The Life Sciences regulatory regime in Malta

i Classification

The Medicines Authority’s Borderline Classification Committee distinguishes between medicinal and non-medicinal products. Assessments are made on a case-by-case basis. The Medicines Authority has issued borderline product classification guidelines and application forms. The guidelines explain the information and materials that must be provided for the classification to be undertaken, including dosage form, container type and packaging. The Borderline Classification Committee takes into account the medicinal claims made, intended use, mode of action, pharmacological properties and similar authorised medicinal products that are on the market.

Medical devices are classified according to the degree of risk the patient is exposed to. Malta’s medical devices regulations establish standards to classify a medical device, centred on the level of invasiveness, mode of action, contact duration and impact on the patient. Active implantable devices are generally classified as high-risk medical devices, and the risk of in vitro diagnostic (IVD) medical devices is decided on the basis of use.

ii Non-clinical studies

The Good Laboratory Practice Regulations (SL 427.56) state that non-clinical studies must be carried out in conformity with the good laboratory practice (GLP) established by EC Directive 2004/10. The transposed regulations state that the inspection and verification of processes and conditions under which laboratory studies are planned, performed, recorded and reported for non-clinical testing shall be carried out in accordance with the rules and regulations, with respect to all chemicals (e.g., cosmetics, industrial chemicals, medicinal products, food additives, animal feed additives, pesticides) to assess the effect of such products on humans, animals and the environment. 

The National Accreditation Body – Malta Standards Authority (NAB-MSA) is the competent authority responsible for verifying compliance with the principles of GLP of any testing laboratory in Malta claiming to use GLP. 

The Animal Welfare Act (Chapter 439 of the Laws of Malta) establishes a Council for Animal Welfare comprising a chairperson and 11 members who advise the Minister responsible for veterinary services on all matters related to biotechnology in animals and animal experiments, and advise on the issuance of licences under the Animal Welfare Act. The Council, with the concurrence of the Minister, can also establish subcommittees for this purpose.

A licence issued by the Minister, acting on the advice of the Council, in conjunction with the Director for Veterinary Services is required to carry out animal experiments. The licence specifies the practice for which it is required and may include conditions and restrictions. Animal experiments must be authorised by the Council, may only be performed by competent authorised persons, or under the direct responsibility of such a person, and only if the experimental or other scientific project concerned is authorised in accordance with the provisions of the Animal Welfare Act to protect animal welfare.

The Good Clinical Practice and Requirements for Manufacturing or Import Authorisation of Investigational Medicinal Products (Human Use) Regulations (SL 458.47) state that available non-clinical and clinical information on an investigational medicinal product shall be adequate to support the proposed clinical trial. 

iii Clinical trials

The Clinical Trials Regulation (EU pharmaceutical legislation) entered into application on 31 January 2022. The Regulation governs large-scale clinical research and harmonises the processes for assessment and supervision of clinical trials throughout the EU. On 31 January 2022, the Regulation repealed the Clinical Trials Directive (EC) No. 2001/20/EC and national implementing legislation in the EU Member States that regulated clinical trials in the EU until the Regulation’s entry into application.

The evaluation, authorisation and supervision of clinical trials are the responsibilities of EU Member States and European Economic Area (EEA) countries. Prior to the Regulation, clinical trial sponsors had to submit clinical trial applications separately to national competent authorities and ethics committees in each country to gain regulatory approval to run a clinical trial. The Regulation enables sponsors to submit one online application via a single online platform known as the Clinical Trials Information System for approval to run a clinical trial in several European countries. 

iv Named-patient and compassionate use procedures

Unlicensed medicinal products

The Committee for Unlicensed Medicinal Products was established to permit the use of unlicensed medicines in Malta. The Pharmaceutical Unit within the Ministry for Health is responsible for the processing of individual requests for medicinal products by certified prescribers and for use in public and private hospitals.

The ‘Guidelines for the supply of medicinal products for human use through processes which are not covered by the Medicines Act, 2003 and its subsidiary legislation (unlicensed medicinal products)’ include application forms. The supply and use of unlicensed medicinal products is restricted to circumstances where the licensed product cannot be obtained or the patient is not in a position to obtain the product directly from abroad for personal use under a doctor’s prescription (Annex 1 of the Guidelines).

