2. člen MESZUC

Sporazum, protokol in dodatni protokol se v izvirniku v angleškem jeziku in v prevodu v slovenskem jeziku glasijo: The governments signatory hereto, being members of the Council of Europe, Considering that therapeutic substances of human origin are by their very nature the result of an act of the human donor and therefore 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 therapeutic substances, should the need arise; Considering that such mutual assistance is only possible if the character and use of such therapeutic substances 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: For the purposes of this Agreement, the expression “therapeutic substances of human origin” refers to human blood and its derivatives. The provisions of this Agreement may be extended to cover other therapeutic substances of human origin by exchange of letters between two or more of the Contracting Parties. The Contracting Parties undertake, provided that they have sufficient stocks for their own needs, to make therapeutic substances of human origin available to other Parties who are in urgent need of them and to charge only those costs involved in the collection, processing and carriage of such substances. Therapeutic substances of human origin shall be made available to the other Contracting Parties subject to the express 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 governments concerned. The Contracting Parties shall certify that the minimum requirements with regard to the properties of the therapeutic substances, and the regulations on labelling, packing and dispatch, 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 standardisation in this field. All consignments of therapeutic substances of human origin 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 Annex 1 to the Protocol. The Protocol and its annexes may be amended or supplemented by the governments of the Parties to this Agreement. 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. 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. 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 therapeutic substances of human origin. 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 b signature with reservation in respect of ratification followed by ratification. Instruments of ratification shall be deposited with the Secretary General of the Council of Europe. The present Agreement shall enter into force on the first day of the month following 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 shall have ratified it. In the case of any member of the Council who shall subsequently sign the Agreement without reservation in respect of ratification, or who shall ratify it, the Agreement shall enter into force on the first day of the month following such signature or deposit of the instrument of ratification. 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 on the first day of the month following the deposit of the instrument of accession with the Secretary General of the Council of Europe. 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 who have ratified it; b of the deposit of any instrument of accession in accordance with Article 9; c of any notification received in accordance with Article 11 and its effective date; d of any amendment to the Protocol or its annexes under Article 4, paragraph 4. 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. In witness whereof the undersigned, duly authorised thereto by their respective governments, have signed the present Agreement. Done at Paris, this 15th day of December 1958, 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 shall transmit certified copies to each of the signatory and acceding governments. 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: 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. 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. 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. 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. Vlade podpisnice tega sporazuma, članice Sveta Evrope, so se glede na to, da zdravilne učinkovine človeškega izvora že po svoji naravi izhajajo iz dejanja človeškega darovalca in torej niso na voljo v neomejenih količinah, glede na to, da je nadvse zaželeno, da si države članice v duhu evropske solidarnosti med seboj pomagajo pri oskrbi s temi zdravilnimi učinkovinami, če se pokaže potreba po njih, glede na to, da je taka medsebojna pomoč možna le, če glede lastnosti in uporabe teh zdravilnih učinkovin veljajo pravila, ki jih skupaj določijo države članice, in če se pri uvozu odobrijo ustrezne olajšave in oprostitve, sporazumele o naslednjem: