Pharmaceuticals

BioTech & Pharmaceuticals

Bio-Tech and pharmaceuticals and in particular generic pharma are robust industries, highly targeted by the Maltese Government and Malta is home to a number of local and international bio-tech and pharmaceuticals companies – a number of which are our clients.

Malta’s interest in the bio-tech 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 centre, as well as conference and meeting rooms, which are also available to hire.

Services We Offer

Regulatory Affairs Services

• Medical Products & API Licensing
• Wholesale Dealers License Attainment
• VWL Attainment (Virtual Wholesale Dealer’s License)
• Mutual recognition procedure
• Contract Manufacturing
• Contract QP and RP Services
• GMP/GDP Audit
• EU Market accession
• Local Representation
• Intellectual Property – Malta | EU | USA & World-Wide Registration & Enforcement

EU Member – A Comprehensive, Cross – Border Licensing Regime

As a full member of the European Union,

Malta’s pharmaceutical industry is over seen by the Medical Authority of Malta, in accordance with Malta’s Medicines Act, Chapter 458.

Whilst medical devices are regulated by Directive 2011/83/EEC, regulation (EC) no 178/2002 and regulation (EC) no 1223/2009 which transposed into Maltese law the EU Regulation (EU) 2017/745 (MDR) concerning the clinical investigation and sale of medical devices for human use and Medical Devices And In-Vitro Diagnostic Medical Devices Provision On The Maltese Market Regulations S.L.458.59 in respect of in-vitro use.
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

Mutual Recognition Procedure

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

Zero-day Mutual Recognition Procedure

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

Efficient Corporate Tax System – Tax Benefits

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).

With over 75+ double tax treaties and as 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.

Whilst Malta’s Participation Exemption rules, means 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 as to the tax efficiency of Malta companies, see our Malta company pages.

Fiscal Benefits

Biotech and pharmaceutical 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.

Intellectual Property – Registration & Defence

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.

How can Acumum help?

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

Acumum’s lawyers have extensive pharmaceutical and intellectual property background around the world including UK, Malta, USA and Switzerland and we can help to guide you in the setting up of your business, the obtaining of licenses and its on-going maintenance and protection.