Product Defect Reporting
In order to protect public health,
market authorisation holders are required to notify the
Medicines Authority of any quality defect in respect of their
products. Upon verifying the information received the
Authority may recommend a batch recall or restriction of
supplies from the distribution chain.
The Authority can also receive
notification of product defects from other competent
authorities, the medical profession, wholesalers, pharmacies
and patients.
Suspected or obvious batch defects can
be reported by mail, email, fax or telephone :
By Mail - The Medicines
Authority
203, Rue D`Argens, Gzira
1368.
By Email -
By Phone –
00356 23439000
By Fax
– 00356 23439162
Out of Hours Quality Defect Reporting
Urgent quality defect reports that warrant
immediate action and arising outside office hours can be
reported on the dedicated telephone number: 00356 79917721
Guidance note regarding Medicinal Product Defect Reporting
Medicinal Product Defect Reporting Form
- 23/10/09
Recalls
Class 2 Recall of Fucidin® (Sodium fusidate) Pdr for Soln for Infusion 500mg
vials - 15/07/2010
Class 2 Recall Fucidin (Sodium fusidate) Pdr for Soln for
Infusion 500mg vials
- 12/07/2010
Class 2 Recall of Citanest 1% (Prilocaine Hydrochloride)
50ml vials
- 17/02/2010
Class III recall of Salofalk 500mg tablets
-
5/1/2010
