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.: 00-0-000-0000 Fax: 00-0-000-0000 for veterinary medicines: Ministry of Agriculture Agricultural Compounds Unit P.O. Box 40063 Upper Hutt New Zealand Tel.: 00-0-000-0000 Fax : 00-0-000-0000 For the European Community : Algemene Farmaceutische Inspectie Rijksadministratief Centrum Vesalius Gebouw Fax : 00-00-000 077 for immunologicals : Xxxx-Xxxxxxx-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 000-000 xxxxxxxxx Xxxxxxx Xxxxxx 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.: +00-0000 0000 Fax : +00-0000 0000 IRELAND National Drugs Advisory Board 00-00 Xxxxxxxx Xxxx XXX-XXXXXX 2 Tel. : 353-1-676.4971 - 7 Fax : 353-1-676.7836 Direzione Generale del Servicio Farmaceutico Xxxxx xxxxx Xxxxxxx Romana 7 I-00144 ROMA Tel. : 39-6-5994 3676 Fax : 39-6-5994 3365 L-2546 LUXEMBOURG Tel. : 000-000 0000 / 93 Fax : 000-00 00 00 Inspectie voor de Gezondheidszorg Postbus 5406 NL-2280 HW RIJSWIJK Tel. : 00-00-000 7911 Fax : 00-00-000 5177 Xxxxxxxxxxxxxx 0 A-1031 WIEN Tel. : 43-1-711 724 642 Fax : 43-1-714 92 22 P.O. Box 278 FIN-00531 HELSINKI Tel. : 000-0-000 72 112 Medicines Control Agency 0 Xxxx Xxxx Xxxx GB-LONDON SW8 5NQ Tel. : 00-000-000 0500 Fax : 00-000-000 0676 for veterinary immunologicals : Veterinary Medicines Directorate Xxxxxxx Xxxx Xxx Haw, Addlestone GB - SURREY KT15 3NB Tel. : 00-0000-000000 Fax : 00-0000-000000

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.: 0061-06-000-0000 Fax: 00-0-000-0000 for veterinary medicines: Ministry of Agriculture Agricultural Compounds Unit P.O. Box 40063 Upper Hutt New Zealand Tel.: 00-0-000-0000 232 8632 Fax : 0061-06-000-0000 232 8659 For the European Community Community: Algemene Farmaceutische Inspectie Rijksadministratief Centrum Vesalius Gebouw DK-2700 BRØNSHØJ Tel. : 00-00-000 320 Fax : 00-00-000 077 GERMANY Bundesministerium für Gesundheit Am Propsthof 78a D-53108 BONN Tel. : 00-000-000 2340 Fax : 00-000-000 4923 for immunologicals : Xxxx-Xxxxxxx-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 000-000 xxxxxxxxx Xxxxxxx Xxxxxx 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.: +00-0000 0000 Fax : +00-0000 0000 IRELAND National Drugs Advisory Board 00-00 Xxxxxxxx Xxxx XXX-XXXXXX 2 Tel. : 353-1-676.4971 - 7 Fax : 353-1-676.7836 Direzione Generale del Servicio Farmaceutico Xxxxx xxxxx Xxxxxxx Romana 7 I-00144 ROMA Tel. : 39-6-5994 3676 Fax : 39-6-5994 3365 L-2546 LUXEMBOURG Tel. : 000-000 0000 / 93 Fax : 000-00 00 00 Inspectie voor de Gezondheidszorg Postbus 5406 5850 NL-2280 HW RIJSWIJK Tel. : 00-00-000 7911 6839 Fax : 00-00-000 5177 7159 Xxxxxxxxxxxxxx 0 A-1031 WIEN Tel. : 43-1-711 724 642 Fax : 43-1-714 92 22 P - 1700 LISBOA Tel. : 000-0-000 7836 Fax : 000-0-000 9116 FINLAND National Agency for Medicines P.O. Box 278 FIN-00531 HELSINKI Tel. : 000-0-000 72 112 Fax : 000-0-000 469 Medicines Control Agency 0 Xxxx Xxxx Xxxx GB-LONDON SW8 5NQ Tel. : 00-000-000 0500 Fax : 00-000-000 0676 for veterinary immunologicals : Veterinary Medicines Directorate Xxxxxxx Xxxx Xxx Haw, Addlestone GB - SURREY KT15 3NB Tel. : 00-0000-000000 Fax : 00-0000-000000

OFFICIAL INSPECTION SERVICES. For New Zealand: for medicines for human use: Ministry of Health Therapeutics Section P.O. Box 5013 Wellington New Zealand X.X. Xxx 0000 Xxxxxxxxxx Xxx Xxxxxxx Tel.: 00-0-000-0000 Fax: 00-0-000-0000 for veterinary medicines: Ministry of Agriculture Agricultural Compounds Unit P.O. Box 40063 Upper Hutt New Zealand Xxxx X.X. Xxx 00000 Xxxxx Xxxx Xxx Xxxxxxx Tel.: 00-0-000-0000 Fax : 00-0-000-0000 For the European Community : Algemene Farmaceutische Inspectie Rijksadministratief Centrum Vesalius Gebouw Xxxxxxxxxxxxxxxxxxx Xxxxxxx Xxxxxxxx Xxxxxx Fax : 00-00-000 077 for immunologicals : Xxxx-Xxxxxxx-Institut, Federal Agency for Sera Xxxx & Vaccines Postfach Xxxxxxxx Xxxxxxxx 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 000-000 xxxxxxxxx Xxxxxxx Xxxxxx 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 Xxxxxxxxx xx Xxxxxxxxxx Xxxxxxxxxxx xx Xxxxx Xxxxxx - Javené F Xxxxxx X - 35133 00000 FOUGERES. Tel.: +00-0000 0000 Fax : +00-0000 0000 IRELAND National Drugs Advisory Board 00-00 Xxxxxxxx Xxxx XXX-XXXXXX 2 Tel. : 353-1-676.4971 - 7 Fax : 353-1-676.7836 Direzione Generale del Servicio Farmaceutico Xxxxx xxxxx Xxxxxxx Romana 7 I-00144 ROMA Tel. : 39-6-5994 3676 Fax : 39-6-5994 3365 L-2546 LUXEMBOURG Tel. : 000-000 0000 / 93 Fax : 000-00 00 00 Inspectie voor de Gezondheidszorg Postbus 5406 NL-2280 HW RIJSWIJK Xxxxxxxxxxxxxxx Xxxxxxx 0000 XX-0000 XX XXXXXXXX Tel. : 00-00-000 7911 Fax : 00-00-000 5177 Xxxxxxxxxxxxxx 0 A-1031 WIEN X-0000 XXXX Tel. : 43-1-711 724 642 Fax : 43-1-714 92 22 P.O. Box 278 FIN-00531 HELSINKI X.X. Xxx 000 XXX-00000 XXXXXXXX Tel. : 000-0-000 72 112 Medicines Control Agency 0 Xxxx Xxxx Xxxx GBXX-LONDON SW8 5NQ XXXXXX XX0 0XX Tel. : 00-000-000 0500 Fax : 00-000-000 0676 for veterinary immunologicals : Veterinary Medicines Directorate Xxxxxxx Xxxx Xxx Haw, Addlestone GB - SURREY KT15 3NB Tel. : 00-0000-000000 Fax : 00-0000-000000