MALTA Law and Practice Contributed by: Deo Falzon, Fenech & Fenech Advocates
• centralised procedure (Regulation (EC) 726/2004); • decentralised or Mutual Recognition Procedures (DCP/MRP) (Directive 2001/83/EC); and • national procedure for Malta-only authorisation. Applications must include a Common Technical Docu- ment (CTD) and are assessed within 210 days (exclud- ing clock stops). Variation procedures follow Regulation (EC) 1234/2008, categorised as follows. • Type IA: Minor changes (immediate or annual noti- fication). • Type IB: Moderate changes requiring notification and tacit approval. • Type II: Major changes (eg, therapeutic indications) requiring prior approval. Transfer of an MA is permissible, subject to a formal request to the MMA, submission of administrative documentation, and agreement from both parties. The new MAH must assume full regulatory responsibility. Medical Devices Manufacturers must ensure compliance with the MDR, conduct a conformity assessment, and obtain a CE marking. The route depends on the device’s risk class: • Class I: Self-declaration by the manufacturer; or • Classes IIa, IIb, III: Involvement of a notified body for review and issuance of an EU certificate. Significant modifications to design, intended purpose, or manufacturing require assessment by the notified body and possible amendment of the existing certifi- cate or issuance of a new one. 3.5 Access to Pharmaceuticals and Medical Devices Without Marketing Authorisations Medicinal products without a marketing authorisation may be supplied in Malta under specific derogations: • compassionate use programmes (Directive 2001/83/EC, Article 83), authorised by the MMA; and • named patient supply under Article 5 (1) of Direc- tive 2001/83/EC, where a prescriber may request
access to unauthorised medicines for an individual patient in the absence of alternative therapies. Similarly, under Article 59 (1) of the MDR, medical devices without CE marking may be authorised on an exceptional basis by the competent authority, where necessary in the interest of public health or patient safety. 3.6 Ongoing Obligations Imposed by Marketing Authorisations Pharmacovigilence is defined here as the pharmaco- logical science relating to the detection, assessment, understanding, and prevention of adverse effects, particularly long-term and short-term side effects of medicines. Technovigilance is defined here as the science relat- ing to the detection, assessment, understanding, and prevention of adverse incidents, particularly the long- term and short-term side effects of medical devices. After obtaining an MA, the holder must: • maintain product safety through pharmacovigilance (for medicines) or vigilance/technovigilance (for medical devices); • submit Periodic Safety Update Reports (PSURs) and comply with post-authorisation study require- ments, if imposed; and • notify the MMA of any changes affecting quality, safety or efficacy. Good Pharmacovigilance Practices (GVP) modules apply to medicines. The MAH must have a Qualified Person for Pharmacovigilance (QPPV) and maintain a Pharmacovigilance System Master File (PSMF). For medical devices, the manufacturer or authorised representative must comply with the MDR’s vigilance requirements (Articles 87–90), report serious incidents, and perform post-market surveillance per Article 83. Based on evolving benefit-risk data, the MMA may impose post-authorisation measures, including Phase IV studies or additional monitoring.
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