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 P.O. Box 5013 Wellington New Zealand Tel.: ▇▇-▇-▇▇▇-▇▇▇▇ Fax: ▇▇-▇-▇▇▇-▇▇▇▇ for veterinary medicines: Ministry of Agriculture Agricultural Compounds Unit P.O. Box 40063 Upper Hutt New Zealand Tel.: ▇▇-▇-▇▇▇-▇▇▇▇ Fax : ▇▇-▇-▇▇▇-▇▇▇▇ For the European Community : Algemene Farmaceutische Inspectie Rijksadministratief Centrum Vesalius Gebouw Fax : ▇▇-▇▇-▇▇▇ 077 for immunologicals : ▇▇▇▇-▇▇▇▇▇▇▇-Institut, Federal Agency for Sera & Vaccines Postfach National Drug Organization (E.O.F.) Mesogion 284 E-28014 MADRID Tel. : 34-1-596 4068 Fax : 34-1-596 4069 FRANCE for medicinal products for human use : Agence du Médicament ▇▇▇-▇▇▇ ▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇ F-93200 SAINT-DENIS Tél. : 33-1-4813 2000 Fax : 33-1-4813 2478 for veterinary medicinal products : Agence Nationale du Médicament Vétérinaire la Haute Marche - Javené F - 35133 FOUGERES. Tel.: +▇▇-▇▇▇▇ ▇▇▇▇ Fax : +▇▇-▇▇▇▇ ▇▇▇▇ IRELAND National Drugs Advisory Board ▇▇-▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇ ▇▇▇-▇▇▇▇▇▇ 2 Tel. : 353-1-676.4971 - 7 Fax : 353-1-676.7836 Direzione Generale del Servicio Farmaceutico ▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇▇ Romana 7 I-00144 ROMA Tel. : 39-6-5994 3676 Fax : 39-6-5994 3365 L-2546 LUXEMBOURG Tel. : ▇▇▇-▇▇▇ ▇▇▇▇ / 93 Fax : ▇▇▇-▇▇ ▇▇ ▇▇ Inspectie voor de Gezondheidszorg Postbus 5406 NL-2280 HW RIJSWIJK Tel. : ▇▇-▇▇-▇▇▇ 7911 Fax : ▇▇-▇▇-▇▇▇ 5177 ▇▇▇▇▇▇▇▇▇▇▇▇▇▇ ▇ A-1031 WIEN Tel. : 43-1-711 724 642 Fax : 43-1-714 92 22 P.O. Box 278 FIN-00531 HELSINKI Tel. : ▇▇▇-▇-▇▇▇ 72 112 Medicines Control Agency ▇ ▇▇▇▇ ▇▇▇▇ ▇▇▇▇ GB-LONDON SW8 5NQ Tel. : ▇▇-▇▇▇-▇▇▇ 0500 Fax : ▇▇-▇▇▇-▇▇▇ 0676 for veterinary immunologicals : Veterinary Medicines Directorate ▇▇▇▇▇▇▇ ▇▇▇▇ ▇▇▇ Haw, Addlestone GB - SURREY KT15 3NB Tel. : ▇▇-▇▇▇▇-▇▇▇▇▇▇ Fax : ▇▇-▇▇▇▇-▇▇▇▇▇▇

OFFICIAL INSPECTION SERVICES. For New Zealand: for medicines for human use: Ministry of Health Therapeutics Section P.O. Box 5013 Wellington New Zealand ▇.▇. ▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇ ▇▇▇ ▇▇▇▇▇▇▇ Tel.: ▇▇-▇-▇▇▇-▇▇▇▇ Fax: ▇▇-▇-▇▇▇-▇▇▇▇ for veterinary medicines: Ministry of Agriculture Agricultural Compounds Unit P.O. Box 40063 Upper Hutt New Zealand ▇▇▇▇ ▇.