuring delivery accuracy, see Appendix 5  

Complete delivery, partial delivery and back-order delivery  

The order shall, as a norm, be delivered complete and on the agreed date to hospital trusts and supply centres.

In special situations, however, partial delivery can be accepted.

This must be agreed specifically between the supplier and the customer if the goods are essential for continued hospital operation.

Back orders must be delivered as quickly as possible, as agreed with the customer  

Goods receipt

The customer must inspect the goods upon receipt. Any visible defects in the packaging, labelling, expiration dates, etc. must be recorded. See Figure 1 Quality control and Appendix 2: Physical requirements.

Goods that are defective or damaged must be set aside for further processing, inspection and complaint to the supplier.

Order lines are verified against the physical shipment. Final acceptance must be made as soon as possible after receipt of the goods, and normally within three (3) business days, at the latest. Correct orders are approved.

Only approved goods may be taken into stock.

If relevant, hidden defects may be claimed after the end customer has received the goods in a hospital trust. See Chapter 3.

 

3.1 Notice of defect

Basis

Examples of defects that require complaint and rectification:

• Condition, packaging and damage in acc. with Figure 1 Quality control.
• Incorrect quantity (too many/too few compared to packing slip).
• Incorrect item.
• Past expiration date or expiration date too imminent.
• Incorrect/missing labelling (ref. Appendix 2).
• Hidden defects discovered after receipt and stocking, traceable to an error on the part of the supplier.
• Missing documents (packing slip, certificates, COCs, etc.).
• Pallet problem (non-approved EUR, damaged/dirty/mouldy pallet).

 

Registered non-conformities form the basis for measuring complaint percentage. See Appendix 5.  

Hidden defects  

If hidden defects and damage are discovered after the goods have been taken into stock, and the defect or damage can be traced to an error on the part of the supplier, the hospital trust or supply centre must be notified immediately.

Relevant documentations and, if relevant, photos must be presented, in accordance with the contract    

Notice of defect

The supplier must confirm having received the notice of defect without undue delay within two (2) business days of the customer issuing the notice  

Replacement goods    

The supplier must immediately replace and without compensation send new goods to hospital trusts or supply centres. If it can wait, it may be agreed to include these goods with the next regular shipment.  

Returns and destruction     

The supplier is responsible for fully handling returns, including transport, destruction of goods that must be destroyed, and any added costs and extra work incurred by hospital trusts or supply centres.

The supplier must pick up returned goods as soon as possible and within 10 business days if not otherwise agreed.

If the supplier fails to pick up return goods within the agreed time limit and no special arrangements have been made, the hospital trust or supply centre may have the goods destroyed at the supplier’s expense  

Pharmaceutical complaints and non-conformities  

Call-off orders for pharmaceuticals via regional supply centres shall follow the same procedure as other goods.

For quality defects, the responsible pharmacist shall follow up on each non-conformity specifically. The national drug shortage centre and the Norwegian Medical Products Agency shall be notified as needed, depending on the nature of the non-conformity.

Upon suspicion of falsified pharmaceuticals the following shall apply: quarantine provisions, NOMVEC notification, return in accordance with procedures developed by the Norwegian Medical Products Agency.

For purchases via supply centres, goods are normally returned from the hospital trusts to the supply centre, where they are picked up by the supplier.

Other pharmaceuticals are returned from the hospital trusts via wholesalers.  

 

3.2 Suspended sales and recalls

General

If sales must be suspended or products must be recalled, the supplier must comply with all relevant statutory requirements to ensure notification and safe and effective suspension of sale or recall of the product batch in question.

The supplier must always notify the contract manager, hospital trust and supply centre in writing, see checklist in Table 2.

Organisation of recall  

The supplier is responsible for handling all aspects of returns, including transport, destruction.

The supplier shall cover any and all added costs and extra work incurred by hospital trusts or supply centres, including the delivery of replacement goods.

Goods purchased via supply centres and distributed to the hospital trusts, shall normally be returned via the supply centre if not otherwise agreed.  

Recall of medical devices    

Recalls are agreed and planned with each hospital trust.

When devices are recalled, including if single-use proprietary consumables linked to the device are no longer to be used, the supplier and hospital trust orsupply centre may agree further returns of stocked consumables. See Ch. 3.4.  

Special provisions for the recall of pharmaceuticals    

Recalled pharmaceuticals must be handled in accordance with the same procedure as other goods, but will, in addition, involve contract management within Sykehusinnkjøp HF, pharmaceuticals; the national drug shortage centre, lead pharmacist and the Norwegian Medical Products Agency.

For pharmaceuticals purchased via a supply centre, guidelines established in the specific quality agreement between the supply centre acting as the wholesaler and the supplier shall apply.  

Figure 2. Checklist for suspended sales and recalls

3.3. Back orders and replacement orders

Back ordered and replacement products to supply centres  

The supplier must use special back order and replacement order forms in case of delayed or disrupted deliveries to supply centres. 

A plan for alternative products must be presented voluntarily as soon as possible, normally within five (5) business days after a defect has been identified, if not otherwise agreed. The plan must ensure continuity of supply.  

Shortages of goods in the market  

  In case goods are sold out for an extended period due to market shortages of goods stocked by the regional supply centres, deliveries shall normally be managed through this solution, unless otherwise agreed between the customer, supplier and contract manager .    

3.4. Agreement for return of goods to supplier

Agreed returns from hospital trust or supply centre  

The customer shall ensure sufficient overlap between existing and future contract suppliers to maintain continuity in supply.

The customer is responsible for actively using up stocked goods from existing product lines to ensure that as few goods as possible have to be returned or destroyed.

Nevertheless, the customer shall be entitled to return goods in special situations. Such special situations include extraordinary surplus stock in connection with replacement purchases, significant changes in the product line, or replacement of equipment with proprietary consumables or other special situations.

 The following criteria apply to returns:

• The goods must be in good condition, fit to be resold
• The goods must be in the sealed, original packaging in an unopened package, consumer unit (CU) or transport unit (TU)

Goods marked “sterile” must, at a minimum, have 2-layer packaging (CU), and it must be documented that the goods have been handled in accordance with hygiene requirements.  

Return of products ordered in error by customer  

The customer shall notify the supplier of the products ordered in error as soon as the error is discovered. The parties shall agree on how to handle the situation and on any compensation for documented added costs between the customer and the supplier.

The supplier is obligated to accept the goods in return if the goods remain in the original packaging and is in good condition, fit to be resold.