In Malta, the regulation of medicinal products for human use is primarily governed by:

• the Medicines Act (Chapter 458 of the Laws of Malta), which transposes Directive 2001/83/EC on the Community code relating to medicinal products for human use, and is also aligned with;
• Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency; and
• associated EU instruments and laws.

The regulation of medical devices is achieved by virtue of:

• the local subsidiary legislation S.L. 458.59, Medical Devices and In-Vitro Diagnostic Medical Devices Provision on the Maltese Market Regulations, and is aligned with; and
• Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR).

These Regulations are directly applicable in Malta without transposition and have repealed the previous Directives 93/42/EEC, 90/385/EEC, and 98/79/EC.

The primary regulatory authority in Malta is the Malta Medicines Authority (MMA), which operates under the remit of the Ministry for Health. The Authority is tasked with regulatory oversight, including the evaluation, authorisation, inspection, pharmacovigilance, and post-market surveillance of medicinal products and medical devices. It functions as a semi-autonomous agency, established by law, and maintains operational independence in technical and scientific matters while being administratively linked to the central government.

Recommendations made by the Medicines Authority to the Licensing Authority relating to the marketing authorisation of a medicinal product or to the suspension, revocation, withdrawal or variance of a marketing authorisation may be appealed before the Medicines Review Board.

Decisions made by the Malta Medicines Authority (MMA) or the Superintendent of Public Health in their regulatory roles can be challenged through judicial review of administrative actions in Malta.

These challenge proceedings are specific to medicinal products and medical devices. Other products may require different considerations.

Medicinal products in Malta are classified in accordance with Directive 2001/83/EC and national implementing measures under the Medicines Act. The main categories include:

• Prescription-only medicines (POM): These require a prescription from a licensed healthcare professional and are solely dispensed by a pharmacist through a pharmacy.
• Over-the-counter (OTC) medicines: These are also dispensed by a pharmacist or under their supervision within a licensed pharmacy.

For medical devices, classification is governed by the MDR and IVDR, which categorise devices based on risk, intended use, and invasiveness:

• Medical devices: Classified into Classes I, IIa, IIb, and III.
• In vitro diagnostic medical devices (IVDs): Classified into Classes A, B, C, and D.

Each classification determines the applicable conformity assessment procedure and the involvement of notified bodies. Other classifications considered are custom-made devices, systems, and procedure packs.

Clinical trials for medicinal products in Malta are regulated under the Clinical Trials Regulation (EU) No 536/2014, which became fully applicable on 31 January 2022. This Regulation repeals Directive 2001/20/EC and establishes a harmonised EU-wide framework for authorising, conducting, and supervising clinical trials through the Clinical Trials Information System (CTIS).

The Malta Medicines Authority (MMA) is the national competent authority responsible for oversight. In addition, the Malta Council for Science and Technology (MCST) and Research Ethics Committees (RECs) established under the national bioethics framework contribute to the ethical review of clinical trials.

Clinical investigations for medical devices are governed by Regulation (EU) 2017/745 (MDR), Articles 62–82, and Annex XV. For performance studies for in vitro diagnostic devices, Regulation (EU) 2017/746 (IVDR), Articles 57–77, and Annex XIV are used. National implementation support is provided through regulatory guidelines published by the MMA. An ethics committee is also used in the process.

A clinical trial sponsor must submit an application for medicinal products through the CTIS portal. The MMA, acting as the Reporting Member State (RMS) or Concerned Member State (CMS), conducts the scientific and regulatory assessment in accordance with Regulation (EU) 536/2014.

Ethical approval is required from a Research Ethics Committee, which must issue its opinion within the timeframe established in the Regulation.

The MDR requires submission to the MMA through national channels for any clinical investigations on medical devices, pending full EUDAMED functionality. Investigations involving medium to high-risk or implantable devices generally require prior authorisation, whereas other classes may proceed upon notification, provided ethical clearance is obtained.

Clinical investigations involving CE-marked devices used outside the scope of their intended purpose (per MDR Article 74) or in multi-country studies (Article 78) must also follow the specific regulatory pathways outlined in the MDR.

The same processes apply to in vitro diagnostic medical devices under the IVDR.

Under Regulation (EU) 536/2014, clinical trials authorised in Malta are recorded in the EU Clinical Trials Information System (CTIS), which is publicly accessible. The Regulation mandates that summaries of trial results and layperson summaries are uploaded irrespective of trial outcome, enhancing transparency.

Similarly, the MDR obliges sponsors to report results of clinical investigations in EUDAMED, including summaries understandable to the public (Articles 77 and 80). Until EUDAMED is fully functional, summary reports are submitted directly to the competent authority.

Data is processed and redacted to comply with the General Data Protection Regulation (GDPR) and other applicable legislation safeguarding patient details.