‘Unlicensed products’ do not include products that are: undergoing clinical trials, approved for compassionate use under European Council Regulation 726/04; prepared in a pharmacy under prescription; prepared by division of authorised packs into smaller units in a pharmacy for dispensing to patients within the same pharmacy; reconstituted intravenous preparations and prepared in centralised intravenous additive services; or used outside the clinical indications of their marketing authorisation.

The request for the use of an unlicensed medicinal product must be submitted by a doctor or a dentist registered in Malta to the Superintendent of Public Health. The request must explain why a licensed product is not a suitable alternative and include a declaration that the prescriber takes direct personal responsibility for the use of the unlicensed product.

Requests on a named patient basis must include the patient’s signature confirming that he or she is aware that the medicinal product is unlicensed. The absence of the patient’s signature has to be justified.

Exceptional medicinal treatment

In March 2018, the Maltese legislature passed the Exceptional Medicinal Treatment (EMT) Committee Regulations (SL 528.08). These regulations cater for medicinal treatment provided to patients suffering from diseases for which medicinal treatment is not listed on the Government Formulary List; or listed on the Government Formulary List but not according to protocol, indication or prescribed criteria; specifically branded medicines; or medicines for the treatment of rare diseases. The Exceptional Medicinal Treatment Committee (EMTC) assesses requests submitted to the Directorate for Pharmaceutical Affairs of the Health Ministry by medical consultants by a prescribed application form. Department of Health Circular 15/2018 (DH 417/2018) comprises the policy addressed to healthcare professionals outlining the procedures, the EMT Request Form, the EMTC Terms of Reference, and the Schedule of Review Criteria.

v Pre-market clearance 

Medicines

Medicinal products are approved and authorised for commercial distribution in Malta through the legal supply chain as follows:

  1. marketing authorisation according to Article 20 of the Medicines Act (Chapter 458 of the Laws of Malta) and Legal Notice 387 of 2004 as amended;
  2. marketing authorisation by centralised procedure (Regulation 726/2004);
  3. parallel import licence according to Legal Notice 437/2004;
  4. authorisation on the ground of public health according to Article 4(2) of the Medicines Marketing Authorisation Regulations (Legal Notice 387 of 2004) in accordance with Article 126a of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community Code relating to medicinal products for human use, as amended by Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004; and
  5. Licensing Authority approval of medicine to be put on the market in exceptional cases, subject to such conditions as the Licensing Authority may attach to it (Article 20(1) of the Medicines Act, 2003) on the ground of public health.

In the past seven years, the Licensing Directorate of the Medicines Authority processed 4,400 licensing applications that were granted a marketing authorisation in Malta. By the end of 2020, there were 2,368 medicines in Malta licensed under the Article 126a procedure. The Medicines Authority has set eligibility criteria for an Article 126a application, stating that ‘this procedure should in no way be considered as an easy way of circumventing the current procedures stipulated by the EU legislation’. However, Malta, because of its small market size and availability challenges, has proven itself to be the biggest user of the Article 126a marketing authorisation. From around 5,400 national authorisations (inclusive of parallel importation licences), more than one-third have been licensed through the Article 126a procedure. A total of 960 national marketing authorisations and licences for new products were issued in 2020. Since 2007, Malta has been a Reference Member State (RMS) or a rapporteur in European registration procedures and has contributed to the authorisation of 557 products. Malta led 40 RMS procedures in the last quarter of 2019 and in the year 2020 resulting in 53 new marketing authorisations for Malta and other EU countries. In 2020, for the first time, Malta carried out an assessment as RMS in the DCP on the legal basis of Article 8(3) of Directive 2001/83/EC. The number of MA applications in the MRP and DCP received in 2020 with Malta as EU Concerned Member State (CMS) resulted in 171 marketing authorisations. 

A study published by senior authorised officers of the Medicines Authority identifying pharmaceutical issues encountered during regulatory review in European marketing authorisation application procedures found that applicants would benefit from following published guidelines to avoid delays in the registration of medicines. 

EU laws apply for the licensing of biologics, biosimilars and generic medicines, and the validity of marketing authorisations. In the case of homeopathic and herbal medicines, the authorisation procedure is simplified and applications are received and reviewed by the Medicines Authority. The quality issues and regulatory challenges the pharmaceutical industry needs to consider when developing and producing biosimilars and in the submission of dossiers for marketing authorisations were studied and published by senior authorised officers of the Medicines Authority. 

