MEDICINES AUTHORITY (FEES) REGULATIONS

SUBSIDIARY LEGISLATION 458.46

MEDICINES AUTHORITY (FEES) REGULATIONS

12th December, 2006

LEGAL NOTICE 315 of 2006, as amended by Legal Notices 427 of 2007,

228, 444 of 2012, 305 of 2014 and 254 of 2025.

The title of these regulations is the Medicines Authority

(Fees) Regulations.

Substituted by

L.N. 427 of 2007;

(regulation 3)

Amended by

L.N. 228 of 2012;

L.N. 444 of 2012;

L.N. 305 of 2014.

Substituted by

L.N. 254 of 2025.

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Application withdrawn during validation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.

For the purposes of these regulations -

"active pharmaceutical ingredient" (API) means any substance or

mixture of substances intended to be used in the manufacture of a

medicinal product and that, when used in the production of a

medicinal product, becomes an active ingredient of the said

product. These substances are intended to furnish pharmacological

activity or other direct effect in the diagnosis, cure, mitigation,

treatment or prevention of disease or to affect the structure and

function of the body;

"API manufacturer" means a person, group of persons or

company involved in the manufacture of active pharmaceutical

ingredients;

"certificate of a pharmaceutical product (CPP)" or "export

certificate" means a certificate, complying with the format

specified by World Health Organisation, providing details about a

single named medicinal product, which may be licensed or

unlicensed in Malta. It provides details about the product and its

manufacture including, but not limited to, the marketing

authorisation (MA) holder, where applicable, the active ingredients

and excipients, the manufacturing and packaging sites and whether

or not the product is placed on the market in Malta;

"concerned Member State" means a Member State or States in

which mutual recognition is sought in the mutual recognition and

decentralised procedures;

"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;

"Directive 2001/83/EC" means Directive 2001/83/EC of the

European Parliament and of the Council of 6 November 2001 on

the Community code relating to medicinal products for human use,

and its amendments as amended by Directive 2004/27/EC and

Directive 2004/24/EC;

"extension of a marketing authorisation" or "extension" means a

variation which is listed in Annex I of Regulation 1234/2008/EC

and fulfils the conditions laid down therein;

"follow-up inspections" refers to inspections other than those

referred to as major inspections;

"GMP certificate" means a certificate issued by the Medicines

Authority for the purpose of confirming to a manufacturer the

overall conclusion of an inspection with respect to compliance with

good manufacturing practice;

"good clinical practice inspection" means an inspection

p e r f o r m e d t o a s s e s s t h e st a n d ar d s f o r t h e d e s i g n, c on d u c t ,

performance, monitoring, auditing, recording, analysis and

reporting of clinical trials so as to provide assurance that the data

and reported results are credible and accurate, and that the rights,

integrity and confidentiality of trial subjects are provided;

"herbal medicinal product" means any medicinal product,

exclusively containing as active ingredients one or more herbal

preparations, or one or more such herbal substances in combination

with one or more such herbal preparations;

"importer" means any person or group of persons or company

involved in the importation of Medicinal products obtained from a

source outside the European Union or the European Economic

Area;

"importing activity" is the action by which medicinal products

s o u rc e d f r om o ut s i de t he E u r op e a n Un i on or th e E ur o p e a n

Economic Area are obtained, stored and distributed;

"major inspection" refers to inspections carried out for the first

time in a particular area or site, or inspections to already existing

sites that had major variations or alterations;

" m a r k e t i n g a u t h o r i s a t i o n t r a n s f e r " is w hen a mar keting

authorisation is transferred from the existing marketing authorisation

holder to another using a transfer procedure. A transfer may occur

either during or after issue of a marketing authorisation and entails a

change in legal entity;

"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;

"partial manufacturing" has the same meaning as "assembly" in

the Medicines Act;

"periodic safety update report" or "PSUR" refers to the

periodical reports containing the records referred to in regulation

32 of the Pharmacovigilance Regulations;

