FORMS ------------------------------------------------------------------------------------------------------- MCA Marketing authorisation application form template MCA Marketing authorisation application guidance UK Home Office Drugs Forms European Union Document Networks Czech Medicinal Products- Registration Guidelines & Forms Czech Medicinal Products Manufacture Guidelines and Forms Ireland Adverse Reaction Report Form Ireland Application Forms, Drug Safety Newsletter, Clinical Trials Netherlands Marketing Authorisation Requirements Norway Register of Medical Devices, Manufacturers and Distributors Norway Regulation No. 25 Relating to Medical Devices Norway Regulations Concerning Medical Devices Biotechnology regulation in Norway Slovakian Registration Forms & Instructions Sweden Forms & Format UK MCA Licence Application Forms UK MCA Clinical trials forms

LEGISATION ------------------------------------------------------------------------------------------------------- Accessing European Union Information CELEX EU Law Database EUROPEAN UNION LAW (EUR-Lex) EUR-OP Europa EuroParl European Law Database SCAD Plus International Privacy Law OECD Organisation for Economic Co-operation and Development Official Journal of the European Communities Pharmaceutical Legislation- Medicinal Products for Human Use Regulatory Information

LAWS OF OTHER REGIONS ------------------------------------------------------------------------------------------------------- Australia TGA Canada Protection of Personal Information Canada Parliament Internet Canada - Fool and Drug Act and Regualtions USA Code of Federal Regulations

DATA PROTECTION ------------------------------------------------------------------------------------------------------- Data Protection Law 1998 Data Protection Act 1998: Subordinate Legislation Preparing for the New Law News/Events Specialist Papers Guidance Notes Notification Regulations Data Protection Working Party Documents

SELECTED COUNTRY LEGISLATION ------------------------------------------------------------------------------------------------------- Estonia Georgia Hungary Northern Ireland Scotland Slovakia Sweden UK Wales