Warehouses Regulations, 2025

Suppliment tal-Gazzetta tal-Gvern ta’ Malta Nru. 21,501, 5 ta’ Settembru, 2025

L.N. 191 of 2025

MEDICINES ACT

(CAP. 458)

Online Dispensing of Medicinal Products to Third Countries from

Free Zones and Customs Authorised

Warehouses Regulations, 2025

IN EXERCISE of the powers conferred by article 106 of the

Medicines Act, the Minister responsible for public health, in

consultation with the Licensing Authority, has made the following

regulations:-

(1) The title of these regulations is the Online Dispensing Citation, scope,

of Medicinal Products to Third Countries from Free Zones and applicability

commencement.

Customs Authorised Warehouse Regulations, 2025.

(2) The scope of these regulations is to govern the sourcing,

storage, handling, online dispensing, and export of medicinal products

from Free Zones and Customs Authorised Warehouses in Malta to

consumers residing in third countries. They establish licensing,

operational, and compliance requirements to ensure the safety, quality,

and traceability of such medicinal products.

(3) These regulations shall apply to the sourcing, storage,

handling, online dispensing, and export of medicinal products from the

Free Zones or Customs Authorised Warehouses in Malta, for the

purpose of sale to consumers residing in third countries.

(4) These regulations shall come into force on such date or

dates as the Minister responsible for public health may by notice in the

Gazette establish and different dates may be so established for

different provisions and, or purposes of these regulations.

Fees payable for the issuing or annual renewal of an online

dispensing licence

(regulation 4)

(a) Applicants for the issuance of an online dispensing licence

shall pay the following fees

(i) Dispensing services only: thirty-five thousand euro

(€35,000);

(ii)

Website only: thirty-five thousand euro (€35,000);

(iii) Both dispensing services and a Website: fifty-two

thousand and five hundred euro (€52,500)

Provided that upon submission of the application, the

applicant shall pay

(iv) the sum of fifteen thousand euro (€15,000) in the case

of an application under sub-paragraph (i) or (ii); or

(v) the sum of twenty thousand euro (€20,000) in the

case of an application under sub-paragraph (iii);

and the balance shall become due and payable following

confirmation by the Licensing Authority that the application is

complete and meets the necessary requirements and shall be settled in

full prior to the issuance of the licence(s).

The application fee covers the first year of operation, and no

additional annual licensing fee shall be due for the first year.

(b) (i) Starting from the second year of operation, a licence

holder shall be required to pay an annual licensing fee, in accordance

with the applicable turnover tiers outlined in the Second Schedule

(Part I).

(ii) The annual licensing fee shall be determined based on

the licensee’s annual turnover and the nature of the services

provided, which shall fall under one of the following categories

•

Dispensing Services Only;

•

Online Website Only;

•

Both Dispensing and Online Website;

(iii) If a license is granted after the start of the calendar

year, the annual fee shall be calculated on a pro rata basis, based

on the number of full months remaining in the year.

(c) The pro rata amount shall be determined by dividing the

applicable annual licensing fee by twelve (12) months and multiplying

it by the number of remaining months in the calendar year.

(d) Any licence issued after the fifteenth day of a month shall be

considered as having commenced in the following month for fee

calculation purposes.

(e) (i) Inspection and audit fees shall be payable to the

Medicines Authority as required under these regulations, in

accordance with the fee structure provided in the Second Schedule

(Part II).

(ii) The licence holder shall not be liable for inspection or audit

fees unless an inspection or audit has been duly conducted.

In these regulations, unless the context otherwise requires

Interpretation.

"Act" means the Medicines Act;

"consumer" means an individual residing in a third country

who receives medicinal products in accordance with these

regulations;

"Customs Authorised Warehouse" means any authorised

government warehouse for lodging, storage and securing of

goods in accordance with article 2 of the Customs Ordinance, Cap. 37.

and in accordance with the applicable procedures under Article

240 of the Union Customs Code, as may be applicable from time

to time;

"dispensing service" means a licensed operation and its

associated premises, located in a Free Zone or Customs

Authorised Warehouse which processes requests for the

dispensing and supply of medicinal products and dispatches such

products via mail in accordance with these regulations;

"EEA market" means the internal market comprising the

Member States of the European Union together with the EEA

EFTA States, namely Iceland, Liechtenstein, and Norway, as

established under the Agreement on the European Economic

Area, within which the free movement of goods, persons,

services, and capital is ensured.

