Common use of OFFICIAL INSPECTION SERVICES Clause in Contracts

OFFICIAL INSPECTION SERVICES. FOR NEW ZEALAND: For medicines for human use: Ministry of Health Therapeutics Section XX Xxx 0000 Xxxxxxxxxx Xxx Xxxxxxx Tel. 64-4-496 2081 Fax 64-4-496 2229 For veterinary medicines: Ministry of Agriculture and Forestry Agricultural Compounds and Veterinary Medicines Group XX Xxx 00000 Xxxxx Xxxx Xxx Xxxxxxx Tel. 64-4-528 0126 Fax 64-4-528 1378 FOR THE EUROPEAN COMMUNITY BELGIUM Inspection générale de la Pharmacie Algemene Farmaceutische Inspectie DENMARK Lægemiddelstyrelsen GERMANY Bundesministerium für Gesundheit GREECE Εθνικός Οργανισµός Φαρµáκo3 Ministry of Health and Welfare National Drug Organisation (EOF) SPAIN For medicinal products for human use: Ministerio xx Xxxxxxx y Consumo Subdirección General de Control Farmacéutico For medicinal products for veterinary use: Ministerio de Agricultura, Pesca y Alimentación (MAPA) Dirección General de la Producción Agraria FRANCE For medicinal products for human use: Agence du Médicament For veterinary medicinal products: CNEVA, Agence nationale du médicament vétérinaire, unité inspections IRELAND Irish Medicines Board ITALY For medicinal products for human use: Ministero xxxxx Xxxxxx Dipartimento Farmaci e Farmacovigilanza For medicinal products for veterinary use: Ministero xxxxx Xxxxxx Dipartimento xxxxxxxx e nutrizione e sanità pubblica veterinaria — Div. IX LUXEMBOURG Division de la Pharmacie et des Médicaments NETHERLANDS Staat der Nederlanden AUSTRIA Bundesministerium für Arbeit, Gesundheit und Soziales PORTUGAL Instituto Nacional da Farmácia e do Medicamento — INFARMED FINLAND Lääkelaitos/Läkemedelsverket National Agency for Medicines SWEDEN Läkemedelsverket — Medicinal Products Agency UNITED KINGDOM For human and veterinary (non immunologicals): Medicines Control Agency For veterinary immunologicals: Veterinary Medicines Directorate EUROPEAN COMMUNITY Commission of the European Communities European Agency for the Evaluation of Medicinal Products (EMEA) SECTION III

OFFICIAL INSPECTION SERVICES. FOR NEW ZEALANDFor Australia: For medicines for human use: Ministry Therapeutic Goods Administration (TGA) Department of Health Therapeutics Section and Family Services XX Xxx 000 Xxxxx XXX 0000 Xxxxxxxxxx Xxx Xxxxxxx Xxxxxxxxx Tel. 64.: 00-40-496 2081 Fax 64000-40000 Fax: 00-496 2229 0-000-0000 For veterinary medicinesthe European Community: Ministry of Agriculture and Forestry Agricultural Compounds and Veterinary Medicines Group XX Xxx 00000 Xxxxx Xxxx Xxx Xxxxxxx Tel. 64-4-528 0126 Fax 64-4-528 1378 FOR THE EUROPEAN COMMUNITY BELGIUM Inspection générale de la Pharmacie Pharma cie Algemene Farmaceutische Inspectie DENMARK Lægemiddelstyrelsen L æ gemiddelstyrelsen GERMANY Bundesministerium für Gesundheit GREECE Εθνικός Οργανισµός Φαρµáκo3 Εθvικός Οργαvισµός Φαρµάκoυ Ministry of Health and Welfare National Drug Organisation Organization (EOF) SPAIN For medicinal products for human use: Ministerio xx Xxxxxxx y Consumo Subdirección General de Control Farmacéutico Farmacéutic o For medicinal products for veterinary veterin ary use: Ministerio de Agricultura, Pesca Pesc a y Alimentación (MAPA) Dirección Dirre cción General de la Producción Agraria FRANCE For medicinal products for human use: Agence du Médicament vétérin aire, For veterinary veterin ary medicinal products: CNEVA, Agence nationale du médicament vétérinaire, unité inspections For cosmetics: Ministre de l'emploi et de la solidarité Direction Générale de la Santé Sous direction pharmacie IRELAND Irish Medicines Board ITALY For medicinal products for human use: Ministero xxxxx Xxxxxx Dipartimento Farmaci e Farmacovigilanza For medicinal products for veterinary veterin ary use: Ministero xxxxx Xxxxxx Dipartimento xxxxxxxx e nutrizione e sanità pubblica veterinaria — veterin aria – Div. IX LUXEMBOURG Division de la Pharmacie Pharma cie et des Médicaments NETHERLANDS Staat der Nederlanden AUSTRIA Bundesministerium für Arbeit, Gesundheit und Soziales PORTUGAL For human and veterin ary (non immunologic als): Instituto Nacional da Farmácia e do Medicamento — – INFARMED For veterin ary immunologic als: Direcç ão-General de Veterin aria FINLAND Lääkelaitos/Lääkelaitos/ Läkemedelsverket National Agency for Medicines SWEDEN Läkemedelsverket — Medicinal – Medical Products Agency UNITED KINGDOM For human and veterinary veterin ary (non immunologicals): Medicines Control Agency For veterinary immunologicalsveterin ary immunologic als: Veterinary Veterin ary Medicines Directorate EUROPEAN COMMUNITY Commission of the European Communities European Agency for the Evaluation of Medicinal Products (EMEA) SECTION IIIIII OPERATIONAL PROVISIONS

