Medicines Act, 2003 [Cap. 458]
Medicines Act, 2003
(Act III of 2003) [Cap. 458] (Maltese & English
versions)
http://www.doi.gov.mt/EN/parliamentacts/2003/Act%203.PDF
Amended by
Act III of 2004 (Maltese version)
http://www.doi.gov.mt/EN/parliamentacts/2004/ACTIIIm.pdf
Amended by
Act III of 2004 (English version)
http://www.doi.gov.mt/EN/parliamentacts/2004/ACTIIIe.pdf
Amended by
Act XI of 2007 (Maltese & English versions)
http://www.doi.gov.mt/EN/parliamentacts/2007/ACT XI.pdf
Legal Notices
General
Legal Notice 358 of 2003: Commencement
notice. (MT & EN)
http://www.doi.gov.mt/EN/legalnotices/2003/11/LN358.pdf
Legal Notice 359 of 2003: Commencement
notice. (MT & EN)
http://www.doi.gov.mt/EN/legalnotices/2003/11/LN%20359.pdf
Legal Notice 334 of 2004: Delegation to
Medicines Authority Order, 2004. (MT & EN)
http://www.doi.gov.mt/EN/legalnotices/2004/06/LN334.pdf
Licensing
Post-Licensing
Legal Notice 380 of 2005: Medicinal
Products (Advertising) Regulations, 2005. (MT &
EN)
http://www.doi.gov.mt/EN/legalnotices/2005/11/LN380.pdf
Legal Notice 61 of 2006:
Pharmacovigilance Regulations, 2006. (MT & EN)
http://www.doi.gov.mt/EN/legalnotices/2006/03/LN61.pdf
Manufacturers
Legal Notice 485 of 2004: Good
Manufacturing Practice in Respect of Medicinal and Investigational Medicinal
Products for Human Use Regulations, 2004. (MT &
EN)
http://www.doi.gov.mt/EN/legalnotices/2004/11/LN485.pdf
Legal Notice 381 of
2005: Manufacture and Importation of Medicinal Products for Human Use
Regulations, 2005. (MT & EN)
http://www.doi.gov.mt/EN/legalnotices/2005/11/LN381.pdf
Legal Notice 119 of 2006: Good Clinical Practice and
Requirements for Manufacturing or Import Authorisation of Investigational
Medicinal Products (Human Use) Regulations, 2006. (MT
& EN)
http://www.doi.gov.mt/EN/legalnotices/2006/05/LN119.pdf
Wholesale Dealers
Legal Notice 386 of 2005: Wholesale
Distribution of Medicinal Products Regulations, 2005.
(MT & EN)
http://www.doi.gov.mt/EN/legalnotices/2005/11/LN386.pdf
Pharmacies / Dispensing
Internal Control of Dangerous Drugs
Rules: Legal Notice 292 of 1939 as amended.
(Maltese version)
http://docs.justice.gov.mt/lom/legislation/maltese/subleg/101/02.pdf
Internal Control of Dangerous Drugs
Rules: Legal Notice 292 of 1939 as amended.
(English version)
http://docs.justice.gov.mt/lom/legislation/english/subleg/101/02.pdf
Drugs (Control) Regulations: Legal
Notice 22 of 1985 as amended (Maltese version).
http://docs.justice.gov.mt/lom/legislation/maltese/subleg/31/18.pdf
Drugs (Control) Regulations: Legal
Notice 22 of 1985 as amended (English version).
http://docs.justice.gov.mt/lom/legislation/english/subleg/31/18.pdf.
