Premises and Medicines (Amendment) Regulations, 2025

L.N. 254 of 2025

MEDICINES ACT

(CAP. 458)

Various Laws relating to Fees in respect of Private Medical

Premises and Medicines (Amendment) Regulations, 2025

IN EXERCISE of the powers conferred by article 106 of the

Medicines Act, the Minister responsible for public health, after

consultation with the Licensing Authority, has made the following

regulations:-

The title of these regulations is the Various Laws relating to Citation.

Fees in respect of Private Medical Premises and Medicines

(Amendment) Regulations, 2025.

PART I

Amendment to the Licensing Fees for

Private Medical Premises Regulations

(regulation 3)

Fees related to Apostille of documents

Apostille Fees

Apostille handling fee (per document, excluding third-party expenses)

€1.26

This Part amends the Licensing Fees for Private Medical Amends the

Premises Regulations and it shall be read and construed as one with the Licensing

for Private

Licensing Fees for Private Medical Premises Regulations, hereinafter Medical

Premises

in this Part referred to as the "principal regulations".

Regulations.

In the Schedule to the principal regulations the item Amends the

Schedule to the

"Pharmacy" shall be substituted by the following new item

principal

regulations.

€ 215".

"Pharmacy

PART II

Amendments to the Medicines Authority (Fees) Regulations

This Part amends the Medicines Authority (Fees) Amends the

Regulations and it shall be read and construed as one with the Medicines

Authority

Medicines Authority (Fees) Regulations, hereinafter in this Part (Fees)

Regulations.

referred to as the "principal regulations".

Regulation 2 of the principal regulations shall be amended Amends

regulation 2 of

as follows

the principal

regulations.

(a) immediately after the definition "concerned Member

State" there shall be added the following new definition

" "decentralised procedure" means the decentralised

procedure for human medicinal products provided for in

Directive 2001/83/EC, as may be amended from time to

time;";

(b) immediately after the definition "marketing

authorisation transfer" there shall be added the following new

definition

" "mutual recognition procedure" means the mutual

recognition procedure for human medicinal products

provided for in Directive 2001/83/EC, as may be amended

from time to time;";

(c) in the definition "variation to the terms of the

marketing authorisation" the words "Article 6(2) of Regulation

(EC) No726/2004, point (a) of Article 7(1) and Article 34(1) of

Regulation(EC) No 1901/2006 of the European Parliament and

of the Council and Articles 7 and 14(1) of Regulation (EC) No

1394/2007 of the European Parliament and of the Council" shall

be substituted by the words "as defined in Commission

Regulation (EC) No 1234/2008 of 24 November 2008

concerning the examination of variations to the terms of

marketing authorisations for medicinal products for human use

and veterinary medicinal products, as may be amended from time

to time,";

Regulation 3 of the principal regulations shall be amended

as follows

(a) sub-regulation (1) thereof shall be substituted by the

following new sub-regulation

"(1) The fees listed in the Schedules shall be paid to

the Medicines Authority.";

(b) sub-regulation (2) thereof shall be substituted by the

following new sub-regulation

"(2) The validation and, or processing of

applications shall commence only upon receipt by the

Medicines Authority of proof of payment.";

(c) immediately after sub-regulation (5) thereof there

shall be added the following new sub-regulations

"(6) The failure to remit payment of any annual fee

pertaining to marketing authorisations or other product

licences may result in administrative measures on

authorisations or licences.

(7) Where any fee or charge payable in accordance

with these regulations remains outstanding after the due

date, the Medicines Authority may, without prejudice to

any other legal remedy available for the recovery thereof,

suspend or decline to provide any service or to undertake

any regulatory procedure until such time as the full amount

due, together with any applicable interest, has been

received.".

Schedule 1 to the principal regulations shall be substituted Substitutes

Schedule 1 to

by the following new Schedule

the principal

regulations.

"SCHEDULE 1

(regulation 3)

PRODUCT AUTHORISATION FEES AND OTHER ACTIVITIES

Fee

Type of Application

€

MUTUAL RECOGNITION PROCEDURE/

DECENTRALISED PROCEDURE/NATIONAL PROCEDURE

(Malta Concerned Member State)

New applications per product

All applications

Type of Application

€

MUTUAL RECOGNITION PROCEDURE/

DECENTRALISED PROCEDURE

(Malta Reference Member State)

