a. The prices and delivery terms shall be valid as set forth in the written "Order Confirmation".
b. BHV Pharma Kft shall not be held liable for any change of supply due to a decision by a manufacturer, a shortage on the market or possible export controls imposed by any supervisory bodies.
c. BHV Pharma Kft. shall be entitled in all cases to examine and request the Buyer’s company information and authorisations.
2.) TRANSPORTATION
a. Transportation shall be the responsibility of the Buyer in all cases, unless there is an individual agreement.
b. BHV Pharma Kft. shall be responsible for medicinal products and the quality assurance until the goods are issued; all subsequent events and costs shall burden the Buyer, unless there is an individual agreement.
c. BHV Pharma Kft. reserves the right to inspect the carrier arriving to it and, in the case of serious shortcomings (e.g. cargo space with inadequate cleanliness, lack of temperature control equipment, tarpaulin-covered transport vehicle), to refuse to release the goods until the shortcoming is eliminated or until a new suitable transport vehicle is provided.
3.) PAYMENT TERMS
a. Unless otherwise agreed in writing, all advance invoices issued by BHV Pharma shall be settled by the Buyer within the specified time limit.
b. BHV Pharma Kft. shall have the right to retain the goods if the invoice is not paid within the time limit (or the invoice has not yet been paid by the agreed shipment date).
c. Certain delay in the payment deadline will cause the invoice to be cancelled.
4.) MAINTENANCE OF OWNERSHIP
a. Unless there is an individual agreement, the medicinal product shall become owned by the Buyer after the full payment of the purchase price
b. BHV Pharma Kft shall be entitled to take possession of the goods if the Buyer has not paid the medicinal product within the specified time period or if the Buyer becomes insolvent or bankrupt.
5.) COMPLAINTS ABOUT GOODS AND SHORTAGES IN SHIPMENT
The conditions for the complaint about goods, which are the subject of the complaint, are as follows:
a. In the event of a price complaint for any reason, prior to returning the goods BHV Pharma Kft. shall authorise the return of the medicinal product in writing.
b. Complaints about shortages in shipment shall be reported to BHV Pharma Kft. within 5 business days of arrival of the consignment.
c. The quality of the medicinal product returned by the Buyer shall be in accordance with the condition in which it has left BHV Pharma's warehouse and the Buyer shall be required to attach a storage and transport declaration to the returned consignment stating that it was stored and transported back to BHV Pharma Kft. at the temperature in accordance with the Marketing Authorisation. Otherwise, the goods will be classified as “rejects” and the Buyer will bear all the costs incurred in connection with this matter.
e. BHV Pharma Kft. does not accept returns of medicinal roducts requiring cold storage (2-8°C), the reason for returning which is a storage or transportation at uncontrolled temperature.
f. Where BHV Pharma Kft. undertakes to accept the return, it will inform the Buyer of its intention 3 days in advance. If the return is not ready for shipment at a specified time, the Buyer shall bear all the costs incurred in connection therewith.
6.) DATA PROTECTION
In some cases listed below, we may provide information about the Buyer to third parties, banks or funding organisations:
a. Obtaining credit insurance
b. In the case of a liquidity test
c. For audit purposes
d. Survey and analysis (including creditworthiness, product and statistical analysis)
e. Securitisation
f. Protecting our interests
g. At the request of supervisory bodies
Summary of Responsibilities:
- The Deliverer
1.1 The responsible person (RP) of BHV Pharma Kft. will only issue those items, according to your order, that have been put into a sellable inventory.
1.2 This person will reassure each of the partners that the medicinal products are handed over to them based on the incoming orders, with the quality set forth in the relevant Marketing Authorisation and in the quantity in accordance with the order confirmation.
1.3 Among medicinal products to be handed over, the multipacks of the following medicinal products requiring differentiated storage have the following markings: White label with black letters + 2-8 oC: According to the marketing authorisation, this product is “To be kept in a cold place”
1.4 Professional documents required for the medicinal products handed over:
• Packing List (signed, stamped, with unique serial number), including: medicinal product name, packaging unit, strength, serial number of the product, quantity delivered.
• A copy of the quality certificate containing: analytical data on the medicinal product, production batch, final release statement, signature and stamp of the quality assurance pharmacist.
• Formal/Final authorization - its copy is provided.