"pharmacovigilance inspection" means an inspection carried out

to assess the pharmacovigilance programme of a market

authorization holder during which the following are assessed

(a) monitoring of adverse drug reactions endorsed by

company for its licensed products;

(b) the assessment of risk and benefits of medicines used

to determine what action should be taken to improve

their safe use;

(c) supply of information to optimise safe and effective

use of medicines;

(d) monitor impact of any action taken by the company;

"post-authorisation safety study" or "PASS" means any study

relating to an authorised medicinal product conducted with the aim of

identifying, characterising or quantifying a safety hazard, confirming

the safety profile of the medicinal product, or of measuring the

effectiveness of risk management measures;

"reference Member State" means the Member State, which has

produced the assessment report for a given medicinal product,

which serves as the basis for the mutual recognition and

decentralised procedures;

"traditional herbal medicinal product" is a herbal medicinal

substance that fulfils the conditions laid down in the Herbal

Medicinal Products Regulations;

"urgent safety restriction" means an interim change in the terms of

the marketing authorisation due to new information having a bearing

on the safe use of the medicinal product;

"variation relating to a pharmaceutical activity" means any

change pertaining to the related activity that may or may not

require an inspection. Variations not requiring an inspection are

those changes in the administrative details appearing on the

licence, such as changes in name of company or change in names of

key personnel. Variations that require an inspection are changes

that can have an effect on the quality system of the company and,

or on the quality of the product directly or indirectly which hence

requires an inspection, such as in a change in a particular stage of

the manufacturing process or installation of new equipment;

"variation to the terms of a marketing authorisation" means an

amendment to the contents of the particulars and documents

referred to in regulations 5 to 8 of the Medicines (Marketing

Authorisation) Regulations, 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, in the case of medicinal products for

human use

(1) "Minor variation of type IA" means a variation which

has only a minimal impact or no impact at all, on the

quality, safety or efficacy of the medicinal product

concerned;

(2) "Minor variation of type IB" means a variation which

is neither a minor variation of type IA nor a major

variation of type II nor an extension;

(3) "Major variation of type II" means a variation which is

not an extension and which may have a significant

impact on the quality, safety or efficacy of the

medicinal product concerned. Major type II variations

may be simple or complex;

(4) "Type II Complex variation" means a variation, when

it falls within one or more of the following

descriptions

(a) the application relates to the results of clinical

trials or other data (including pharmacological

and toxicological tests as well as extensive

evidence from post marketing experience or

publications) that need to be newly assessed;

(b) the application is supported by substantial

amounts of data, that have not previously been

assessed;

(c) the application relates to changes in indications

for use in a therapeutic area for which the

product was not previously indicated for use;

(d) the application relates to changes in indications

for use in respect of an organ, or any other part,

of the human body for which the product was

not previously indicated for use;

(e) the application is supported by data which

comprises or includes the results of clinical

trials or physico-chemical, microbiological or

pharmacological and toxicological tests;

(f) the application relates to an increase in the

maximum dose;

(g) the application relates to a new dosage regimen;

(h) the application relates to a change in the method

of sale or supply of an active ingredient from

prescription only to pharmacy sale;

(i) the application relates to a change in the

conditions of prescribing;

(j) the application relates to the removal of a

contra-indication;

(k) the application relates to an increased duration

of treatment;

(l) the application relates to a change in the route of

administration of the same dosage form;

(m) the application relates to a new route of

synthesis that has not previously been assessed

and a European Pharmacopoeia Certificate of

Suitability is not available for the active

ingredient;

(n) the application relates to a new method of

sterilisation of the product;

(o) the application relates to a new container

materials for a sterile product;

(p) the application relates to a new active ingredient

manufacturer not previously approved to

manufacture the active ingredient concerned and

who does not hold a European Pharmacopoeia

Certificate of Suitability for the substance

concerned;

(q) the application relates to a major formulation

change which affects more than one section in

Module 3 of the dossier and, or requires a re-

evaluation of the safety or efficacy of the

product, such as -

(i)

a change in more than one excipient,

except for a change in a key excipient

(such as a preservative, release-controlling

excipient, or stabiliser);