New Applications per product

Article 8.3 of Directive 2001/83/EC: New active substance*

140,000

Article 8.3 of Directive 2001/83/EC: Known active substance*

125,000

Article 10 (a) of Directive 2001/83/EC*

35,000

Article 10 (b) of Directive 2001/83/EC*

40,000

Article 10(1) of Directive 2001/83/EC*

26,000

Article 10(3) of Directive 2001/83/EC*

28,000

Article 10(c) of Directive 2001/83/EC*

17,000

Article 10(4) of Directive 2001/83/EC*

50,000

Article 10(5) of Directive 2001/83/EC*

26,000

Additional strength (applied for at the same time)

3,000

Additional pharmaceutical form (applied for at the same time)

4,000

Line extension

15,000

Parallel application (same timetable as lead procedure)

10,000

Mutual Recognition Procedure

10,000

Duplicate application (different timetable from lead procedure)

15,000

90% of relevant fee

Application withdrawn during validation

is refunded

Change from Malta Concerned Member State to Reference Member State

5,000

Zero Day procedure (per product included in procedure)

*A discount of 30% shall be given on fees for Micro Enterprises as defined in

Commission Recommendation 2003/361/EC

Malta Reference Member State in a Mutual Recognition Procedure/

€

Decentralised Procedure – Other activities

Renewal of Marketing Authorisation

1,000

Annual Maintenance fee (for each form and strength) †

†

Activities covered include pharmacovigilance;

Type of Application

€

OTHER ACTIVITIES

Renewal application per product (where applicable)

National procedure

Mutual Recognition Procedure/Decentralised Procedure (Malta Concerned

Member State)

Annual fee (for each form and strength) (All Authorisations) †

Transfer of Marketing Authorisation Holder (change in legal entity)

† Activities covered include variations (all types) and

pharmacovigilance

Type of Application

€

Traditional Herbal Medicinal Products (Article 16 of Directive 2001/83/EC)

(National/MT Reference Member State)

Registration for Traditional Herbal Medicinal Product

10,000

Variations

Administrative

Technical

Renewal

Type of Application

Authorisation in accordance with regulation 4(2) of the Medicines (Marketing

Authorisation) Regulations (S.L. 456.34)

New application

Annual fee †

†

Activities covered include pharmacovigilance and notifications of varia-

tions

Homeopathic Product

New Product (single stock)

New Product (for two (2) or more stocks)

Variations

Administrative

Technical

Renewal

Parallel importation licence (per strength/form/source country))

New parallel import licence application/renewal# of Parallel Import Licence

†

Annual fee

#

Renewal application shall be submitted 6 months before the

expiration of the licence (every 5 years)

†

Activities covered include pharmacovigilance and notifications of varia-

tion

Request for Authorisation under of the Clinical Trial Regulations (S.L. 458.43)

Phase I, II, III or IV of Clinical Trials

Investigational medicinal product containing an established active substance

Investigational medicinal product containing a new active substance

Amendments to Clinical Trials

Notice of Amendment under the Clinical Trial Regulations (S.L. 458.43)

Amendments to include a new investigational medicinal product dossier

Application for clinical trial authorisation [under Regulation (EU) No 536/2014 of

the European Parliament and of the Council of 16 April 2014 on clinical trials on me-

dicinal products for human use and repealing Directive 2001/20/EC

Applications with Investigational Medicinal Product Dossier (IMPD)

Mono National

MT – Reporting Member State

MT – Concerned Member State

Supplement – where MT subsequently becomes the Reporting Member State

Reporting Member State – 2 nd & subsequent phases

Non Commercial/Academic Clinical Trials

Applications without Investigational Medicinal Product Dossier or with

simplified Investigational Medicinal Product Dossier or a low interven-

tion trial

Mono National

MT – Reporting Member State

MT – Concerned Member State

Supplement - where MT subsequently becomes the Reporting Member State

Reporting Member State - 2nd & subsequent phases

Non Commercial/Academic Clinical Trials

Substantial Modifications (Part one only) - with the addition of a new Investiga-

tional Medicinal Product Dossier (IMPD)

Mono National

MT - Reporting Member State

MT - Concerned Member State

Non Commercial/Academic Clinical Trials

Substantial Modifications – other

Mono National

MT - Reporting Member State

MT - Concerned Member State

Non Commercial/Academic Clinical Trials

Classification Committee

Classification Committee per product

Scientific advice/pre-submission meetings

Malta Reference Member State/Rapporteur in European procedures or for national

procedures

1 The fees in brackets are for applications for academic research without any financial support from

industry. The decision shall be at the sole discretion of the Licensing Authority .

