MRU meeting on market authorisation process

FOI Pharmaceutical Manufacturing Sector Group co-ordinator Dr Claude Farrugia, together with two other sector group members, Michelle Magro (Pharmamed Ltd.) and Vincent Bartolo (Multigas Ltd), participated at a meeting late last month of the Medicines Regulatory Unit (MRU) that focused on the market authorisation process.

Until recently, the process of authorising products for the local market involved the World Health Organisation CPP scheme, which was valid until November 2002. At this meeting, the MRU officials announced that, at the beginning of this year, the Ministry of Health was to launch the new programme for the granting of market authorisations for medicinal products to be placed on the local market in terms of the Medicines Act (Act III of 2003).

Prospective marketing authorisation holders were advised to complete the respective applications and submit them to the MRU directly or through their officially appointed contact persons.

Four classes of products were highlighted and discussed:

a) products on the transition list that are authorised in the EU;

b) products on the transition list that are not authorised in the EU;

c) products not on the transition list that are authorised in the EU; and

d) products not on the transition list that are not authorised in the EU.

Among the other points raised during the meeting were those relating to mutual recognition and centrally authorised applications; priority of dossier evaluations; and management of current stocks.