EN Official Journal of the European Communities L 295/8

EUROPEAN AGREEMENT ON THE EXCHANGE OF TISSUE-TYPING REAGENTS

THE MEMBER STATES OF THE COUNCIL OF EUROPE, SIGNATORY HERETO

Considering that tissue-typing reagents are not available in unlimited quantities;

Considering that it is highly desirable that Member States, in a spirit of European solidarity, should assist one another in the supply of these tissue-typing reagents, should the need arise:

Considering that such mutual assistance is only possible if the character and use of such tissue-typing regents are subject to rules to be laid down jointly by the Member States and if the necessary import facilities and exemptions are granted,

HAVE AGREED AS FOLLOWS

Article 1

1. For the purposes of this Agreement, the expression ‘tissue-typing reagents’ refers to reagents of human, animal, plant and other origin, used for the determination of tissue-typing

2. The provisions of Articles 2 to 6 of this Agreement shall also apply to cells of known antigenic composition to be used for the investigation of typing reagents.

Article 2

The Contracting Parties undertake, provided that they have sufficient stocks for their own needs, to make tissue-typing reagents available to other Parties who are in 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

Tissue-typing reagents shall be made available to the other Contracting Parties subject to the condition that no profit is made on them, and that they shall be used solely for medical and scientific, i.e. non-commercial, purposes and shall be delivered only to laboratories designated by the Governments concerned in accordance with Article 6 of this Agreement.

Article 4

1. The contracting parties shall certify that the provisions as laid down in the Protocol to this Agreement have been observed.

2. They shall also comply with any rules to which they have subscribed with regard to international standardization in this field.

3. All consignments of tissue-typing 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.

4. 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

1. The Contracting Parties shall take all necessary measures to exempt from all import duties the tissue-typing reagents placed at their disposal by the other Parties.

2. 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 national and/or regional reference laboratories empowered to issue certificates as provided in Article 4 of the Agreement and to distribute imported tissue-typing reagents.

Article 7

1. This Agreement shall be open to signature by the Member States of the Council of Europe, who may become parties to it either by:

(a) signature without reservation in respect of ratification or acceptance, or

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

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

Article 8

1. This Agreement shall enter into force one month after the date on which three Member States of the Council shall have become Parties to the Agreement, in accordance with the provisions of Article 7.

2. As regards any Member State who shall subsequently sign the Agreement without reservation in respect of ratification or acceptance or who shall ratify or accept it, the Agreement shall enter into force one month after the date of such signature or after the date of deposit of the instrument of ratification or acceptance.

Article 9

1. After the entry into force of this Agreement, the Committee of Ministers of the Council of Europe may invite any non-member Stare to accede thereto.

2. Such accession shall be effected by depositing with the Secretary-General of the Council of Europe an instrument of accession which shall take effect one month after the date of its deposit

Article 10

1. Any Contracting Party may at the time of signature or when depositing its instrument of ratification, acceptance or accession, specify the territory or territories to which this Agreement shall apply.

2. Any Contracting Party may, when depositing its instrument of ratification, acceptance or accession or at any later date, by declaration addressed to the Secretary-General of the Council of Europe, extend this Agreement to any other territory or territories specified in the declaration and for whose international relations it is responsible or on whose behalf it is authorized to give undertakings.

3. Any declaration made in pursuance of the preceding paragraph may, in respect of any territory mentioned in such declaration, be withdrawn according to the proccedure laid down in Article 11 of this Agreement.

Article 11

1. Any Contracting Party may, in so far as it is concerned, denounce this Agreement by means of a notification adressed to the Secretary-General of the Council of Europe.

2. Such denunciation shall take effect six months after the date of receipt by the Secretary-General of such notification.

Article 12

The Secretary-General of the Council of Europe shall notify the Member States of the Council and any State which has acceded to this Agreement, of:

(a) any signature without reservation in respect of ratification or acceptance;

(b) any signature with reservation in respect of ratification or acceptance;

(c) the deposit of any instrument of ratification, acceptance or accession;

(d) any date of entry into force of this Agreement in accordance with Article 8 thereof;

(e) any declaration received in pursuance of the provisions of paragraphs 2 and 3 of Article 10;

(f) any notification received in pursuance of the provisions of Article 11 and the date on which denunciation takes effect;

(g) any amendment of or supplement to the Protocol and its Annex under Article 4 (4) of this Agreement.

In witness whereof the undersigned, being duly authorized thereto, having signed this Agreement. Done at Strasbourg, this 17th day of September 1974, in the English and French languages, both texts being equally authoritative, in a single copy which shall remain deposited in the archives of the Council of Europe. The Secretary-General of the Council of Europe shall transmit certified copies to each of the signatory and acceding States.