Exemption in line with Article 20 of the Medicines Act (Cap. 458)

New application for medicinal products sourced from within the EU (per

specific product details)

and

processing

fee

New application for medicinal products sourced from third countries (per

specific product details)

and

processing

fee

Exemption in accordance with Delegated Regulation EU 2016/161 of 2

October 2015 supplementing Directive 2001/83/EC of the European

Parliament and of the Council by laying down detailed rules for the safety

features appearing on the packaging of medicinal products for human use

New application (per specific product details)

and

processing

fee

Non-resolution of alerts breach

and

processing fee

*The processing fee is not refundable if the application is withdrawn or rejected.".

Schedule 2 to the principal regulations shall be substituted

Substitutes

Schedule 2 to

the principal

regulations.

by the following new Schedule

"SCHEDULE 2

(regulation 3)

VARIATION FEES PER PRODUCT

Variation Type (for national procedures* and procedures where Malta is the

Reference Member State in the Mutual Recognition Procedure and

Decentralised Procedure)

Type I

Type IA

Batch specific exemption request

Type IB

Type II

Type II Simple

Type II Complex

*

Where an application is not accompanied by an acceptable EU

approval

For grouped variations (in accordance with the Communication

from the Commission – Guideline on the details of the various categories of

variations to the terms of marketing authorisations for medicinal products for

human use and veterinary medicinal products) fees shall be charged for each

variation included in the group for the first marketing authorisation (Marketing

Authorisation number/Procedure number) but not for additional strengths which

are included in the group and subject of the same variations.

Specific exemption request for a batch (applicable to all registration

routes)

Other post-authorisation activities (Malta Rapporteur/Reference

Member State)

Assessment of PSUR/DSURs/ASR

Assessment of Post Authorisation Safety Studies (PASS) protocol

Assessment of Post Authorisation Efficacy Studies (PAES) protocol

Assessment of PASS Results

Assessment of PAES Results

Assessment of safety annual reports for coordinated safety member state

procedure in accordance with Commission Implementing Regulation (EU)

2022/20 of 7 January 2022 laying down rules for the application of Regulation

(EU) No 536/2014 of the European Parliament and of the Council as regards

setting up the rules and procedures for the cooperation of the Member States in

safety assessment of clinical trials

1 The fees in brackets are for applications for academic research without any financial sup-

port from industry. The decision shall be at the sole discretion of the Licensing Author-

ity .

Schedule 3 to the principal regulations shall be substituted Substitutes

by the following new Schedule

"SCHEDULE 3

(regulation 3)

INSPECTORATE FEES

Fee for type of Licence

€

Activity

Issue of new

(involving an inspection in Malta or within the European

Annual

licence and, or

Union/European Economic Area)

renewal of

major initial

licence 2

inspection 1

GOOD MANUFACTURING PRACTICE 3

Issue of licence and annual renewal

Full manufacture

Small (less than 15 employees 4 )

4,700

1,000

Medium (15 to 75 employees 4 )

7,000

1,500

Large (76 to 200 employees 4 )

9,350

2,000

Super (more than 200 employees 4 )

14,000

3,000

Partial manufacturing

1,400

Fee per type of Licence

€

Activity

Issue of new

(involving an inspection in Malta or within the European

Annual

licence and, or

Union/European Economic Area)

renewal of

major initial

licence 2

Inspection 1

IMPORTATION, WHOLESALE DEALING

Issue of licence and annual renewal

Import 5

Wholesale

PHARMACY

Issue of pharmacy licence and inspection every year (includes

In accordance

all follow up and other inspections)

with the

Licensing Fees

for Private

Medical

Premises

Regulations

(S.L. 458.26)

Variation to pharmacy licence

Administrative variation

80*

Non-administrative variation including an inspection

150*

*Fast-track service is offered at double the original fee

Initial

Follow-up and

OTHER ACTIVITIES

inspection

routine

(Frequency as required and involving an inspection in Malta or

inspections

within the European Union)

Good Clinical Practice (clinical trials) / centre / trial

1,100

Pharmacovigilance inspections

Activity

Fee for type of Certificate/

Inspection

6,9 )

(involving an inspection in a third country

€

GOOD MANUFACTURING PRACTICE

Issue of new

Annual

Issue of licence and annual renewal

certificate and,

renewal of

or major initial

certificate 2

inspection 1

Full manufacture

25,000 and 600

7,500 and 600

per day per

per day per

inspector 7

inspector 7

Partial manufacturing

15,000

5,000

and 600 per day and 600 per day

per inspector 7

per inspector 7

Follow up and

OTHER ACTIVITIES

Initial

routine

(Frequency as required and involving an inspection in a third

Inspection

Inspections

6,

country )

Good Clinical Practice (clinical trials) / centre / trial

20,000

5,000 and

and 600 per day 600 per day per

per inspector 7

inspector 7

Pharmacovigilance inspections

20,000

5,000 and

and 600 per day 600 per day per

per inspector 7

inspector 7

ADMINISTRATIVE ACTIVITIES

Fee

€

Variations (not requiring an inspection)

Issue of Certificate of a Pharmaceutical Product

Issue of Certificate of a Pharmaceutical Product (fast-

track) 8

Issue of Good Manufacturing Practice Certificates (not

requiring an inspection)

Supervision of destruction of pharmaceutical waste

1 Includes issue of licence and first time inspection.

2 Includes inspections for licence renewal, routine inspections and other inspections. Fees also

apply to variation applications that involve an inspection.

