Source: EURLEX
Language: en
Format: md

**Council of the**
**European Union**

**Interinstitutional File:**

**2014/0165 (COD)**

**INFORMATION NOTE**

From: General Secretariat of the Council

**Brussels, 10 March 2016**
**(OR. en)**

**6843/16**

**CODEC 254**
**CODIF 9**
**ECO 22**
**INST 87**
**MI 130**
**PE 28**

To: Permanent Representatives Committee/Council

Subject: Proposal for a Regulation of the European Parliament and of the Council to
avoid trade diversion into the European Union of certain key medicines
(codification)

          - Outcome of the European Parliament's first reading

(Strasbourg, 7 to 10 March 2016)

**I.** **INTRODUCTION**

The rapporteur, Mrs Laura FERRARA (EFDD - IT), presented a report, on behalf of the Committee

on Legal Affairs. One amendment in the form of an addendum to the report was presented to the

plenary.

In accordance with the provisions of Article 294 of the TFEU and the joint declaration on practical

arrangements for the codecision procedure **[1]**, informal contacts have taken place between the

Council, the European Parliament and the Commission with a view to reaching an agreement on

this dossier at first reading, thereby avoiding the need for second reading and conciliation.

**1** OJ C 145, 30.6.2007, p. 5

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**II.** **VOTE**

When the plenary voted on 9 March 2016, the addendum to the report was adopted by means of a

single vote.

The text adopted and the legislative resolution constitute the European Parliament's first reading

position [2], it reflects what had been agreed during the informal contacts referred to above.

The Council should therefore be in a position to approve the Parliament's position.

The act would then be adopted in the wording which corresponds to the Parliament's position.

**2** The text adopted and the European Parliament's legislative resolution are set out in the Annex.

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**ANNEX**

**(09.03.2016)**

## **Trade diversion into the European Union of certain key medicines ***I**

**European Parliament legislative resolution of 9 March 2016 on the proposal for a regulation**
**of the European Parliament and of the Council to avoid trade diversion into the European**
**Union of certain key medicines (codified text) (COM(2014)0319 – C8-0015/2014 –**
**2014/0165(COD))**

**(Ordinary legislative procedure – codification)**

_The European Parliament_,

– having regard to the Commission proposal to the European Parliament and the Council
(COM(2014)0319),

– having regard to Article 294(2) and Article 207(2) of the Treaty on the Functioning of the
European Union, pursuant to which the Commission submitted the proposal to Parliament
(C8-0015/2014),

– having regard to Article 294(3) of the Treaty on the Functioning of the European Union,

– having regard to the Interinstitutional Agreement of 20 December 1994 - Accelerated working
method for official codification of legislative texts [3],

– having regard to Rules 103 and 59 of its Rules of Procedure,

– having regard to the report of the Committee on Legal Affairs (A8-0038/2016),

A. whereas, according to the Consultative Working Party of the legal services of the European
Parliament, the Council and the Commission, the proposal in question contains a
straightforward codification of the existing texts without any change in their substance;

1. Adopts its position at first reading, hereinafter set out;

2. Instructs its President to forward its position to the Council, the Commission and the national
parliaments.

**3** OJ C 102, 4.4.1996, p. 2.

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**P8_TC1-COD(2014)0165**

**Position of the European Parliament adopted at first reading on 9 March 2016 with a view to**
**the adoption of Regulation (EU) 2016/... of the European Parliament and of the Council to**
**avoid trade diversion into the European Union of certain key medicines (codification)**

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article

207(2) thereof,

Having regard to the proposal from the European Commission,

After transmission of the draft legislative act to the national parliaments,

Acting in accordance with the ordinary legislative procedure [4],

Whereas:

(1 _)_ Council Regulation (EC) No 953/2003 [5] has been substantially amended several times [6] . In

the interests of clarity and rationality, that Regulation should be codified.