OFFICIAL INSPECTION SERVICES. FOR NEW ZEALANDAUSTRALIA: For medicines for human use: Ministry Therapeutic Goods Administration (TGA) Department of Health Therapeutics Section and Family Services XX Xxx 000 Xxxxx XXX 0000 Xxxxxxxxxx Xxx Xxxxxxx Xxxxxxxxx Tel. 6461-46-496 2081 232 8632 Fax 6461-46-496 2229 For veterinary medicines: Ministry of Agriculture and Forestry Agricultural Compounds and Veterinary Medicines Group XX Xxx 00000 Xxxxx Xxxx Xxx Xxxxxxx Tel. 64-4-528 0126 Fax 64-4-528 1378 232 8659 FOR THE EUROPEAN COMMUNITY COMMUNITY: BELGIUM Inspection générale de la Pharmacie pharmacie Algemene Farmaceutische Inspectie DENMARK Lægemiddelstyrelsen GERMANY Bundesministerium für Bundesministeriumfür Gesundheit GREECE Εθνικός Οργανισµός Φαρµáκo3 Εθνικóς Γργανισµóς Φαρµáκoϊ Ministry of Health and Welfare National Drug Organisation (EOF) SPAIN For medicinal products for human use: Ministerio xx Xxxxxxx y Consumo Subdirección General de Control Farmacéutico For medicinal products for veterinary use: Ministerio de Agricultura, Pesca y Alimentación (MAPA) Dirección General de la Producción Agraria FRANCE For medicinal products for human use: Agence du Médicament médicament For veterinary medicinal products: CNEVA, Agence nationale du médicament vétérinaire, unité inspections For cosmetics: Ministère de l’emploi et de la solidarité Direction générale de la santé Sous direction pharmacie IRELAND Irish Medicines Board ITALY For medicinal products for human use: Ministero xxxxx Xxxxxx Dipartimento Farmaci e Farmacovigilanza For medicinal products for veterinary use: Ministero xxxxx Xxxxxx Dipartimento xxxxxxxx e nutrizione e sanità pubblica veterinaria — Div. IX LUXEMBOURG Division de la Pharmacie pharmacie et des Médicaments médicaments NETHERLANDS Staat der Nederlanden AUSTRIA Bundesministerium für Arbeit, Gesundheit und Soziales PORTUGAL For human and veterinary (non immunologicals): Instituto Nacional da Farmácia e do Medicamento — INFARMED Infarmed For veterinary immunologicals: Direcção-Geral de Veterinaria FINLAND Lääkelaitos/Läkemedelsverket National Agency for Medicines SWEDEN Läkemedelsverket — Medicinal Products Agency UNITED KINGDOM For human and veterinary (non immunologicals): Medicines Control Agency For veterinary immunologicals: Veterinary Medicines Directorate EUROPEAN COMMUNITY Commission of the European Communities European Agency for the Evaluation of Medicinal Products (EMEA) SECTION III

