A final national stage that enables applicants to obtain a Marketing Authorisation according to the Decentralised procedure (DCP), or the Mutual Recognition Procedure (MRP).
Certificate if the application is positively evaluated.
Market Authorisation Holders (MAH).
Fill in the online form and submit.
i) Proof of payment
ii) Curriculum Vitae of Qualified Person
iii) Copies of the Summary of Product Characteristics (SmPC) and Package Information Leaflet (PIL)
iv) Mock-ups of the outer and immediate labelling of the product. The Maltese Marketing Authorisation number should be clearly visible on the outer pack
v) Letter of access of Market Authorisation Holders (MAH)