(ii) when a change in the key excipient alone

will be regarded as a major formulation

change;

(iii) the inclusion for the first time of a novel

excipient not used before in any product;

(iv) a change which requires an in-vivo

bioavailability study to be carried out;

(v) a change which results in a change to the

therapeutic characteristics of the product;

(r) the application relates to change in the method

of manufacture of the active ingredient which

introduces new impurities or changes the level

of impurities and which requires further

qualification in safety studies;

(s) the application relates to any change in the

source materials, method of manufacture or

analytical procedures for a product of biological

or biotechnological origin which might

significantly affect the quality of the product;

(t) the application relates to a change in the

qualitative composition of the immediate

packaging of a sterile product, where the

container material has not been previously

approved for such use;

(u) the application relates to the introduction of a

novel method of analysis;

(v) the application relates to a new manufacturer or

process for a flu vaccine;

(5) "Grouped variations" are variations that can be submitted

in one application form; grouping must be in line with

Annex III of Regulation 1234/2008 and official grouping

guidelines;

"wholesale dealer" means any person or group of persons or

company involved in the wholesale dealing activity;

"wholesale dealing activity" has the same meaning as "wholesale

distribution" in the Medicines Act.

Substituted by

L.N. 427 of 2007;

(regulation 3)

Amended by

L.N. 228 of 2012;

L.N. 305 of 2014.

Substituted by

L.N. 254 of 2025.

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

800 (400) 1

Assessment of Post Authorisation Safety Studies (PASS) protocol

800 (400) 1

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 .

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

Medicines Authority.

(2) The validation and, or processing of applications shall

commence only upon receipt by the Medicines Authority of proof of

payment.

(3) Such fees shall not include any fees charged by other

competent authorities in relation to any documentation, reports, or

services required by the Medicines Authority for final issue of

authorisations and licences, where these are required.

(4) Any additional expenses incurred by the Medicines

Authority shall be charged separately.

(5) In exceptional circumstances and at the discretion of the

Chief Executive Officer of the Medicines Authority, in consultation

with the designated Minister, waivers for fees due under these

regulations may be granted.

(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.

Substituted by

L.N. 427 of 2007;

(regulation 3)

L.N. 254 of 2025.

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/

6,9

Inspection

(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, 9 )

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.

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.

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.

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.

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.

Includes days spent for actual inspection and for travel.

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

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.

For the purpose of these regulations, products which were

on the derogation list and were granted a marketing authorisation

through the transitional PMA/MA process prior to 31st December,

2006 and their line extensions, will be charged fees as applicable to

the mutual recognition procedure (Malta Concerned Member

State), provided that the authorisation requested would have

already been approved in at least one other Member State.

Alternatively, national fees shall apply.

Substituted by

L.N. 427 of 2007;

(regulation 3)

L.N. 254 of 2025.

GENERAL

Activity

Fee

€

Consultation (per man hour)

Issue of original copies of licences/certificates

Appeals

Appeals to Medicines Review Board*

11,650

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

Added by

L.N. 254 of 2025.

(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

100*

annually)

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

2,500*

Manufacturer

Annual Organisation Registration for Manufacturer

> 150 employees 1

25,000

18,000

100 – 150 employees 1

50 – 99 employees 1

12,000

16 – 49 employees 1

5,000

5 – 15 employees 1

1,250

< 5 employees 1

Change in Organisation Registration application for Manufacturer

100*

*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 com-

pany 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

2,500*

Representative is based in Malta

Annual Organisation Registration of Manufacturer (Non-EU) whose

2,500

Authorised Representative is based in Malta Annual Fee

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

100*

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

500*

Annual Organisation Registration of Authorised Representative (maximum

1,000

€50,000)

Change in Organisation Registration for Authorised Representatives

100*

*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

2,300

Added by

L.N. 254 of 2025.

(regulation 3)

Fees related to Apostille of documents

Apostille Fees

€

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