MALTA Law and Practice Contributed by: Deo Falzon, Fenech & Fenech Advocates
under an appropriate legal basis (typically consent or public interest in public health or scientific research). 2.6 Personal or Sensitive Data The creation and maintenance of databases contain- ing clinical trial data must be conducted in compli- ance with the GDPR. Again, an appropriate legal basis should have been obtained in this case. The Research Ethics Committee must also review such databases during the clinical trial approval process, particularly if data is to be used for secondary research purposes. In Malta, a product is classified as either a medicinal product or a medical device according to the criteria set out under Directive 2001/83/EC and Regulation (EU) 2017/745 (MDR). The primary distinction lies in the mechanism of action, as outlined below. • A medicinal product exerts its principal intended action by pharmacological, immunological, or metabolic means. • A medical device, by contrast, achieves its prin- cipal intended action by physical or mechanical means, even if it is supported by pharmacological action. 3. Marketing Authorisations 3.1 Product Classification In cases of borderline products, the Malta Medicines Authority (MMA) makes the classification determina- tion based on the product’s intended use, mode of action, and claims, often referring to the European Commission’s Borderline and Classification Manual and EU guidance (eg, MDCG 2022-5). 3.2 Marketing Authorisation for Biologic Medicinal Products Biologic medicinal products are authorised via pro- cedures established in Regulation (EC) No 726/2004. Products developed using biotechnological process- es (eg, recombinant DNA and monoclonal antibodies) must undergo a centralised procedure co-ordinated by the European Medicines Agency (EMA).
For other biologics, authorisation may follow national or decentralised procedures under Directive 2001/83/ EC. In Malta, the MMA processes these in accordance with the Medicines (Marketing Authorisation) Regula- tions (SL 458.34). Due to the biologicals’ complexity, applications require a complete dossier with extensive quality, non-clinical, and clinical data, as well as a Risk Management Plan (RMP) in accordance with Module V of GVP guide- lines. Biosimilars must demonstrate comparability with the reference product per EMA biosimilar guidelines and In accordance with Directive 2001/83/EC, marketing authorisations (MAs) for medicinal products in Malta are initially valid for five years. Upon renewal, and fol- lowing a favourable risk-benefit reassessment, the MA may be renewed for an unlimited period, unless the MMA decides to grant a further five-year renewal on justified grounds. The MMA may revoke a marketing authorisation if: • the product proves harmful under normal use; • the therapeutic efficacy is lacking; • the risk-benefit ratio is no longer favourable; and • the product is not placed on the market within three years of the MA grant, or is absent from the market for three consecutive years, unless justified on public health grounds. For medical devices, the CE certificate (issued by a notified body for applicable classes) has a validity of up to five years, subject to periodic surveillance and reassessment. Under the MDR, certificates issued under previous Directives are valid only within the tran- sitional periods defined in Regulation (EU) 2023/607. 3.4 Procedure for Obtaining a Marketing Authorisation Medicinal Products Authorisation may be obtained via: Article 10 (4) of Directive 2001/83/EC. 3.3 Period of Validity of Marketing Authorisations
183 CHAMBERS.COM
Powered by FlippingBook