Medical devices

The European Medical Device Regulation 2017/745 repealed the directives on medical devices: the European Medical Devices Directive 93/42 and the European Active Implantable Medical Device Directive 90/38. The Medical Device Regulation was published on 5 May 2017 and became applicable on 26 May 2021. 

The following national legislation applies to medical devices:

  1. the In Vitro Diagnostic Medical Devices (Amendment) Regulations (SL 427.16);
  2. the Active Implantable Medical Devices (Amendment) Regulations (SL 427.10);
  3. the Medical Devices Regulations (SL 427.44); and
  4. the Medical Devices and In-Vitro Diagnostic Medical Devices Provision on the Maltese Market Regulations (SL 458.59).

vi Regulatory incentives

Malta applies European pharmaceutical law, including data and market exclusivity, orphan medicines and paediatric medicines. The EU and the US in particular have adopted regulations, incentives and policies targeted at improving orphan drug access to patients suffering from rare diseases. Malta has no additional national regulatory requirements beyond the EU requirements.

Data exclusivity

The Medicines Act regulates the period of data exclusivity. The Medicines Act data protection and exclusivity provision arises from the derogation of Article 10 of European Council Directive 2004/27.

Generic medicines and Roche Bolar

Malta is one of the few EU Member States that has a broad interpretation of the Roche Bolar provision, which has been incorporated in the Maltese Patents and Designs Act, and fully recognises the research exemption of the Patent Cooperation Treaty and European Patent Convention, by which generic companies can undertake development, but not authorization, of drugs prior to patent expiry. 

Joint/multilingual labelling

The Medicines Authority recognises joint or multilingual labelling with other countries to be an incentive for retaining medicinal products on the Maltese market. The Medicines Authority has facilitated joint or multilingual labelling with the UK, Ireland and other markets, and continues to pursue collaboration opportunities with other European competent authorities for multilingual labelling.

Day zero mutual recognition procedure (simplified procedure)

To address medicines availability challenges in Malta, the Medicines Authority accepts the assessment of the RMS or the national competent authority (where the product had been authorised nationally), without any comments or questions. The approved product information will also be accepted without any comments. The Medicines Authority does not request any update of the assessment report or the dossier, nor are there any changes related to such procedure, except that in this simple way Malta joins a mutual recognition procedure (MRP). These procedures are finalised once the application has been accepted by the RMS and the Medicines Authority, known as an ‘MRP day zero procedure’. Day zero licensing procedures have already been executed successfully with various RMS countries.

Article 126a authorisations

One-third of all medicine registrations in Malta are authorised through Article 126a. The Public Contracts Review Board (PCRB or the Board) decision of 18 February 2020 ushered in a reviewed and improved Article 126a marketing authorization (MA) process that same year, starting on 1 October 2020.

The PCRB’s Case 1412 regarding the Tender CT2340/2018 for the Supply of Human Biosynthetic Insulin Preparations for Injection in Cartridges decided on the objections against the Central Procurement and Supplies Unit (CPSU or Contracting Authority).

The appellants contested the safety and quality of gensulin, particularly because of the importance and wide use of insulin in Malta. The appellants claimed gensulin did not ensure patients’ safety; and the product is not bio-equivalent to the original product but is bio-similar.

The Board ruled that:

  1. the chosen bidder’s offer for the procurement of gensulin was the cheapest offer and complied with the technical specifications;
  2. the evaluation committee, comprising qualified professionals in pharmacology, carried out the evaluation process in a fair and transparent manner;
  3. the product gensulin is registered in Malta by the Medicines Authority through an Article 126a Marketing Authorisation, which allows a EU member state (Malta) to authorise a product registered in another EU member state (Poland);
  4. no negative results have been reported since the product’s authorisation in Poland;
  5. the appellants did not present any evidence to demonstrate that gensulin did not satisfy the tender’s technical specifications; and
  6. the appellants could have taken remedial action before submitting their tender offer by disputing the tender specifications.

