Malta Pharmaceutical Licensing

This guide covers only pharmacy retail, wholesale and manufacturing／import of human medicines in Malta. The Superintendent of Public Health is the Licensing Authority under the Medicines Act; no state- or provincial-level business licensing system was identified in this research. Planning permission is not a medicines licence.

The application forms contain sections for individuals and companies, but this does not establish any mandatory company form, capital requirement, local ownership or foreign investment restriction; general company, tax and employment rules have not been verified in this draft.

— Pharmacy retail: sale／dispensing to the public.

— Wholesale: procurement, holding, supply or export, but not supply to the public.

— Manufacturing／import: includes all or partial manufacture, dividing, packaging／presentation and applicable imports.

The Medicines Act designates the Superintendent of Public Health as the Licensing Authority, empowered to establish standards for pharmacies, manufacturing and wholesale, and to issue, renew, amend, suspend or revoke licences and conduct inspections. The Malta Medicines Authority assists with regulation and inspections.

The Malta Medicines Authority publishes guidance on pharmacy, GDP and GMP. The Pharmacy Council is responsible for recognising pharmacists’ qualifications, registering them in the register and recommending the grant of a warrant to practise; this personal regulatory system does not replace premises licensing.

— Core legislation: Cap.458; retail, wholesale and manufacturing／import are governed separately by S.L.458.16, 458.37 and 458.36.

A pharmacy licence is required to open or operate a pharmacy and for the general retail sale of medicines to the public. The application should state the applicant, premises, equipment and superintendent pharmacist; before issuing a licence, the premises must be inspected to determine whether they are suitable for storing and dispensing medicines.

The regulations generally require a walking distance of at least 300 metres between pharmacies in the same town/village and limit pharmacies to one per 2,500 residents. These distance/population rules do not apply in certain areas, such as Smart City, Malta International Airport and cruise terminals. Exceptions for specific sites and existing pharmacies are subject to review by the competent authority.

A pharmacy licence holder must not be a medical practitioner, dentist or veterinary surgeon, nor enter into an arrangement involving an interest that is prohibited by law with a person authorised to prescribe. This rule is not a general restriction on all pharmaceutical companies or foreign investment.

— Typical attachments listed on the application form: certificate of good conduct; premises and pharmacy floor plans; confirmation by an architect of the total area and shortest walking distance to other pharmacies; description of the storage/dispensing layout; planning permission; and proof of the applicable fees.

— A pharmacy may use an identified additional storage site once approved; an unapproved site must not be used as a regular pharmacy stock location.

— Prescription medicines should be supplied in accordance with the prescription; non-prescription categories should also be dispensed by a pharmacist in accordance with the applicable rules.

A wholesale dealer’s licence is required to engage in the wholesale of medicinal products, and operations may be conducted only at the premises and subject to the conditions specified in the licence. The competent authority inspects the premises before making a decision; applicants must have suitable premises, facilities, equipment, personnel and a responsible person.

Wholesale dealers should purchase from licensed entities and supply eligible downstream recipients; export falls within the scope of the wholesale licence. They must maintain procedures for recalls, transaction records, a quality system and controls against falsified medicines, and retain records for five years.

The responsible person must be a pharmacist registered with the Pharmacy Council and recognised as fit by the Medicines Authority, and is responsible for storage, distribution, records and the GDP quality system.

— The application form requires details of the proposed activities, such as purchasing, holding, supplying and exporting, as well as the product scope and any potential additional categories, including cold-chain products, narcotic/psychotropic medicines, blood products, immunological products and radiopharmaceuticals.

— The attachments checklist includes the responsible person’s CV, plans of the premises/all storage areas, a certificate of good conduct and planning permission. Corporate applicants must also submit constitutional documents issued by the MBR.

— Sourcing only from eligible EU/EEA sources and supplying only eligible downstream recipients does not remove the separate obligation to check product marketing authorisation, import rules or controlled-drug requirements.

A manufacturing licence is required to manufacture medicinal products, applicable active substances or active substances for clinical trials. Its scope includes all or part of manufacturing, dividing, packaging or presentation, as well as manufacturing for export. Repackaging and imports from outside the EU should also be addressed within the manufacturing-licence framework.

