ONLINE DISPENSING OF MEDICINAL PRODUCTS TO THIRD COUNTRIES FROM FREE ZONES AND CUSTOMS AUTHORISED WAREHOUSES

THIRD COUNTRIES FROM FREE ZONES AND CUSTOMS

AUTHORISED WAREHOUSES

SUBSIDIARY LEGISLATION 458.64

ONLINE DISPENSING OF MEDICINAL PRODUCTS

TO THIRD COUNTRIES FROM FREE ZONES AND

CUSTOMS AUTHORISED WAREHOUSES

REGULATIONS

28th April, 2026

LEGAL NOTICE 191 of 2025.

(1)

The title of these regulations is the Online

Dispensing of Medicinal Products to Third Countries from Free Zones

and Customs Authorised Warehouse Regulations.

(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.

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

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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

"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,

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

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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;

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"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

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Locator which signifies the address of a unique resource on the

internet.

(Part I)

From

To

Dispensing

Online

Dispensing and

services only Storefront only Online storefront

€

€

€

€

€

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AUTHORISED WAREHOUSES

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

160 Euro per hour (minimum chargeable is 5,000

Audit Fee

Euro)

160 Euro per hour (minimum chargeable is 5,000

Inspection Fee

Euro)

(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;

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(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,

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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

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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

(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

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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

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

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.

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(1)

The Licensing Authority may refuse to grant or

renew a licence in accordance with these regulations on any of the

following 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.

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(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.

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(1)

The licence holder shall establish and maintain a

quality management system to ensure that medicinal products are

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;

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(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

contact details of the managing pharmacist for guidance regarding

medicinal products.

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(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

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(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;

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(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;

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(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 to believe that

(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

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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.

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(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

(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;

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(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 who breaches any provision of these regulations shall be guilty

of an 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.