MEDICINES AUTHORITY

Inspections

Inspections are carried out by Medicines Inspectors of the Authority in order to assess compliance with the provisions of the Medicines Act 2003 as well as EU standards relating to the specific activity. Inspections are always performed when a new application is received. Upon the outcome of the inspection findings a licence can be recommended or rejected. Routine follow-up inspections are also carried out. Surprise inspections may be warranted in specific circumstances or following a complaint.

Inspections constitute a major activity within the Directorate and are considered as being crucial in ascertaining that the conditions of the licence are met.

GMP and GDP Inspections

These inspections are aimed at establishing the compliance, or otherwise, with GMP and GDP requirements and standards as laid down in the Medicines Act 2003 and EU legislation..

http://www.emea.eu.int

Pharmacy Inspections

Pharmacy inspections are aimed at verifying that the conditions and standards as laid down in the Medicines Act 2003 are met..

http://www.fip.org/pdf/GPP97_en.PDF

Managing Pharmacist Declaration