MALTA Law and Practice Contributed by: Deo Falzon, Fenech & Fenech Advocates
3.7 Third-Party Access to Pending Applications for Marketing Authorisations Applications for marketing authorisation are subject to confidentiality obligations, particularly regarding proprietary information, manufacturing processes, and clinical data. Under Maltese law and the EU legal framework, third- party access is limited to what is necessary to ensure transparency while protecting commercially confiden- tial information and personal data, in accordance with: • Regulation (EC) No 1049/2001 on public access to EU documents; • GDPR for personal and health data; and • EMA’s Policy 0070 on publication of clinical data. Once an MA is granted, public access may be permit- ted to the European Public Assessment Report (EPAR) (for centrally authorised products) or summary infor- mation via the MMA website for nationally authorised products. Limited public access may be available via EUDAMED for medical devices, particularly for the Summary of Safety and Clinical Performance (SSCP) for implant- able and Class III devices. 4. Regulatory Reliance and Fast-Track Registration Routes 4.1 Fast-Track Registration Routes Malta, as a Member State of the European Union, does not operate a national fast-track authorisation route independent of the procedures established under EU law. However, accelerated or priority evaluation may occur under the following EU-level mechanisms. • Accelerated assessment under Regulation (EC) No 726/2004, where the Committee for Medicinal Products for Human Use (CHMP) may reduce the timeframe for evaluation to 150 days for medicinal products of major public health interest, particularly innovative therapies addressing unmet medical needs. • Conditional Marketing Authorisations (CMAs) and authorisation under exceptional circumstances, in
accordance with Article 14-a and 14 (8) of Regula- tion (EC) No 726/2004 and Directive 2001/83/EC, respectively. The MDR does not explicitly provide for a fast-track pathway for medical devices. However, under Arti- cle 59 (1) of the MDR, the Malta Medicines Authority (MMA) may grant national derogations from conform- ity assessment requirements in exceptional cases to protect public health or patient safety. 4.2 Regulatory Reliance Malta actively engages in regulatory reliance and mutual recognition mechanisms, in line with its obli- gations under Directive 2001/83/EC and Regulation (EU) 2017/745, as outlined below. • For medicines, Malta participates in the Mutual Recognition Procedure (MRP) and Decentralised Procedure (DCP), whereby marketing authorisa- tions granted by another EU Member State (Refer- ence Member State) are recognised and validated by Malta (Concerned Member State), provided no serious objections are raised. • Work-sharing arrangements within the EU Heads of Medicines Agencies (HMA) network are also utilised for variations, renewals, and pharmacovigi- lance assessments. • For medical devices, the CE mark affixed following a conformity assessment conducted by a notified body designated by another EU Member State is automatically recognised in Malta under the princi- ples of the internal market. Malta does not maintain separate reliance mecha- nisms for authorisations issued by non-EU jurisdic- tions. However, information from other stringent regu- latory authorities (SRAs) may be considered during scientific assessments.
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