Qualified Person Eligibility (On a Manufacturing Importation Authorisation)

Overview

For a person to be named on a Manufacturing Importation Authorisation (MIA) as a Qualified Person (QP), s/he must be approved by the Competent Authority issuing that MIA as being eligible to be named as a QP. The Competent Authority must be satisfied that Directive 2001/83/EC (Article 49) requirements as transposed into the national legislation (Medicines Act 2003 Article 38 (1e) and Regulation 9 of L.N. 381 of 2005 as amended) are fully met.

What you'll get

Any person who wishes to be eligible as a 'Qualified Person' (QP) with the Medicines Authority in Malta.

Eligibility

Applications are being considered as being positively assessed and hence eligible for a QP interview if a number of criteria are met, particularly EU citizenship or permanent Maltese residence with working permit; work experience in the quality aspect of an EU/EEA/MRA Competent Authority authorised manufacturing facility producing medicinal products for human use and covering the dosage form/s for which s/he will be interviewed; a primary degree in a scientific discipline.

How to apply

Fill in the online form, print it, sign it and send to:

The Medicines Authority
The Malta Life Sciences Park
Sir Temi Zammit Buildings
San Ġwann SGN 3000

Interviews are usually carried out twice a year, one interview session generally held in the first quarter and another session held in the last quarter of every calendar year (subject to availability of applications eligible for interview).