Source: EURLEX
Language: en
Format: md

**EUROPEAN UNION**

**THE EUROPEAN PARLIAMENT** **THE COUNCIL**

**Strasbourg, 11 May 2016**
**(OR. en)**

**2014/0165 (COD)**
**LEX 1662**

**PE-CONS 5/1/16**

**REV 1**

**CODIF 5**

**ECO 9**

**INST 29**

**MI 57**

**CODEC 120**

**REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL**

**TO AVOID TRADE DIVERSION INTO THE EUROPEAN UNION**

**OF CERTAIN KEY MEDICINES (CODIFICATION)**

PE-CONS 5/1/16 REV 1

# **EN**

**REGULATION (EU) 2016/...**

**OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL**

**of 11 May 2016**

**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 **[1]**,

**1** Position of the European Parliament of 9 March 2016 (not yet published in the Official
Journal) and decision of the Council of 11 April 2016.

PE-CONS 5/1/16 REV 1 1

# **EN**

Whereas:

(1) Council Regulation (EC) No 953/2003 **[1]** has been substantially amended several times **[2]** . 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 dependent on imports of medicines as local manufacturing is scarce.

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

country 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

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

risk becoming insufficient where substantial volumes of heavily discounted

pharmaceuticals are sold to the poorest developing country markets, and the economic

interest in trade diversion into high priced markets therefore may increase significantly.

**1** 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).
**2** See Annex VI.

PE-CONS 5/1/16 REV 1 2

# **EN**

(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.

PE-CONS 5/1/16 REV 1 3

# **EN**

(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 **[1]** 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 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:

**1** 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).

PE-CONS 5/1/16 REV 1 4

# **EN**

_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.

PE-CONS 5/1/16 REV 1 5

# **EN**

_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.

PE-CONS 5/1/16 REV 1 6

# **EN**

_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 prevents, diagnoses or treats;

(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 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 **[1]** and, where appropriate, supplemented by

TARIC subdivisions, to identify unambiguously the goods concerned; and

**1** 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).

PE-CONS 5/1/16 REV 1 7

# **EN**

(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 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 for 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.

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.

PE-CONS 5/1/16 REV 1 8

# **EN**

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.

PE-CONS 5/1/16 REV 1 9

# **EN**

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.

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.

PE-CONS 5/1/16 REV 1 10

# **EN**

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 to 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.

PE-CONS 5/1/16 REV 1 11

# **EN**

_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 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 that

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.

PE-CONS 5/1/16 REV 1 12

# **EN**

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.

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

this Regulation.

PE-CONS 5/1/16 REV 1 13

# **EN**

_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.

PE-CONS 5/1/16 REV 1 14

# **EN**

_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 **[1]** and

Regulation (EC) No 726/2004 of the European Parliament and of the Council **[2]** .

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.

**1** 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).
**2** 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).

PE-CONS 5/1/16 REV 1 15

# **EN**

_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 Strasbourg,

_For the European Parliament_ _For the Council_

_The President_ _The President_

PE-CONS 5/1/16 REV 1 16

# **EN**

**ANNEX I**

LIST OF TIERED-PRICED PRODUCTS

|Product|Manufacturer/exporter|Country of<br>destination|Distinctive features|Date of<br>approval|CN/TARIC<br>1<br>code|
|---|---|---|---|---|---|
|TRIZIVIR<br>750 mg × 60|GLAXO SMITH<br>KLINE<br>GSK House<br>980 Great West Road<br>BRENTFORD,<br>MIDDLESEX<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 Republic<br>of the Congo<br>Djibouti<br>Equatorial Guinea<br>Eritrea<br>Ethiopia<br>Gambia<br>Ghana<br>Guinea<br>Guinea- Bissau|Distinctive access pack —<br>trilingual text|19.4.2004|30049019|
|EPIVIR<br>150 mg × 60|GLAXO SMITH<br>KLINE<br>GSK House<br>980 Great West Road<br>BRENTFORD,<br>MIDDLESEX<br>TW8 9GS<br>United Kingdom|GLAXO SMITH<br>KLINE<br>GSK House<br>980 Great West Road<br>BRENTFORD,<br>MIDDLESEX<br>TW8 9GS<br>United Kingdom|Distinctive access pack —<br>trilingual text — red<br>tablets||30049019|
|RETROVIR<br>250 mg × 40|GLAXO SMITH<br>KLINE<br>GSK House<br>980 Great West Road<br>BRENTFORD,<br>MIDDLESEX<br>TW8 9GS<br>United Kingdom|GLAXO SMITH<br>KLINE<br>GSK House<br>980 Great West Road<br>BRENTFORD,<br>MIDDLESEX<br>TW8 9GS<br>United Kingdom|General export pack<br>(blue) not used in EU.<br>French hospital pack —<br>Francophone markets|19.4.2004|30049019|
|RETROVIR<br>300 mg × 60|GLAXO SMITH<br>KLINE<br>GSK House<br>980 Great West Road<br>BRENTFORD,<br>MIDDLESEX<br>TW8 9GS<br>United Kingdom|GLAXO SMITH<br>KLINE<br>GSK House<br>980 Great West Road<br>BRENTFORD,<br>MIDDLESEX<br>TW8 9GS<br>United Kingdom|General export pack<br>(blue) not used in EU.<br>French hospital pack —<br>Francophone markets|19.4.2004|30049019|