"EU market" means the internal market comprising the

Member States of the European Union, within which the free

movement of goods, persons, services, and capital is guaranteed

under the Treaty on the Functioning of the European Union and

relevant Union legislation.

"European Union licensed wholesale distributor" means

any wholesale dealer licensed in accordance with Title III of the

Act, the provisions of any regulation or rules made thereunder,

and any applicable European Union law governing such licences;

"Free Zone" shall have the same meaning as assigned to it

in the Malta Free Zones Act;

"Good Manufacturing Practice" means that part of quality

assurance which ensures that products are consistently produced,

imported and controlled in accordance with the quality standards

appropriate to their intended use and in accordance with these

regulations;

"Good Pharmacy (Dispensing) Practice" means the

standards applicable to the proper sourcing, storage, record-

keeping and dispensing that may, from time to time, be issued by

means of regulations under the Act;

"Licensing Authority" means the Licensing Authority

established by article 3 of the Act;

"licence" means a licence issued by the Licensing

Authority in accordance with these regulations to operate an

online dispensing service for medicinal products from the Free

Zones and Customs Authorised Warehouses to consumers

residing in third countries;

"logo" means the logo authorised by the Licensing

Authority signifying compliance with these regulations and any

other applicable law;

"managing pharmacist" shall be interpreted in accordance

with article 75 of the Act;

"Medicines Authority" means the Medicines Authority

established by article 4 of the Act;

"medicinal products" shall have the same meaning as

assigned to it in the Act;

"Minister" shall have the same meaning as assigned to it in

the Act;

"MRA countries" means those third countries which hold a

Mutual Recognition Agreement with the European Union;

"Regulation (EU) 2016/679" means the Regulation (EU)

2016/679 of the European Parliament and of the Council of 27

April 2016 on the protection of natural persons with regard to the

processing of personal data and on the free movement of such

data, and repealing Directive 95/46/EC (General Data Protection

Regulation);

"online dispensing of medicinal products" means the

dispensing of medicinal products to consumers residing in third

countries from the premises of a licence holder in accordance

with these regulations and any other applicable law, including

any guidelines issued by the Licensing Authority from time to

time;

"premises" means any physical location or facility,

including but not limited to buildings, warehouses, or other

structures, located within a Free Zone or Customs Authorised

Warehouse, which is approved by the Licensing Authority for the

storage, handling, and dispensing of medicinal products intended

for consumers residing in third countries;

"registered pharmacist" shall be interpreted in accordance

with article 13 of the Health Care Professions Act;

"Special Purpose Assurance Report" means a formal,

independent report prepared and signed by a certified auditor or

audit firm;

"third country" means any country outside the European

Union or the European Economic Area;

"WHO Listed Authorities Level 4" means regulatory

bodies recognised by the World Health Organization for meeting

rigorous safety and quality standards;

"website" means a digital platform or website through

which prescriptions are received and the dispensing of medicinal

products to consumers residing in third countries is facilitated;

"website URL" means the Website Uniform Resource

Locator which signifies the address of a unique resource on the

internet.

(Part I)

Annual

From

To

Dispensing

Online

Dispensing and

Licence

services only Storefront only Online storefront

€

€

Fee

€

€

€

Turnover

-

5,000,000

35,000

35,000

52,500

Tier 1

Turnover

5,000,000

10,000,000

55,000

55,000

82,500

Tier 2

Turnover

10,000,000

15,000,000

72,500

72,500

108,750

Tier 3

Turnover

15,000,000

20,000,000

87,500

87,500

131,250

Tier 4

Turnover

20,000,000

25,000,000

100,000

100,000

150,000

Tier 5

Turnover

25,000,000

30,000,000

110,000

110,000

165,000

Tier 6

Turnover

30,000,000

35,000,000

117,500

117,500

176,250

Tier 7

Turnover

35,000,000

40,000,000

122,500

122,500

183,750

Tier 8

Turnover

40,000,000

45,000,000

125,000

125,000

187,500

Tier 9

Turnover

45,000,000

50,000,000

125,000

125,000

187,500

Tier 10

(Part II)

Audit and Inspection Fees

Audit Fee

160 Euro per hour (minimum chargeable is 5,000 Euro)

Inspection Fee

160 Euro per hour (minimum chargeable is 5,000 Euro)

€0.99

(1) No person shall engage in the dispensing of medicinal

products from the Free Zones and Customs Authorised Warehouses in

Malta to consumers residing in third countries, unless they hold a valid

licence issued by the Licensing Authority in accordance with the

provisions of these regulations.

