Health and Community Care

The Malta Medicines Authority reviews applications for the importation and/or wholesale distribution of cannabis based products or synthetic cannabinoid products in Malta, in line with the requirements set out in the Drug Dependence, (Treatment not Imprisonment) Act, as amended.

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 application provides importers with a licence to import medicinal products for human use from outside the European Economic Area (EEA).

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.

Notification of changes to labelling and package leaflets.

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.

This application will provide an authorisation to open or keep a pharmacy for medicinal products for use in humans granted under the Medicines Act and issued by the Licensing Authority.

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.

Marketing Authorisations (MA) granted in the Community shall have an initial duration of 5 years according to Regulation 19(1) of the Marketing Authorisation Regulations (Article 24(1) of Directive 2001/83/EC, as amended). After these 5 years, the MA needs to be renewed on the basis of a re-evaluation of the risk-benefit balance. An application for renewal of a MA shall include the below documents: 
Signed covering letter in paper format (if submitting through CESP);
EU application form for renewal list of all post-authorisation submissions since authorisation/last renewal;
Certificate of compliance with Good Manufacturing Practice;
Quality overview (quality expert statement);
Addendum to clinical overview (if required);
Reports of post-marketing experience (PSURs). 

The renewal application should be submitted according to the EU-CTD format. All the information can be sent electronically through CESP or if on DVD/CD, these should be accompanied by a signed cover letter.