Before a licence is issued or renewed, the applicant must specify the products/pharmaceutical forms and manufacturing or control sites, and demonstrate that suitable premises, equipment, control facilities and at least one QP are available. The licence applies only to the sites, products and pharmaceutical forms listed.

Licence holders must comply with EU GMP and verify the active-substance supply chain. The QP ensures that batches are manufactured, tested and released in accordance with the law and the relevant marketing authorisation; third-country imports are subject to additional quality-control/certification requirements.

— Attachments to the official application form include a Site Master File, CVs of the head of production and the head of quality control, company registration evidence (for private/public companies), and planning permission for premises not yet licensed.

— API manufacturers/importers and distributors are subject to a separate registration scheme; API registration or a GMP certificate must not automatically be treated as a full finished-product manufacturing licence.

— An independent contract laboratory may be included in the manufacturing licence arrangements; the specific contract and licence scope must be verified against the site and activities.

An individual pharmacist’s right to practise is separate from business licensing. The Pharmacy Council’s official guidance states that a pharmacist must first have their qualifications recognised and be entered in the Register of Pharmacists, after which the Council recommends the issue of a licence to practise in Malta. A retail pharmacy must be under the responsibility of a managing pharmacist, and that pharmacist or another pharmacist must be present during opening hours.

The responsible person for wholesale must be a pharmacist registered with the Pharmacy Council and recognised by the Medicines Authority. A manufacturing/import licence holder must continuously have at least one QP; qualification is determined jointly by the regulations and case-specific assessment by the competent authority/Council.

— Pharmacy: The managing pharmacist should give notice before taking up or leaving the post; if unable to perform the duties for five consecutive days or more, a substitute managing pharmacist should be appointed and notice given.

— Wholesale: The responsible person is accountable for licence conditions, storage, records and the quality system.

— Manufacturing: The QP is responsible for ensuring batch compliance with the law and marketing authorisation, and should maintain batch certification records.

A pharmacy should be accessible to the public, and its environment, layout, cleanliness, temperature and humidity, and security should be suitable for work and public use. Medicines should be stored as indicated on their packaging. Structural alterations require prior approval; storage outside the pharmacy requires a separate licence for the relevant premises.

Wholesale premises must ensure proper storage and distribution; manufacturing/import premises are assessed for site, equipment and control facilities and are subject to GMP inspections. The application form requires warehouse plans and a description of facilities.

— Pharmacy: Provide areas for dispensing/preparation, segregate expired or stock awaiting disposal, and maintain appropriate storage conditions.

— Wholesale: Premises, equipment, the quality system, recall capability and records must be available for inspection.

— Manufacturing: The Site Master File, production and quality-control arrangements, materials storage and controlled operations must be consistent with the application scope and GMP.

All three types of new application are submitted to the Licensing Authority, using the competent authority’s forms to describe the licence holder, premises, activities, equipment and key personnel. Pharmacy, wholesale and manufacturing/import premises must all be inspected before a decision; requests for additional information may suspend the statutory processing period.

The retail focus is on site selection, planning permission, premises information and the managing pharmacist; wholesale applications focus on actual activities, product scope, the responsible person and GDP facilities; manufacturing/import applications must specify each site, pharmaceutical form, operation, QP and production/quality-control arrangements.

— Pharmacy: Application form, site and floor-plan information, architect’s declaration, planning permission, managing pharmacist details and applicable company information.

— Wholesale: Application form, responsible person’s CV, premises/warehouse plans, certificate of good conduct, planning permission and company documents (if applicable).

— Manufacturing/import: Application form, Site Master File, CVs of production/quality-control heads, company evidence (if applicable) and planning permission for premises not yet licensed.

Wholesale applications should be processed within 90 days of receipt; manufacturing/import licences should be issued no later than 90 days, and either period may be suspended if further information is requested. These timeframes exclude preparation, remediation and time spent providing additional information, and do not constitute a promise of approval. A uniform review timeframe for new pharmacies was not confirmed in this review.

The validity period of a licence is set by the Licensing Authority. Following a renewal inspection, it decides whether to renew the licence, renew it subject to amendments, or refuse renewal; therefore, there is no fixed nationwide validity period. Pharmacy issue and annual renewal fees are charged according to floor area; the applicable fee in Gozo is reduced by 25%. Current wholesale and manufacturing/import fees have not been reliably verified.

