# L_2016131EN.01003401.xml

| 20.5.2016 | EN | Official Journal of the European Union | L 131/34 |
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20.5.2016

EN

Official Journal of the European Union

L 131/34

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AGREEMENT

in the form of an Exchange of Diplomatic Notes with Japan in accordance with Article 15(3)(b) of the Agreement on Mutual Recognition (MRA) in order to amend Part B of the Sectoral Annex on Good Manufacturing Practice (GMP) for medicinal products

Brussels, April 22, 2016

Sir,

I have the honour to propose, on behalf of the Government of Japan, that Sections I and II of Part B of the Sectoral Annex on Good Manufacturing Practice (GMP) for Medicinal Products of the Agreement on Mutual Recognition between Japan and the European Community, done at Brussels on April 4, 2001 (hereinafter referred to as the ‘Agreement’) be replaced by the Sections I and II of Part B attached to this Note, in accordance with subparagraph 3(b) of Article 15 of the Agreement.

I have further the honour to propose that, if the above proposal is acceptable to the European Union, it is suggested that this Note and your reply to that effect shall be regarded as constituting an agreement between the Government of Japan and the European Union on this matter which shall enter into force on the date of your reply.

I avail myself of this opportunity to extend to you the assurance of my high consideration.

Keiichi KATAKAMI

Ambassador Extraordinary and Plenipotentiary of Japan to the European Union

Mr Jean-Luc DEMARTY

Director-General

Directorate-General for Trade European Commission

Brussels, April 22, 2016

Excellency,

I have the honour to acknowledge the receipt of Your Excellency's Note of today's date, which reads as follows.

‘I have the honour to propose, on behalf of the Government of Japan, that Sections I and II of Part B of the Sectoral Annex on Good Manufacturing Practice (GMP) for Medicinal Products of the Agreement on Mutual Recognition between Japan and the European Community, done at Brussels on April 4, 2001 (hereinafter referred to as the “Agreement”) be replaced by the Sections I and II of Part B attached to this Note, in accordance with subparagraph 3(b) of Article 15 of the Agreement.

I have further the honour to propose that, if the above proposal is acceptable to the European Union, it is suggested that this Note and your reply to that effect shall be regarded as constituting an agreement between the Government of Japan and the European Union on this matter which shall enter into force on the date of your reply.’

I have the honour to inform Your Excellency, on behalf of the European Union, that the European Union accepts the above proposal of the Government of Japan and to confirm that Your Excellency's Note and this reply shall be regarded as constituting an agreement between the European Union and the Government of Japan on this matter which shall enter into force on the date of this reply.

I avail myself of this opportunity to extend to Your Excellency the assurance of my highest consideration.

Jean-Luc DEMARTY

Director-General

Directorate-General for Trade European Commission

His Excellency

Mr Keiichi KATAKAMI

Ambassador Extraordinary and Plenipotentiary of Japan to the European Union

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ANNEX

PART B

Section I

The applicable laws, regulations and administrative provisions stipulating medicinal products, GMP requirements for medicinal products, verification and confirmation

| European Union | Japan |
| --- | --- |
| 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) and amendments thereto |

European Union

Japan

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) and amendments thereto

| 2. | Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use (OJ L 121, 1.5.2001, p. 34) and amendments thereto |
| --- | --- |

2.

Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use (OJ L 121, 1.5.2001, p. 34) and amendments thereto

| 3. | Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products (OJ L 91, 9.4.2005, p. 13) and amendments thereto |
| --- | --- |

3.

Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products (OJ L 91, 9.4.2005, p. 13) and amendments thereto

| 4. | Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (OJ L 158, 27.5.2014, p. 1)and amendments thereto |
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4.

Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (OJ L 158, 27.5.2014, p. 1)and amendments thereto

| 5. | Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use (OJ L 262, 14.10.2003, p. 22) and amendments thereto |
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5.

Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use (OJ L 262, 14.10.2003, p. 22) and amendments thereto

| 6. | Commission Delegated Regulation (EU) No 1252/2014 of 28 May 2014 supplementing Directive 2001/83/EC of the European Parliament and of the Council with regard to principles and guidelines of good manufacturing practice for active substances for medicinal products for human use (OJ L 337, 25.11.2014, p. 1) and amendments thereto |
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6.

Commission Delegated Regulation (EU) No 1252/2014 of 28 May 2014 supplementing Directive 2001/83/EC of the European Parliament and of the Council with regard to principles and guidelines of good manufacturing practice for active substances for medicinal products for human use (OJ L 337, 25.11.2014, p. 1) and amendments thereto

| 7. | Current versions of the Guide to good manufacturing practices contained in volume IV of Rules governing medicinal products in the European Union and Compilation of the European Union Procedures on Inspections and exchange of Information |
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7.

