EN Official Journal of the European Communities L 37/31

European Agreement

on the Exchange of Blood-grouping Reagents

THE SIGNATORY GOVERNMENTS OF THE MEMBER STATES OF THE COUNCIL OF EUROPE,

Considering that blood-grouping reagents are not available in unlimited quantities;

Considering that it is most desirable that member countries, in a spirit of European solidarity, should assist one another in the supply of these blood-grouping reagents, should the need arise;

Considering that such mutual assistance is only possible if the character and use of such blood-grouping reagents are subject to rules laid down jointly by the member countries and if the necessary import facilities and exemptions are granted,

HAVE AGREED AS FOLLOWS:

Article 1

For the purposes of this Agreement, the expression ‘blood-grouping reagents’ refers to reagents of human, animal and plant and other origin, used for blood-grouping and for the detection of blood incompatibilities.

Any Contracting Party may, by a declaration addressed to the Secretary-General of the Council of Europe, when signing this Agreement or depositing its instrument of ratification or approval, or accession, limit the application of this Agreement to blood-grouping reagents of human origin. This declaration may be withdrawn at any time, by notification addressed to the Secretary-General of the Council of Europe.

Article 2

The Contracting Parties undertake, provided that they have sufficient stocks for their own needs, to make blood-grouping reagents available to other Parties who are in urgent need of them and to charge only those costs of collection, processing and carriage of such substances and the cost (if any) of their purchase.

Article 3

Blood-grouping reagents shall be made available to the other Contracting Parties subject to the 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 Government concerned.

Article 4

The Contracting Parties shall certify that the provisions 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 standardization in this field.

All consignments of blood-grouping reagents 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 the Annex to the Protocol.

The Protocol and its Annex constitute an administrative arrangement and may be amended or supplemented by the Governments of the Parties to this Agreement.

Article 5

The Contracting Parties shall take all necessary measures to exempt from all import duties the blood-grouping reagents 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.

Article 6

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 blood-grouping reagents. Wherever possible these bodies should be the same as those referred to in Article 6 of the European Agreement on the Exchange of Therapeutic Substances of Human Origin.

Article 7

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 approval; or

(b) signature with reservation in respect of ratification or approval, followed by ratification or approval.

Instruments of ratification or approval shall be deposited with the Secretary-General of the Council of Europe.

Article 8

The present Agreement shall enter into force one month after 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 approval or shall have ratified or approved it.

In the case of any Member of the Council who shall subsequently sign the Agreement without reservation in respect of ratification or approval or who shall ratify or approve it, the Agreement shall enter into force one month after the date of such signature or the date of deposit of the instrument of ratification or approval.

Article 9

After the entry into force of this Agreement, 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 one month after the date of deposit of the instrument of accession with the Secretary-General of the Council of Europe.

Article 10

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 approval or who have ratified or approved it;

(b) of the deposit of any instrument of accession in accordance with Article 9;

(c) of any declaration or notification received in accordance with the provisions of Article 1, paragraph 2;

(d) of any notification received in accordance with Article 11 and its effective date;

(e) of any amendment of the Protocol and of its Annex under Article 4, paragraph 4.

Article 11

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.