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

Commission Guideline on Braille requirements for labelling and package leaflet.

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

  Diclogesic 12.5mg Suppositories (Class II Medicines Recall)

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

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