Common use of LIST OF AUTHORITIES Clause in Contracts

LIST OF AUTHORITIES. UNITED STATES Country For medicinal products for human use For medicinal products for veterinary use Austria Austrian Agency for Health and Food Safety/Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH See responsible authority for human medicinal products Belgium Federal agency for medicines and health products/Federaal Agentschap voor geneesmiddelen en gezondheid- sproducten/Agence fédérale des médi- caments et produits de santé See responsible authority for human medicinal products Bulgaria Bulgarian Drug Agency/ ИЗПЪЛНИТЕЛНА АГЕНЦИЯ ПО ЛЕКАРСТВАТА Bulgarian Food Safety Agency/Българска агенция по безопасност на храните Cyprus Ministry of Health — Pharmaceutical Services/Φαρμακευτικές Υπηρεσίες, Υπουργείο Υγείας Ministry of Agriculture, Rural Devel- opment and Environment-Veterinary Services/Κτηνιατρικές Υπηρεσίες- Υπουργείο Γεωργίας, Αγροτικής Ανάπτυξης και Περιβάλλοντος Czech Republic State Institute for Drug Control/Státní ústav pro kontrolu léčiv (SÚKL) Institute for State Control of Veterinary Biologicals and Medicaments/Ústav pro státní kontrolu veterinárních biopreparátů a léčiv (ÚSKVBL) Croatia Agency for Medicinal Products and Medical Devices/Agencija za lijekove i medicinske proizvode (HALMED) Ministry of Agriculture, Veterinary and Food Safety Directorate/Ministarstvo Poljoprivrede, Uprava za veterinarstvo i sigurnost hrane Denmark Danish Medicines Agency/Laegemid- delstyrelsen See responsible authority for human medicinal products Germany Federal Institute for Drugs and Medical Devices/Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) Federal Office for Consumer Protection and Food Safety/Bundesamt für Verbrau- cherschutz und Lebensmittelsicherheit (BVL) Xxxx-Xxxxxxx-Institute (PEI), Federal Institute for Vaccines and Biomedi- cines/Xxxx-Xxxxxxx-Institut (PEI) Bundesinstitut für Impfstoffe und biomedizinische Arzneimittel Federal Ministry of Food and Agriculture, Bundesministerium für Ernährung und Landwirtschaft Federal Ministry of Health/Bundes- ministerium für Gesundheit (BMG)/ Zentralstelle der Länder für Gesund- heitsschutz bei Arzneimitteln und Medizinprodukten (ZLG) (1) The Food and Drug Administration EUROPEAN UNION ▼M30 Country For medicinal products for human use For medicinal products for veterinary use Estonia State Agency of Medicines/Ravi- miamet See responsible authority for human medicinal products Greece National Organisation for Medicines/ Ethnikos Organismos Farmakon (EOF) — (ΕΘΝΙΚΟΣ ΟΡΓΑΝΙΣΜΟΣ ΦΑΡΜΑΚΩΝ)) See responsible authority for human medicinal products Spain Spanish Agency of Medicines and Medical Devices/Agencia Española de Medicamentos y Productos Xxxxxx- xxxx (2) See responsible authority for human medicinal products Finland Finnish Medicines Agency/Lääkealan turvallisuus- ja kehittämiskeskus (FIMEA) See responsible authority for human medicinal products France French National Agency for Medicines and Health Products Safety Agence nationale de sécurité du médicament et des produits de santé (ANSM) French agency for food, environmental and occupational health safety — National Agency for Veterinary Medicinal Products/Agence Nationale de Sécurité Sanitaire de l'alimentation, de l'environ- nement et du travail-Agence Nationale du Médicament Vétérinaire (Anses-ANMV) Hungary Országos Gyógyszerészeti és Élel- mezés-egészségügyi Intézet/National Institute of Pharmacy and Nutrition National Food Chain Safety Office, Direc- torate of Veterinary Medicinal Products/ Nemzeti Élelmiszerlánc-biztonsági Hivatal, Állatgyógyászati Termékek Igazgatósága (ÁTI) Ireland Health Products Regulatory Authority (HPRA) See responsible authority for human