(2) Many of the poorest developing countries are in urgent need of access to affordable essential

medicines for the treatment of communicable diseases. Those countries are heavily

dependant on imports of medicines as local manufacturing is scarce.

(3) Price segmentation between developed country markets and the poorest developingcountry

markets is necessary to ensure that the poorest developing countries are supplied with

essential pharmaceutical products at heavily reduced prices. Therefore, those heavily

reduced prices cannot be understood as a reference for the price to be paid for the same

products in developed country markets.

(4) Legislative and regulatory instruments are in place in most developed countries to prevent

importation, in certain circumstances, of pharmaceutical products, but such instruments risk

becoming insufficient where substantial volumes of heavily discounted pharmaceuticals are

**4** Position of the European Parliament of 9 March 2016.
**5** Council Regulation (EC) No 953/2003 of 26 May 2003 to avoid trade diversion into the
European Union of certain key medicines (OJ L 135, 3.6.2003, p. 5).
**6** See Annex VI.

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sold to the poorest developing country markets, and the economic interest in trade diversion

into high priced markets thereforemay increase significantly.

(5) There is a need to encourage pharmaceutical manufacturers to make pharmaceutical

products available at heavily reduced prices in significantly increased volumes by ensuring

through this Regulation that such products remain on the poorest developing country

markets. Donations of pharmaceutical products and products sold under contracts awarded

in response to competitive tenders from national governments or international procurement

bodies, or under a partnership agreed between the manufacturer and the government of a

country of destination should be able to qualify under this Regulation on equal conditions,

bearing in mind that donations do not contribute to the improvement of access to such

products on a sustainable basis.

(6) It is necessary to provide for a procedure which identifies the products, countries and

diseases covered by this Regulation.

(7) This Regulation serves the purpose of preventing tiered-priced products from being

imported into the Union . Exemptions are laid down for certain situations on the strict

condition that it is ensured that the final destination of the products in question is one of the

countries listed in Annex II.

(8) Manufacturers of tiered-priced products should differentiate the appearance of tiered- priced

products to facilitate the task of identifying them.

(9) It will be appropriate to review the lists of the diseases and the countries of destination

covered by this Regulation, as well as the formulae used to identify tiered-priced products in

the light, _inter alia_, of the experience gained from its application.

(10) With regard to tiered-priced products contained in travellers' personal luggage for personal

use, the same rules as set out in Regulation (EU) No 608/2013 of the European Parliament

and of the Council [7] apply.

(11) Where tiered-priced products have been seized under this Regulation, the competent

authority should be able in accordance with national legislation and with a view to ensuring

**7** Regulation (EU) No 608/2013 of the European Parliament and of the Council of 12 June
2013 concerning customs enforcement of intellectual property rights and repealing Council
Regulation (EC) No 1383/2003 (OJ L 181, 29.6.2013, p. 15).

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that the intended use is made of the seized products to the full benefit of the countries listed

in Annex II, to decide to make them available for humanitarian purposes in those countries.

In the absence of such decision, the seized products should be destroyed.

(12) In order to add products to the list of products covered by this Regulation, the power to

adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European

Union should be delegated to the Commission in order to amend the Annexes to this

Regulation. It is of particular importance that the Commission carry out appropriate

consultations during its preparatory work, including at expert level. The Commission, when

preparing and drawing up delegated acts, should ensure a simultaneous, timely and

appropriate transmission of relevant documents to the European Parliament and to the

Council,

HAVE ADOPTED THIS REGULATION:

_Article 1_

1. This Regulation lays down:

(a) the criteria for establishing what is a tiered-priced product;

(b) the conditions under which the customs authorities shall take action;

(c) the measures which shall be taken by the competent authorities in the Member States.