(2) The online dispensing of medicinal products under this

regulation shall be conducted in accordance with recognised standards

of Good Pharmacy (Dispensing) Practices. Licence holders shall

ensure that all medicinal products dispensed meet high standards of

safety, quality, and efficacy as stipulated in these regulations.

(3) The licence holder shall bear full responsibility for all

activities carried out under these regulations, including compliance

with any applicable regulatory requirements in the country of

destination.

(1) An application for a licence in accordance with these

regulations shall be submitted to the Licensing Authority and shall

include the following information

(a)

the name and address of the applicant;

(b) the address of the website URL and, or the address of

the premises located within a Free Zone or Customs Authorised

Warehouse intended for the dispensing of medicinal products to

third countries;

(c) the equipment and control facilities as may be

required by these regulations, under the Act and any other

applicable law;

(d) the name of the managing pharmacist responsible for

overseeing dispensing operations and ensuring compliance with

good dispensing practices as outlined by, or under these

regulations.

(e) a detailed plan outlining the quality management

system that shall be implemented to ensure the safety,

authenticity, and efficacy of medicinal products, with a

commitment to full implementation upon licensure;

(f) documented procedures or a plan for their

development, to prevent the dispensing of counterfeit,

unauthorised, or substandard medicinal products through online

platforms, with confirmation that these procedures shall be fully

in place prior to the commencement of operations;

(g) an outline of the applicant’s approach to complying

with Good Pharmacy (Dispensing) Practice, including a

commitment to implement the necessary procedures for the

storage, handling, and dispensing of medicinal products within

the premises, prior to operation;

(h) a data management plan that ensures full traceability

of each medicinal product from point of source to country of

destination in accordance with these regulations;

(i) the address of the hosting location of the website and

of the servers where the data related to the online dispensing

operations shall be stored, including confirmation that the

hosting complies with cybersecurity requirements;

(j) any other information, documentation or evidence as

may be requested by the Licensing Authority in accordance with

these regulations, under the Act and any other applicable law.

(2) Upon submission of the application, an application fee in

accordance with the First Schedule shall be payable to the Medicines

Authority.

(3) For the purposes of these regulations, any notice may be

served electronically at the email address provided by the applicant to

the Licensing Authority. Such service shall, unless otherwise provided

in these regulations, be deemed duly served if delivered to the most

recent residential or email address furnished by the applicant, provided

that proof of delivery is available

Provided that proof of delivery may include, but shall not

be limited to, a delivery receipt, server log entry, acknowledgment of

receipt from the recipient, or confirmation generated by a registered

electronic delivery system.

(1) The processing of personal data conducted by the

Licensing Authority for the purposes of these regulation shall fully

comply with Regulation (EU) 2016/679 and the Data Protection Act

including the regulations made thereunder and the fundamental rights

and freedoms of the data subjects.

(2) The Licensing Authority, acting in its capacity of a

controller in terms of Article 4(7) of Regulation (EU) 2016/679 shall

perform the relevant processing operations which are strictly necessary

for the purposes of these regulations.

(3) The controller, taking into account the nature, scope,

context and purposes of processing as well as the risks of varying

likelihood and severity for the rights and freedoms of the data subjects,

shall implement appropriate technical and organisational measures, in

an effective manner and to integrate the necessary safeguards into the

processing, in order to protect the rights of the data subjects and to

ensure a level of security appropriate to the risk.

(4) For the purpose of ensuring and to be able to demonstrate

that the processing of data is performed in accordance with the

provisions of Regulation (EU) 2016/679, the controller shall

implement the appropriate data protection policies, which policies

shall be periodically reviewed and updated where necessary.

(5) The controller shall ensure that the physical and, or

electronic access to personal data processed for the purposes of these

regulations shall be strictly granted to personnel authorised by the

controller.

