Medicinal products, Medical Devices & Cannabis for Medicinal use
Classified by the World Health Organisation as the 5th best overall providers of healthcare systems in the world, Malta as a Mediterranean EU and Eurozone member and centre of intercontinental transhipment, provides unique infrastructure and opportunity for the Pharmaceutical & Biotech industry, enhanced by an established resident community of experts, support resources and investor-friendly environment.
In Malta, the Ministry of Health governs the regulatory aspect and service provision of healthcare, and the local healthcare system provides an all-encompassing, tax financed, broad spectrum of services to patients. As an EU member state since 2004; Malta is actively involved in all procedures for the 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.
On 4th August 2020; the Malta Medicines Authority has been appointed as the National Competent Authority for Medical Devices. The Medical Device Unit in the Malta Medicines Authority regulatory role is to manage the operations which includes the monitoring of all medical devices placed on the local market, while making sure that they are safe for the public and that they function as intended. As a European Member State, Malta follows Good Practice legislation for the distribution for medical products distributed from within EU/EEA (GDP) and a wholesale dealers license is required to trade in these products. Brokerage licenses are also required when acting as intermediary and connecting different licensed entities together for future trade of medicinal products.
Given Malta’s strategic location within the Mediterranean and highly developed regulatory body for the licensing and distribution of medicine together with Malta enterprise incentives for the setting up of plants locally, Malta offers benefits for the setting up of manufacturing sites for medicinal products inline with Good practice (GMP). These incentives include:-
- 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.
Patent Protection & Roche Bolar Exemption
In selecting the most appropriate jurisdiction to file a patent, Malta emerges as one of the most versatile EU locations due to its unique blend of Anglo-Saxo & Civil law, and advantageous protection to patent-owners in terms of a 20-year protection from date of filing. This is of strategic importance to manufacturers as it allows development of generics whilst safeguarding their research and development and competitive advantage. In the context of framing research within a competitive and robust intellectual property frame, Malta assures (since 2003) effective Bolar implementation such that Malta’s Patent & Design law allows manufacturers of generics to conduct clinical trials and testing so as to secure regulatory approval prior to expiration of the patent. This allows pre-market readiness in anticipation of expiry of a patent.
DAL’s team can provide advice 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. Review of dossiers and existent quality systems and other key elements will allow the team to provide best options to facilitate the Malta company in acting as a steppingstone to other markets and safeguarding the direct/ indirect interests whether through consulting on additional procedure implementation, applying for grants and incentives related to research, development, and innovation. We have a long-established collaboration with Malta’s leading intellectual property specialists, enabling us to provide the client with peace of mind on such fundamental matters, whilst in parallel focusing on the business frame and strategy to develop current and or new business.
Since 2006; we have worked extensively in this sector, building a strong knowledge of contact between multinational manufacturers and distributors, MAH’s and pharmacovigilance, logistics and supply chain audits, assisting clients to manage their relationships with regulatory authorises, Malta enterprise, suppliers, Vat & Tax authorities and outsourced service providers. 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. Through other related companies, we can offer ongoing administration and also outsourced key personnel as required or assistance in recruitment depending on the needs of the company.