— Statutory annual pharmacy fee schedule: less than 200 square metres: €69.88; more than 200 and less than 400 square metres: €139.76; more than 400 and less than 800 square metres: €419.29; more than 800 square metres: 5% of the rental value, and not less than €1,164.69. Confirm the area thresholds and their application to individual cases with the competent authority.

— The pharmacy change-process flowchart lists administrative changes such as the licence holder/address, superintendent pharmacist or pharmacy name at €80; and non-administrative changes such as structural changes, relocation, adding a warehouse or medical gases at €150. It also lists higher-priced fast-track options. The flowchart does not specify the complete legal status of the fees; verify them before submission.

All three licence types are subject to ongoing compliance and inspections. Pharmacies must maintain appropriate storage and records, ensure a pharmacist is present and fulfil management responsibilities; wholesalers must maintain a GDP quality system, recall procedures and records for five years; manufacturers/importers must comply with GMP and maintain QP batch records.

The Medicines Authority states that wholesale and manufacturing premises are inspected on a risk or periodic basis. Pharmacy inspections include new premises, renewals, changes, follow-up, unannounced inspections and risk-based self-assessments/desktop assessments. Failure to comply with GxP or licence conditions may result in a licence being varied, suspended or revoked.

— Pharmacy: storage, records, pharmacist presence and disposal of expired products.

— Wholesale: GDP, supplier/customer qualification, traceability, recalls and five-year record retention.

— Manufacturing: GMP, QP batch responsibilities, change control and the quality system.

A pharmacy licence may not be transferred independently; a new licence holder must obtain authorisation from the Licensing Authority, meet the applicable requirements and pay the prescribed fees. Pharmacy regulations also provide that an existing licence holder must obtain authorisation to relocate and meet the same-area and applicable distance requirements. The official change process lists changes of licence holder/licence-holder address, superintendent pharmacist, pharmacy name, structural changes, relocation, addition of a warehouse and medical gases as separate application categories.

Changes to wholesale and manufacturing/import licence conditions must be applied for by the licence holder. Inaccurate application information, material changes, breach of licence conditions or non-compliance with GDP/GMP may result in a variation, suspension, revocation or refusal to renew. A change of superintendent pharmacist at a pharmacy must be notified in advance.

No official basis was found in this review for concluding that a change in shareholding, directors or assets automatically transfers a licence or leaves it unaffected. If a transaction involves a change to the licence-holding entity or control, obtain written confirmation from the competent authority before the transaction as to whether a variation or new application is required.

— New pharmacy application: if the proposed licence holder or premises address changes while the application is being processed, the official form states that the original application becomes void and must be resubmitted.

— Change of pharmacy licence holder: the official form requires evidence of good conduct, proof of payment and company details, where applicable.

— Manufacturing/import and wholesale: for a proposed change to the licence scope, premises, personnel or other material matters, apply for a variation first and await the competent authority’s decision.

Medicines placed on the Malta market generally require an MA, which may be obtained through national, mutual-recognition, decentralised or EU centralised procedures. Verify the product MA, its holder and its prescription/over-the-counter classification separately from the premises licence. The Medicines Database is for informational purposes only.

Wholesale regulations require products distributed or brokered in Malta to have the appropriate MA. Wholesalers must also provide the competent authority with a certified copy of the MA and an authorisation letter from the holder, unless they hold an applicable parallel import authorisation. The manufacturing/import application form also requires declarations concerning the relevant product authorisations.

Dangerous drugs are separately controlled under the Dangerous Drugs Ordinance: import requires a valid import authorisation and a valid export authorisation or transhipment certificate; export requires a valid export authorisation. An ordinary business licence does not automatically replace these authorisations. Herbal and homeopathic products, if they are medicinal products, must still be assessed according to their product MA and any special rules.

— Check each product individually: MA status, authorisation holder, dosage form, labelling/packaging, POM or OTC category and the scope of the supply-chain licences.

— Imports from outside the EU, parallel imports, repackaging/relabeling, free-zone/bonded warehousing and export activities require additional checks under the rules applicable to the actual operating model, including manufacturing, wholesale, customs and product rules.

— For controlled-drug activities, confirm the required import/export authorisations, certificates and customs documents with the relevant competent authority, in addition to ordinary business licences.