medicinal products Italy Italian Medicines Agency/Agenzia Italiana del Farmaco Direction General for Animal Health and Veterinary Medicinal Products Ministero della Salute, Direzione Generale xxxxx Xxxxxx Animale e dei Farmaci Veterinari Latvia State Agency of Medicines/Zāļu valsts aģentūra Assessment and Registration Department of the Food and Veterinary Service/ Pārtikas un veterinārā dienesta Novērtēšanas un reģistrācijas departaments Lithuania State Medicines Control Agency/ Valstybinė vaistų kontrolės tarnyba State Food and Veterinary Service/ Valstybinės maisto ir veterinarijos tarnyba Xxxxx- xxxxx Minìstere de la Santé, Division de la Pharmacie et des Médicaments See responsible authority for human medicinal products Malta Medicines Regulatory Authority Veterinary Medicines and Animal Nutrition section VMANS) (Veterinary Regulation Directorate (VRD) within The Veterinary and Phytosanitary Regulation Department (VPRD) Country For medicinal products for human use For medicinal products for veterinary use Netherlands Healthcare Inspectorate/Inspectie voor de Gezondheidszorg (IGZ) Medicines Evaluation Board/Bureau Diergeneesmiddelen, College ter Beoor- deling van Geneesmiddelen (CBG) Poland The Main Pharmaceutical Inspectorate/ Główny Inspektorat Farmaceutyczny (GIF) See responsible authority for human medicinal products Portugal National Authority of Medicines and Health Products/INFARMED, I.P Autoridade Nacional do Medicamento e Produtos de Saúde, I.P General Directorate of Food and Veterinary/DGAV — Direção Geral de Alimentação e Veterinária (PT) Romania National Agency for Medicines and Medical Devices/Agenția Națională a Medicamentului și a Dispozitivelor Medicale National Sanitary Veterinary and Food Safety Authority/Autoritatea Națională Sanitară Veterinară și pentru Siguranța Alimentelor Sweden Medical Products Agency/Läkemedels- verket See responsible authority for human medicinal products Slovenia Agency for Medicinal Products and Medical Devices of the Republic of Slovenia/Javna agencija Republike Slovenije za zdravila in medicinske pripomočke (JAZMP) See responsible authority for human medicinal products Slovak Republic(Slovakia) State Institute for Drug Control/Štátny ústav pre kontrolu liečiv (ŠÚKL) Institute for State Control of Veterinary Biologicals and Medicaments/Ústav štátnej kontroly veterinárnych bioprep- arátov a liečiv (USKVBL) United Kingdom Medicines and Healthcare products Regulatory Agency Veterinary Medicines Directorate

LIST OF AUTHORITIES. UNITED STATES Country For medicinal products for human use For medicinal products for veterinary use Austria Austrian Agency for Health and Food Safety/Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH See responsible authority for human medicinal products Belgium Federal agency for medicines and health products/Federaal Agentschap voor geneesmiddelen en gezondheid- sproducten/Agence fédérale des médi- caments et produits de santé See responsible authority for human medicinal products Bulgaria Bulgarian Drug Agency/ ИЗПЪЛНИТЕЛНА АГЕНЦИЯ ПО ЛЕКАРСТВАТА Bulgarian Food Safety Agency/Българска агенция по безопасност на храните Cyprus Ministry of Health — Pharmaceutical Services/Φαρμακευτικές Υπηρεσίες, Υπουργείο Υγείας Ministry of Agriculture, Rural Devel- opment Develop- ment and Environment-Veterinary Services/Κτηνιατρικές Υπηρεσίες- Υπουργείο Γεωργίας, Αγροτικής Ανάπτυξης και Περιβάλλοντος Czech Republic State Institute for Drug Control/Státní ústav pro kontrolu léčiv (SÚKL) Institute for State Control of Veterinary Biologicals and Medicaments/Ústav pro státní kontrolu veterinárních biopreparátů a léčiv (ÚSKVBL) Croatia Agency for Medicinal Products and Medical Devices/Agencija za lijekove i