3 Includes manufacture of finished dosage forms, Active Pharmaceutical Ingredients and

Investigational Medicinal Products. When a company additionally manufactures Investigational

Medicinal Products and a separate inspection is required the fee for this service shall be

charged at 25% of that for initial inspections.

4 Includes all the personnel employed within the company. It is the responsibility of the

company to inform the Regulatory Authority of any changes in the number of its employees.

5 Applications for an import authorisation by a company already in possession of a

manufacturing or wholesale dealer licence shall be charged at 50% of the normal applicable

rates for import activities.

6 For applications involving an inspection in a third country the applicant has to additionally cover

the flight and all accommodation and subsistence expenses allowance of the inspectors together

with an additional €500 per inspector for other additional and sundry expenses.

7 Includes days spent for actual inspection and for travel.

8 This fee applies for the issue of Certificate of a Pharmaceutical Product within 48 hours.

9 If a mutually agreed-upon scheduled inspection is cancelled 30 calendar days or less before

the first day of inspection due to reasons attributable to the applicant, all applicable fees for

third country inspections shall apply, including any costs related to flights and accommodation

cancellations, if the cancellation occurs more than 30 calendar days before the first day of the

inspection for reasons attributable to the applicant, a charge of €3,000 shall apply in addition to

any costs associated with flights and accommodation cancellations.

Brokers of medicinal products and importers or distributors of active pharmaceutical

ingredients shall be subject to all fees applicable for wholesale dealers.

".

Schedule 4 to the principal regulations shall be substituted

by the following new Schedule

"SCHEDULE 4

(regulation 3)

GENERAL

Activity

Fee

€

Consultation (per man hour)

Issue of original copies of licences/certificates

Appeals to Medicines Review Board*

11,650

(*Fee for appeals shall be fully refunded if appeal is successful)

Immediately after Schedule 4 to the principal regulations,

as substituted, there shall be added the following new Schedules

"SCHEDULE 5

(regulation 3)

Fees related to Medical Devices and In Vitro Diagnostic Medical Devices

Standard service for the processing of an application is within a 30 working

day timeframe from date of submission of the application and supporting

documentation, unless otherwise specified with respective application fee details,

below. Fast-track service is available for selected applications (marked with an

asterisk*), for the processing of the application to be completed within a 10 working

day timeframe. If the Authority requires any further information and, or clarification,

this shall be communicated to the applicant and the time period shall be interrupted

and the time period shall recommence to run, accordingly, upon receipt of the

applicant’s response.

All fees under Schedule 5 are non-refundable.

Distributor / Importer

€

Initial Application for Organisation Registration of Distributor/Importer

500*

Annual Registration of Distributor / Importer (renewable annually)

500*

Change in Organisation Registration Application details

100*

Initial Application for Notification of device per manufacturer

Annual Notification per device (renewable annually per group)

15*

Amending Notification of Medical Device

100*

Initial Application for Medical Device Registered Person (MDRP)

100*

Annual Registration of Medical Device Registered Person (MDRP) (renewable annually)

100*

Amending Medical Device Registered Person (MDRP) details

50*

*Fast-track service is offered at double the original fee

Manufacturer based in Malta

€

Initial Application for Organisation Registration application of Manufacturer

2,500*

Annual Organisation Registration for Manufacturer

25,000

> 150 employees 1

18,000

100 – 150 employees 1

12,000

50 – 99 employees 1

5,000

16 – 49 employees 1

5 – 15 employees 1

< 5 employees 1

Change in Organisation Registration application for Manufacturer

*Fast-track service is offered at double the original fee

1 Includes all the personnel employed within the company. It is the responsibility of the

company to inform the Regulatory Authority of any changes in the number of its

employees

Manufacturer (Non-EU) whose Authorised Representative is based in Malta

Initial Application fee for Manufacturer (Non-EU) with Authorised Representative is

based in Malta

Annual Organisation Registration of Manufacturer (Non-EU) whose Authorised

Representative is based in Malta Annual Fee

Change in Organisation Registration of Manufacturer (Non-EU) whose Authorised

Representative is based in Malta

*Fast-track service is offered at double the original fee

Authorised Representative

Initial Application for Organisation Registration of Authorised Representative

Annual Organisation Registration of Authorised Representative (maximum €50,000)

Change in Organisation Registration for Authorised Representatives

*Fast-track service is offered at double the original fee

Notified Body

Notified Body Designation application – Initial Setup of Notified Body

Notified Body Designation application – Extension of Scope

Annual Application for Notified Body Designation

Application timeframe is according to EU legislation and Guidance document timelines .