OFFICIAL INSPECTION SERVICES. FOR NEW ZEALANDFor Australia: For medicines for human use: Ministry Therapeutic Goods Ad ministration (TGA) Department of Health Therapeutics Section and Family Servic es XX Xxx 000 Xxxxx XXX 0000 Xxxxxxxxxx Xxx Xxxxxxx Xxxxxxxxx Tel. 64.: 00-40-496 2081 Fax 64000-40000 Fax: 00-496 2229 0-000-0000 For veterinary medicinesthe European Community: Ministry of Agriculture and Forestry Agricultural Compounds and Veterinary Medicines Group XX Xxx 00000 Xxxxx Xxxx Xxx Xxxxxxx Tel. 64-4-528 0126 Fax 64-4-528 1378 FOR THE EUROPEAN COMMUNITY BELGIUM Inspection générale de la Pharmacie Pharma cie Algemene Farmaceutische Farma c eutische Inspectie DENMARK Lægemiddelstyrelsen Læ gemid delstyrelsen GERMANY Bundesministerium für Gesundheit GREECE Εθνικός Οργανισµός Φαρµáκo3 Εθvικός Οργαvισµός Φαρµάκoυ Ministry of Health and Welfare National Drug Organisation Organization (EOF) SPAIN For medicinal products for human use: Ministerio xx Xxxxxxx de Sanid ad y Consumo Subdirección General de Control Farmacéutico Farma c éutic o For medicinal products for veterinary use: Ministerio de Agricultura, Pesca Pesc a y Alimentación Alimenta ción (MAPA) Dirección Dirre cción General de la Producción Agraria FRANCE For medicinal products for human use: Agence Agenc e du Médicament Médic xxxxx vétérinaire, For veterinary medicinal products: CNEVA, Agence Agenc e nationale du médicament vétérinaire, médic xxxxx unité inspections For c osmetics: Ministre de l'emploi et de la solid arité Direction Générale de la Santé Sous direction pharma cie IRELAND Irish Medicines Board ITALY For medicinal products for human use: Ministero xxxxx Xxxxxx Dipartimento Farmaci Farma ci e Farmacovigilanza Farma c ovigilanza For medicinal products for veterinary use: Ministero xxxxx Xxxxxx Dipartimento xxxxxxxx alim enti e nutrizione e sanità pubblica pubblic a veterinaria — – Div. IX LUXEMBOURG Division de la Pharmacie Pharma cie et des Médicaments Médic aments NETHERLANDS Staat der Nederlanden AUSTRIA Bundesministerium für Arbeit, Gesundheit und Soziales PORTUGAL For human and veterinary (non immunologic als): Instituto Nacional da Farmácia Na cional d a Farmá cia e do Medicamento — d o Medic amento – INFARMED For veterinary immunologic als: Direcç ão-General de Veterinaria FINLAND Lääkelaitos/Lääkelaitos/ Läkemedelsverket National Agency for Medicines SWEDEN Läkemedelsverket — Medicinal – Medic al Products Agency UNITED KINGDOM For human and veterinary (non immunologicalsimmunologic als): Medicines Control Agency For veterinary immunologicalsimmunologic als: Veterinary Medicines Directorate EUROPEAN COMMUNITY Commission of the European Communities European Agency for the Evaluation of Medicinal Products (EMEA) SECTION IIIIII OPERATIONAL PROVISIONS

OFFICIAL INSPECTION SERVICES. FOR NEW ZEALANDAUSTRALIA: For medicines for human use: Ministry Therapeutic Goods Administration (TGA) Department of Health Therapeutics Section and Family Services XX Xxx 000 Xxxxx XXX 0000 Xxxxxxxxxx Xxx Xxxxxxx Xxxxxxxxx Tel. 6461-46-496 2081 232 8632 Fax 6461-46-496 2229 For veterinary medicines: Ministry of Agriculture and Forestry Agricultural Compounds and Veterinary Medicines Group XX Xxx 00000 Xxxxx Xxxx Xxx Xxxxxxx Tel. 64-4-528 0126 Fax 64-4-528 1378 232 8659 FOR THE EUROPEAN COMMUNITY COMMUNITY: BELGIUM Inspection générale de la Pharmacie pharmacie Algemene Farmaceutische Inspectie DENMARK Lægemiddelstyrelsen GERMANY Bundesministerium für Bundesministeriumfür Gesundheit GREECE Εθνικός Οργανισµός Φαρµáκo3 Ministry of Health and Welfare National Drug Organisation (EOF) SPAIN For medicinal products for human use: Ministerio xx Xxxxxxx y Consumo Subdirección General de Control Farmacéutico For medicinal products for veterinary use: Ministerio de Agricultura, Pesca y Alimentación (MAPA) Dirección General de la Producción Agraria FRANCE For medicinal products for human use: Agence du Médicament médicament For veterinary medicinal products: CNEVA, Agence nationale du médicament vétérinaire, unité inspections For cosmetics: Ministère de l’emploi et de la solidarité Direction générale de la santé Sous direction pharmacie IRELAND Irish Medicines Board ITALY For medicinal products for human use: Ministero xxxxx Xxxxxx Dipartimento Farmaci e Farmacovigilanza For medicinal products for veterinary use: Ministero xxxxx Xxxxxx Dipartimento xxxxxxxx e nutrizione e sanità pubblica veterinaria — Div. IX LUXEMBOURG Division de la Pharmacie pharmacie et des Médicaments médicaments NETHERLANDS Staat der Nederlanden AUSTRIA Bundesministerium für Arbeit, Gesundheit und Soziales PORTUGAL For human and veterinary (non immunologicals): Instituto Nacional da Farmácia e do Medicamento — INFARMED Infarmed For veterinary immunologicals: Direcção-Geral de Veterinaria FINLAND Lääkelaitos/Läkemedelsverket National Agency for Medicines SWEDEN Läkemedelsverket — Medicinal Products Agency UNITED KINGDOM For human and veterinary (non immunologicals): Medicines Control Agency For veterinary immunologicals: Veterinary Medicines Directorate EUROPEAN COMMUNITY Commission of the European Communities European Agency for the Evaluation of Medicinal Products (EMEA) SECTION III