Medicines Act,
2003 (Act No III of 2003)
(Maltese & English versions)
Amended by Act III of 2004(Maltese version)
Amended by Act III of 2004(English version)
Legal Notices
General
Legal Notice 358 of 2003: Commencement Notice
Legal Notice 359 of 2003: Commencement Notice
Legal Notice 398 of 2003: Government Health Services
(List of Medicinal Products) Regulations, 2003
Legal Notice 399 of 2003: Government Health Services
(List of Available Medicinal Products) Regulations, 2003
Legal Notice 334 of 2004: Delegation to Medicines
Authority Order, 2004
Licensing
Legal Notice 324 of 2007: Medicines
(Marketing Authorisation) Regulations
←NEW
Legal Notice 325: Medicinal Products (Package Leaflets
and Labelling) (Transitional Arrangments) Regulations, 2006
Legal Notice 401 of 2003: Medicinal Products
(Labelling and Packaging) Regulations, 2003
Repealed by Legal Notice 393 of 2005: Medicinal
Products (Labelling and Packaging) Regulations, 2005
Legal Notice 387 of 2004: Medicines (Marketing
Authorisation) Regulations, 2004
Amended by Legal Notice 465 of 2004: Medicines
(Marketing Authorisation) (Amendment) Regulations, 2004
Amended by Legal Notice 72 of 2005: Medicines
(Marketing Authorisation) (Amendment ) Regulations, 2005
Legal Notice 437 of 2004: Parallel Importation of
Medicinal Products Regulations, 2004
Legal Notice 490 of 2004: Clinical Trials Regulations,
2004
Legal Notice 379 of 2005: Herbal Medicinal Products
Regulations, 2005
Post-Licensing
Legal Notice 380 of 2005: Medicinal Products
(Advertising) Regulations, 2005 ←NEW
Legal Notice 61 of 2006: Pharmacovigilance
Regulations, 2006 ←NEW
Manufacturers
Legal Notice 485 of 2004: Good Manufacturing Practice
in Respect of Medicinal and Investigational Medicinal Products for Human Use
Regulations, 2004
Legal Notice 381 of 2005 - Manufacture and Importation of
Medicinal Products for Human Use Regulations, 2005
Wholesale Dealers
Legal Notice 386 of 2005 - Wholesale Distribution of Medicinal
Products Regulations, 2005
Pharmacies
Pharmacy Licence Regulations, 2007
Pharmacy Licence (Amendment) Regulations, 2008
Legal Notice 292 of 1939 as amended: Internal Control
of Dangerous Drugs Rules (Maltese Version)
Legal Notice 292 of 1939 as amended: Internal Control
of Dangerous Drugs Rules (English Version)
Legal Notice 31 of 1984 as amended: Dispensaries (Licensing Regulations)
(Maltese Version)