(6) The data protection officer designated by the controller in

terms of Article 37(1)(a) of Regulation (EU) 2016/679 shall be

consulted properly and in a timely manner on all issues in relation to

the protection of personal data processed for the purposes of these

regulations.

All licensed holders are required to

(a) follow applicable Good Pharmacy (Dispensing)

Practice standards;

(b) ensure that medicinal products are sourced solely

from operators listed in regulation 12.

(c) ensure the proper storage of medicinal products,

maintaining environmental controls, including monitoring for

temperature and humidity in compliance with any applicable law

and, or regulations.

(d) maintain a traceable record for all received and

dispensed medicinal products

Provided that such records are to be updated on a

daily basis.

(e) comply with the requirements relating to the website

and, or the logo, including the proper display of the authorised

logo on the online storefront and, or on the third-party packaging

or labelling of dispensed products, thereby confirming the

licencing status of the shopfront and, or dispensing operation;

(f) ensure that during all operational hours of the online

dispensing service, a managing pharmacist or, in the absence of a

managing pharmacist, a locum pharmacist is always present;

(g) any other requirements as may be requested by the

Licensing Authority in accordance with these regulations, the

Act and any other applicable law.

The licence holder shall

Obligations of

the licence

holder.

(a) ensure continuous compliance with all licence

conditions and shall conduct activities and operations in full

compliance with the provisions of these regulations and any

other applicable law;

(b)

appoint a managing pharmacist who shall

(i) be a registered pharmacist in accordance with

the Health Care Professions Act;

(ii)

hold a valid licence to practice as a pharmacist;

(iii) possess a minimum of two (2) years

professional experience in pharmaceutical management or

the dispensing of medicinal products;

(c) ensure that the managing pharmacist is granted

sufficient authority and resources to effectively carry out the

responsibilities associated with the dispensing of medicinal

products and adherence with Good Pharmacy (Dispensing)

Practice standards;

(d) develop and annually update a risk management plan

that addresses relevant risks, including those related to

information security, business, indemnity, and dispensing

medicinal products to third countries

Provided that the plan shall comply with these

regulations and any applicable guidelines issued by the

Licensing Authority and shall also be certified by an approved

auditor in the Maltese Islands;

(e) ensure that all medicinal products dispensed, fully

comply with all relevant legislative, regulatory and quality

standards applicable in the third-country in respect of the

importation of medicinal products by the patient for personal

use;

(f) not source, dispense or sell any medicinal product or

item prohibited by the Dangerous Drugs Ordinance or any other

applicable law;

(g) ensure compliance with all standards and

requirements for the website as may be issued by means of

regulations under the Act or any other applicable law;

(h) ensure that, in the event of the absence of the

managing pharmacist, a locum pharmacist is present to perform

the duties of the managing pharmacist;

(i) comply with any other requirements as may be

requested by the Licensing Authority in accordance with these

regulations, the Act and any other applicable law;

(j) comply with the provisions of these regulations, the

Act and any other applicable law.

The managing pharmacist shall

(a) be responsible for the oversight, safety, and

compliance of the storage and dispensing activities carried out

by the licence holder with particular emphasis on the compliance

to Good Pharmacy (Dispensing) Practice standards;

(b) be available during all operational hours of the

dispensing service to oversee dispensing practices and address

any third-country consumer inquiries;

(c) ensure that, in the event of his absence, a locum

pharmacist is nominated to perform the duties of the managing

pharmacist;

(d) comply with any other requirements as may be

requested by the Licensing Authority in accordance with these

regulations, the Act and any other applicable laws;

(e) comply with the provisions of these regulations, the

Act and any other applicable law.

(1) Any licence issued in accordance with these Renewal of

regulations shall, be valid for a period of one (1) year from the date of licence.

issuance.

(2) Applications for the renewal of a licence shall be submitted

at least three (3) months prior to the expiration of the licence.

(3) The Licensing Authority shall have the right to reject

renewal applications if compliance standards are not satisfied.