There is no express prohibition under Maltese Law on using digital or online tools to support clinical trials (eg, for recruitment, eConsent, monitoring, or data collection). However, their use must comply with the General Data Protection Regulation (GDPR) (Regulation (EU) 2016/679) and Good Clinical Practice (GCP) guidelines, including ICH E6(R2). It must also be approved by the relevant Research Ethics Committee, especially if involving patient interaction.

Online tools must not compromise data integrity, participant privacy, or ethical standards.

Data derived from clinical trials is generally considered a special category of personal data under Article 9 of the General Data Protection Regulation. The use, storage, and transfer of such data must be justified under an appropriate legal basis (typically consent or public interest in public health or scientific research).

The creation and maintenance of databases containing clinical trial data must be conducted in compliance with the GDPR. Again, an appropriate legal basis should have been obtained in this case. The Research Ethics Committee must also review such databases during the clinical trial approval process, particularly if data is to be used for secondary research purposes.

In Malta, a product is classified as either a medicinal product or a medical device according to the criteria set out under Directive 2001/83/EC and Regulation (EU) 2017/745 (MDR).

The primary distinction lies in the mechanism of action, as outlined below.

• A medicinal product exerts its principal intended action by pharmacological, immunological, or metabolic means.
• A medical device, by contrast, achieves its principal intended action by physical or mechanical means, even if it is supported by pharmacological action.

In cases of borderline products, the Malta Medicines Authority (MMA) makes the classification determination based on the product’s intended use, mode of action, and claims, often referring to the European Commission’s Borderline and Classification Manual and EU guidance (eg, MDCG 2022-5).

Biologic medicinal products are authorised via procedures established in Regulation (EC) No 726/2004. Products developed using biotechnological processes (eg, recombinant DNA and monoclonal antibodies) must undergo a centralised procedure co-ordinated by the European Medicines Agency (EMA).

For other biologics, authorisation may follow national or decentralised procedures under Directive 2001/83/EC. In Malta, the MMA processes these in accordance with the Medicines (Marketing Authorisation) Regulations (SL 458.34).

Due to the biologicals’ complexity, applications require a complete dossier with extensive quality, non-clinical, and clinical data, as well as a Risk Management Plan (RMP) in accordance with Module V of GVP guidelines.

Biosimilars must demonstrate comparability with the reference product per EMA biosimilar guidelines and Article 10(4) of Directive 2001/83/EC.

In accordance with Directive 2001/83/EC, marketing authorisations (MAs) for medicinal products in Malta are initially valid for five years. Upon renewal, and following a favourable risk-benefit reassessment, the MA may be renewed for an unlimited period, unless the MMA decides to grant a further five-year renewal on justified grounds.

The MMA may revoke a marketing authorisation if:

• the product proves harmful under normal use;
• the therapeutic efficacy is lacking;
• the risk-benefit ratio is no longer favourable; and
• the product is not placed on the market within three years of the MA grant, or is absent from the market for three consecutive years, unless justified on public health grounds.

For medical devices, the CE certificate (issued by a notified body for applicable classes) has a validity of up to five years, subject to periodic surveillance and reassessment. Under the MDR, certificates issued under previous Directives are valid only within the transitional periods defined in Regulation (EU) 2023/607.

Medicinal Products

Authorisation may be obtained via:

• centralised procedure (Regulation (EC) 726/2004);
• decentralised or Mutual Recognition Procedures (DCP/MRP) (Directive 2001/83/EC); and
• national procedure for Malta-only authorisation.

Applications must include a Common Technical Document (CTD) and are assessed within 210 days (excluding clock stops).

Variation procedures follow Regulation (EC) 1234/2008, categorised as follows.

• Type IA: Minor changes (immediate or annual notification).
• Type IB: Moderate changes requiring notification and tacit approval.
• Type II: Major changes (eg, therapeutic indications) requiring prior approval.

Transfer of an MA is permissible, subject to a formal request to the MMA, submission of administrative documentation, and agreement from both parties. The new MAH must assume full regulatory responsibility.

Medical Devices

Manufacturers must ensure compliance with the MDR, conduct a conformity assessment, and obtain a CE marking. The route depends on the device’s risk class:

• Class I: Self-declaration by the manufacturer; or
• Classes IIa, IIb, III: Involvement of a notified body for review and issuance of an EU certificate.

Significant modifications to design, intended purpose, or manufacturing require assessment by the notified body and possible amendment of the existing certificate or issuance of a new one.

Medicinal products without a marketing authorisation may be supplied in Malta under specific derogations:

• compassionate use programmes (Directive 2001/83/EC, Article 83), authorised by the MMA; and
• named patient supply under Article 5(1) of Directive 2001/83/EC, where a prescriber may request access to unauthorised medicines for an individual patient in the absence of alternative therapies.

