Health and Community Care

It is unlawful for any person to carry out any activity in connection with testing, processing, preservation, storage or distribution of human tissue and cells intended for human applications otherwise than in accordance with a licence issued under Article 3 of the Human Blood and Transplant Act.

This authorisation procedure is being applied mainly to cover the public health need created by the lack of applications for Marketing Authorisations for products which were on the derogation list and for products which were authorised in the period between the publication of the derogation list and the date of accession. An authorisation is granted in accordance with Regulation 4(2) of the Medicines (Marketing Authorisation) Regulations (Subsidiary Legislation 458.34), under the Medicines Act, 2003 (Chapter 458 of the Laws of Malta). The authorisation is valid for 5 years. A renewal application should be submitted at least 6 months before the end of validity of the authorisation.

Clinical trials are performed to find out how a medicine works, what side effects it causes and how it is metabolised by the body. Trials are conducted on new medicines and at times using medicines that are already on the market in Malta. Clinical trials refer to any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of one or more Investigational Medicinal Products (IMP). They are also used to identify any adverse reactions to one or more IMPs, and/or to study absorption, distribution, metabolism and excretion of one or more IMPs with the object of ascertaining their safety and/or efficacy. The legal framework for clinical trials with medicinal products for human use is set out in the Clinical Trials Regulations (Subsidiary legislation 458.43) implementing the European Clinical Trials Directive 2001/20/EC.

Certificates of Free Sale for medical devices are issued by a European Competent Authority, upon request by a manufacturer or an authorised representative. These Certificates verify that a medical device may be legally marketed in Malta and in the European

The Application is being presented by the Malta Medicines Authority to increase functionality at all regulatory levels and to allow better communication between the competent Authority and the Distributors, Importers, Manufacturers, Authorised Representatives and Notified Bodies.

A parallel import licence is granted for medicinal products which have a Marketing Authorisation (MA) in Malta. Once issued, it is valid for 5 years. A renewal application must be submitted at least 6 months before the expiry date.