medicinske proizvode (HALMED) Ministry of Agriculture, Veterinary and Food Safety Directorate/Ministarstvo Poljoprivrede, Uprava za veterinarstvo i sigurnost hrane Denmark Danish Medicines Agency/Laegemid- delstyrelsen See responsible authority for human medicinal products Germany Federal Institute for Drugs and Medical Devices/Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) Federal Office for Consumer Protection and Food Safety/Bundesamt für Verbrau- cherschutz und Lebensmittelsicherheit (BVL) Xxxx-Xxxxxxx-Institute (PEI), Federal Institute for Vaccines and Biomedi- cines/Xxxx-Xxxxxxx-Institut (PEI) Bundesinstitut für Impfstoffe und biomedizinische Arzneimittel Federal Ministry of Food and Agriculture, Bundesministerium für Ernährung und Landwirtschaft Federal Ministry of Health/Bundes- ministerium für Gesundheit (BMG)/ Zentralstelle der Länder für Gesund- heitsschutz bei Arzneimitteln und Medizinprodukten (ZLG) (1) The Food and Drug Administration EUROPEAN UNION ▼M30 Country For medicinal products for human use For medicinal products for veterinary use Estonia State Agency of Medicines/Ravi- miamet See responsible authority for human medicinal products Greece National Organisation for Medicines/ Ethnikos Organismos Farmakon (EOF) — (ΕΘΝΙΚΟΣ ΟΡΓΑΝΙΣΜΟΣ ΦΑΡΜΑΚΩΝ)) See responsible authority for human medicinal products Spain Spanish Agency of Medicines and Medical Devices/Agencia Española de Medicamentos y Productos Xxxxxx- xxxx (2) See responsible authority for human medicinal products Finland Finnish Medicines Agency/Lääkealan turvallisuus- ja kehittämiskeskus (FIMEA) See responsible authority for human medicinal products France French National Agency for Medicines and Health Products Safety Agence nationale de sécurité du médicament et des produits de santé (ANSM) French agency for food, environmental and occupational health safety — National Agency for Veterinary Medicinal Products/Agence Nationale de Sécurité Sanitaire de l'alimentation, de l'environ- nement et du travail-Agence Nationale du Médicament Vétérinaire (Anses-ANMV) Hungary Országos Gyógyszerészeti és Élel- mezés-egészségügyi Intézet/National Institute of Pharmacy and Nutrition National Food Chain Safety Office, Direc- torate of Veterinary Medicinal Products/ Nemzeti Élelmiszerlánc-biztonsági Hivatal, Állatgyógyászati Termékek Igazgatósága (ÁTI) Ireland Health Products Regulatory Authority (HPRA) See responsible authority for human medicinal products Italy Italian Medicines Agency/Agenzia Italiana del Farmaco Direction General for Animal Health and Veterinary Medicinal Products Ministero della Salute, Direzione Generale xxxxx Xxxxxx Animale e dei Farmaci Veterinari Latvia State Agency of Medicines/Zāļu valsts aģentūra Assessment and Registration Department of the Food and Veterinary Service/ Pārtikas un veterinārā dienesta Novērtēšanas un reģistrācijas departaments Lithuania State Medicines Control Agency/ Valstybinė vaistų kontrolės tarnyba State Food and Veterinary Service/ Valstybinės maisto ir veterinarijos tarnyba Xxxxx- xxxxx Minìstere de la Santé, Division de la Pharmacie et des Médicaments See responsible authority for human medicinal products Malta Medicines Regulatory Authority Veterinary Medicines and Animal Nutrition section VMANS) (Veterinary Regulation Directorate (VRD) within The Veterinary and Phytosanitary Regulation Department (VPRD) ▼M30 Country For medicinal products for human use For medicinal products for veterinary use Netherlands Healthcare Inspectorate/Inspectie voor de Gezondheidszorg (IGZ) Medicines Evaluation Board/Bureau Diergeneesmiddelen, College ter Beoor- deling van Geneesmiddelen (CBG) Poland The Main Pharmaceutical Inspectorate/ Główny Inspektorat