2. For the purposes of this Regulation:

(a) ‘tiered-priced product’ means any pharmaceutical product which is used in the prevention,

diagnosis or treatment of a disease, referred to in Annex IV, and which is priced in

accordance with one of the optional price calculations set out in Article 3, verified by the

Commission or an independent auditor as provided for in Article 4 and entered in the list of

tiered-priced products set out in Annex I;

(b) ‘countries of destination’ means the countries listed in Annex II;

(c) ‘competent authority’ means an authority designated by a Member State to determine

whether goods suspended by the customs authorities in the respective Member State are

tiered-priced products and to give instructions depending on the outcome of the review.

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_Article 2_

1. The importation into the Union of tiered-priced products for the purposes of release for free

circulation, re-export, placing under suspensive procedures or placing in a free zone or free

warehouse shall be prohibited.

2. The following shall be exempted from the prohibition regarding tiered-priced products as set out

in paragraph 1:

(a) re-export to countries of destination;

(b) placing under a transit or customs warehouse procedure or in a free zone or free warehouse

for the purpose of re-export to a country of destination.

_Article 3_

The tiered price referred to in Article 4(2)(b) shall, at the option of the applicant, be either:

(a) no higher than the percentage set out in Annex III of the weighted average ex factory price

charged by a manufacturer in markets of the Organisation for Economic Co-operation and

Development (OECD) for the same product at the time of application; or

(b) a manufacturer's direct production costs, with the addition of the maximum percentage

which is set out in Annex III.

_Article 4_

1. In order for products to benefit from this Regulation, manufacturers or exporters of

pharmaceutical products shall submit applications to the Commission.

2. Any application addressed to the Commission shall contain the following information:

(a) the product name and active ingredient of the tiered-priced product and sufficient

information to verify which disease it is preventing, diagnosing or treating;

(b) the price offered in relation to either of the optional price calculations set out in Article 3 in

sufficient detail to enable verification. Instead of submitting such detailed information, the

applicant may submit a certificate issued by an independent auditor, stating that the price

has been verified and corresponds to one of the criteria set out in Annex III. The

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independent auditor shall be appointed in agreement between the manufacturer and the

Commission. Any information submitted by the applicant to the auditor shall remain

confidential;

(c) the country or countries of destination to which the applicant intends to sell the product

concerned;

(d) the code number based on the Combined Nomenclature as set out in Annex I to Council

Regulation (EEC) No 2658/87 [8] and, where appropriate, supplemented by TARIC

subdivisions, to identify unambiguously the goods concerned; and

(e) any measures taken by the manufacturer or exporter to make the tiered-priced product

easily distinguishable from identical products offered for sale within the Union .

3. Where the Commission determines that a product fulfils the requirements set out in this

Regulation, the Commission shall be empowered to adopt delegated acts in accordance with Article

5 to add the product concerned to Annex I at the next following update. The Commission shall

inform the applicant of its decision within 15 days of its adoption thereof.

Where a delay in the addition of a product to Annex I would cause a delay in responding to an

urgent need of access to affordable essential medicines in a developing country, and therefore

imperative grounds of urgency so require, the procedure provided for in Article 6 shall apply to

delegated acts adopted pursuant to the first subparagraph.

4. If an application is not sufficiently detailed for a review as to substance, the Commission shall

request the applicant in writing to submit such missing information. If the applicant does not

complete the application within the time period set out in that written request, the application shall

be null and void.

5. If the Commission finds that the application does not fulfil the criteria set out in this Regulation,

the application shall be rejected and the applicant shall be informed within 15 days of the date of the

decision. Nothing shall prevent the applicant from submitting a modified application for the same

product.

**8** Council Regulation (EEC) No 2658/87 of 23 July 1987 on the tariff and statistical
nomenclature and on the Common Customs Tariff (OJ L 256, 7.9.1987, p. 1).

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6. Products destined to be donated to recipients in one of the countries listed in Annex II may be the

subject of a notification to that effect for the purposes of approval and insertion in Annex I.