**1** Only if applicable.

PE-CONS 5/1/16 REV 1 1

# ANNEX I EN

|Product|Manufacturer/exporter|Country of<br>destination|Distinctive features|Date of<br>approval|CN/TARIC<br>1<br>code|
|---|---|---|---|---|---|
|RETROVIR<br>100 mg × 100|GLAXO SMITH<br>KLINE<br>GSK House<br>980 Great West Road<br>BRENTFORD,<br>MIDDLESEX<br>TW8 9GS<br>United Kingdom|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<br>Niger<br>Nigeria<br>North Korea<br>Pakistan<br>Rwanda|General export pack<br>(blue) not used in EU.<br>French hospital pack —<br>Francophone markets|19.4.2004|30049019|
|COMBIVIR<br>300/150 mg × 60|GLAXO SMITH<br>KLINE<br>GSK House<br>980 Great West Road<br>BRENTFORD,<br>MIDDLESEX<br>TW8 9GS<br>United Kingdom|GLAXO SMITH<br>KLINE<br>GSK House<br>980 Great West Road<br>BRENTFORD,<br>MIDDLESEX<br>TW8 9GS<br>United Kingdom|Distinctive access pack —<br>trilingual text<br>Bottle (rather than blister<br>pack) ‘A22’ embossed red<br>tablets||30049019|
|EPIVIR ORAL<br>SOLUTION<br>10 mg/ml<br>240 ml|GLAXO SMITH<br>KLINE<br>GSK House<br>980 Great West Road<br>BRENTFORD,<br>MIDDLESEX<br>TW8 9GS<br>United Kingdom|GLAXO SMITH<br>KLINE<br>GSK House<br>980 Great West Road<br>BRENTFORD,<br>MIDDLESEX<br>TW8 9GS<br>United Kingdom|Distinctive access pack —<br>trilingual text|19.4.2004|30049019|
|ZIAGEN<br>300 mg × 60|GLAXO SMITH<br>KLINE<br>GSK House<br>980 Great West Road<br>BRENTFORD,<br>MIDDLESEX<br>TW8 9GS<br>United Kingdom|GLAXO SMITH<br>KLINE<br>GSK House<br>980 Great West Road<br>BRENTFORD,<br>MIDDLESEX<br>TW8 9GS<br>United Kingdom|General export pack —<br>not used in EU.<br>French hospital pack —<br>Francophone countries|20.9.2004|30049019|

PE-CONS 5/1/16 REV 1 2

# ANNEX I EN

|Product|Manufacturer/exporter|Country of<br>destination|Distinctive features|Date of<br>approval|CN/TARIC<br>1<br>code|
|---|---|---|---|---|---|
|RETROVIR<br>ORAL<br>SOLUTION<br>10 mg/ml<br>200 ml|GLAXO SMITH<br>KLINE<br>GSK House<br>980 Great West Road<br>BRENTFORD,<br>MIDDLESEX<br>TW8 9GS<br>United Kingdom|Samoa<br>São Tomé and<br>Príncipe<br>Senegal<br>Sierra Leone<br>Solomon Islands<br>Somalia<br>South Africa<br>Sudan<br>Swaziland<br>Tajikistan<br>Tanzania<br>Timor-Leste<br>Togo<br>Tuvalu<br>Uganda<br>Vanuatu<br>Yemen<br>Zambia<br>Zimbabwe|Distinctive access pack<br>Trilingual text|20.9.2004|30049019|

PE-CONS 5/1/16 REV 1 3

# ANNEX I EN

**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

PE-CONS 5/1/16 REV 1 1

# ANNEX II EN

Côte d'Ivoire

Democratic Republic of the Congo

Djibouti

Equatorial Guinea

Eritrea

Ethiopia

Gambia

Ghana

Guinea

Guinea-Bissau

Haiti

Honduras

India

Indonesia

Kenya

Kiribati

Kyrgyzstan

Laos

Lesotho

Liberia

PE-CONS 5/1/16 REV 1 2

# ANNEX II EN

Madagascar

Malawi

Maldives

Mali

Mauritania

Moldova

Mongolia

Mozambique

Myanmar/Burma

Namibia

Nepal

Nicaragua

Niger

Nigeria

North Korea

Pakistan

Rwanda

Samoa

São Tomé and Príncipe

Senegal

PE-CONS 5/1/16 REV 1 3

# ANNEX II EN

Sierra Leone

Solomon Islands

Somalia

South Africa

Sudan

Swaziland

Tajikistan

Tanzania

Timor-Leste

Togo

Turkmenistan

Tuvalu

Uganda

Vanuatu

Vietnam

Yemen

Zambia

Zimbabwe

PE-CONS 5/1/16 REV 1 4

# ANNEX II EN

**ANNEX III**

PERCENTAGES REFERRED TO IN ARTICLE 3

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

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

PE-CONS 5/1/16 REV 1 1

# ANNEX III EN

**ANNEX IV**

SCOPE OF DISEASES

HIV/AIDS, malaria, tuberculosis and related opportunistic diseases

PE-CONS 5/1/16 REV 1 1

# ANNEX IV EN

**ANNEX V**

LOGO

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

PE-CONS 5/1/16 REV 1 1

# ANNEX V EN

**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

PE-CONS 5/1/16 REV 1 1

# ANNEX VI EN

**ANNEX VII**

CORRELATION TABLE

|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|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|

PE-CONS 5/1/16 REV 1 1

# ANNEX VII EN

|Regulation (EC) No 953/2003|This Regulation|
|---|---|
|Article 12<br>- <br>Article 13<br>Annexes I to V<br>- <br>-|Article 13<br>Article 14<br>Article 15<br>Annexes I to V<br>Annex VI<br>Annex VII|

PE-CONS 5/1/16 REV 1 2

# ANNEX VII EN