Licensing Fees for Private Medical
Premises Regulations: Legal Notice 143 of 1998 (Maltese version).
http://docs.justice.gov.mt/lom/Legislation/Maltese/SubLeg/458/26.PDF
Licensing Fees for Private Medical
Premises Regulations: Legal Notice 143 of 1998 (English version).
http://docs.justice.gov.mt/lom/Legislation/English/SubLeg/458/26.pdf
Opening Hours of Dispensaries Order:
Legal Notice 364 of 2002 (Maltese version).
http://docs.justice.gov.mt/lom/Legislation/Maltese/SubLeg/458/28.PDF
Opening Hours of Dispensaries Order:
Legal Notice 364 of 2002 (English version).
http://docs.justice.gov.mt/lom/Legislation/English/SubLeg/458/28.PDF
Legal Notice 365 of 2005: Methadone
Rules, 2005.
http://www.doi.gov.mt/EN/legalnotices/2005/11/LN365.pdf
Legal Notice 292 of 2006: Prescription and Dispensing
Requirements Rules, 2006.
http://www.doi.gov.mt/EN/legalnotices/2006/11/LN292.pdf
Legal Notice 67 of 2007: Prescription Forms for Free
Medicinals Rules, 2007.
http://www.doi.gov.mt/EN/legalnotices/2007/03/LN 67.pdf
Legal Notice 243 of 2007: Authorisation of Dispensing of
Medicinal Gases from Premises other than a Pharmacy Rules, 2007.
http://www.doi.gov.mt/EN/legalnotices/2007/08/LN 243.pdf
Legal Notice 279 of 2007: Pharmacy Licence Regulations,
2007.
http://www.doi.gov.mt/EN/legalnotices/2007/10/LN 279.pdf
Amended by
Legal Notice 81 of 2008: Pharmacy
Licence (Amendment) Regulations, 2008.
http://www.doi.gov.mt/EN/legalnotices/2008/02/LN 81.pdf
Legal Notice 235 of 2008: Dispensing of
Medicinal Products (Foundation for Social Welfare Services) Rules,
2008.
http://www.doi.gov.mt/EN/legalnotices/2008/09/LN%20235.pdf
Fees
Legal Notice 260 of 2004: Qualified
Person (Fees for Application) Regulations, 2004.
http://www.doi.gov.mt/EN/legalnotices/2004/05/LN260.pdf
Legal Notice 315 of 2006: Medicines Authority (Fees)
Regulations, 2006.
http://www.doi.gov.mt/EN/legalnotices/2006/12/LN315.pdf
Legal Notice 427 of 2007 [under the
EURO ADOPTION ACT, 2006 (ACT X of 2006)]: Adaptation of Laws
(Chapters 451-492) Order, 2007.
http://www.doi.gov.mt/EN/legalnotices/2007/12/LN427.pdf
Legal Notice 236 of
2008: Pharmacy Licences (Fees) Regulations,
2008.
http://www.doi.gov.mt/EN/legalnotices/2008/09/LN%20236.pdf
Legal Notice 29 of 2009: Health Ethics
Committee (Fees) Regulations, 2009.
http://www.doi.gov.mt/EN/legalnotices/2009/01/LN%2029.pdf
Other
Legal Notice 474 of 2004: Colouring
Matters in Medicinal Products for Human Use Regulations, 2004.
http://www.doi.gov.mt/EN/legalnotices/2004/11/LN474.pdf
Legal
Notice 80 of 2006: Government Health Services (List of Medicinal Products)
(Repeal) Regulations, 2006.
http://www.doi.gov.mt/EN/legalnotices/2006/03/LN80.pdf
Legal Notice 264 of 2006: Special Procedure (Penalties in
respect of the Medicines Act) Regulations, 2006.
http://www.doi.gov.mt/EN/legalnotices/2006/10/LN264.pdf
Legal Notice 165 of 2007: Availability of Medicinal
Products within the Government Health Services Regulations, 2007.
http://www.doi.gov.mt/EN/legalnotices/2007/06/LN 165.pdf
Legal Notice 60 of 2008: Medicines Products (Injunction to Advertising)
Regulations, 2008.
http://www.doi.gov.mt/EN/legalnotices/2008/02/LN 60.pdf
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