Farmaceutyczny (GIF) See responsible authority for human medicinal products Portugal National Authority of Medicines and Health Products/INFARMED, I.P Autoridade Nacional do Medicamento e Produtos de Saúde, I.P General Directorate of Food and Veterinary/DGAV — Direção Geral de Alimentação e Veterinária (PT) Romania National Agency for Medicines and Medical Devices/Agenția Națională Agenţia Naţională a Medicamentului și a Dispozitivelor Medicale National Sanitary Veterinary and Food Safety Authority/Autoritatea Națională Naţională Sanitară Veterinară și pentru Siguranța Siguranţa Alimentelor Sweden Medical Products Agency/Läkemedels- verket See responsible authority for human medicinal products Slovenia Agency for Medicinal Products and Medical Devices of the Republic of Slovenia/Javna agencija Republike Slovenije za zdravila in medicinske pripomočke (JAZMP) See responsible authority for human medicinal products Slovak Republic(SlovakiaRepublic (Slovakia) State Institute for Drug Control/Štátny ústav pre kontrolu liečiv (ŠÚKL) Institute for State Control of Veterinary Biologicals and Medicaments/Ústav štátnej kontroly veterinárnych bioprep- arátov a liečiv (USKVBL) United Kingdom Medicines and Healthcare products Regulatory Agency Veterinary Medicines Directorate

LIST OF AUTHORITIES. UNITED STATES Country For medicinal products for human use For medicinal products for veterinary use Austria Austrian Agency for Health and Food Safety/Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH See responsible authority for human medicinal products Belgium Federal agency for medicines and health products/Federaal Agentschap voor geneesmiddelen en gezondheid- sproducten/Agence fédérale des médi- caments et produits de santé See responsible authority for human medicinal products Bulgaria Bulgarian Drug Agency/ ИЗПЪЛНИТЕЛНА АГЕНЦИЯ ПО ЛЕКАРСТВАТА Bulgarian Food Safety Agency/Българска агенция по безопасност на храните Cyprus Ministry of Health — Pharmaceutical Services/Φαρμακευτικές Υπηρεσίες, Υπουργείο Υγείας Ministry of Agriculture, Rural Devel- opment Develop- ment and Environment-Veterinary Services/Κτηνιατρικές Υπηρεσίες- Υπουργείο Γεωργίας, Αγροτικής Ανάπτυξης και Περιβάλλοντος Czech Republic State Institute for Drug Control/Státní ústav pro kontrolu léčiv (SÚKL) Institute for State Control of Veterinary Biologicals and Medicaments/Ústav pro státní kontrolu veterinárních biopreparátů a léčiv (ÚSKVBL) Croatia Agency for Medicinal Products and Medical Devices/Agencija za lijekove i medicinske proizvode (HALMED) Ministry of Agriculture, Veterinary and Food Safety Directorate/Ministarstvo Poljoprivrede, Uprava za veterinarstvo i sigurnost hrane Denmark Danish Medicines Agency/Laegemid- delstyrelsen See responsible authority for human medicinal products Germany Federal Institute for Drugs and Medical Devices/Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) Federal Office for Consumer Protection and Food Safety/Bundesamt für Verbrau- cherschutz und Lebensmittelsicherheit (BVL) Xxxx-Xxxxxxx-Institute (PEI), Federal Institute for Vaccines and Biomedi- cines/Xxxx-Xxxxxxx-Institut (PEI) Bundesinstitut für Impfstoffe und biomedizinische Arzneimittel Federal Ministry of Food and Agriculture, Bundesministerium für Ernährung und Landwirtschaft Federal Ministry of Health/Bundes- ministerium für Gesundheit (BMG)/ Zentralstelle der Länder für Gesund- heitsschutz bei Arzneimitteln und Medizinprodukten (ZLG) (1) The Food and Drug Administration EUROPEAN UNION ▼M30 Country For medicinal products for human use For medicinal products for veterinary use Estonia State Agency of Medicines/Ravi- miamet See responsible authority for human medicinal products Greece National Organisation for