7. Annex I shall be updated every second month by the Commission.

8. The Commission shall be empowered to adopt delegated acts in accordance with Article 5 to

amend Annexes II, III and IV where necessary in order to revise the list of diseases, the countries of

destination covered by this Regulation as well as the formulae used to identify tiered-priced

products, in the light of the experience gained from its application or to respond to a health crisis.

_Article 5_

1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid

down in this Article.

2. The power to adopt delegated acts referred to in Article 4(3) and (8) shall be conferred on the

Commission for a period of five years from 20 February 2014. The Commission shall draw up a

report in respect of the delegation of power not later than nine months before the end of the five

year period. The delegation of power shall be tacitly extended for periods of an identical duration,

unless the European Parliament or the Council opposes such extension not later than three months

before the end of each period.

3. The delegation of power referred to in Article 4(3) and (8) may be revoked at any time by the

European Parliament or by the Council. A decision to revoke shall put an end to the delegation of

power specified in that decision. It shall take effect the day following the publication of the decision

in the _Official Journal of the European Union_ or at a later date specified therein. It shall not affect

the validity of any delegated acts already in force.

4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the

European Parliament and to the Council.

5. A delegated act adopted pursuant to Article 4(3) shall enter into force only if no objection has

been expressed either by the European Parliament or the Council within a period of two months of

notification of that act to the European Parliament and the Council or if, before the expiry of that

period, the European Parliament and the Council have both informed the Commission that they will

not object. That period shall be extended by two months at the initiative of the European Parliament

or of the Council.

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6. A delegated act adopted pursuant to Article 4(8) shall enter into force only if no objection has

been expressed either by the European Parliament or the Council within a period of two months of

notification of that act to the European Parliament and the Council or if, before the expiry of that

period, the European Parliament and the Council have both informed the Commission that they will

not object. That period shall be extended by four months at the initiative of the European Parliament

or of the Council.

_Article 6_

1. Delegated acts adopted under this Article shall enter into force without delay and shall apply as

long as no objection is expressed in accordance with paragraph 2. The notification of a delegated

act to the European Parliament and to the Council shall state the reasons for the use of the urgency

procedure laid down in this Article.

2. Either the European Parliament or the Council may object to a delegated act in accordance with

the procedure referred to in Article 5(5) and (6). In such a case, the Commission shall repeal the act

without delay following the notification of the decision to object by the European Parliament or by

the Council.

_Article 7_

A product approved as a tiered-priced product and listed in Annex I shall remain on that list for as

long as the conditions set out in Article 4 are fulfilled and annual sales reports have been submitted

to the Commission in accordance with Article 12. The applicant shall submit information to the

Commission on any change which has occurred with respect to the scope or conditions set out in

Article 4 in order to ensure that those requirements are met.

_Article 8_

A permanent logo, as set out in Annex V, shall be affixed on any packaging or product and any

document used in connection with the approved product sold at tiered prices to countries of

destination. This requirement shall apply as long as the tiered-priced product concerned remains

listed in Annex I.

_Article 9_

1. Where there is reason to suspect that, contrary to the prohibition provided for in Article 2, tiered

priced products will be imported into the Union, customs authorities shall suspend the release of, or

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detain, the products concerned for the time necessary to obtain a decision of the competent

authorities on the character of the merchandise. The period of suspension or detention shall not

exceed 10 working days unless special circumstances apply, in which case the period may be

extended by a maximum of 10 working days. Upon expiry of this period, the products shall be

released, provided that all customs formalities have been complied with.

2. It shall be sufficient reason for the customs authorities to suspend the release of, or detain,

products if there is sufficient information available to consider that the product in question is tiered

priced.

3. The competent authority in the Member State concerned and the manufacturer or exporter

mentioned in Annex I shall be informed without delay of the suspended release or detention of the

products and shall receive all information available with respect to the products concerned. Due

account shall be taken of national provisions on the protection of personal data, commercial and

industrial secrecy and professional and administrative confidentiality. The importer, and where

appropriate, the exporter, shall be given ample opportunity to supply the competent authority with

the information which it deems appropriate regarding the products.

