Pharmaceuticals

Biotech and pharmaceuticals and, in particular, generic pharma, are robust industries, highly targeted by the Maltese Government.

Malta is home to a number of local and international biotech and pharmaceuticals companies, a number of which are our clients.

Malta’s interest in the biotech and pharmaceuticals industry can be seen in the €35 million investment that Malta’s government has made in Malta’s Life Sciences Park and contains not only laboratories available to rent to tenants, but also laboratory training centres as well as conference and meeting rooms, which are also all available to hire.

Our expertise in pharmaceutical law caters to a diverse range of clients, from innovative biotech startups to established multinational pharmaceutical corporations. We provide tailored legal solutions for generic drug manufacturers, contract research organisations (CROs), and companies seeking to establish a European hub for their operations in Malta. Whether you are entering the market for the first time or expanding your existing presence, our team is equipped to support your specific business objectives.

The journey from concept to market in the pharmaceutical industry is governed by a complex web of regulations. At Acumum, we specialise in demystifying Malta’s regulatory framework. We provide strategic guidance on the requirements set by the Medical Authority of Malta, ensuring your operations are fully compliant with both local and EU legislation, including GMP (Good Manufacturing Practice) and GDP (Good Distribution Practice) standards. Our proactive approach helps you anticipate regulatory hurdles, streamline approvals, and maintain compliance throughout your product’s lifecycle.

As a full member of the European Union, Malta’s pharmaceuticals industry is overseen by the Medical Authority of Malta, in accordance with Malta’s Medicines Act, Chapter 458.

The Medical Authority of Malta is a comprehensive, robust and responsive regulator, which allows for medical licensing to be applied for online https://medicinesauthority.gov.mt/onlineapplications

As Malta is a full EU member state, there is a decentralised and streamlined process among member states, whereby if a medicine is authorised in one EU member state (referring state) it may obtain authorisation for marketing and sale in another EU member state, by way of mutual recognition. Where mutual recognition is relied upon, mere notification of that product to the medicines authority in that other member state is sufficient, which saves both time and money, as full authorisation to market and to sell in the other EU member state is not required. The mutual recognition procedure works in both directions: companies with medicines in other EU member states may use the mutual recognition procedure to sell medicines in Malta and vice versa.

Malta’s Medicines Authority (MMA) has undertaken to abide by the zero-day mutual recognition procedure. This means that as long as the product has been nationally recognised in another EU member state, that approved product will also be accepted without any comments from the MMA in exceptional cases, to mitigate shortages or issues with access to critical medicines.

Malta’s corporate tax system for Malta companies is highly efficient, with a headline rate of 35%, which upon the application of shareholder refunds is reduced to a 5% effective Malta tax rate on trading income or 6.25% on passive income (i.e. interest or passive royalties).

Malta has over 75 double tax treaties and is one of the few remaining countries to follow the Full Imputation Scheme. This results in the avoidance of double economic taxation, meaning that there are no taxes levied at the level of the shareholder.

Malta’s Participation Exemption rules mean that in most cases no tax is levied on the distribution of dividends distributed by a subsidiary to its Malta holding company.

For more information on the tax efficiencies of Malta companies, see our Malta company pages.

Biotech and pharmaceuticals companies can enjoy a number of fiscal benefits and grants offered by Malta’s government via its offshoot, Malta Enterprise.

Malta Enterprise offers a number of programmes, including grants, soft loans and tax credits to assist with the set-up, as well as the ongoing operation of your company.

Our lawyers have deep knowledge and experience in the registration and protection of trademarks, patents and design rights. Our experience includes the European Union Intellectual Property Office, the UK Intellectual Property Office and the United States Patent & Trademark Office. Depending on the nature of your business and intended markets, our registrations may be direct with a particular intellectual property office, or via a global forum such as the World Intellectual Property Office. See our intellectual property page for more information.

The law relating to medical devices, pharmaceuticals and biotechnology can be complicated. The need for intellectual property protection and at times the prosecution of counterfeit or other intellectual property infringement, may complicate this area of the law at times, particularly due to its global nature.

Acumum’s lawyers have extensive experience in pharmaceuticals and intellectual property around the world, including in the UK, Malta, the US and Switzerland. We can help guide you through the obstacles and complexities that arise.