Europese Overeenkomst betreffende de uitwisseling van geneesmiddelen van menselijke oorsprong

For the purposes of this Agreement, the expression „therapeutic substances of human origin” refers to human blood and its derivatives.
The provisions of this Agreement may be extended to cover other therapeutic substances of human origin by exchange of letters between two or more of the Contracting Parties.

A human red cell concentrate is a unit of Whole Human Blood from which most of the plasma has been removed.
It contains most of the red cells of the unit from which it has been prepared; other cell components may be present or may have been partially removed.
The liquid content of the concentrate will consist either of the residual plasma, or of an appropriate isotonic artificial aqueous solution added after the plasma was removed. The volume of red cells should constitute between 65 and 75% of the total volume of the product, but if a greater red cell concentration is applied the approximate percentage of erythrocyte volume (haematocrit) shall be indicated on the label.
All operations required in the preparation shall be carried out under aseptic conditions: decantation shall be carried out using a sterile, closed system and by compression only. No antiseptic or bacteriostatic agents should be added.
Blood group and storage - as for Whole Human Blood.
Labelling - The label on the container shall give all the information shown on the model label (Annex 2 bis). The Rhesus group shall be written as “Positive” or “Negative” or, in abbreviated form, “POS” or “NEG”. If an artificial aqueous solution has been added, the label shall also indicate its volume and composition.

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The Contracting Parties undertake, provided that they have sufficient stocks for their own needs, to make therapeutic substances of human origin available to other Parties who are in urgent need of them and to charge only those costs involved in the collection, processing and carriage of such substances.

Therapeutic substances of human origin shall be made available to the other Contracting Parties subject to the express condition that no profit is made on them, that they shall be used solely for medical purposes and shall be delivered only to bodies designated by the Governments concerned.

The Contracting Parties shall certify that the minimum requirements with regard to the properties of the therapeutic substances, and the regulations on labelling, packing and dispatch, as laid down in the Protocol to this Agreement, have been observed.
They shall also comply with any rules to which they have subscribed with regard to international standardisation in this field.
All consignments of therapeutic substances of human origin shall be accompanied by a certificate to the effect that they were prepared in accordance with the specifications in the Protocol. This certificate shall be based on the model to be found in Annex 1 to the Protocol.
The Protocol and its Annexes may be amended or supplemented by the Governments of the Parties to this Agreement.

The Contracting Parties shall take all necessary measures to exempt from all import duties the therapeutic substances of human origin placed at their disposal by the other Parties.
They shall also take all necessary measures to provide for the speedy delivery of these substances, by the most direct route, to the consignees referred to in Article 3 of this Agreement.

The Contracting Parties shall forward to one another, through the Secretary-General of the Council of Europe, a list of the bodies empowered to issue certificates as provided in Article 4 of this Agreement.
They shall also forward a list of bodies empowered to distribute imported therapeutic substances of human origin.

The present Agreement shall be open to the signature of Members of the Council of Europe, who may become Parties to it either by:
(a) signature without reservation in respect of ratification, or
(b) signature with reservation in respect of ratification followed by ratification.
Instruments of ratification shall be deposited with the Secretary-General of the Council of Europe.

The present Agreement shall enter into force on the first day of the month following the date on which three Members of the Council shall, in accordance with Article 7, have signed the Agreement without reservation in respect of ratification or shall have ratified it.
In the case of any Member of the Council who shall subsequently sign the Agreement without reservation in respect of ratification, or who shall ratify it, the Agreement shall enter into force on the first day of the month following such signature or deposit of the instrument of ratification.

The Committee of Ministers of the Council of Europe may invite any non-Member State to accede to the present Agreement. Such accession shall take effect on the first day of the month following the deposit of the instrument of accession with the Secretary-General of the Council of Europe.

The Secretary-General of the Council of Europe shall notify Members of the Council and acceding States:
(a) of the date of entry into force of this Agreement and of the names of any Members who have signed without reservation in respect of ratification or who have ratified it;
(b) of the deposit of any instrument of accession in accordance with Article 9;
(c) of any notification received in accordance with Article 11 and its effective date;
(d) of any amendment to the Protocol or its Annexes under Article 4, paragraph 4.

The present Agreement shall remain in force indefinitely.
Any Contracting Party may terminate its own application of the Agreement by giving one year's notice to that effect to the Secretary-General of the Council of Europe.

A label printed in English and French, based on the appropriate model to be found in Annexes 2 to 10 to the Protocol, shall be affixed to each container or giving-set.

Whole human blood shall be dispatched in containers in which a temperature of 4° to 6° C is maintained throughout the period of transport.
This condition is not required for the derivatives mentioned in the Protocol.

The products and apparatus referred to in Part II of this Protocol shall be sterile, non-pyrogenic and non-toxic.
It is recommended that the giving-set, as well as the solvents required for the dried products, be sent with each consignment.

Equipment shall comply with the provisions set out in Annex 11 to this Protocol.