Medicines/ Ethnikos Organismos Farmakon (EOF) — (ΕΘΝΙΚΟΣ ΟΡΓΑΝΙΣΜΟΣ ΦΑΡΜΑΚΩΝ)) See responsible authority for human medicinal products Spain Spanish Agency of Medicines and Medical Devices/Agencia Española de Medicamentos y Productos Xxxxxx- xxxx (2) See responsible authority for human medicinal products Finland Finnish Medicines Agency/Lääkealan turvallisuus- ja kehittämiskeskus (FIMEA) See responsible authority for human medicinal products France French National Agency for Medicines and Health Products Safety Agence nationale de sécurité du médicament et des produits de santé (ANSM) French agency for food, environmental and occupational health safety — National Agency for Veterinary Medicinal Products/Agence Nationale de Sécurité Sanitaire de l'alimentation, de l'environ- nement et du travail-Agence Nationale du Médicament Vétérinaire (Anses-ANMV) Hungary Országos Gyógyszerészeti és Élel- mezés-egészségügyi Intézet/National Institute of Pharmacy and Nutrition National Food Chain Safety Office, Direc- torate of Veterinary Medicinal Products/ Nemzeti Élelmiszerlánc-biztonsági Hivatal, Állatgyógyászati Termékek Igazgatósága (ÁTI) Ireland Health Products Regulatory Authority (HPRA) See responsible authority for human medicinal products Italy Italian Medicines Agency/Agenzia Italiana del Farmaco Direction General for Animal Health and Veterinary Medicinal Products Ministero della Salute, Direzione Generale xxxxx Xxxxxx Animale e dei Farmaci Veterinari Latvia State Agency of Medicines/Zāļu valsts aģentūra Assessment and Registration Department of the Food and Veterinary Service/ Pārtikas un veterinārā dienesta Novērtēšanas un reģistrācijas departaments Lithuania State Medicines Control Agency/ Valstybinė vaistų kontrolės tarnyba State Food and Veterinary Service/ Valstybinės maisto ir veterinarijos tarnyba Xxxxx- xxxxx Minìstere de la Santé, Division de la Pharmacie et des Médicaments See responsible authority for human medicinal products Malta Medicines Regulatory Authority Veterinary Medicines and Animal Nutrition section VMANS) (Veterinary Regulation Directorate (VRD) within The Veterinary and Phytosanitary Regulation Department (VPRD) Country For medicinal products for human use For medicinal products for veterinary use Netherlands Healthcare Inspectorate/Inspectie voor de Gezondheidszorg (IGZ) Medicines Evaluation Board/Bureau Diergeneesmiddelen, College ter Beoor- deling van Geneesmiddelen (CBG) Poland The Main Pharmaceutical Inspectorate/ Główny Inspektorat Farmaceutyczny (GIF) See responsible authority for human medicinal products Portugal National Authority of Medicines and Health Products/INFARMED, I.P Autoridade Nacional do Medicamento e Produtos de Saúde, I.P General Directorate of Food and Veterinary/DGAV — Direção Geral de Alimentação e Veterinária (PT) Romania National Agency for Medicines and Medical Devices/Agenția Națională a Medicamentului și a Dispozitivelor Medicale National Sanitary Veterinary and Food Safety Authority/Autoritatea Națională Sanitară Veterinară și pentru Siguranța Alimentelor Sweden Medical Products Agency/Läkemedels- verket See responsible authority for human medicinal products Slovenia Agency for Medicinal Products and Medical Devices of the Republic of Slovenia/Javna agencija Republike Slovenije za zdravila in medicinske pripomočke (JAZMP) See responsible authority for human medicinal products Slovak Republic(Slovakia) State Institute for Drug Control/Štátny ústav pre kontrolu liečiv (ŠÚKL) Institute for State Control of Veterinary Biologicals and Medicaments/Ústav štátnej kontroly veterinárnych bioprep- arátov a liečiv (USKVBL) United Kingdom Medicines and Healthcare products Regulatory Agency Veterinary Medicines Directorate