Certificate of Free Sale

Certificate of Free Sale application (per DoC)

*Fast-track service is offered at double the original fee

Device Registration in the European Market

Device Registration – placing a medical device on the European market application (per

DoC)

Device Registration – placing a medical device on the European market application –

Amending Registration of Medical Device (Revised)

Withdrawal incurs no charge

*Fast-track service is offered at double the original fee

Derogations

Derogation application in terms of Article 59 of Regulation (EU) 2017/745 of the

European Parliament and Council and Article 54 of Regulation (EU) 2017/746 of the

European Parliament and Council

Derogation application in terms of Article 97 of Regulation (EU) 2017/745 of the

European Parliament and Council and Article 92 of Regulation (EU) 2017/746 of the

European Parliament and Council

MDR Derogation (Regulation (EU) 2017/745 on medical devices) Article 59 and

IVDR (Regulation (EU) 2017/746 on in vitro diagnostic medical devices) Article 54,

and MDR (Regulation (EU) 2017/745 on medical devices) Article 97 and IVDR

(Regulation (EU) 2017/746 on in vitro diagnostic medical devices) Article 92

(Renewal)

Timeline for the processing of an application is within a 90 working day timeframe from

date of submission of the application and supporting documentation.

Clinical Investigation/ Performance Study

Pre-Submission Meeting Request application

Application/notification for clinical investigation in accordance with Articles 62 and

74(1) of EU Regulation 2017/745 of the European Parliament and Council

Application/notification for clinical investigation in accordance with Article 82 of the

EU Regulation 2017/745 of the European Parliament and Council

Application/notification for performance study in accordance with EU Regulation

2017/746 of the European Parliament and Council

Modification to Clinical Investigation/ Performance Study application

Application timeframe is according to EU legislation and Guidance document timelines.

Applications related to Point-of-Care Covid-19 Testing

Initial Application for a designated premises for the performing of Point-of-Care

Covid-19 Tests application

Annual renewal application for a designated premises for the performing of Point-of-

Care Covid-19 Tests

Amending details for Designated Premises for the performing of Point-of-Care Covid-

19 Tests application (to revise premises details within approved premises)

Amending details for Designated Premises for the performing of Point-of-Care Covid-

19 Tests application (to revise details of owner/manager and/or details of the

responsible healthcare professional)

Application for Initial Notification of Point-of-Care Covid-19 Test or Device for Self-

Testing for Covid-19 to be placed on the local market

Renewal of Annual Notification of Point-of-Care Covid-19 Test or Device for Self-

Testing for Covid-19 to be placed on the local market

Amending details of Notification of Point-of-Care Covid-19 Test or Device for Self-

Testing for Covid-19 to be placed on the local market –Withdrawal notification incurs

no charge

*Fast-track service is offered at double the original fee

Application for use of a Non-CE marked medical device in Malta

Application for use of a Non-CE marked medical device in Malta

Request for advice on Making Available Medical Device / In Vitro Diagnostic

Products in Malta

Request Form for Advice on Making Available Medical Device / In Vitro Diagnostic

Products in Malta

Request Form for Medical Device / In Vitro Diagnostic confirmation of risk

classification

Timeline for the processing of an application is within a 90 working day timeframe from

date of submission of the application and supporting documentation

Audit / Inspection fees - If the activity is of 8 hours, that is a whole working

day, the ‘per day’ fee is applicable. Otherwise, ‘per hour’ fee applies. The fees below

refer to the unannounced or ‘for-cause’ local reviews, addressing a particular issue or

to verify compliance; which may include but are not limited, to inspections intended

for clinical investigations/performance studies and notified bodies.

Audit/Inspection Fees

Per day, per member of the surveillance team

Per hour, per member of the surveillance team

Inspection Letter for Good Practice for Manufacturer (every 3 years)

Inspection Letter for Good Practice for Authorised Representative (every 3 years)

Inspection Letter for Distributor/Importer (every 3 years)

Clinical investigations/performance study initial inspection

Clinical investigations/performance study follow up inspection

Other Activities

Search Function fee of national medical devices database

Scientific Advice request