Similarly, under Article 59(1) of the MDR, medical devices without CE marking may be authorised on an exceptional basis by the competent authority, where necessary in the interest of public health or patient safety.

Pharmacovigilence is defined here as the pharmacological science relating to the detection, assessment, understanding, and prevention of adverse effects, particularly long-term and short-term side effects of medicines.

Technovigilance is defined here as the science relating to the detection, assessment, understanding, and prevention of adverse incidents, particularly the long-term and short-term side effects of medical devices.

After obtaining an MA, the holder must:

• maintain product safety through pharmacovigilance (for medicines) or vigilance/technovigilance (for medical devices);
• submit Periodic Safety Update Reports (PSURs) and comply with post-authorisation study requirements, if imposed; and
• notify the MMA of any changes affecting quality, safety, or efficacy.

Good Pharmacovigilance Practices (GVP) modules apply to medicines. The MAH must have a Qualified Person for Pharmacovigilance (QPPV) and maintain a Pharmacovigilance System Master File (PSMF).

For medical devices, the manufacturer or authorised representative must comply with the MDR’s vigilance requirements (Articles 87–90), report serious incidents, and perform post-market surveillance per Article 83.

Based on evolving benefit-risk data, the MMA may impose post-authorisation measures, including Phase IV studies or additional monitoring.

Applications for marketing authorisation are subject to confidentiality obligations, particularly regarding proprietary information, manufacturing processes, and clinical data.

Under Maltese law and the EU legal framework, third-party access is limited to what is necessary to ensure transparency while protecting commercially confidential information and personal data, in accordance with:

• Regulation (EC) No 1049/2001 on public access to EU documents;
• GDPR for personal and health data; and
• EMA’s Policy 0070 on publication of clinical data.

Once an MA is granted, public access may be permitted to the European Public Assessment Report (EPAR) (for centrally authorised products) or summary information via the MMA website for nationally authorised products.

Limited public access may be available via EUDAMED for medical devices, particularly for the Summary of Safety and Clinical Performance (SSCP) for implantable and Class III devices.

Malta, as a Member State of the European Union, does not operate a national fast-track authorisation route independent of the procedures established under EU law. However, accelerated or priority evaluation may occur under the following EU-level mechanisms.

• Accelerated assessment under Regulation (EC) No 726/2004, where the Committee for Medicinal Products for Human Use (CHMP) may reduce the timeframe for evaluation to 150 days for medicinal products of major public health interest, particularly innovative therapies addressing unmet medical needs.
• Conditional Marketing Authorisations (CMAs) and authorisation under exceptional circumstances, in accordance with Article 14-a and 14(8) of Regulation (EC) No 726/2004 and Directive 2001/83/EC, respectively.

The MDR does not explicitly provide for a fast-track pathway for medical devices. However, under Article 59(1) of the MDR, the Malta Medicines Authority (MMA) may grant national derogations from conformity assessment requirements in exceptional cases to protect public health or patient safety.

Malta actively engages in regulatory reliance and mutual recognition mechanisms, in line with its obligations under Directive 2001/83/EC and Regulation (EU) 2017/745, as outlined below.

• For medicines, Malta participates in the Mutual Recognition Procedure (MRP) and Decentralised Procedure (DCP), whereby marketing authorisations granted by another EU Member State (Reference Member State) are recognised and validated by Malta (Concerned Member State), provided no serious objections are raised.
• Work-sharing arrangements within the EU Heads of Medicines Agencies (HMA) network are also utilised for variations, renewals, and pharmacovigilance assessments.
• For medical devices, the CE mark affixed following a conformity assessment conducted by a notified body designated by another EU Member State is automatically recognised in Malta under the principles of the internal market.

Malta does not maintain separate reliance mechanisms for authorisations issued by non-EU jurisdictions. However, information from other stringent regulatory authorities (SRAs) may be considered during scientific assessments.

Pharmaceuticals

In accordance with Directive 2001/83/EC and transposing national legislation under the Medicines Act (Cap. 458) and Subsidiary Legislation 458.36, any entity engaged in the manufacture or import of medicinal 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 assessment including:

• Compliance with Good Manufacturing Practice (GMP),
• Appointment of a Qualified Person (QP),
• Inspection of facilities by the MMA.

Manufacturing authorisations cover production, packaging, 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 revocations of the authorisation may occur.

Medical Devices

Medical device manufacturing is governed by Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR). In Malta, no separate national manufacturing 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 technical documentation;
• assign a Unique Device Identifier (UDI); and
• register the device in EUDAMED when functional.

Pharmaceuticals

The Medicines Act (Cap 458) and Subsidiary Legislation 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 compliance with:

• 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 requirements.

The WDL is valid for three years from the date of issuance. 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 legislation obliges them to register as economic operators of medical devices in Malta. Distributors must comply 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-conforming products.