4. The procedure of suspension or detention of the goods shall be carried out at the expense of the

importer. If it is not possible to recover those expenses from the importer, they may, in accordance

with national legislation, be recovered from any other person responsible for the attempted illicit

importation.

_Article 10_

1. If products suspended for release or detained by customs authorities are recognised by the

competent authority as tiered-priced products under this Regulation, the competent authority shall

ensure that those products are seized and disposed of in accordance with national legislation. Those

procedures shall be carried out at the expense of the importer. If it is not possible to recover those

expenses from the importer, they may, in accordance with national legislation, be recovered from

any other person responsible for the attempted illicit importation.

2. Where products suspended for release or detained by customs authorities subsequent to further

control by the competent authority are found not to qualify as tiered-priced products under this

Regulation, the customs authority shall release the products to the consignee, provided that all

customs formalities have been complied with.

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3. The competent authority shall inform the Commission of all decisions adopted pursuant to this

Regulation.

_Article 11_

This Regulation shall not apply to goods of a non-commercial nature contained in travellers'

personal luggage for personal use within the limits laid down in respect of relief from customs duty.

_Article 12_

1. The Commission shall monitor on an annual basis the volumes of exports of tiered-priced

products listed in Annex I and exported to the countries of destination on the basis of information

provided to it by pharmaceutical manufacturers and exporters. For this purpose a standard form

shall be issued by the Commission. Manufacturers and exporters shall submit such sales reports

annually for each tiered-priced product to the Commission on a confidential basis.

2. The Commission shall report biennially to the European Parliament and to the Council on the

volumes exported under tiered prices, including on the volumes exported within the framework of a

partnership agreement agreed between the manufacturer and the government of a country of

destination. The report shall examine the scope of countries and diseases and general criteria for the

implementation of Article 3.

3. The European Parliament may, within one month of submission of the Commission's report,

invite the Commission to an ad hoc meeting of its responsible committee to present and explain any

issues related to the application of this Regulation.

4. No later than six months from the date of submission of the report to the European Parliament

and to the Council, the Commission shall make the report public.

_Article 13_

1. The application of this Regulation shall in no circumstances interfere with procedures laid down

in Directive 2001/83/EC of the European Parliament and of the Council [9] and Regulation (EC) No

726/2004 of the European Parliament and of the Council [10] .

**9** Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001
on the Community code relating to medicinal products for human use (OJ L 311,
28.11.2001, p. 67).

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2. This Regulation shall not interfere with intellectual property rights or rights of intellectual

property owners.

_Article 14_

Regulation (EC) No 953/2003 is repealed.

References to the repealed Regulation shall be construed as references to this Regulation and shall

be read in accordance with the correlation table in Annex VII.

_Article 15_

This Regulation shall enter into force on the twentieth day following that of its publication in the

_Official Journal of the European Union_ .

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at …,

_For the European Parliament_ _For the Council_
_The President_ _The President_

**10** Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March
2004 laying down Community procedures for the authorisation and supervision of medicinal
products for human and veterinary use and establishing a European Medicines Agency (OJ
L 136, 30.4.2004, p. 1).