(1) The Licensing Authority may refuse to grant or renew Refusal to grant

a licence in accordance with these regulations on any of the following or

licence.

grounds

(a) where the applicant has failed to meet all or any of

the requirements established in these regulations during the

application stage;

(b) where the Licensing Authority has reasonable

grounds to believe that the medicinal products to be dispensed do

not meet established safety and quality standards, as prescribed

by relevant health authorities;

(c) where the applicant or the managing pharmacist

nominated by the applicant has previously been found to be in

violation of any of the provisions of these regulations and the

Act;

(d) where the applicant lacks the necessary facilities,

equipment, personnel or managing pharmacist to ensure safe and

effective storage, handling, and dispensing of medicinal products

in conformity with these regulations, the Act and any applicable

law;

(e) where the applicant has engaged in any act of

misrepresentation, deceit, or fraudulent conduct related to the

application process or the operation of the licensed premises;

(f)

where the granting or renewal of the licence would

pose a significant risk to public health or safety, considering the

potential consequences of the online dispensing activities;

(g) where the applicant has failed to demonstrate

technical capacity, operational capability, or financial resources

necessary for the lawful, safe and effective online dispensing

services;

(h) for any other reason that would normally be a valid

reason for the refusal or renewal of the licence, including

criminal convictions and regulatory actions;

(i) for any other reason which the Licensing Authority

deems appropriate in accordance with these regulations, the Act,

or any other applicable law.

(2) In the event of a refusal to grant or renew a licence, the

Licensing Authority shall provide written notice to the applicant,

specifying the grounds for such refusal and any applicable rights to

appeal the decision.

(3) The applicant shall have the right to request a review of the

decision to refuse, grant or renew the licence, in accordance with the

procedures established in these regulations.

Decisions in accordance with these regulations shall be

subject to a right of appeal before the Administrative Review Tribunal

established in terms of article 5(1) of the Administrative Justice Act by

not later than twenty (20) days from the service of the decision,

wherein the person aggrieved by the said decision shall specify the

reasons on the basis of which the said decision of the Director should

be cancelled or modified

Provided that the decision shall become immediately

applicable and enforceable and shall remain applicable throughout the

term of appeal until final judgement by the Administrative Review

Tribunal, unless such decision is reversed by the said Tribunal and, or

the Court of Appeal or cancelled or modified by the Director

Provided further that any party, who feels aggrieved by a

decision of the Tribunal, may on a point of law, appeal to the Court of

Appeal in accordance with article 22 of the Administrative Justice Act.

The managing pharmacist shall ensure that medicinal

products offered for online dispensing in accordance with these

regulations shall be sourced from a European Union licensed

wholesale dealer who sources them from manufacturers or wholesale

distributors established in one of the following

(a) the EU and, or EEA market, provided that the export

of critical medicinal products subject to shortages in the

originating EU and, or EEA Member State is prohibited.

(b) MRA countries, provided that the medicinal product

is licensed in that country forming part of the Mutual

Recognition Agreement;

(c) suppliers who have procured products manufactured

in compliance with Good Manufacturing Practice standards

established by a regulatory authority listed in paragraphs (a) and

(b).

(d) operators licensed by regulatory bodies classified

under the WHO Listed Authorities Level 4 strictly for products

which would be authorised to be placed on their respective

markets.

(e) the United Kingdom and any other operator, supplier

or country as established by Government notice in the Gazette by

the Minister after consultation with the Licensing Authority.

(1) The licence holder shall establish and maintain a Quality

quality management system to ensure that medicinal products are assurance

traceability.

procured solely in accordance with the provisions of regulation 12.

Furthermore, the licence holder shall ensure that each medicinal

product dispensed complies with the safety, quality, and efficacy

standards specified in the authorisation of the product in the country of

origin, without exception

Provided that, for the purpose of this regulation,

"authorisation" means an authorisation equivalent to, or substantially

similar to, a marketing authorisation as defined in accordance with

Regulation (EC) No 726/2004 of the European Parliament and of the

Council of 31 March 2004 laying down Union procedures for the

authorisation and supervision of medicinal products for human use and

establishing a European Medicines Agency.

(2) The licence holder shall ensure that there is full traceability

of all medicinal products purchased, stored and dispensed in

accordance with these regulations, which shall, at a minimum include

records and documentation in relation to

(a) prescriptions, including consumer’s details, country

of

prescription,

prescribing

healthcare

professional’s

information, and prescription dates

Provided that a scanned or electronic copy of the

prescription as provided by the consumer through the website

shall suffice;

(b) product name, active ingredient, dosage form, dose,

pack size, batch and lot numbers, supplier, expiration date, and

storage conditions;

(c) purchasing, storage, and dispensing of a medicinal

product, including date of dispensing and the registration number

of the dispensing pharmacist;

(d) any other information, as may from time to time, be

established by the Licensing Authority in accordance with

regulation 20(3).