From 1 October 2020, the new Article 126a application process asks the applicant to provide detailed public health justifications for choosing this route. The Medicines Authority now states that ‘if a product is eligible to be authorised through the established legal routes for marketing authorisation, the Medicines Authority has the right to refuse the application under the Article 126(a) legal basis’. Applicants are asked to consider all other possible routes for registration, effectively leaving Article 126a as a last resort. Article 126a authorisations are now valid for three years, and validity can only be extended if the product has been procured by a government tender beyond the validity of the authorisation, to ensure that the public procurement obligation is fulfilled. The Medicines Authority has established an Advisory Committee with the purpose of discussing Article 126a applications. The Medicines Authority is expected to accept less Article 126a authorisations for each product on the market, with the effect of reducing the number of Article 126a authorisations. 

vii Post-approval controls

Medicines

Pharmacovigilance

Pharmaceutical companies and regulatory authorities must honour their pharmacovigilance obligations according to EU law. The Medicines Act (Chapter 458 of the laws of Malta), and its subsidiary legislation namely the Pharmacovigilance Regulations SL 459.35, transpose the European Council Directive 2001/83 (as amended). The Medicines Authority has also published Guidance Notes for Pharmaceutical Companies on Pharmacovigilance Obligations and Adverse Drug Reaction (ADR) Reporting Requirements for Medicinal Products for Human Use (last amended in December 2019). There are no significant country-specific obligations provided for by Maltese law.

The Medicines Authority ensures patient safety by communicating with healthcare professionals, evaluating safety reports and conducting pharmacovigilance inspections to assess marketing authorisation holders’ (MAH) compliance with pharmacovigilance obligations. MAHs must comply with their pharmacovigilance obligations to maintain the marketing authorisation of a medicines product. 

If there are concerns affecting the risk-benefit balance of an authorised medicinal product, the Medicines Authority may impose an obligation on a MAH to operate a risk management system and to submit a detailed description of the risk-management system that the MAH intends to introduce for the medicinal product concerned. The imposition of such obligations shall be duly justified, notified in writing and shall include the time frame for submission of the detailed description of the risk management system. 

Staffing requirements for MAHs – the QPPV

MAHs in Malta must appoint a qualified person for pharmacovigilance (QPPV). The MAH shall submit the name and contact details of the QPPV to the Medicines Authority and the European Medicines Agency. The Medicines Authority may request the nomination of a contact person for pharmacovigilance issues in Malta (at national level) who reports to the QP responsible for pharmacovigilance activities.

Variations and transfer of ownership of product approvals

Post-authorisation procedures are handled by the Medicines Authority and include variations, notifications, renewals and withdrawals. Variations of marketing authorisations are governed by European Variation Regulation 1234/2008, amended by European Regulation 712/2012, which introduced work-sharing of different types of procedures, timelines, and takes into account the new European pharmacovigilance regulations. European Council Directive 2009/53 applies to variations submitted for nationally authorised medicines. The transfer of ownership of the marketing authorisation is made by filing the relevant request forms to the Medicines Authority depending on whether the marketing authorisation has already been issued or not.

Medical devices

The Medical Devices Regulations impose post-market surveillance obligations. Medical devices that compromise the health and safety of patients may be withdrawn from the market or prohibited or restricted by the Director of Market Surveillance after interim measures are taken. The Market Surveillance Directorate may carry out inspections, including the technical documentation and the CE conformity declaration. The Medical Devices Regulations specify that regulatory data must be uploaded to the European databank and made accessible to the national competent authorities.

viii Manufacturing controls

The main applicable legal instruments are (1) the Manufacture and Importation of Medicinal Products for Human Use Regulations (SL 458.36); (2) the Good Manufacturing Practice in Respect of Medicinal and Investigational Medicinal Products for Human Use Regulations (SL 458.42); and (3) the Good Clinical Practice and Requirements for Manufacturing or Import Authorisation of Investigational Medicinal Products (Human Use) Regulations (SL 458.47).

The manufacture of any dosage form of a medicinal product must be in conformity with EU good manufacturing practice (GMP) throughout the entire manufacturing process until its release on the market. The applicant must hire qualified staff, particularly the qualified person (QP) responsible for manufacturing. The Medicines Authority Inspectorate and Enforcement Directorate carries out inspections to verify that the technical facilities and equipment is in place and that the manufacturing site fulfils all legal and EU GMP requirements.

The authorisation timeline is as follows: the application is vetted within 10 days of being submitted by the applicant; the assessment is then expected to take six months (unless further information or clarifications are needed); and the approval is issued within five days of conclusion of the assessment. The decision is then delivered within the following two days.

