CELEX: 22016A0520(02)
Language: en
Date: 2016-04-22 00:00:00
Title: 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

20.5.2016   
            
            
               EN
            
            
               Official Journal of the European Union
            
            
               L 131/34
            
         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
      
   
   
      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
                           
                        
                              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
                           
                        
                              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
                           
                        
                              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
                           
                        
               
                  
                              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
                           
                        
                              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
                           
                        
                              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
                           
                        
            
         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
                           
                        
                               
                           
                           
                              Belgium
                              Federaal Agentschap voor geneesmiddelen en gezondheidsproducten/Agence fédérale des médicaments et produits de santé
                           
                        
                               
                           
                           
                              Bulgaria
                              Изпълнителна агенция по лекарствата
                           
                        
                               
                           
                           
                              Croatia
                              Agencija za lijekove i medicinske proizvode (HALMED)
                           
                        
                               
                           
                           
                              Cyprus
                              Φαρμακευτικές Υπηρεσίες, Υπουργείο Υγείας
                           
                        
                               
                           
                           
                              Czech Republic
                              Státní ústav pro kontrolu léčiv (SÚKL)
                           
                        
                               
                           
                           
                              Denmark
                              Lægemiddelstyrelsen
                           
                        
                               
                           
                           
                              Estonia
                              Ravimiamet
                           
                        
                               
                           
                           
                              Finland
                              Lääkealan turvallisuus- ja kehittämiskeskus
                           
                        
                               
                           
                           
                              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)
                           
                        
                               
                           
                           
                              Greece
                              Ethnikos Organismos Farmakon (EOF) (ΕΘΝΙΚΟΣ ΟΡΓΑΝΙΣΜΟΣ ΦΑΡΜΑΚΩΝ)
                           
                        
                               
                           
                           
                              Hungary
                              Országos Gyógyszerészeti és Élelmezés-egészségügyi Intézet (OGYÉI)
                           
                        
                               
                           
                           
                              Ireland
                              Health Products Regulatory Authority (HPRA)
                           
                        
                               
                           
                           
                              Italy
                              Agenzia Italiana del Farmaco
                           
                        
                               
                           
                           
                              Latvia
                              Zāļu valsts aģentūra
                           
                        
                               
                           
                           
                              Lithuania
                              Valstybinė vaistų kontrolės tarnyba
                           
                        
                               
                           
                           
                              Luxembourg
                              Ministère de la Santé, Division de la Pharmacie et des Médicaments
                           
                        
                               
                           
                           
                              Malta
                              Medicines Authority
                           
                        
                               
                           
                           
                              Netherlands
                              Inspectie voor de Gezondheidszorg (IGZ)
                           
                        
                               
                           
                           
                              Poland
                              Główny Inspektorat Farmaceutyczny (GIF)
                           
                        
                               
                           
                           
                              Portugal
                              INFARMED — Autoridade Nacional do Medicamento e Produtos de Saúde, I.P
                           
                        
                               
                           
                           
                              Romania
                              Agenţia Naţională a Medicamentului şi a Dispozitivelor Medicale
                           
                        
                               
                           
                           
                              Slovakia
                              Štátny ústav pre kontrolu liečiv (SUKL)
                           
                        
                               
                           
                           
                              Slovenia
                              Javna agencija Republike Slovenije za zdravila in medicinske pripomočke (JAZMP)
                           
                        
                               
                           
                           
                              Spain
                              Agencia Española de Medicamentos y Productos Sanitários
                           
                        
                               
                           
                           
                              Sweden
                              Läkemedelsverket
                           
                        
                               
                           
                           
                              United Kingdom
                              Medicines and Healthcare Products Regulatory Agency
                           
                        
                               
                           
                           
                              European Union
                              European Medicines Agency
                           
                        
               
                  Ministry of Health, Labour and Welfare or an authority succeeding this ministry