Maltese Law

Medicines Act, 2003 (Act III of 2003), amended by Act III of 2004, Act XI of 2007, Act XXIX of 2007 and L.N. 427 of 2007.

• Commencement Notice (L.N. 358 of 2003)
• Commencement Notice (L.N. 359 of 2003)
• Qualified Person (Fees for Application) Regulations, 2004 (L.N. 260 of 2004), amended by L.N. 427 of 2007
• Delegation to Medicines Authority Order, 2004 (L.N. 334 of 2004)
• Parallel Importation of Medicinal Products Regulations, 2004 (L.N. 437 of 2004)
• Colouring Matters in Medicinal Products for Human Use Regulations, 2004 (L.N. 474 of 2004)
• Good Manufacturing Practice in Respect of Medicinal and Investigational Medicinal Products for Human Use Regulations, 2004 (L.N. 485 of 2004)
• Clinical Trials Regulations, 2004 (L.N. 490 of 2004), amended by L.N. 248 of 2007
• Herbal Medicinal Products Regulations, 2005 (L.N. 379 of 2005)
• Medicinal Products (Advertising) Regulations, 2005 (L.N. 380 of 2005)
• Manufacture and Importation of Medicinal Products for Human Use Regulations, 2005 (L.N. 381 of 2005), amended by L.N. 252 of 2009
• Wholesale Distribution of Medicinal Products Regulations, 2005 (L.N. 386 of 2005)
• Medicinal Products (Labelling and Packaging) Regulations, 2005 (L.N. 393 of 2005)
• Pharmacovigilance Regulations, 2006 (L.N. 61 of 2006)
• Government Health Services (List of Medicinal Products) (Repeal) Regulations, 2006 (L.N. 80 of 2006)
• Good Clinical Practice and Requirements for Manufacturing or Import Authorisation of Investigational Medicinal Products (Human Use) Regulations, 2006 (L.N. 119 of 2006)
• Special Procedure (Penalties in respect of the Medicines Act) Regulations, 2006 (L.N. 264 of 2006), amended by L.N. 427 of 2007
• Prescription and Dispensing Requirements Rules, 2006 (L.N. 292 of 2006)
• Medicines Authority (Fees) Regulations, 2006 (L.N. 315 of 2006), amended by L.N. 427 of 2007
• Medicinal Products (Package Leaflets and Labelling) (Transitional Arrangements) Regulations, 2006 (L.N. 325 of 2006), amended by L.N. 253 of 2010
• Prescription Forms for Free Medicinals Rules, 2007 (L.N. 67 of 2007)
• Authorization of Dispensing of Medicinal Gases from Premises other than a Pharmacy Rules, 2007 (L.N. 243 of 2007)
• Pharmacy Licence Regulations, 2007 (L.N. 279 of 2007), amended by L.N. 81 of 2008
• Medicines (Marketing Authorisation) Regulations, 2007 (L.N. 324 of 2007), amended by L.N. 231 of 2008 and L.N. 252 of 2010
• Medicines Products (Injunction to Advertising) Regulations, 2008 (L.N. 60 of 2008)
• Dispensing of Medicinal Products (Foundation for Social Welfare Services) Rules, 2008 (L.N. 235 of 2008)
• Pharmacy Licences (Fees) Regulations, 2008 (L.N. 236 of 2008)
• Health Ethics Committee (Fees) Regulations, 2009 (L.N. 29 of 2009)
• Availability of Medicinal Products within the Government Health Services Regulations, 2009 (L.N. 58 of 2009)
• Rules of 2009 on the Provision of Medicinal Products through the GenitoUrinary Clinic within the Government Health Services (L.N. 188 of 2009)

Repealed Legislation.

• Marketing Authorisation (Fees) Regulations, 2003 (L.N. 372 of 2003), repealed by L.N. 315 of 2006
• Government Health Services (List of Medicinal Products) Regulations, 2003 (L.N. 398 of 2003), repealed by L.N. 80 of 2006
• Government Health Services (List of Available Medicinal Products) Regulations, 2003 (L.N. 399 of 2003), repealed by L.N. 165 of 2007
• Medicinal Products (Advertising) Regulations, 2003 (L.N. 400 of 2003), amended by L.N. 269 of 2004, repealed by L.N. 380 of 2005
• Medicinal Products (Labelling and Packaging) Regulations, 2003 (L.N. 401 of 2003), repealed by L.N. 393 of 2005
• Medicines (Marketing Authorisation) Regulations, 2003 (L.N. 426 of 2003), repealed by L.N. 387 of 2004
• Pharmacovigilance Regulations, 2003 (L.N. 22 of 2004), repealed by L.N. 61 of 2006
• Manufacture of Medicinal Products for Human Use Regulations, 2004 (L.N. 143 of 2004), repealed by L.N. 381 of 2005
• Importation and Wholesale Distribution of Medicinal Products Regulations, 2004 (L.N. 154 of 2004), amended by L.N. 378 of 2004, repealed by L.N. 386 of 2005
• List of Active Substances in a Medicinal Product (Requirement of Prescription) Regulations, 2004 (L.N. 200 of 2004), repealed by L.N. 368 of 2007
• Medicines (Marketing Authorisation) Regulations, 2004 (L.N. 387 of 2004), amended by L.N. 465 of 2004 and L.N. 72 of 2005, repealed by L.N. 324 of 2007
• Authorization of Dispensing of Medicinal Oxygen from Premises other than a Pharmacy Rules, 2005 (L.N. 398 of 2005), repealed by L.N. 243 of 2007
• Medicines Authority (Fees) Regulations, 2006 (L.N. 26 of 2006), repealed by L.N. 315 of 2006
• Availability of Medicinal Products within the Government Health Services Regulations, 2007 (L.N. 165 of 2007), amended by L.N. 427 of 2007, repealed by L.N. 58 of 2009

Veterinary Medicinal Products