MALTA Law and Practice Contributed by: Deo Falzon, Fenech & Fenech Advocates
7.2 Importer of Record of Pharmaceuticals and Medical Devices Only entities holding a Manufacturer’s Authorisation for Import may act as the importer of record for medic- inal products entering Malta from third countries. These entities must comply with Good Manufacturing Practice (GMP) and are required to appoint a Qualified Person (QP) responsible for batch certification. For medical devices, importers are defined under Arti- cle 13 of the MDR and must ensure that devices are CE-marked, compliant with applicable requirements, and properly labelled. Importers must maintain rel- evant documentation and co-operate with authorities in the context of market surveillance and vigilance activities. 7.3 Prior Authorisations for the Import of Pharmaceuticals and Medical Devices Pharmaceutical imports into Malta from non-EU/EEA countries require prior authorisation via a valid Man- ufacturer’s Authorisation for Import. Exceptions are permitted for: • named patient use under Article 5 (1) of Directive 2001/83/EC; • compassionate use schemes under Article 83 of Regulation (EC) No 726/2004; and • personal use, subject to defined limitations. Prior authorisation is not generally required for medi- cal devices if they are CE-marked and compliant with MDR requirements. 7.4 Non-Tariff Regulations and Restrictions Imposed Upon Imports Non-tariff measures applicable to pharmaceutical and medical device imports include GMP certification (for medicines), CE conformity (for devices), labelling requirements, and compliance with applicable safety and performance standards. Such obligations are enforced through import declarations and verification by Customs and the MMA, based on the Combined Nomenclature (CN) and TARIC classification. 7.5 Trade Blocs and Free Trade Agreements As a Member State of the European Union, Malta is a party to all EU Free Trade Agreements (FTAs) and
The MMA routinely inspects distributors to ensure compliance with the MDR/IVDR. Distributors must also assign a Medical Device Registered Person (MDRP) as a regulatory contact. 6.2 Different Classifications Applicable to Pharmaceuticals Pharmaceutical products in Malta are classified according to their mode of supply and regulatory requirements, consistent with Directive 2001/83/EC and national legislation. The main classifications have been outlined below. • Prescription-only medicines (POM): These require a prescription from a licensed healthcare profes- sional and are solely dispensed by a pharmacist through a pharmacy. • Over-the-counter (OTC) medicines: These are also dispensed by a pharmacist or under their supervi- sion within a licensed pharmacy. The Malta Medicines Authority is responsible for over- seeing classification status. Reclassification (eg, from POM to OTC) requires submission of supporting data and may be subject to regulatory and public health considerations. 7. Import and Export of Pharmaceuticals and Medical Devices 7.1 Governing Law and Relevant Enforcement Bodies The importation and exportation of medicinal prod- ucts in Malta are regulated under the Medicines Act (Cap 458), which is aligned with Directive 2001/83/EC and Regulation (EC) No 726/2004. Regulation governs medical devices (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR). The Malta Medicines Authority (MMA) is the compe- tent authority for pharmaceuticals and devices, while the Customs Department, in co-operation with the MMA, provides enforcement at the border.
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