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European Medicines Agency Home (437 words) |
 | The European Medicines Agency (EMEA) has finalised a guideline on the conduct of pharmacovigilance for medicines used by the paediatric population - children from birth to 18 years of age. |
 | The first live submission to the product information management (PIM) system was received by the EMEA in support of a new marketing authorisation application via the centralised procedure in June 2006, with a start date for the review procedure of 21 June. |
 | The EMEA, Rapporteur and Co-Rapporteur have committed to the use of the PIM review system for all comments and changes to the product information submitted during the lifecycle of the product. |
| EudraVigilance - Pharmacovigilance in EEA (1357 words) |
 | The EMEA was created by Council Regulation (EEC) No 2309/93 of 22 July 1993 and began its activites on 1 February 1995. |
 | EMEA’s role is to ensure the safe and effective use of Centrally Authorised medicinal products (products authorised throughout the European Union). |
 | EMEA staff are dedicated to the upkeep of the database. |