Current versions of the Guide to good manufacturing practices contained in volume IV of Rules governing medicinal products in the European Union and Compilation of the European Union Procedures on Inspections and exchange of Information

| 1. | The Law on Securing Quality, Efficacy and Safety of Products including Pharmaceuticals and Medical Devices (Law No 145, 1960) and amendments thereto |
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1.

The Law on Securing Quality, Efficacy and Safety of Products including Pharmaceuticals and Medical Devices (Law No 145, 1960) and amendments thereto

| 2. | Cabinet Order of the Law on Securing Quality, Efficacy and Safety of Products including Pharmaceuticals and Medical Devices (Cabinet Order No 11, 1961) and amendments thereto |
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2.

Cabinet Order of the Law on Securing Quality, Efficacy and Safety of Products including Pharmaceuticals and Medical Devices (Cabinet Order No 11, 1961) and amendments thereto

| 3. | Ordinance of the Law on Securing Quality, Efficacy and Safety of Products including Pharmaceuticals and Medical Devices (Ordinance of the Ministry of Health and Welfare No 1, 1961) and amendments thereto |
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3.

Ordinance of the Law on Securing Quality, Efficacy and Safety of Products including Pharmaceuticals and Medical Devices (Ordinance of the Ministry of Health and Welfare No 1, 1961) and amendments thereto

| 4. | Pharmaceuticals Designated by the Minister for Health, Labour and Welfare under the provisions of subparagraphs 6 and 7 of Article 20-1 of the Cabinet Order of the Law on Securing Quality, Efficacy and Safety of Products including Pharmaceuticals and Medical Devices, and under the provisions of subparagraphs 6 and 7 of Article 96 of Ordinance of the Law on Securing Quality, Efficacy and Safety of Products including Pharmaceuticals and Medical Devices (Notice of Ministry of Health, Labour and Welfare No 431, 2004) and amendments thereto |
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4.

Pharmaceuticals Designated by the Minister for Health, Labour and Welfare under the provisions of subparagraphs 6 and 7 of Article 20-1 of the Cabinet Order of the Law on Securing Quality, Efficacy and Safety of Products including Pharmaceuticals and Medical Devices, and under the provisions of subparagraphs 6 and 7 of Article 96 of Ordinance of the Law on Securing Quality, Efficacy and Safety of Products including Pharmaceuticals and Medical Devices (Notice of Ministry of Health, Labour and Welfare No 431, 2004) and amendments thereto

| 5. | Ordinance for Facilities and Equipments for Pharmacies etc. (Ordinance of the Ministry of Health and Welfare No 2, 1961) and amendments thereto |
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5.

Ordinance for Facilities and Equipments for Pharmacies etc. (Ordinance of the Ministry of Health and Welfare No 2, 1961) and amendments thereto

| 6. | Ministerial Ordinance for the Standard of Manufacturing Control and Quality Control for Drugs and Quasi Drugs (Ordinance of the Ministry of Health, Labour and Welfare No 179, 2004) and amendments thereto |
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6.

Ministerial Ordinance for the Standard of Manufacturing Control and Quality Control for Drugs and Quasi Drugs (Ordinance of the Ministry of Health, Labour and Welfare No 179, 2004) and amendments thereto

Section II

Competent authorities

| European Union | Japan |
| --- | --- |
| Competent Authorities of the European Union are the following authorities of the Member States of the European Union or authorities succeeding them: | Austria
  Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH |

European Union

Japan

Competent Authorities of the European Union are the following authorities of the Member States of the European Union or authorities succeeding them:

Austria

Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH

| | Belgium
  Federaal Agentschap voor geneesmiddelen en gezondheidsproducten/Agence fédérale des médicaments et produits de santé |
| --- | --- |

Belgium

Federaal Agentschap voor geneesmiddelen en gezondheidsproducten/Agence fédérale des médicaments et produits de santé

| | Bulgaria
  Изпълнителна агенция по лекарствата |
| --- | --- |

Bulgaria

Изпълнителна агенция по лекарствата

| | Croatia
  Agencija za lijekove i medicinske proizvode (HALMED) |
| --- | --- |