The list of licensed manufacturers is published on the Medicines Authority website. 

Inspections and enforcement

The Inspectorate and Enforcement Directorate of the Medicines Authority is responsible for carrying out inspections of wholesalers and manufacturers or importers, and issuing licences, licence renewals, and variations. The Directorate enforces the Medicines Act (Chapter 458 of the Laws of Malta) and its subsidiary legislation, EU GMP and EU good distribution practice (GDP). The Directorate regulates 70 licensed or certified entities, in Malta and in third countries, involved in the manufacturing, importation or other GMP-related activities of medicinal products for human use. In 2020 the Directorate carried out eight national GMP inspections including inspections for (1) cannabis for medicinal or research purposes; (2) full line non-sterile solid dosage manufacturers; (3) MAs for repackaging and re-labelling or partial manufacturing operations; (4) repackaging and re-labelling or partial manufacturing operations; and (5) import activities. The Directorate regulates 90 licensed or certified local entities involved in wholesale dealing and brokering activities of medicinal products for human use, and of active pharmaceutical ingredients distribution and importation. During 2020, the Directorate fulfilled its GDP inspection plan and carried out 25 GDP inspections. In regard to EU and third country inspections, the Directorate carried out only four EU GMP inspections in India in the first months of 2020 as third country GMP inspections were interrupted as a result of the covid-19 travel restrictions. Applications were validated to be processed, and inspections carried out when travel restrictions were lifted. 

Medical devices

The same national legal framework protecting the safety, efficacy and quality of medicines includes medical devices.

ix Advertising and promotion

Medicines

The advertising of medicinal products is governed by the Medicinal Products (Advertising) Regulations (SL 458.32), which transpose European Directive 2004/27 into Maltese law and regulate advertising to the general public and to healthcare professionals. The Medicines Authority has also issued guidelines, last updated in February 2020. The system of medicines advertising is based on self-regulation as the Medicines Authority does not review advertising prior to its publication but offers guidance and monitors advertisements.

It is unlawful to advertise medicinal products that have not been granted marketing authorisation. No medicinal products may be distributed directly to the public by the industry for promotional purposes. There are exceptions to the advertising criteria/requirements with respect to vaccination campaigns carried out by industry after having obtained the approval of the Licensing Authority. 

Compliance orders issued by ‘qualified entities’ as defined by law, administrative penalties, and other administrative sanctions are made under the Medicines Products (Injunction to Advertising) Regulations (SL 458.51), which transpose European Directive 92/28 implementing it into Maltese law.

Medical devices

EU laws apply.

Other laws

The Broadcasting Act (Chapter 350 of the Laws of Malta) includes rules on the broadcasting of medicinal products advertising. The Commercial Code (Chapter 13 of the Laws of Malta) applies to all advertising in Malta.

x Distributors and wholesalers Medicines

The applicable legal instrument is the Wholesale Distribution and Brokering of Medicinal Products and Active Substances Regulations (SL 458.37). These Regulations also apply to homeopathic medicinal products. The Medicines Act (Chapter 458 of the Laws of Malta) defines ‘wholesale distribution’. The Medicines Authority publishes a list of licensed wholesale dealers in Malta, last updated in December 2019. 

Application

The national competent authority (the Licensing Authority) shall grant the applicant a wholesale distribution licence (WDL) within 90 days of the date of receipt of the application provided the requirements listed in Article 8 of SL458.37 are met. This timeline is suspended if the applicant is asked to provide additional information. The application must also include the pharmaceutical forms of the medicinal products to be distributed, in particular whether they are sterile, require storage below 8ºC, details on whether they are narcotic or psychotropic substances, blood, immunological medicinal products or radiopharmaceuticals.

Responsible person

One of the requirements is that the applicant must engage a responsible person (RP). The RP is a registered pharmacist with the Malta Pharmacy Council and recognised as suitable by the national competent authority. The RP must be knowledgeable of proper conditions for the storage and distribution of medicinal products and have an understanding of GDP and must comply with the duties assigned to the RP as described in the Regulations. The RP can be a full-time employee, a part-time employee or work on a contract basis for the wholesale dealer. The Medicines Authority publishes a list of pharmacists accepted by the Medicines Authority to act as RPs.

