ADDITIONAL PROTOCOL TO THE EUROPEAN AGREEMENT

on the exchange of therapeutic substances of human origin

THE MEMBER STATES OF THE COUNCIL OF EUROPE,

Contracting Parties to the European Agreement of 15 December 1958 on the exchange of therapeutic substances of human origin (hereinafter called ‘the Agreement’),

Having regard to the provisions of Article 5, paragraph 1, of the Agreement, according to which ‘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’;

Considering that so far as the Member States of the European Economic Community are concerned, the undertaking to grant this exemption falls within the competence of the Community, which possesses the necessary powers in this respect by virtue of the treaty which instituted it;

Considering therefore that for the purpose of the implementation of Article 5, paragraph 1, of the Agreement, it is necessary for the European Economic Community to be able to become a Contracting Party to the Agreement,

HAVE AGREED AS FOLLOWS:

Article 1

The European Economic Community may become a Contracting Party to the Agreement by signing it. In respect of the Community, the Agreement shall enter into force on the first day of the month following such signature.

Article 2

1. This Additional Protocol shall be open for acceptance by the Contracting Parties to the Agreement. It shall enter into force on the first day of the month following the date on which the last of the Contracting Parties has deposited its instrument of acceptance with the Secretary-General of the Council of Europe.

2. However, this Additional Protocol shall enter into force on the expiration of a period of two years from the date on which it has been opened for acceptance, unless one of the Contracting Parties has notified an objection to the entry into force. If such an objection has been notified, paragraph 1 of this Article shall apply.

Article 3

From the date of its entry into force, this Additional Protocol shall form an integral part of the Agreement. From that date, no State may become a Contracting Party to the Agreement without at the same time becoming a Contracting Party to the Additional Protocol.

Article 4

The Secretary-General of the Council of Europe shall notify the member States of the Council of Europe, any State having acceded to the Agreement and the European Economic Community of any acceptance or objection made under Article 2 and of the date of entry into force of this Additional Protocol in accordance with Article 2.

The Secretary-General shall also notify the European Economic Community of any act, notification or communication relating to the Agreement.

Done at Strasbourg, the 29th day of September 1982, in English and in French, and opened for acceptance the 1st day of January 1983. Both texts are equally authentic and shall be deposited in a single copy in the archives of the Council of Europe. The Secretary-General of the Council of Europe shall transmit certified copies to each member State of the Council of Europe, to any State invited to accede to the Agreement and to the European Economic Community.