MESZUC – Zakon o ratifikaciji Evropskega...

107. Zakon o ratifikaciji Evropskega sporazuma o izmenjavi zdravilnih učinkovin človeškega izvora, Protokola k Evropskemu sporazumu o izmenjavi zdravilnih učinkovin človeškega izvora ter Dodatnega protokola k Evropskemu sporazumu o izmenjavi zdravilnih učinkovin človeškega izvora (MESZUC)

Na podlagi druge alinee prvega odstavka 107. člena in prvega odstavka 91. člena Ustave Republike Slovenije izdajam

U K A Z
O RAZGLASITVI ZAKONA O RATIFIKACIJI EVROPSKEGA SPORAZUMA O IZMENJAVI ZDRAVILNIH UČINKOVIN ČLOVEŠKEGA IZVORA, PROTOKOLA K EVROPSKEMU SPORAZUMU O IZMENJAVI ZDRAVILNIH UČINKOVIN ČLOVEŠKEGA IZVORA TER DODATNEGA PROTOKOLA K EVROPSKEMU SPORAZUMU O IZMENJAVI ZDRAVILNIH UČINKOVIN ČLOVEŠKEGA IZVORA (MESZUC)

Razglašam Zakon o ratifikaciji Evropskega sporazuma o izmenjavi zdravilnih učinkovin človeškega izvora, Protokola k Evropskemu sporazumu o izmenjavi zdravilnih učinkovin človeškega izvora ter Dodatnega protokola k Evropskemu sporazumu o izmenjavi zdravilnih učinkovin človeškega izvora (MESZUC), ki ga je sprejel Državni zbor Republike Slovenije na seji 19. julija.

Št. 001-22-139/00

Ljubljan, dne 27. julija 2000

Predsednik
Republike Slovenije
Milan Kučan l. r.

Z A K O N
O RATIFIKACIJI EVROPSKEGA SPORAZUMA O IZMENJAVI ZDRAVILNIH UČINKOVIN ČLOVEŠKEGA IZVORA, PROTOKOLA K EVROPSKEMU SPORAZUMU O IZMENJAVI ZDRAVILNIH UČINKOVIN ČLOVEŠKEGA IZVORA TER DODATNEGA PROTOKOLA K EVROPSKEMU SPORAZUMU O IZMENJAVI ZDRAVILNIH UČINKOVIN ČLOVEŠKEGA IZVORA (MESZUC)

1. člen

Ratificirajo se Evropski sporazum o izmenjavi zdravilnih učinkovin človeškega izvora, sklenjen v Strasbourgu 15. decembra 1958, Protokol k Evropskemu sporazumu o izmenjavi zdravilnih učinkovin človeškega izvora, sklenjen v Strasbourgu 19. aprila 1982, ter Dodatni protokol k Evropskemu sporazumu o izmenjavi zdravilnih učinkovin človeškega izvora, sklenjen v Parizu 29. septembra 1982 in dan na voljo za sprejetje 1. januarja 1983.

2. člen

Sporazum, protokol in dodatni protokol se v izvirniku v angleškem jeziku in v prevodu v slovenskem jeziku glasijo:

EUROPEAN AGREEMENT
ON THE EXCHANGE OF THERAPEUTIC SUBSTANCES OF HUMAN ORIGIN

Preamble

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:

Article 1

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.

Article 2

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.

Article 3

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.

Article 4

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.

Article 5

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.

Article 6

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.

Article 7

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.

Article 8

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.

Article 9

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.

Article 10

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.

Article 11

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 &fbco;binary entityId="a8cd4870d-9bbf-4325-af98-5e0c51af9467" type="pdf"&fbcc;

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.

EVROPSKI SPORAZUM
O IZMENJAVI ZDRAVILNIH UČINKOVIN ČLOVEŠKEGA IZVORA

Uvod

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:

1. člen

V tem sporazumu se izraz »zdravilne učinkovine človeškega izvora« nanaša na človeško kri in njene pripravke.

Določbe tega sporazuma se lahko z izmenjavo pisem med dvema ali več pogodbenicami razširijo na druge zdravilne učinkovine človeškega izvora.

2. člen

Pogodbenice se zavezujejo, da dajo zdravilne učinkovine človeškega izvora na voljo drugim pogodbenicam, ki jih nujno potrebujejo, če imajo dovolj zalog za lastne potrebe, in da zaračunajo le stroške zbiranja, predelave in prevoza teh učinkovin.

3. člen

Zdravilne učinkovine človeškega izvora se dajo drugim pogodbenicam na voljo pod izrecnim pogojem, da z njimi ne ustvarjajo dobička, da jih uporabljajo izključno v medicinske namene in da jih dobavljajo le organom, ki jih določijo njihove vlade.

4. člen

Pogodbenice potrjujejo, da upoštevajo minimalne zahteve glede lastnosti zdravilnih učinkovin in predpise o označevanju, pakiranju in pošiljanju, kot so določeni v protokolu k temu sporazumu.

Izpolnjujejo tudi pravila, ki so jih sprejele glede na mednarodno standardizacijo na tem področju.