Marketing authorisation holder letter of access

For each medicinal product distributed in Malta, the wholesale dealer must provide the Licensing Authority with an authenticated copy of the marketing authorisation together with a letter of access issued by the MAH granting the wholesale dealer the use of such marketing authorisation. The only exception is if the wholesale dealer is in possession of a valid parallel import licence.

Patients’ needs and medicines supply obligations

The Regulations also require every wholesale dealer, within the limits of their responsibilities, to ensure that ‘an appropriate and continuous supply of medicinal products is provided to pharmacies and persons authorised to supply medicinal products’ to satisfy patients’ needs.

Good distribution practice

The Licensing Authority requires full traceability of product quality throughout the entire supply chain and the wholesale dealer’s conformity with the EU Good Distribution Practice (EU GDP) standards. The Medicines Authority carries out EU GDP inspections. The licensed entity is given a list of findings after the Medicines Authority inspection, which they are required to respond to with proposals for corrective action within 28 days. Once all findings have been addressed with a satisfactory corrective action plan and measures, the renewal of the wholesale dealer’s licence is recommended to the Licensing Authority. Site re-inspection is performed at a frequency determined by the Medicines Authority by a systematic risk-based assessment.

Medical devices

The Medicines Act (Chapter 458 of the Laws of Malta) regulates the wholesale dealing of medical devices.

xi Classification of products 

Medicines

The Borderline Classification Committee classifies borderline products into medicinal or non-medicinal products in line with the EU pharmaceutical law definition of medicinal product.

In Malta, medicines can only be dispensed to a patient from a licensed pharmacy. Medicinal products are either prescription-only medicines (POM) (dispensed by a pharmacist to the patient under a physician’s prescription) or over-the-counter products (OTC) (dispensed by a pharmacist to the patient without a prescription).

Classifying medicines as prescription-only or over-the-counter is part of the Marketing Authorisation process that licenses and ensures the quality, safety and efficacy of the medicinal product. The Medicines (Marketing Authorisation) Regulations (SL 458.34) specify the POM classification criteria. The Prescription and Dispensing Requirements Rules (SL 458.49) stipulate the content of the prescription and the dispensing regulations.

The Prescription Forms for Free Medicinals Rules (SL 458.24) govern the provision and prescription of medicinal products and medical aids to the patients at no cost to the end-user through the national health service (NHS) under the Social Security Act (Chapter 318 of the Laws of Malta).

Medical devices

Medical devices are classified in line with European law, on the basis of their risk to patients.

xii Imports and exports

Maltese legislation governing the import and export of medicinal products and medical devices generally reflects EU rules. Import regulations are enforced by the Customs Authority, and the Commissioner for Revenue also plays a part. Import tariff regulations are established by the Import Duties Act (Chapter 337 of the Laws of Malta). Product classification in Malta is made under the Harmonised Standard (the HS code number). The Dual-Use Items (Export Control) Regulations (SL 365.12) control dual-use export goods. European Council Regulation 428/2009, which governs the EU’s export control regime, applies to Malta.

Medicines

The main applicable legal instrument is the Manufacture and Importation of Medicinal Products for Human Use Regulations (SL 458.36). In Malta, an importer’s licence (IL) is required for the importation of medicinal products. ‘Imported medicinal products’ means medicinal products obtained from a source outside the EU or the EEA. 

All medicinal products for human use imported into Malta and the EU from a non-EU or non-EEA country, including medicinal products intended for export outside the EU and not intended for the Maltese market, are to be manufactured in accordance with the principles and guidelines of EU GMP. It is the importer’s duty to ensure that medicinal products imported from third countries have been manufactured in accordance with standards equivalent to the EU GMP standards by authorised manufacturers. 

In Malta, any licence holder (whether the holder of a manufacturing or importation licence, a wholesale dealing licence) must be a natural person or a legal person. ‘Licensee’ means any person who is the holder of a licence for a particular activity granted under the Medicines Act. Whichever entity within the EU or EEA first physically receives medicinal products entering the EU or EEA market from a non-EU or non-EEA country must be in possession of an IL.

The IL is issued by the national competent authority following verification of the contents of the application, but no later than 90 days from the date of receipt of the application. This time period is suspended when additional information is requested from the applicant. The national competent authority may grant a conditional licence subject to the applicant’s fulfilment of the legal requirements. The IL shall only apply to the premises, medicinal products and pharmaceutical forms specified in the application. 

