TISSUE-TYPING REAGENTS.

Tissue-typing reagent anti HL-AI. 3.

Tissue-typing reagents may be preserved in the liquid or in the dried state.

Tissue-typing reagents for use in a complement fixation technique on platelets

Tissue-typing reagents shall be dispensed in such a way and in such volumes that the reagent in one container is sufficient for the performance of tests with positive and negative control corpuscles in addition to the performance of tests with the unknown corpuscles.

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.

Additional Protocol to the European Agreement on the exchange of tissue-typing reagents

ADDITIONAL PROTOCOL TO THE EUROPEAN AGREEMENT ON THE EX-CHANGE OF TISSUE-TYPING REAGENTS

THE SIGNATORY STATES TO THE EUROPEAN AGREEMENT ON THE EXCHANGE OF TISSUE-TYPING REAGENTS,

Therapeutic substances of human origin and blood-grouping and tissue-typing reagents 61 C16

Council Decision of 28 October 1977 on the conclusion of the European Agreement on the exchange of tissue-typing reagents and the Additional Protocol thereto

Recalling the provisions of Article 5 (1) of the Agreement, whereby 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;

storing and supplying corresponding tissues containing the agent, for the development or production of the relevant diagnostic tests or for typing strains of the agent;

EUROPEAN AGREEMENT ON THE EXCHANGE OF TISSUE-TYPING REAGENTS

European Agreement on the exchange of tissue-typing reagents

COUNCIL OF EUROPE European Agreement on the exchange of tissue-typing reagents

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

Potency A. Tissue-typing reagents to be used in cytotoxic techniques on lymphocytes

THERAPEUTIC SUBSTANCES OF HUMAN ORIGIN AND BLOOD-GROUPING AND TISSUE-TYPING REAGENTS

Specificity A. Tissue-typing reagents to be used in cytotoxic techniques on lymphocytes

ADDITIONAL PROTOCOL TO THE EUROPEAN AGREEMENT ON THE EXCHANGE OF TISSUE-TYPING REAGENTS

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.

"TISSUE-TYPING REAGENTS" MEANS ALL REAGENTS WHETHER OF HUMAN, ANIMAL, PLANT OR OTHER ORIGIN USED FOR THE DETERMINATION OF HUMAN TISSUE-TYPES.

(1)To be completed under Article 4 (4) of the European Agreement on the exchange of tissue-typing reagents.

THE SIGNATORY STATES TO THE EUROPEAN AGREEMENT ON THE EXCHANGE OF TISSUE-TYPING REAGENTS, hereinafter called the "Agreement",

The European Agreement on the exchange of tissue-typing reagents and the additional Protocol thereto are hereby approved on behalf of the Community.

COUNCIL DECISION of 28 October 1977 on the conclusion of the European Agreement on the exchange of tissue-typing reagents and the Additional Protocol thereto

Whereas the European Agreement on the exchange of tissue-typing reagents, drawn up on the initiative of the Council of Europe, provides in Article 5 (1) that 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;

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.

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.

Further provisions, for tissue-typing reagents to be used in cytotoxic techniques on lymphocytes as well as for reagents to be used in a complement fixation technique on platelets:

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.

RELIEF SHALL INCLUDE THE SPECIAL PACKAGING ESSENTIAL FOR THE TRANSPORT OF THERAPEUTIC SUBSTANCES OF HUMAN ORIGIN OR BLOOD-GROUPING OR TISSUE-TYPING REAGENTS AND ALSO ANY SOLVENTS AND ACCESSORIES NEEDED FOR THEIR USE WHICH MAY BE INCLUDED IN THE CONSIGNMENTS.

EXEMPTION SHALL INCLUDE THE SPECIAL PACKAGING ESSENTIAL FOR THE TRANSPORT OF THERAPEUTIC SUBSTANCES OF HUMAN ORIGIN OR BLOOD-GROUPING OR TISSUE-TYPING REAGENTS AND ALSO ANY SOLVENTS AND ACCESSORIES NEEDED FOR THEIR USE WHICH MAY BE INCLUDED IN THE CONSIGNMENTS.

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.

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.