Vsem pošiljkam zdravilnih učinkovin človeškega izvora mora biti priložen certifikat, ki potrjuje, da so bile pripravljene v skladu s specifikacijami v protokolu. Ta certifikat je narejen po vzorcu iz Priloge 1 k protokolu.

Protokol in njegove priloge lahko vlade pogodbenic tega sporazuma spremenijo ali dopolnijo.

5. člen

Pogodbenice ukrenejo vse potrebno, da so zdravilne učinkovine človeškega izvora, ki jim jih dajo na voljo druge pogodbenice, oproščene vseh uvoznih dajatev.

Prav tako ukrenejo vse potrebno, da omogočijo hitro dobavo teh učinkovin po najkrajši poti prejemnikom, omenjenim v 3. členu tega sporazuma.

6. člen

Pogodbenice si po generalnem sekretarju Sveta Evrope pošljejo seznam organov, pooblaščenih za izdajo certifikatov, določenih v 4. členu tega sporazuma.

Prav tako pošljejo seznam organov, pooblaščenih za distribucijo uvoženih zdravilnih učinkovin človeškega izvora.

7. člen

Ta sporazum je na voljo za podpis članicam Sveta Evrope, ki lahko postanejo njegove pogodbenice s:

a)

podpisom brez pridržka glede ratifikacije ali

b)

podpisom s pridržkom glede ratifikacije, ki mu sledi ratifikacija.

Listine o ratifikaciji se deponirajo pri generalnem sekretarju Sveta Evrope.

8. člen

Ta sporazum začne veljati prvi dan v mesecu, ki sledi dnevu, ko tri članice Sveta v skladu s 7. členom tega sporazuma podpišejo sporazum brez pridržka glede ratifikacije ali ga ratificirajo.

Za vsako drugo članico Sveta, ki pozneje podpiše sporazum brez pridržka glede ratifikacije ali ga ratificira, začne sporazum veljati prvi dan v mesecu, ki sledi temu podpisu ali deponiranju listine o ratifikaciji.

9. člen

Odbor ministrov Sveta Evrope lahko povabi katero koli državo nečlanico, da pristopi k temu sporazumu. Pristop začne veljati prvi dan v mesecu po deponiranju listine o pristopu pri generalnem sekretarju Sveta Evrope.

10. člen

Generalni sekretar Sveta Evrope uradno obvesti članice Sveta in države, ki so pristopile k sporazumu, o:

a)

datumu začetka veljavnosti tega sporazuma in imenih tistih članic, ki so ga podpisale brez pridržka glede ratifikacije ali so ga ratificirale,

b)

deponiranju vsake listine o pristopu v skladu z 9. členom,

c)

vsakem uradnem obvestilu, prejetem na podlagi 11. člena, in datumu začetka njegove veljavnosti,

d)

vsaki spremembi protokola ali njegovih prilog po četrtem odstavku 4. člena.

11. člen

Ta sporazum velja nedoločen čas.

Vsaka pogodbenica lahko preneha uporabljati sporazum eno leto po uradnem obvestilu generalnemu sekretarju Sveta Evrope.

V potrditev tega so podpisani, ki so jih njihove vlade za to pravilno pooblastile, podpisali ta sporazum.

Sestavljeno v Parizu 15. decembra 1958 v angleškem in francoskem jeziku, pri čemer sta besedili enako verodostojni, v enem izvodu, ki se hrani v arhivu Sveta Evrope. Generalni sekretar pošlje overjene kopije vsem vladam podpisnic in vladam tistih držav, ki pristopijo k temu sporazumu.

PROTOKOL
K EVROPSKEMU SPORAZUMU O IZMENJAVI ZDRAVILNIH UČINKOVIN ČLOVEŠKEGA IZVORA

I. DEL
SPLOŠNE DOLOČBE

A. Označevanje

Etiketa, natisnjena v angleščini in francoščini, narejena po ustreznem vzorcu, ki je v prilogah od 2 do 10 tega protokola, je nalepljena na vsak vsebnik ali set za dajanje.

B. Pakiranje in pošiljanje

Polno človeško kri pošiljamo v vsebnikih, v katerih je temperatura ves čas transporta od 4 °C do 6 °C.

Ta pogoj ni predpisan za pripravke, navedene v protokolu.

C. Pripravki in oprema

Pripravki in oprema, ki so navedeni v drugem delu tega protokola, so sterilni, apirogeni in netoksični.

Priporočamo, da se vsaki pošiljki priložijo set za dajanje kot tudi predpisana topila za dehidrirane pripravke.

D. Netoksičnost plastične opreme za transfuzijo krvi

Oprema je v skladu z določbami, določenimi v prilogi 11 tega protokola.

Zakon o ratifikaciji Evropskega sporazuma o izmenjavi zdravilnih učinkovin človeškega izvora, Protokola k Evropskemu sporazumu o izmenjavi zdravilnih učinkovin človeškega izvora ter Dodatnega protokola k Evropskemu sporazumu o izmenjavi zdravilnih učinkovin človeškega izvora (MESZUC)

Časovnica