1.5 BHV Pharma Kft. issues products only and exclusively to companies possessing official Wholesale Distribution Authorisation for medicinal products and audited for quality assurance
2.) Taking Over by the Buyer
2.1 The receiving party takes over the ordered pharmaceutical consignment at the premises of BHV Pharma Kft. and certifies that fact by signing the delivery documents/Packing List. The receiving of medicinal products by items is carried out at the Buyer's premises.
2.2 After receiving the medicinal product at the premises of BHV Pharma Kft., the receiving party shall be responsible for safety of this product and its storage without damage and according to the professional requirements.
2.3 The receiving and/or ordering party shall accept the responsibility for the safety aspects of the moves of medicinal products at the receiving party’s premises.
3.) Handing Over of Products
3.1 The document of quantitative handing over/receiving of finished medicinal products is the Packing List.
3.2 The Packing List shall be shipped with the medicinal product. During receiving procedure at the BHV Pharma premises, the receiving party / its agent as well shall sign and stamp the required documents.
4.) Handling Complaints, Investigating Complaints
4.1 Issuing/receiving a product with defect, in damaged packaging is prohibited.
4.2 When receiving medicinal products, both parties shall be required to check and verify the integrity of multipacks of items being handed over.
4.3 The occurrence of hidden defects (inside a multipack or a packaging unit) shall be reported in writing to the competent person of the deliverer’s premises within 5 business days of receiving of the pharmaceutical consignment (with reference to the date of delivery and the Packing List) with a detailed description of the deficiency and a digital photograph annexed.
4.4 BHV Pharma Kft. shall be required to investigate the reported defects / complaint and send a written report thereon.
4.5 Compensation for non-qualified medicinal products shall be settled based on an agreement between the competent representatives of the parties and this shall be recorded in the final report on the complaint.
4.6 If complaints give reason to suspect falsification of medical products, the parties to the contract shall initiate a joint investigation into the subject, and the results thereof shall be concluded in the minutes. In case the suspicion of falsification is confirmed, the notification of the authorities shall be the obligation of BHV Pharma Kft.
4.7 Management of medicinal products with short shelf lives: The supplier is entitled to hand over the medicinalproducts until twelve /12/ months before their expiration date, unless the customer who knows the expiration date, orders those in spite of it.
5.) Change Tracking and Deviation Handling
5.1 Holders of a Marketing-Authorisation for a medicinal product shall be required to interact with the professional authority in matters affecting changes to the Marketing Authorisation.
5.2 The deviation from the provisions of this agreement as a deviation shall be initiated and documented by the parties' quality assurance managers.
5.3 In the event of occurrence of any critical aspect, a prompt corrective and preventive (CA/PA) action shall be integrated into the process and documented toward both parties.
5.4 In the case of an official withdrawal of a medicinal product in Hungary, the Buyer must return the medicinal product in question. The responsibility for the notification shall be borne by BHV Pharma Kft.
5.5 If the medicinal product delivered is withdrawn in the country of destination, the Buyer shall inform BHV Pharma Kft. of this in writing.
6.) Miscellaneous Provisions
6.1 The wholesale partners shall be entitled to an administrative or on-site EU GMP inspection. Notice of inspection shall be expected in advance (min.30 days).
6.2 The wholesale partners shall mutually provide each other with their contact details to access them during non-working hours in emergency situations.
6.3 This Quality Agreement shall apply in conjunction with the relevant General Trading Terms and Conditions, but shall not prevail over the provisions thereof.
6.4 By accepting this contract, the parties (including their employees) undertake confidentiality obligation regarding the details of the product(s) covered by the agreement and shall handle respective documents thereof confidentially.
Contact persons |
||
BHV Pharma |
||
Address: |
8000 Székesfehérvár, Raktár utca 2. Hungary |
|
Warehouse address: |
8000 Székesfehérvár, Raktár utca 2. Hungary |
|
Wholesale license number |
OGYÉI/60893-3/2018 |
|
Name: |
Robert Bánhidi Pharm.D |
Gubó-Urbán Andrea |
Position: |
Responsible Person |
General Manager |
E-mail address: |
||
Signature: |
||
Customer |
||
Address: |
||
Warehouse address: |
||
Wholesale license number |
||
Name: |
||
Position: |
||
E-mail address: |
||
Signature: |
||