(1) All licence holders shall prominently display the logo

on their website as a verification of legitimacy.

(2)

The website shall allow customers to

(a)

verify the licensing status of the licence holder;

(b) view the contact details of the licence holder;

(c) access the consumer support policy of the licence

holder, including information on how to contact the licence

holder in the event of complaints related to the medicinal

product, and any other issues;

(d) any other information as may from time to time be

established by the Licensing Authority in accordance with

regulation 20(3).

(3) Each online medicinal product listing on the website shall

as a minimum include

(a) the product name, active ingredient, dosage form,

pack size and intended use, or a link to the patient information

leaflet;

(b) the potential risks, contraindications, and necessary

usage guidelines, or a link to the patient information leaflet;

(c) instructions for consumers to verify the authenticity

of the medicinal product being sold. These shall include, where

applicable, guidance on how to use safety features, such as anti-

tampering devices, or access links to official verification

systems, including those provided by national or international

regulatory authorities;

(d) the pricing details, which shall be provided in a

manner that ensures full transparency to the consumer, clearly

specifying the individual price components such as product cost,

transport fees, and the corresponding cost for each, as well as the

total price payable.

(e) the licence number, name of the Licencing Authority

and the contact details for the Licencing Authority;

(f) any other information, as may from time to time, be

established by the Licencing Authority in accordance with

regulation 20(3).

(4) For each dispensed medicinal product delivered in a

package, the licence holder shall include on or within the package the

licence number, the contact information of the licence holder and the

official website of the Medicines Authority that provides access to the

official list of licensed holder.

(1) Licence holders shall offer consumers access and Consumer

contact details of the managing pharmacist for guidance regarding safety

protections.

medicinal products.

(2) An electronic verification and decommissioning system

shall be maintained to ensure adherence to the principles of safety,

quality, and regulatory compliance.

(3) The dispensed medicinal product shall be delivered to

consumers in third countries in suitable tertiary outer packaging that is

properly labelled and that preserves the integrity of the medicinal

product, including its primary and secondary packaging. The contents

of each package shall be accurately declared on the relevant customs

documentation as may be required from time to time and shall be

designated as "Medicinal Products for Personal Use".

(4) The Licensing Authority shall not be held responsible for

any infringements or breaches committed by the licence holder in

failing to adhere to the consumer’s country of destination’s laws and

regulations.

(5) The licence holder shall ensure that all medicinal products

dispensed for delivery to consumers in a third country comply with the

legislation regulating prescription applicable in the country of

destination. In particular, the licence holder shall observe the

following requirements

(a) the quantity and form of the medicinal product shall

be consistent with the specific prescription requirements

established by the regulatory authorities of the country of

destination;

(b) in jurisdictions where a general prescription may be

accepted for a full supply, the licence holder shall adhere to local

practices to ensure compliance;

(c) the period of validity of the prescription shall also

conform to the regulations of the country of destination, ensuring

that prescriptions are honoured only within the authorised time

frame.

(1) Medicinal products procured in accordance with

these regulations shall only be dispensed to consumers residing in

third countries.

(2) The licence holder shall be entirely responsible for

ensuring that all dispensed medicinal products comply with these

regulations and ensure that all medicinal products dispensed, fully

comply with all relevant legislative, regulatory and quality standards

applicable in the third country in respect of the importation of

medicinal products by the patient for personal use.

(3)

Licence holders shall

(a) prohibit the redistribution or dispensing of any

medicinal product in their supply within the European Union;

(b) not dispense any medicinal product which is banned

or otherwise subject to restrictions in the jurisdiction of the

country of destination.

(c) comply with any other requirements as may be

requested by the Licensing Authority in accordance with these

regulations, the Act and any other applicable laws.

(1) Licence holders shall maintain detailed transaction

records and prescriptions for each medicinal product dispensed, which

shall be kept for a minimum period of five (5) years which shall as a

minimum include

(a) the date of dispensing, the product details, the

quantity supplied, the batch, lot numbers and registration number

of dispensing pharmacist;

(b)

the consumer’s details and the country of destination;

(c) comply with any other requirements as may be

requested by the Licensing Authority in accordance with these

regulations, the Act and any other applicable laws.