The MMA routinely inspects distributors to ensure compliance with the MDR/IVDR. Distributors must also assign a Medical Device Registered Person (MDRP) as a regulatory contact.

Pharmaceutical products in Malta are classified according to their mode of supply and regulatory requirements, consistent with Directive 2001/83/EC and national legislation. The main classifications have been outlined below.

• Prescription-only medicines (POM): These require a prescription from a licensed healthcare professional and are solely dispensed by a pharmacist through a pharmacy.
• Over-the-counter (OTC) medicines: These are also dispensed by a pharmacist or under their supervision within a licensed pharmacy.

The Malta Medicines Authority is responsible for overseeing classification status. Reclassification (eg, from POM to OTC) requires submission of supporting data and may be subject to regulatory and public health considerations.

The importation and exportation of medicinal products in Malta are regulated under the Medicines Act (Cap 458), which is aligned with Directive 2001/83/EC and Regulation (EC) No 726/2004. Regulation governs medical devices (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR).

The Malta Medicines Authority (MMA) is the competent authority for pharmaceuticals and devices, while the Customs Department, in co-operation with the MMA, provides enforcement at the border.

Only entities holding a Manufacturer’s Authorisation for Import may act as the importer of record for medicinal products entering Malta from third countries. These entities must comply with Good Manufacturing Practice (GMP) and are required to appoint a Qualified Person (QP) responsible for batch certification.

For medical devices, importers are defined under Article 13 of the MDR and must ensure that devices are CE-marked, compliant with applicable requirements, and properly labelled. Importers must maintain relevant documentation and co-operate with authorities in the context of market surveillance and vigilance activities.

Pharmaceutical imports into Malta from non-EU/EEA countries require prior authorisation via a valid Manufacturer’s Authorisation for Import. Exceptions are permitted for:

• named patient use under Article 5(1) of Directive 2001/83/EC;
• compassionate use schemes under Article 83 of Regulation (EC) No 726/2004; and
• personal use, subject to defined limitations.

Prior authorisation is not generally required for medical devices if they are CE-marked and compliant with MDR requirements.

Non-tariff measures applicable to pharmaceutical and medical device imports include GMP certification (for medicines), CE conformity (for devices), labelling requirements, and compliance with applicable safety and performance standards. Such obligations are enforced through import declarations and verification by Customs and the MMA, based on the Combined Nomenclature (CN) and TARIC classification.

As a Member State of the European Union, Malta is a party to all EU Free Trade Agreements (FTAs) and trade blocs. These agreements may facilitate regulatory co-operation and reduce technical trade barriers. However, EU regulatory requirements for market access, such as CE marking or GMP compliance, remain applicable irrespective of FTA provisions.

Pharmaceutical prices in the public sector are regulated by the Ministry for Health. Reimbursed medicines are included in the Government Formulary List and procured through centralised tendering mechanisms. Price negotiations consider external reference pricing and therapeutic value. Prices in the private sector are not subject to statutory control but may be indirectly influenced by public pricing benchmarks.

Medical device prices are not subject to statutory price control in the private market. In the public sector, pricing is determined through competitive public procurement, and evaluations consider both cost and technical merit in accordance with applicable public procurement law.

Malta applies external reference pricing for pharmaceuticals included in public reimbursement schemes, typically benchmarking against prices in other EU Member States. This ensures equitable and sustainable access to essential medicines. In the case of medical devices, prices are primarily determined through public procurement and market competition rather than formal benchmarking systems.

The national Government Formulary List governs pharmaceutical reimbursement. The list defines eligibility based on therapeutic need and cost-effectiveness. Medicines are provided free of charge to entitled patients under the national healthcare system.

For medical devices, reimbursement is available for specific categories (eg, ostomy products, insulin pumps, and assistive devices) under defined entitlement criteria. Healthcare providers co-ordinate access to publicly funded devices in accordance with clinical protocols.

The Ministry for Health and advisory bodies conduct cost-effectiveness assessments during the evaluation of new medicines and devices for reimbursement. While Malta does not have a dedicated national health technology assessment (HTA) agency, pharmacoeconomic data and budget impact models are considered during formulary decisions. Malta also participates in EU-level HTA initiatives, including EUnetHTA and the implementation of Regulation (EU) 2021/2282 on HTA co-operation.

The Medicines Act and the Pharmacy and Poisons Act regulate prescribing and dispensing practices in Malta. Key controls include:

• mandatory electronic prescribing for publicly funded medicines,
• controls on the prescribing of high-cost or high-risk medicines,
• promotion of generic substitution where clinically appropriate,
• routine audits of prescribing trends.

Dispensing pharmacies must be licensed by the Pharmacy Council and adhere to Good Pharmacy Practice (GPP) standards. Reimbursed medicines must be dispensed in accordance with Government Formulary protocols and patient eligibility criteria.