Having more than 20 years of experience and expertise in the field managing local and international relationships and multi-national obligations; DAL offers a wide range of services for EU and international Pharma and Medical Device matters, either by acting as representative in relation to the Malta Medicines Authority, or as strategic support consultants, providing tailored training, operations and legal support, via our in-house pool of experienced Responsible People, Legal experts, Medical Device Registered Persons and proprietary tried and tested systems which we can transpose accordingly.
Malta’s Medicines Authority thus provides a comprehensive, transparent and reliable regulatory framework for pharmaceutical companies that has gained respect in the international pharma industry due to the culture of high standards it secures in inspections of non-EU manufacturers which it carries out worldwide on behalf of the European Union. To appreciate the successful development of the Malta Medicines Authority in terms of Structures and Systems; one need only take note of the fact that Malta was in the first group of countries which achieved mutual USA recognition in terms of GMP, thus further enhancing the value of local systems and of related regulations’ close adherence to the FDA. The Malta Medicines Authority has thus evolved over the years, positioning Malta strategically as a hub for compliance-driven pharmaceutical and medicinal companies using local versatility to tailor advantageous servicing of target international models and markets; achieved via the following key features:
- Strategic Geo-location, EU Status and compliance-driven tax competitiveness
- Cost effective registration fees & ease of access to Regulatory authorities
- Skilled English speaking multi-cultural work force
- Internationally recognised high standards of the Malta Medicines Authority
- Proactive management of EU’s recent regulation of Medical Devices
Patent management & Generics development
As an EU member state since 2004; Malta follows Good Practice legislation for the distribution of medical products distributed from within EU/EEA (GDP) including the requirement of a Wholesale-Dealers license to trade in these products. Brokerage registration is also required when acting as intermediary and connecting different licensed entities together for future trade of medicinal products. In parallel; Malta has developed a leading EU profile in timely and quality implementation of EU legislation and best practices, especially in the field of registration of medicines and medical devices. The procedure varies depending on whether the product is already traded in the European Union or otherwise. In the former case, a mutual recognition procedure is implemented. If the product is not already authorised in another member state the decentralised process can be used. The Medicines Authority has been acting as a Reference Member State (RMS) for the decentralised process since 2007.
Working extensively in Pharma Advisory & Support; we have built a strong knowledge of the interaction between multinational manufacturers and distributors, MAH’s and pharmacovigilance, logistics and supply chain audits, assisting clients to manage their relationships with regulatory authorities, Malta Enterprise, suppliers, Vat & Tax authorities and outsourced service providers. DAL thus offers a comprehensive range of support to pharmaceutical companies, Market Authorisation Holders, parallel importers, and other related entities on licensing of companies and products within the European Union, and licensing third country products in Europe through the right licensing procedure.
We must emphasise the importance of review of dossiers and existent quality systems and other key elements, as this will allow the team to best understand and service each individual client.
Competitive EU basis for international operations
Malta offers attractive benefits for the setting up of manufacturing sites for medicinal products inline with Good practice (GMP); incentives including :
- Investment Aid
- Allocation of Industrial Space
- Research and Development Schemes
These incentives and robust regulatory framework have enabled Malta to be front runners in the importation, wholesale distribution and production of medicinal products, medical devices and now also for cannabis for medicinal use and research.
As more international operations make Malta their home, our team has shared its hard-earned experience and expertise so that our clients increase value both from a consolidation as well as a business potential perspective. We specialise in ensuring the right systems are designed, operated and monitored firstly in terms of regulatory integrity and secondly in terms of intelligent operational functioning, combining the legal, technical and operational, including assistance in securing appropriate key and admin support depending on the Client needs.
Patent Protection & Roche Bolar Exemption
In selecting the most appropriate jurisdiction for patent and generics management, Malta emerges as one of the most versatile EU locations due to its unique blend of Anglo-Saxo & Civil law. This is of strategic importance to manufacturers as it allows development of generics whilst safeguarding their research and safeguarding competitive advantage. In the context of framing research within a competitive and robust intellectual property frame, Malta assures (since 2003) effective Bolar implementation allowing manufacturers to conduct clinical trials and testing so as to secure regulatory approval prior to expiration of the patent, achieving pre-market EU readiness in anticipation of expiry of a patent.
Pro-active management of EU regulation on Medical devices
On 4th August 2020; the Malta Medicines Authority was appointed as National Competent Authority for Medical Devices. Its Medical Device Unit regulates operations; including the monitoring of all medical devices placed on the local market, ensuring public safety and that they function as intended. Via licensed notified bodies, manufacturers ensure that the products dossier is in line with EU standards to allow issuance of certificates of conformity. Thus Non-European manufacturers can appoint authorised representatives of the non-EU company to act as their European stepping stone. DAL offers clients; access to MDRPs (Medical device registered persons) and responsible guidance with the setup of Quality-Systems for distribution and appropriate post-marketing surveillance of the medical devices in the European Union.
In securing licensing of companies and products within the European Union, and licensing third country products in Europe through the right licensing procedure, DAL’s review of dossiers and existent quality systems and other key elements will allow the team to provide best options to manage new business and safeguard direct/ indirect interests, also applying for grants and incentives related to research, development, and innovation.