(2) Every licence holder shall, on an annual basis and at their

own expense, submit to the Licensing Authority the following

documents

(a) a Special Purpose Assurance Report prepared by an

independent auditor, duly warranted by the Accountancy Board,

and possessing expertise in the pharmaceutical field; and

(b) an audited financial statement relating to the

preceding financial year, which shall not, in any case, be more

than two (2) years. The financial statements shall include a

revenue note that clearly identifies the turnover derived from

dispensing services, the online store-front or both.

(3) The Special Purpose Assurance Report shall be submitted

not later than the first (1) of July of each year, covering the preceding

financial year and shall include the following

(a) verification of the total annual turnover of the licence

holder for the reporting period, commencing on the 1st of July

and ending on the 30th June of each calendar year;

(b) verification that all medicinal products handled by the

licence holder during the reporting period were sourced and

dispensed in accordance with these regulations.

(4) (a) Failure to submit the Special Purpose Assurance

Report within the timeframe in sub-regulation (3), or submission of a

report found to be materially deficient, shall constitute a breach of

these regulations.

(b) In response to any such breach, the Licensing

Authority may impose one or more of the following measures

(i)

issuance of a warning or notice of deficiency.

(ii) administrative penalties as referred to in

regulation 21.

(iii) suspension or revocation of the licence holder’s

licence.

(iv) the institution of criminal proceedings.

(5) (a) The Licensing Authority reserves the right to audit

the licence holder’s operations to verify the accuracy of the submitted

Special Purpose Assurance Report.

(b) Licence holders shall grant full access to relevant records

and documentation upon request by the Licensing Authority or its

authorised representatives.

(1) The Licensing Authority is vested with the authority

to conduct periodic inspections of licensed premises and online

platforms to verify compliance with these regulations, the Act and any

applicable legislation. For the purpose of executing these duties more

effectively, the Licensing Authority may appoint officers and, or

engage experts to provide assistance.

(2) The Licensing Authority may, if it has reasonable suspicion

to believe that any licence holder is acting in breach of any of the

provisions of these regulations may

(a)

suspend or revoke the licence;

(b)

seize the non-compliant medicinal products;

(c) order any person to undertake any action or refrain to

undertake any action to comply with the provisions of these

regulations;

(d) impose any conditions in relation to the licence

holder and, or the managing pharmacist; and, or

(e) initiate the special procedure as established in article

100 of the Act.

(1) All websites operated under these regulations, along

with their related data and content, shall be required to store such data

on servers physically located within the jurisdiction of Malta.

(2) Non-compliance with sub-regulation (1) may result in

administrative penalties as referred to in these regulations, as well as

the suspension or revocation of the licence.

(1) The Licensing Authority shall possess all powers and

functions as established in the Act and shall have the right to delegate

any of these powers and functions to another public authority to

facilitate compliance with the provisions of these regulations.

(2) The Licensing Authority shall also be empowered to issue

guidelines to further define and regulate the provisions of these

regulations. Such guidelines shall be binding on any person to whom

they are addressed, including the licence holder and the managing

pharmacist.

(3) The Licensing Authority shall have the power to request

such information, documents, data, or records as it may deem necessary

for the proper exercise of its functions and for ensuring compliance with

the provisions of these regulations.

(1) When the Licensing Authority has reasonable cause Administrative

penalties and

to believe that

proceedings.

(a) an offence against

the

regulations

has

been

committed by any person; and

(b) having regard to the previous conduct of the person

concerned, it would be appropriate to impose an administrative

penalty under this regulation, the Licensing Authority may cause

a notice in writing in accordance with sub-regulation (2) in the

appropriate form to be served on such person.

