Where is industry getting it wrong? A review of quality concerns raised during Marketing Authorisation submissions - 17/8/09

Medicines Authority Circular No P09/2008  Re:  Requirements for submission of E2B(M) Individual Case Safety Reports (ICSRs) to the Medicines Authority - 04.07.2008

PLU01/2006 Report on the European Commission Assessment of the Community System of Pharmacovigilance

DH Circular 97/06 - Update on registration on medicinal products for human use

DH Circular No 138/05 - Update on Medicinal Products for Human Use

Commission Guideline on Braille requirements for labelling and package leaflet.

DH Circular No 70/05

Fees (L.N. 315/2006)

Fees in Euros

Letter of access to be signed by Marketing Authorisation Holders giving access to local licensed wholesale dealers (pharmaceuticals) to use the Marketing Authorisation issued by the Medicines Authority to place a medicinal product on the market in Malta

Guidance note regarding Medicinal Product Defect Reporting

Medicinal Product Defect Reporting Form

Communication regarding the Transition List for Traditional Herbal Medicinal Products

  Diclogesic 12.5mg Suppositories (Class II Medicines Recall)

  Amsidine 75mg ampoules, solution for infusion (Class 2 Medicines Recall) 

  Qualified Person (QP) Eligibility Interviews 4th-7th May 2004 

  Application for a wholesale dealer's licence for medicinal products for human use

  Application for an import licence for medicinal products for human use - 18/01/2006

 Application for a Manufacturers Licence for Medicinal products for Human Use  - 18/01/2006

 Application for a Certificate of a Pharmaceutical Product 

  Information for Wholesale Dealers/Distributors Regarding the Regulation of Traditional Herbal Medicinal Products

For all other publications not included above please refer to the relevant section below:

• Pre-Licensing (Marketing Authorisations)

• Post-Licensing

• Inspectorate (Manufacturing, Importer and Wholesaler licensing)

• Linguistic Check Process (QRD)

• Advertising

• Legislation

• Old Circulars