▇. ▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇ ▇▇▇ ▇▇▇▇▇▇▇ Tel.: ▇▇-▇-▇▇▇-▇▇▇▇ Fax : ▇▇-▇-▇▇▇-▇▇▇▇ For the European Community : Algemene Farmaceutische Inspectie Rijksadministratief Centrum Vesalius Gebouw ▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇ Fax : ▇▇-▇▇-▇▇▇ 077 for immunologicals : ▇▇▇▇-▇▇▇▇▇▇▇-Institut, Federal Agency for Sera ▇▇▇▇ & Vaccines Postfach ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇ GREECE ⮲🡺🡿🡹V✓⇩ 🙗⇧🡬🡩🡿🡹⬄🡽✓⇩ ⌫🡩⇧🡽⮊V⇦⬁ National Drug Organization (E.O.F.) Mesogion 284 GR-ATHENS 15562 Tel. : 30-1-654 5530 Fax : 30-1-654 9591 E-28014 MADRID Tel. : 34-1-596 4068 Fax : 34-1-596 4069 FRANCE for medicinal products for human use : Agence du Médicament ▇▇▇-▇▇▇ ▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇ F-93200 SAINT-DENIS Tél. : 33-1-4813 2000 Fax : 33-1-4813 2478 for veterinary medicinal products : Agence Nationale du Médicament Vétérinaire la Haute Marche ▇▇▇▇▇▇▇▇▇ ▇▇ ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇▇ ▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇ - Javené F ▇▇▇▇▇▇ ▇ - 35133 ▇▇▇▇▇ FOUGERES. Tel.: +▇▇-▇▇▇▇ ▇▇▇▇ Fax : +▇▇-▇▇▇▇ ▇▇▇▇ IRELAND National Drugs Advisory Board ▇▇-▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇ ▇▇▇-▇▇▇▇▇▇ 2 Tel. : 353-1-676.4971 - 7 Fax : 353-1-676.7836 Direzione Generale del Servicio Farmaceutico ▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇▇ Romana 7 I-00144 ROMA Tel. : 39-6-5994 3676 Fax : 39-6-5994 3365 L-2546 LUXEMBOURG Tel. : ▇▇▇-▇▇▇ ▇▇▇▇ / 93 Fax : ▇▇▇-▇▇ ▇▇ ▇▇ Inspectie voor de Gezondheidszorg Postbus 5406 NL-2280 HW RIJSWIJK ▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇ ▇▇-▇▇▇▇ ▇▇ ▇▇▇▇▇▇▇▇ Tel. : ▇▇-▇▇-▇▇▇ 7911 Fax : ▇▇-▇▇-▇▇▇ 5177 ▇▇▇▇▇▇▇▇▇▇▇▇▇▇ ▇ A-1031 WIEN ▇-▇▇▇▇ ▇▇▇▇ Tel. : 43-1-711 724 642 Fax : 43-1-714 92 22 P.O. Box 278 FIN-00531 HELSINKI ▇.▇. ▇▇▇ ▇▇▇ ▇▇▇-▇▇▇▇▇ ▇▇▇▇▇▇▇▇ Tel. : ▇▇▇-▇-▇▇▇ 72 112 Medicines Control Agency ▇ ▇▇▇▇ ▇▇▇▇ ▇▇▇▇ GB▇▇-LONDON SW8 5NQ ▇▇▇▇▇▇ ▇▇▇ ▇▇▇ Tel. : ▇▇-▇▇▇-▇▇▇ 0500 Fax : ▇▇-▇▇▇-▇▇▇ 0676 for veterinary immunologicals : Veterinary Medicines Directorate ▇▇▇▇▇▇▇ ▇▇▇▇ ▇▇▇ Haw, Addlestone GB - SURREY KT15 3NB Tel. : ▇▇-▇▇▇▇-▇▇▇▇▇▇ Fax : ▇▇-▇▇▇▇-▇▇▇▇▇▇