(2)

A notice as provided for in sub-regulation (1) shall specify

(a)

the date and nature of the offence;

(b) a summary of the facts upon which the allegation that

an offence has been committed is based, this being sufficient for

the purpose of fully and fairly informing the person of the

allegation against him;

(c) any other matter, not being related to previous

convictions, that the Licensing Authority considers relevant in

the given circumstances, for the imposition of an administrative

penalty, including any precautionary suspension of the licence

that is issued in accordance with these regulations; and

(d) the amount of the administrative penalty due, which

amount shall be decided in accordance with the severity of the

case and the previous conduct of the person concerned

Provided that the administrative penalty imposed

shall not exceed the amount of twenty-three thousand, two

hundred and ninety-three euro and seventy-three cents

(€23,293.73)

Provided further that in addition to the administrative

penalty as imposed under this paragraph, the Licensing

Authority may also order the suspension or revocation of the

licence

Provided further that in any event, the Licensing

Authority shall have the option to issue a warning instead of an

administrative penalty, if it considers that in the interests of

fairness and equity, depending on the circumstances of the case,

it is preferable to do so.

(3) Any person on whom a notice under sub-regulation (2) is

served may, within thirty (30) days after such service, by notice in

writing in the appropriate form served on the Licensing Authority,

require that proceedings in respect of the alleged offence shall be dealt

with by the court, in which case the provisions of sub-regulation (7)

shall apply.

(4) Any person on whom a notice under sub-regulation (2) is

served may by notice in writing served on the Licensing Authority

(a)

admit the offence; and

(b) pay the amount of the administrative penalty to the

Medicines Authority within thirty (30) days after the notice of

the penalty is served upon him or after such subsequent period as

the Licensing Authority may determine.

(5) The administrative penalty imposed under sub-regulation

(2)(d) shall be due as a civil debt enforceable by the competent court

of civil jurisdiction in favour of the Government and the declaration by

the person on whom the administrative penalty is imposed, that he

admits the charge shall constitute an executive title for the purposes of

article 253 of the Code of Organization and Civil Procedure.

(6) Without prejudice to any other provision of these

regulations or of any other law, where an offence has been admitted

under this regulation, no charge may be brought in respect of the

offence against any person by whom it has been admitted, unless such

person fails to effect payment within the time limit provided in the

notice.

(7) In the case that a person on whom a notice under sub-

regulations (1) and (2), either does not admit the offence within thirty

(30) days from the service of the notice, or chooses to proceed with the

proceedings mentioned under sub-regulation (3), the Licensing

Authority shall institute proceedings or cause proceedings to be

instituted before the Court in respect of the alleged offence

Provided that where the licence holder is not habitually

resident or established in Malta, such person shall be deemed to have

submitted to the jurisdiction of the Courts and tribunals of Malta in

respect of any matter arising under or in connection with these

regulations, and service effected in accordance with this regulation

shall be deemed valid and binding.

Any person who

Offences and

punishments.

(a) assaults, hinders, obstructs, molests or interferes, or

attempts to assault, hinder, obstruct, resist or wilfully obstructs

any authorised official of the Medicines Authority, in the

execution of their duties in accordance with these regulations;

(b) refuses or fails to comply with any order or direction

lawfully made or given under these regulations;

(c)

without reasonable cause fails to

(i) provide the requested information to an

authorised official of the Medicines Authority; or

(ii) produce anything required to be produced in

accordance with these regulations;

(d) fails to allow a search or inspection in accordance

with these regulations;

(e) prevents or attempts to prevent another person from

complying with any orders or directions or from answering any

questions, or producing anything or allowing a search or

inspection; or

(f) for the purpose of obtaining any licence or permit, or

for the purported compliance with any requirement to provide

any information under these regulations, provides information

which he knows to be false in a material fact or recklessly

provides information which is false in a material fact, shall be

guilty of an offence and shall be liable on conviction, to a fine

(multa) of not less than one thousand euro (€1,000), but not

exceeding ten thousand euro (€10,000).

Unless otherwise provided in these regulations, any person Fines (multi)

who breaches any provision of these regulations shall be guilty of an and punishment.

offence and shall on conviction, be subject to a fine (multa) of not less

than five thousand euro (€5,000), but not exceeding fifty thousand

euro (€50,000), or to imprisonment for a term not exceeding two (2)

years, or to both such fine and imprisonment.

In the Second Schedule to the Administrative Justice Act

immediately after the last item of the subsidiary legislation there shall

be added the following new item

"Online Dispensing of Medicinal Products to Third

Countries from Free Zones and Customs Authorised Warehouses

Regulations, S.L. 458.64, Superior/Inferior Competence".