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**ANNEX I**

LIST OF TIERED-PRICED PRODUCTS

|Product|Manufacturer/ex<br>porter|Country of<br>destination|Distinctive<br>features|Date of approval|CN/TARIC code11|
|---|---|---|---|---|---|
|TRIZIVIR<br>750 mg × 60|GLAXO SMITH<br>KLINE<br>GSK House<br>980 Great West<br>Road<br>BRENTFORD,<br>MIDDX<br>TW8 9GS<br>United Kingdom|Afghanistan<br>Angola<br>Armenia<br>Azerbaijan<br>Bangladesh<br>Benin<br>Bhutan<br>Botswana<br>Burkina Faso<br>Burundi<br>Cambodia<br>Cameroon<br>Cape Verde<br>Central African<br>Republic<br>Chad<br>Comoros<br>Congo<br>Côte d’Ivoire<br>Democratic<br>Republic of the<br>Congo<br>Djibouti|Distinctive access<br>pack — trilingual<br>text|19.4.2004|30049019|
|EPIVIR<br>150 mg × 60|GLAXO SMITH<br>KLINE<br>GSK House<br>980 Great West<br>Road<br>BRENTFORD,<br>MIDDX<br>TW8 9GS<br>United Kingdom|GLAXO SMITH<br>KLINE<br>GSK House<br>980 Great West<br>Road<br>BRENTFORD,<br>MIDDX<br>TW8 9GS<br>United Kingdom|Distinctive access<br>pack — trilingual<br>text — red tablets||30049019|
|RETROVIR<br>250 mg × 40|GLAXO SMITH<br>KLINE<br>GSK House<br>980 Great West<br>Road<br>BRENTFORD,<br>MIDDX<br>TW8 9GS<br>United Kingdom|GLAXO SMITH<br>KLINE<br>GSK House<br>980 Great West<br>Road<br>BRENTFORD,<br>MIDDX<br>TW8 9GS<br>United Kingdom|General export<br>pack (blue) not<br>used in EU.<br>French hospital<br>pack —<br>Francophone<br>markets|19.4.2004|30049019|

**11** Only if applicable.

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|RETROVIR<br>300 mg × 60|GLAXO SMITH<br>KLINE<br>GSK House<br>980 Great West<br>Road<br>BRENTFORD,<br>MIDDX<br>TW8 9GS<br>United Kingdom|Equatorial Guinea<br>Eritrea<br>Ethiopia<br>Gambia<br>Ghana<br>Guinea<br>Guinea- Bissau<br>Haiti<br>Honduras<br>India<br>Indonesia<br>Kenya<br>Kiribati<br>Kyrgyzstan<br>Laos<br>Lesotho<br>Liberia<br>Madagascar<br>Malawi<br>Maldives<br>Mali<br>Mauritania<br>Moldova<br>Mongolia<br>Mozambique<br>Myanmar/Burma<br>Namibia<br>Nepal<br>Nicaragua|General export<br>pack (blue) not<br>used in EU.<br>French hospital<br>pack —<br>Francophone<br>markets|19.4.2004|30049019|
|---|---|---|---|---|---|
|RETROVIR<br>100 mg × 100|GLAXO SMITH<br>KLINE<br>GSK House<br>980 Great West<br>Road<br>BRENTFORD,<br>MIDDX<br>TW8 9GS<br>United Kingdom|GLAXO SMITH<br>KLINE<br>GSK House<br>980 Great West<br>Road<br>BRENTFORD,<br>MIDDX<br>TW8 9GS<br>United Kingdom|General export<br>pack (blue) not<br>used in EU.<br>French hospital<br>pack —<br>Francophone<br>markets|19.4.2004|30049019|
|COMBIVIR<br>300/150 mg × 60|GLAXO SMITH<br>KLINE<br>GSK House<br>980 Great West<br>Road<br>BRENTFORD,<br>MIDDX<br>TW8 9GS<br>United Kingdom|GLAXO SMITH<br>KLINE<br>GSK House<br>980 Great West<br>Road<br>BRENTFORD,<br>MIDDX<br>TW8 9GS<br>United Kingdom|Distinctive access<br>pack — trilingual<br>text<br>Bottle (rather than<br>blister pack)<br>‘A22’ embossed<br>red tablets||30049019|
|EPIVIR ORAL<br>SOLUTION<br>10 mg/ml<br>240 ml|GLAXO SMITH<br>KLINE<br>GSK House<br>980 Great West<br>Road<br>BRENTFORD,<br>MIDDX<br>TW8 9GS<br>United Kingdom|GLAXO SMITH<br>KLINE<br>GSK House<br>980 Great West<br>Road<br>BRENTFORD,<br>MIDDX<br>TW8 9GS<br>United Kingdom|Distinctive access<br>pack — trilingual<br>text|19.4.2004|30049019|

