MALTA Law and Practice Contributed by: Deo Falzon, Fenech & Fenech Advocates
5. Manufacturing of Pharmaceuticals and Medical Devices 5.1 Requirement for Authorisation for Manufacturing Plants Pharmaceuticals In accordance with Directive 2001/83/EC and trans- posing national legislation under the Medicines Act (Cap. 458) and Subsidiary Legislation 458.36, any entity engaged in the manufacture or import of medici- nal products in Malta must obtain a Manufacturer’s Authorisation (also known as MIA – Manufacturer’s and Importer’s Authorisation), issued by the Malta Medicines Authority (MMA). The MIA is granted following a comprehensive assess- ment including: • compliance with good manufacturing practice (GMP); • appointment of a qualified person (QP); • inspection of facilities by the MMA. Manufacturing authorisations cover production, pack- aging, quality control, and importation. Although there is no formal expiry, the MMA conducts regular GMP inspections, usually every 2–3 years or risk-based. If a site fails inspection, conditions, suspensions, or revo- cations of the authorisation may occur. Medical Devices Medical device manufacturing is governed by Reg- ulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR). In Malta, no separate national manu- facturing licence is required for medical devices. Local manufacturers are subject to periodic inspections. Economic operators must comply with obligations in Articles 10–14 of the MDR. Manufacturers must: • comply with General Safety and Performance Requirements (Annex I); • maintain a quality management system; • conduct conformity assessment and prepare tech- nical documentation; • assign a Unique Device Identifier (UDI); and • register the device in EUDAMED when functional.
6. Distribution of Pharmaceuticals and Medical Devices 6.1 Wholesale of Pharmaceuticals and The Medicines Act (Cap 458) and Subsidiary Leg- islation 458.37 govern the wholesale distribution of medicinal products in Malta, in line with Directive 2001/83/EC. A Wholesale Distribution Licence (WDL) issued by the Malta Medicines Authority (MMA) is mandatory for entities involved in procuring, holding, supplying, or exporting medicinal products. To obtain a WDL, applicants must demonstrate com- pliance with: Medical Devices Pharmaceuticals • good distribution practice (GDP), as set out in the EU Guidelines on GDP of medicinal products (2013/C 343/01); • suitable premises, storage conditions, and quality systems; and • appointment of a Responsible Person (RP) who ensures continuous compliance with GDP require- ments. The WDL is valid for three years from the date of issu- ance. The licence is subject to routine inspections by the MMA for renewal. Medical Devices Wholesale and distribution of medical devices are regulated under Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR). National legisla- tion obliges them to register as economic operators of medical devices in Malta. Distributors must com- ply with the obligations under Article 14 of the MDR, including: • verifying that the device bears the CE mark and is accompanied by the EU Declaration of Conformity; • ensuring appropriate labelling and instructions for use; • co-operating with manufacturers, authorised representatives, and competent authorities during market surveillance; and • maintaining a record of complaints and non-con- forming products.
186 CHAMBERS.COM
Powered by FlippingBook