CELEX: 51982PC0198
Language: en
Date: 1982-04-23 00:00:00
Title: Recommendation for a COUNCIL DECISION approving a draft Additional Protocol to the European Agreement on the Exchange of Therapeutic Substances of Human Origin (submitted to the Council by the Commission)

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COM (82) 198
Vol. 1982/0061
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 ---pagebreak--- COMMISSION OF THE EUROPEAN COMMUNITIES
                                                       COM(82)198 final
                                                       Brussels . 23 April 1982
                           Recommendation for a
                               COUNCIL DECISION
approving a draft Additional Protocol to the European Agreement on
      the Exchange of Therapeutic Substances of Human Origin
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            ( submitted to the Council by the Commission )
C0MC82 ) 198 final
 ---pagebreak---                                                            COM yiiE
                       E X PL AN ATOR Y M E MOR A N DU M
By its Decision of 25 3une 1979 the Council authorized the Commission to
conduct negotiations within the framework of the Council of Europe with the
object of. adding to the European Agreement, on the Exchange of Therapeutic
Substances of Human Origin a Protocol which would enable the European
Economic Community to become a Contracting Party to this Agreement .
Behind this Decision was the fact that Article 5(1 ) of the European
Agreement on the Exchange of Therapeutic Substances of Human Origin
specifies that 'The Contracting Parties shall take all the necessary measures
to exempt from all Import duties the therapeutic substances of human origin
put at their disposal by the other Parties' , Only the Community is competent
to grant derogations from the application of Common Customs Tariff
duties .
Negotiations between the Commission and the Secretariat-General of the
Council of Europe have resulted in a draft Additional Protocol which has
been conceived as an integral part of the Agreement and which wiii enable
the European Economic Community to become a Contracting Party to the
Agreement by signing it .
Once it has received the prior approval of the Council of Ministers of the
EEC , the Secretariat-Genera I of the Council of Europe will submit this draft
Additional Protocol to the Committee of Ministers of that body. It would
like to be abie to do so during a meeting to be held Irs May of this year.
When the Committee of Ministers of the Council of Europe has decided to
add this Protocol to the Agreement, the European Community will, be able
to become a Contracting Party to the latter ,
 ---pagebreak---                                       - 2 -
Consequently , the Commission recommends the Council to approve the draft
Additional Protocol to the European Agreement on the Exchange of
Therapeutic Substances of Human Origin and to authorize the Commission
to notify the Secretariat-General of the Council of Europe of such
acceptance (Annex 1 ).
When this Additional Protocol has been adopted by the Committee of
Ministers of the Council of Europe (probably during the second half of 1984),
the Commission will recommend the Council of Ministers of the Community
to accede on the latter's behalf to the European Agreement on the Exchange
of Therapeutic Substances of Human Origin .
 ---pagebreak---                                                   ANNEX I
                               Recommendation
                            for a Council Decision
                               approving a draft
               Additional Protocol to the European Agreement
        on the Exchange of Therapeutic Substances of Human Origin ,
THE COUNCIL OF THE EUROPEAN COMMUNITIES ,
Having    regard   to the    Treaty   establishing the  European   Economic
Community,
Having regard to the Recommendation from the Commission ,
Whereas Article 5(1 ) of the European Agreement on the Exchange of
Therapeutic Substances of Human Origin Jays down that The Contracting
Parties shall take all the necessary measures to exempt from all import
duties the therapeutic substances of human origin placed at their disposal by
the other Parties'?
Whereas only the Community is competent to grant derogations from the
application of the Common Customs Tariff in respect of autonomous or
conventional rates of duty;
Whereas the Secretariat-General of the Council of Europe proposes to
add to the said Agreement          an Additional Protocol which would enable
the European Economic Community to become a Contracting Party thereto
and thereby exercise its competence?
Whereas the draft Additional Protocol meets the requirements
of the European Economic Community,
 ---pagebreak---                                    - 2 -
HAS DECIDED as follows:
                                 Article 1
The draft Additional Protocol to the European Agreement on the Exchange
of Therapeutic Substances of Human Origin , proposed by the Secretariat-
General of the Council of Europe , is hereby approved on behalf of the
Community .
The text of this Additional Protocol is annexed to this
Decision .
                                 Article 2
The Commission shall inform the Secretariat-General of the Council of
Europe that the Community approves the draft Protocol referred to in
Article 1 .
                                      Done at Brussels,
                                      For the Council,
                                      The President ,
 ---pagebreak---                            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 13 December 1953 on the exchange of therapeutic
substances of human origin (hereinafter called "the Agreement"),
Having regard to the provisions of Article 5, paragraph I , of the Agreement,
according to which "The Contracting Parties shall take all the 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 falis
within the competence of the Community,, which possesses the necessary
powers in this respect by virtue of the Treaty which established its
Considering therefore that for the purpose of the implementation of Article
5, paragraph I , 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
 ---pagebreak---                                        - 2 -
                                   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
                                                            i
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 objections
made under Article 2 and of the date of entry into force of this Additional
Protocol in accordance with Article 2 .
Done at Strasbourg, the               , in English and French , both texts being
equally authentic , in a single original which shall be deposited 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.