Capital: Warsaw Language: Polish Population: 38 million

2. GENERAL INFORMATION Capital: Warsaw Language: Polish Population: 38 million Climate: Temperate with mild summers and moderately severewinters Currency: Zloty (PLN, zł), 1 zloty = 100 groszy Approx. 11 500 authorized medicinal products

3. GEOGRAPHY Poland has beautiful coastal beaches and dunes, lake districts carved out by glaciers, plains as flat as a pastry board, lush forests, mountains old and new, including the only Table Mountains in Europe, and even a desert region.

4. HISTORY Poland had two historical capitals – Gniezno and Krakow andthe present capital is Warsaw – Thesecities should not to be missed when travelling along the historical trail.

5. These are the most important dates in Polish History 966 – Baptism of Poland 1410 – Battle of Grunwald 1772 – The First Partition of Poland 1791 – Constitution of May 3 1793 – Second Partition of Poland 1795 – Third Partition of Poland 1816 – The Kingdom of Poland 1914 - 1918 – World War I 1918 – Polish Independence 1939 – 1945 – World War II 1989 – Fall of Communism 1999 – Accession to NATO 2004 – Accession to the European Union

6. These are the names of Poles who are famous worldwidely Nicolaus Copernicus – the astronomer and author of “On the Revolutions of the Heavenly Spheres” Frederic Chopin – one of the greatest pianists of the 19th century Maria Sklodowska-Curie - discovered polonium and radium and did research into radioactivity and its use in cancer treatment Karol Wojtyla, known as Pope John Paul II Polish Nobel prize winners include: Henryk Sienkiewicz, Wladyslaw Reymont, Czeslaw Milosz, Lech Walesa and Wislawa Szymborska

7. WHAT AND WHERE MEETINGS OF POLISH PRESIDENCY

8. Meeting of the Group for Coordination of Mutual and Decentralized Procedure – CMDh (28-30 of September, Warsaw); • Meeting of the Committee for Medicinal Products for Human Use – CHMP (28-30 of September, Warsaw); • Meeting of the Pediatric Committee – PDCO (28-30 of September, Warsaw); • Meeting of the Committee for Medicinal Products for Veterinary Use –CVMP (19-21 of September, Warsaw); • Meeting of the Group for Coordination of Mutual and Decentralized Procedure (veterinary) – CMDv (19-21 of September, Warsaw); • Meeting of the Committee on Herbal Medicinal Products – HMPC (5-7 of October Warsaw); • Meeting of the Pharmacovigilance Working Party – PhVWP (5-7 of October Warsaw); • European Medicines Agencies Cooperation on Legal and Legislative Issues – EMACOLEX 11-12 of October, Warsaw • Competent Authority Medical Devices Meeting – CAMD (26-28 of October, Krakow); • Central Management Committee Meeting – CMA (26-28 of October, Krakow).

9. PROPOSED ITEMS FOR AGENDA • Court cases, • Transposition problems of the new legislation on pharmacovigilance and falsified medicinal products, • Other subjects you find interesting. • Please, kindly send your proposals of subjects you would liketo present in Warsaw to: lidia.retkowska@urpl.gov.pl • cc to rafal.gizinski@urpl.gov.pl , for court cases also to: JULIAN.SHELLARD@DWP.GSI.GOV.UK by July 15, 2011

10. VENUE The Marriot Hotel downtown Warsaw

12. We will be happy to host you in Poland !