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_______________________

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**ANNEX II**

**COUNTRIES OF DESTINATION**

Afghanistan

Angola

Armenia

Azerbaijan

Bangladesh

Benin

Bhutan

Botswana

Burkina Faso

Burundi

Cambodia

Cameroon

Cape Verde

Central African Republic

Chad

China

Comoros

Congo

Côte d'Ivoire

Democratic Republic of the Congo

Djibouti

Equatorial Guinea

Eritrea

Ethiopia

Gambia

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Ghana

Guinea

Guinea-Bissau

Haiti

Honduras

India

Indonesia

Kenya

Kiribati

Kyrgyzstan

Laos

Lesotho

Liberia

Madagascar

Malawi

Maldives

Mali

Mauritania

Moldova

Mongolia

Mozambique

Myanmar/Burma

Namibia

Nepal

Nicaragua

Niger

Nigeria

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North Korea

Pakistan

Rwanda

Samoa

São Tomé and Príncipe

Senegal

Sierra Leone

Solomon Islands

Somalia

South Africa

Sudan

Swaziland

Tajikistan

Tanzania

Timor-Leste

Togo

Turkmenistan

Tuvalu

Uganda

Vanuatu

Vietnam

Yemen

Zambia

Zimbabwe

_______________________

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**ANNEX III**

**PERCENTAGES REFERRED TO IN ARTICLE 3**

Percentage referred to in Article 3(a): 25 %

Percentage referred to in Article 3(b): 15 %

_______________________

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**ANNEX IV**

**SCOPE OF DISEASES**

HIV/AIDS, malaria, tuberculosis and related opportunistic diseases

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**ANNEX V**

**LOGO**

The winged staff of Aesculapius with a coiled serpent, in the centre of a circle formed by 12 stars.

__________________

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**ANNEX VI**

**Repealed Regulation with list of its successive amendments**

Council Regulation (EC) No 953/2003
(OJ L 135, 3.6.2003, p. 5)

Commission Regulation (EC) No 1876/2004
(OJ L 326, 29.10.2004, p. 22)

Commission Regulation (EC) No 1662/2005
(OJ L 267, 12.10.2005, p. 19)

Regulation (EU) No 38/2014 of the European Parliament and of
the Council
(OJ L 18, 21.1.2014, p. 52)

_____________

Only point 3 of the Annex

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**ANNEX VII**

**C** **ORRELATION** **T** **ABLE**

|Regulation (EC) No 953/2003|This Regulation|
|---|---|
|Articles 1, 2 and 3<br>Article 4(1)<br>Article 4(2), introductory wording<br>Article 4(2)(i)<br>Article 4(2)(ii)<br>Article 4(2)(iii)<br>Article 4(2)(iv)<br>Article 4(2)(v)<br>Article 4(4)<br>Article 4(5)<br>Article 4(6)<br>Article 4(7)<br>Article 4(8)<br>Article 4(9)<br>Article 5<br>Article 5a<br>Article 6<br>Article 7<br>Article 8<br>Article 9<br>Article 10<br>Article 11<br>Article 12<br>-|Articles 1, 2 and 3<br>Article 4(1)<br>Article 4(2), introductory wording<br>Article 4(2)(a)<br>Article 4(2)(b)<br>Article 4(2)(c)<br>Article 4(2)(d)<br>Article 4(2)(e)<br>Article 4(3)<br>Article 4(4)<br>Article 4(5)<br>Article 4(6)<br>Article 4(7)<br>Article 4(8)<br>Article 5<br>Article 6<br>Article 7<br>Article 8<br>Article 9<br>Article 10<br>Article 11<br>Article 12<br>Article 13<br>Article 14|

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Article 13 Article 15

Annexes I to V Annexes I to V

- Annex VI

- Annex VII

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