QUALITY AGREEMENT between Euroleki GK SP. Z o.o. Sp.k. Sw

QUALITY AGREEMENT
between
Euroleki GK SP. Z o.o. Sp.k.
Sw. Teresy od Dzieciątka Jezus 111, 91-222 Lodz, Poland
(SUPPLIER / RECIPIENT)
and
________________________________
________________________________
________________________________
(CUSTOMER / SUPPLIER)
The Supplier and the Customer are also referred to as the “PARTY” or collectively as the “PARTIES”, as
the case may be.
The undersigned Parties intend to ensure product and patient safety in accordance with the European
and national law and regulations.
1. WHOLESALER PERMIT (WHOLESALER LICENSE)
a) The PARTIES assure to possess a valid wholesaler license.
b) The PARTIES provide each other a translated copy in English, of his current wholesaler license.
c) The PARTIES notify each other immediately about revocation, expiration or any other changes
of the wholesaler license.
2. SOURCES OF THE ORDERED GOODS, COUNTERFEITS, RECALLS
a) The SUPPLIER assures that he will only sell/deliver goods sourced from authorized companies
to the CUSTOMER.
b) The SUPPLIER assures the CUSTOMER that he will only sell/deliver goods which have been put
on the market solely by the original pharmaceutical manufacturer within the EAA.
c) The SUPPLIER assures the CUSTOMER that medical devices and diagnostics are of European
Union origin and are intended for European Union market.
d) The PARTIES immediately notify each other and the competent authorities of any occurrences
of suspected counterfeited goods and recalls of goods.
3. GOOD DISTRIBUTION PRACTICE (GDP)
a) The PARTIES assure to be familiar with the Good Distribution Practice guidelines of European
Economic Area and assure to comply with the last updated version of the GDP guidelines.
b) The PARTIES assure that they store the goods under the conditions specified by manufacturer
in order to avoid any deterioration by light, moisture or temperature. Temperature must be
monitored and recorded constantly. Records of temperature should be reviewed regularly.
c) Storage and distribution of each batch of product must be carried out and recorded in a manner
that allows easy traceability and reconciliation to facilitate a recall if necessary.
4. PACKAGING OF THE GOODS
a) The SUPPLIER assures that he will not open, modify or remove the original packaging or the
contents of the ordered goods and that he will not remove safety features or devices.
b) The SUPPLIER delivers/sells the goods in their unopened original packaging to the CUSTOMER.
c) The SUPPLIER is responsible that the goods are suitably protected in a manner that does not
affect the quality of products.
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5. RESPOSIBILITIES
a) Both PARTIES agree to RESPOSIBILITIES provided in Annex 1 to this agreement.
6. DURATION
a) This Quality Agreement expires at the end of the business relationship between the CUSTOMER
and the SUPPLIER.
b) Signatures on this agreement received by the way of Facsimile, Mail and/or e-mail shall be
deemed to be an executed contract.
7. CONFIDENTIALITY
a) The Parties shall treat the contents of this agreement as confidential, except to the extent that
such disclosure is necessary to execute this agreement.
8. CHANGES TO THIS AGREEMENT
a) Any changes to this agreement shall be made in writing.
b) No collateral agreements to this agreement have been made.
For and behalf of the CUSTOMER:
For and behalf of the SUPPLIER:
General Management
Position:
Name:
Signature:
Date:
General Management
Position:
Name:
Signature:
Date:
Position:
Name:
Signature:
Date:
Position:
Name:
Signature:
Date:
Responsible Person
Position:
Name:
Signature:
Date:
Responsible Person
Position:
Name:
Signature:
Date:
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