There must be a QP approved by the Maltese national competent authority for batch release, who ensures that each batch complies with the law, the GMP, the importer’s or manufacturer’s authorisation and the marketing authorisation. 

The Wholesale Distribution and Brokering of Medicinal Products and Active Substances Regulations (SL 458.37) state that wholesale distributors of active substances must comply with EU GDP, including active substances intended for export.

Falsified medicines

The Licensing Authority is responsible for taking the necessary measures to prevent medicinal products that are brought to the EU, but are not intended to be placed on the EU market, from entering into circulation if there are sufficient grounds to suspect that those products are falsified. These measures include applying the SL 458.37 regulations to warehouses in the free trade zones and customs bonded warehouses used to store medicinal products. Licensed entities are obliged to implement the Falsified Medicines Directive (2011/62/EU) and the Delegated Regulation on Safety Features (2016/161).

The Falsified Medicines Directive (Directive 2011/62/EU) established the need for a safety feature that enables authenticity to be verified and to identify individual packs. The Delegate Regulation on Safety Features (2016/161) imposes the following measures:

  1. a requirement for medicine packs to carry special safety features in the form of an anti-tamper device (e.g., foil seal, breakable cap) and a two-dimensional barcode containing ‘unique identifiers’ (including a serial number) to enable the authenticity of the pack to be checked before dispensing; and
  2. a common, EU-wide logo to identify legal online medicines suppliers, making it easier to distinguish them from illegal operators. 

The Malta Medicines Verification Organization (MaMVO) was established in 2018 as a not-for-profit entity. The MaMVO is authorised to establish, administer, operate and monitor the Malta Medicines Verification System (MaMVS) to support all the licensed entities that are obliged to implement the Falsified Medicines Directive. The MaMVO’s objective is to permit the verification of the authenticity of medicines dispensed in Malta throughout the pharmaceutical supply chain, and to permit the identification of potential incidents of falsification. 

Medical devices

The import and export of medical devices is regulated by the Medicines Act (Chapter 458 of the Laws of Malta) and by the applicable European regulations.

xiii Controlled substances

Malta ratified the Single Convention on Narcotic Drugs on 22 February 1990. The Single Convention has 186 state parties.

The importation, manufacture, exportation, purchasing and selling of any controlled drug is subject to the Drugs (Control) Regulations (SL 31.18). These activities need to be authorised by the Superintendent of Public Health and registered and reported to the Superintendent at specified time frames. Importation and exportation procedures including details to be submitted and labelling requirements are at the Superintendent’s discretion. Dispensing controlled medicines must follow the applicable protocols.

According to the Medical and Kindred Professions Ordinance, the Health Minister, after consultation with the Council of Health, can amend, add to, revoke or substitute the list of psychotropic drugs. The Health Minister can also make regulations for controlling the manufacture, exportation, importation, possession, distribution and sale of psychotropic drugs, in the public interest.

xiv Enforcement

The Licensing Authority has delegated its enforcement powers to the Medicines Authority. A dedicated Inspectorate and Enforcement Directorate within the Medicines Authority is tasked with enforcement and market surveillance. Article 101 and 101A of the Medicines Act (Chapter 458 of the Laws of Malta) establishes broad enforcement powers including right of entry, inspection, taking of samples, and seizure of goods and documents of any person duly authorised in writing by the national competent authority.

On production of his or her authorisation or credentials, such authorised person shall have a right to enter and carry out repeated and unannounced inspections at any premises (including any building, place or means of transport) at any reasonable time for the purposes of ascertaining whether there is, has been or is likely to be any breach of the provisions of the Medicines Act and its subsidiary legislation.

An authorised officer shall, on the production of his or her authorisation, have a right to board any ship or aircraft at any reasonable time to ensure that no substance or article is imported in contravention of the Medicines Act and its subsidiary legislation.

Offences and penalties

Article 99 of the Medicines Act establishes the penalties, in the form of fines and terms of imprisonment, in the event of conviction for failure to comply with any of the provisions of the Medicines Act or any regulations or rules made thereunder.

Published by Lexology on 23 February 2022 as an extract from the Malta chapter of The Life Sciences Law Review 10th edition authored by Dr Anthia A Zammit.