General Business Rules

1.) PRICES AND AVAILABILITY
a. Prices and delivery terms are valid as defined in written Order Confirmation.
b. In the event of a shortage in the market or by manufacturer’s decision, EU Pharma cannot be held responsible to supply.

2.)TRANSPORTATION
a. Transportation is organized by Customer, unless otherwise agreed.
b. Unless otherwise agreed, EU Pharma operates based on the incoterm 'EX WORKS'.

3.) PAYMENT TERMS
a. Unless otherwise agreed in writing by EU Pharma to the Customer, then all Invoices are liable for prepayment on the due date of the Pro-Forma Invoice.
b. In the case of non-payment of the account by the due date, (or if agreed, by the day of collection), EU Pharma has the right to retain all the drugs (see '4.) Title of Goods.)

4.) TITLE OF GOODS
a. Unless otherwise agreed, Title of the Goods shall remain with EU Pharma until payment of the drugs has been received for the said goods.
b. EU Pharma will be entitled to take possession of unpaid drugs if: the Customer has failed to pay for the drugs within agreed timescale, or the Customer shall become insolvent or bankrupt.

5.) RETURNS OF GOODS AND DELIVERY SHORTAGES
Conditions for returns of drugs, which are the subject of complaint, are as follows:
a. Any stock for return, for whatever reason, must be authorized by EU Pharma in writing.
b. Any delivery shortages must be reported within 3 working days of receipt of the delivery.
c. Drugs returned by the customer must be returned in the same condition as when they left EU Pharma – if they are not, then they shall be classed as ‘defective’ where the Customer shall incur all cost for rectifying the situation.
e. EU Pharma will not accept returns of refrigerated lines, in case the defect of the drugss is a reason of storage or transport at uncontrolled temperature.
f. If we are to collect the defective drugss we will issue a 48 hours notice of intent to pick up. If the goods are not ready for collection, then the Customer shall incur all costs for a re-collection.

6.) DATA PROTECTION
We may transfer information about you to our bankers/financiers for the purposes of providing services for the following reasons:
a. Obtaining Credit Insurance,
b. Making Credit reference agency searches,
c. Credit Control,
d. Assessment and analysis (including credit scoring, product and statistical analysis)
e. Securitization,
f. Protecting our interest

GENERAL RULES OF QUALITY ASSURANCE

Summary of liabilities:

1.) Deliverer
1.1 The quality insurance pharmacist of the EU Pharma Kft. shall only deliver released items upon your order.
1.2 It guarantees that its medicinal products will be delivered in the quality specified in the Marketing Authorization (MA) and in the quantity indicated in the confirmation for the partners.
1.3 Among the medicaments to be delivered it shall use the following marks on the multipack of the medicinal products requiring special storage: Product “To be stored in a cool place” – at a temperature of 2 to 8, according to MA, with black letters on an orange label
1.4 Technical documents required to the delivered medicinal products:
• Packing List (with signature, stamp and unique numbering),
• which contains: name, pack unit, strength, production number and the delivered number of units of the medicinal products.
• Copy of the quality certificate, which contains: analytical data related to the medicinal product, production item, statement on the final release, signature of the quality assurance pharmacist and stamp.
• Formal/Final authorization - its duplicate is provided.

2.) Acceptance by the Buyer
2.1 The consignee shall take the delivery of the ordered medicinal products on the premises of the EU Pharma Kft. and he shall verify the fact of the delivery with his signature on the documents of acceptance/Packing List-en. The itemized receipt shall take place on the premises of the Buyer.
2.2 Following the receipt on the premises of the EU Pharma Kft. the consignee shall be responsible for the safety of the medicinal products, for the sound storage and compliance with the regulations.
2.3 The responsibility for the safe movement of the medicinal products on the premises of the consignee shall be undertaken by the consignee or customer.

3.) Delivery of products
3.1 The document of the quantitative delivery shall be the Packing List.
3.2 The A Packing List shall be delivered along with the medicinal products. Upon the receipt on the premises of the EU Pharma the consignee / his authorized agent shall also sign and stamp the required documents.

4.) Complaint settlement and investigation of complaint
4.1 Medicinal products with deficient or damaged packaging shall not be delivered / taken over.
4.2 Upon the delivery of the medicinal products both parties shall inspect and verify integrity of the packaging of the multipacks.
4.3 Occurrence of hidden defects (within the multipack or packaging unit) shall be reported to the competent employee of the deliverer’s premises by providing a detailed description of the deficiency verified with a photograph annexed (date of transport, reference to the Packing List) within 5 working days following the receipt of the consignment of the medicinal products.
4.4 The EU Pharma Kft. shall carry out the investigation of the reported defects/complaint and send a written report thereon.
4.5 Compensation of the countervalue of any medicinal product qualified non-compliant with regulations shall be settled according to the competent employees of the parties and recorded in the final report of the complaint.
4.6 In case any complaint gives rise to the suspicion of counterfeit medicines the competent employees of the parties shall commence a joint investigation which they shall close by recording the outcome thereof in minutes. If the suspicion of counterfeiting is confirmed, the reporting liability toward the authorities shall be borne by the EU Pharma Kft.
4.7 Management of medicinal products with short-term expiry: The supplier may deliver medicinal products within a period of 10 /ten/ months prior to their expiry date unless the customer orders them in the knowledge and in spite of the expiry date.

5.) Tracking changes and management of deviation
5.1 The holder of the Marketing Authorization shall act with the competent authority in any issue concerning the changes in the Marketing Authorization.
5.2 Any deviation from the stipulations of this agreements shall be initiated and documented by the quality assurance managers of the parties.
5.3 In case of occurrence of any crucial aspect, corrective and preventive actions (CA/PA) shall be commenced and documented for both parties.
5.4.1. Upon drug withdrawal by the authority in Hungary the Buyer shall transport back the medicine in question. The obligation of the notification shall be borne by the EU Pharma Kft.
5.4.2. If the delivered medicinal product is withdrawn in the country of destination, the Buyer shall notify the EU Pharma Kft in writing.

6.) Miscellaneous
6.1 Wholesale partners may carry out administrative or spot inspection according to the EU GMP. Notification of any inspection shall be sent in advance (min. 30 days).
6.2 Wholesale partners shall provide each other with their contact details beyond working time in case of occurrence of emergency.
6.3 This Quality Assurance Agreement shall be valid along with the General Trading Terms and Conditions related to the subject-matter of the Agreement, however, it shall not supersede the provision therein.
6.4 By executing this agreement the parties (including their colleagues) undertake obligation of confidentiality concerning the data of the product(s) forming the object of the agreement and the parties shall keep the documents related thereto confidential.