Croatia

Agencija za lijekove i medicinske proizvode (HALMED)

| | Cyprus
  Φαρμακευτικές Υπηρεσίες, Υπουργείο Υγείας |
| --- | --- |

Cyprus

Φαρμακευτικές Υπηρεσίες, Υπουργείο Υγείας

| | Czech Republic
  Státní ústav pro kontrolu léčiv (SÚKL) |
| --- | --- |

Czech Republic

Státní ústav pro kontrolu léčiv (SÚKL)

| | Denmark
  Lægemiddelstyrelsen |
| --- | --- |

Denmark

Lægemiddelstyrelsen

| | Estonia
  Ravimiamet |
| --- | --- |

Estonia

Ravimiamet

| | Finland
  Lääkealan turvallisuus- ja kehittämiskeskus |
| --- | --- |

Finland

Lääkealan turvallisuus- ja kehittämiskeskus

| | France
  Agence nationale de sécurité du médicament et des produits de santé (ANSM) |
| --- | --- |

France

Agence nationale de sécurité du médicament et des produits de santé (ANSM)

| | Germany
  Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)
  Paul-Ehrlich-Institut (PEI) Bundesinstitut für Impfstoffe und biomedizinische Arzneimittel (biologicals only) |
| --- | --- |

Germany

Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)

Paul-Ehrlich-Institut (PEI) Bundesinstitut für Impfstoffe und biomedizinische Arzneimittel (biologicals only)

| | Greece
  Ethnikos Organismos Farmakon (EOF) (ΕΘΝΙΚΟΣ ΟΡΓΑΝΙΣΜΟΣ ΦΑΡΜΑΚΩΝ) |
| --- | --- |

Greece

Ethnikos Organismos Farmakon (EOF) (ΕΘΝΙΚΟΣ ΟΡΓΑΝΙΣΜΟΣ ΦΑΡΜΑΚΩΝ)

| | Hungary
  Országos Gyógyszerészeti és Élelmezés-egészségügyi Intézet (OGYÉI) |
| --- | --- |

Hungary

Országos Gyógyszerészeti és Élelmezés-egészségügyi Intézet (OGYÉI)

| | Ireland
  Health Products Regulatory Authority (HPRA) |
| --- | --- |

Ireland

Health Products Regulatory Authority (HPRA)

| | Italy
  Agenzia Italiana del Farmaco |
| --- | --- |

Italy

Agenzia Italiana del Farmaco

| | Latvia
  Zāļu valsts aģentūra |
| --- | --- |

Latvia

Zāļu valsts aģentūra

| | Lithuania
  Valstybinė vaistų kontrolės tarnyba |
| --- | --- |

Lithuania

Valstybinė vaistų kontrolės tarnyba

| | Luxembourg
  Ministère de la Santé, Division de la Pharmacie et des Médicaments |
| --- | --- |

Luxembourg

Ministère de la Santé, Division de la Pharmacie et des Médicaments

| | Malta
  Medicines Authority |
| --- | --- |

Malta

Medicines Authority

| | Netherlands
  Inspectie voor de Gezondheidszorg (IGZ) |
| --- | --- |

Netherlands

Inspectie voor de Gezondheidszorg (IGZ)

| | Poland
  Główny Inspektorat Farmaceutyczny (GIF) |
| --- | --- |

Poland

Główny Inspektorat Farmaceutyczny (GIF)

| | Portugal
  INFARMED — Autoridade Nacional do Medicamento e Produtos de Saúde, I.P |
| --- | --- |

Portugal

INFARMED — Autoridade Nacional do Medicamento e Produtos de Saúde, I.P

| | Romania
  Agenţia Naţională a Medicamentului şi a Dispozitivelor Medicale |
| --- | --- |

Romania

Agenţia Naţională a Medicamentului şi a Dispozitivelor Medicale

| | Slovakia
  Štátny ústav pre kontrolu liečiv (SUKL) |
| --- | --- |

Slovakia

Štátny ústav pre kontrolu liečiv (SUKL)

| | Slovenia
  Javna agencija Republike Slovenije za zdravila in medicinske pripomočke (JAZMP) |
| --- | --- |

Slovenia

Javna agencija Republike Slovenije za zdravila in medicinske pripomočke (JAZMP)

| | Spain
  Agencia Española de Medicamentos y Productos Sanitários |
| --- | --- |

Spain

Agencia Española de Medicamentos y Productos Sanitários

| | Sweden
  Läkemedelsverket |
| --- | --- |

Sweden

Läkemedelsverket

| | United Kingdom
  Medicines and Healthcare Products Regulatory Agency |
| --- | --- |

United Kingdom

Medicines and Healthcare Products Regulatory Agency

| | European Union
  European Medicines Agency |
| --- | --- |

European Union

European Medicines Agency

Ministry of Health, Labour and Welfare or an authority succeeding this ministry

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