OFFICIAL INSPECTION SERVICES. For New ZealandAustralia: for medicines for human use: Ministry Therapeutic Goods Administration (TGA) Department of Health Therapeutics Section P.O. and Family Services PO Box 5013 Wellington New Zealand 100 Woden ACT 2606 Australia Tel.: ▇▇61-▇6-▇▇▇-▇▇▇▇ Fax: ▇▇-▇-▇▇▇-▇▇▇▇ for veterinary medicines: Ministry of Agriculture Agricultural Compounds Unit P.O. Box 40063 Upper Hutt New Zealand Tel.: ▇▇-▇-▇▇▇-▇▇▇▇ 232 8632 Fax : ▇▇61-▇6-▇▇▇-▇▇▇▇ 232 8659 For the European Community Community: Algemene Farmaceutische Inspectie Rijksadministratief Centrum Vesalius Gebouw DK-2700 BRØNSHØJ Tel. : ▇▇-▇▇-▇▇▇ 320 Fax : ▇▇-▇▇-▇▇▇ 077 GERMANY Bundesministerium für Gesundheit Am Propsthof 78a D-53108 BONN Tel. : ▇▇-▇▇▇-▇▇▇ 2340 Fax : ▇▇-▇▇▇-▇▇▇ 4923 for immunologicals : ▇▇▇▇-▇▇▇▇▇▇▇-Institut, Federal Agency for Sera & Vaccines Postfach National Drug Organization (E.O.F.) Mesogion 284 E-28014 MADRID Tel. : 34-1-596 4068 Fax : 34-1-596 4069 FRANCE for medicinal products for human use : Agence du Médicament ▇▇▇-▇▇▇ ▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇ F-93200 SAINT-DENIS Tél. : 33-1-4813 2000 Fax : 33-1-4813 2478 for veterinary medicinal products : Agence Nationale du Médicament Vétérinaire la Haute Marche - Javené F - 35133 FOUGERES. Tel.: +▇▇-▇▇▇▇ ▇▇▇▇ Fax : +▇▇-▇▇▇▇ ▇▇▇▇ IRELAND National Drugs Advisory Board ▇▇-▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇ ▇▇▇-▇▇▇▇▇▇ 2 Tel. : 353-1-676.4971 - 7 Fax : 353-1-676.7836 Direzione Generale del Servicio Farmaceutico ▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇▇ Romana 7 I-00144 ROMA Tel. : 39-6-5994 3676 Fax : 39-6-5994 3365 L-2546 LUXEMBOURG Tel. : ▇▇▇-▇▇▇ ▇▇▇▇ / 93 Fax : ▇▇▇-▇▇ ▇▇ ▇▇ Inspectie voor de Gezondheidszorg Postbus 5406 5850 NL-2280 HW RIJSWIJK Tel. : ▇▇-▇▇-▇▇▇ 7911 6839 Fax : ▇▇-▇▇-▇▇▇ 5177 7159 ▇▇▇▇▇▇▇▇▇▇▇▇▇▇ ▇ A-1031 WIEN Tel. : 43-1-711 724 642 Fax : 43-1-714 92 22 P - 1700 LISBOA Tel. : ▇▇▇-▇-▇▇▇ 7836 Fax : ▇▇▇-▇-▇▇▇ 9116 FINLAND National Agency for Medicines P.O. Box 278 FIN-00531 HELSINKI Tel. : ▇▇▇-▇-▇▇▇ 72 112 Fax : ▇▇▇-▇-▇▇▇ 469 Medicines Control Agency ▇ ▇▇▇▇ ▇▇▇▇ ▇▇▇▇ GB-LONDON SW8 5NQ Tel. : ▇▇-▇▇▇-▇▇▇ 0500 Fax : ▇▇-▇▇▇-▇▇▇ 0676 for veterinary immunologicals : Veterinary Medicines Directorate ▇▇▇▇▇▇▇ ▇▇▇▇ ▇▇▇ Haw, Addlestone GB - SURREY KT15 3NB Tel. : ▇▇-▇▇▇▇-▇▇▇▇▇▇ Fax : ▇▇-▇▇▇▇-▇▇▇▇▇▇