S.L. 458.46 Art. 4Products on derogation list.

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. SCHEDULE 1

(regulation 3)

PRODUCT AUTHORISATION FEES AND OTHER ACTIVITIES

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*

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

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

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

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

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

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

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

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

Additional strength (applied for at the same time)

Additional pharmaceutical form (applied for at the same time) 15,000

application (same timetable as lead procedure) 10,000

Recognition Procedure 10,000

application (different timetable from lead procedure) 15,000

90% of relevant fee withdrawn during validation is refunded

Malta Concerned Member State to Reference Member State 5,000

procedure (per product included in procedure) 500

discount of 30% shall be given on fees for Micro Enterprises as defined in Commission 2003/361/EC

Member State in a Mutual Recognition Procedure/ € Procedure – Other activities Marketing Authorisation 1,000

Maintenance fee (for each form and strength) † 900

covered include pharmacovigilance;

Type of Application € ACTIVITIES

application per product (where applicable) 450 procedure Recognition Procedure/Decentralised Procedure (Malta Concerned 450

† 275 each form and strength) (All Authorisations) 150 Marketing Authorisation Holder (change in legal entity)

covered include variations (all types) and pharmacovigilance Type of Application € Herbal Medicinal Products (Article 16 of Directive 2001/83/EC) Reference Member State) Traditional Herbal Medicinal Product 10,000

115 500 800 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 nd Reporting Member State – 2 & 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 2,155 Member State 6,750 Member State 1,500 where MT subsequently becomes the Reporting Member State 4,595 Member State - 2nd & subsequent phases 500 Commercial/Academic Clinical Trials 300

Modifications (Part one only) - with the addition of a new Investiga-Product Dossier (IMPD) € 1,230 Member State 1,450 Member State 1,175 Commercial/Academic Clinical Trials 100

Modifications – other € 760 Member State 1,060 Member State 300 Commercial/Academic Clinical Trials 100

Committee € Committee per product 50

advice/pre-submission meetings € Member State/Rapporteur in European procedures or for national 2,300

brackets are for applications for academic research without any financial support from decision shall be at the sole discretion of the Licensing Authority. line with Article 20 of the Medicines Act (Cap. 458) € application for medicinal products sourced from within the EU (per 550 details) and 50* processing fee application for medicinal products sourced from third countries (per 1,500 details) and 50* processing fee Exemption in accordance with Delegated Regulation EU 2016/161 of 2 € supplementing Directive 2001/83/EC of the European of the Council by laying down detailed rules for the safety appearing on the packaging of medicinal products for human use application (per specific product details) 150 and 50* processing fee Non-resolution of alerts breach 400 and 50* processing fee *The processing fee is not refundable if the application is withdrawn or rejected.

SCHEDULE 2 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 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 in brackets are for applications for academic research without any financial sup-industry. The decision shall be at the sole discretion of the Licensing Author-

SCHEDULE 3 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 inspection in Malta or within the European Annual licence and, or Union/European Economic Area) renewal of major initial licence2 1 inspection 3 MANUFACTURING PRACTICE and annual renewal manufacture 4 15 employees ) 4,700 1,000 4 75 employees ) 7,000 1,500 employees4) 9,350 2,000 4 than 200 employees ) 14,000 3,000 manufacturing 1,400 300

Fee per type of Licence € Activity Issue of new inspection in Malta or within the European Annual licence and, or Union/European Economic Area) renewal of major initial 2 1 licence Inspection IMPORTATION, WHOLESALE DEALING and annual renewal

950 500 500 250

pharmacy licence and inspection every year (includes In accordance other inspections) 400 with the Licensing Fees for Private Medical Premises Regulations (S.L. 458.26)

pharmacy licence variation 80* Non-administrative variation including an inspection 150* *Fast-track service is offered at double the original fee Initial OTHER ACTIVITIES inspection (Frequency as required and involving an inspection in Malta or within the European Union) Good Clinical Practice (clinical trials) / centre / trial 1,100 Pharmacovigilance inspections 600

Activity Fee for type of (involving an inspection in a third country6,9) Inspection € GOOD MANUFACTURING PRACTICE Issue of new

Issue of licence and annual renewal certificate and, or major initial

1 inspection Full manufacture 25,000 and 600

per day per 7 inspector

Partial manufacturing 15,000 and 600 per day 7 per inspector

OTHER ACTIVITIES Initial (Frequency as required and involving an inspection in a third Inspection country6, 9) Good Clinical Practice (clinical trials) / centre / trial 20,000 and 600 per day 7 per inspector Pharmacovigilance inspections 20,000 and 600 per day 7 per inspector

ADMINISTRATIVE ACTIVITIES Fee € Variations (not requiring an inspection) 80 Issue of Certificate of a Pharmaceutical Product 100 Issue of Certificate of a Pharmaceutical Product (fast-150 track)8 Issue of Good Manufacturing Practice Certificates (not requiring an inspection) 80 Supervision of destruction of pharmaceutical waste 50

1 Includes issue of licence and first time inspection. 2 Includes inspections for licence renewal, routine inspections and other inspections. apply to variation applications that involve an inspection. 3 Includes manufacture of finished dosage forms, Active Pharmaceutical Investigational Medicinal Products. When a company additionally manufactures Medicinal Products and a separate inspection is required the fee for this charged at 25% of that for initial inspections. 4 Includes all the personnel employed within the company. It is the responsibility company to inform the Regulatory Authority of any changes in the number of for an import authorisation by a company already in possession of a or wholesale dealer licence shall be charged at 50% of the normal applicable activities. applications involving an inspection in a third country the applicant has to additionally cover all accommodation and subsistence expenses allowance of the inspectors together additional €500 per inspector for other additional and sundry expenses.

spent for actual inspection and for travel.

applies for the issue of Certificate of a Pharmaceutical Product within 48 hours. agreed-upon scheduled inspection is cancelled 30 calendar days or less before inspection due to reasons attributable to the applicant, all applicable fees for inspections shall apply, including any costs related to flights and accommodation if the cancellation occurs more than 30 calendar days before the first day of the reasons attributable to the applicant, a charge of €3,000 shall apply in addition to associated with flights and accommodation cancellations. medicinal products and importers or distributors of active pharmaceutical be subject to all fees applicable for wholesale dealers.

SCHEDULE 4 Substituted by: L.N. 427 of 2007; (regulation 3) L.N. 254 of 2025. GENERAL

Activity Fee € (per man hour) 40 copies of licences/certificates 20 40 Medicines Review Board* 11,650

appeals shall be fully refunded if appeal is successful)

SCHEDULE 5

(regulation 3)

related to Medical Devices and Diagnostic Medical Devices In Vitro service for the processing of an application is within a 30 working day date of submission of the application and supporting documentation, otherwise specified with respective application fee details, below. Fast-track available for selected applications (marked with an asterisk*), for the the application to be completed within a 10 working day timeframe. If the requires any further information and, or clarification, this shall be to the applicant and the time period shall be interrupted and the time 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 Annual Registration of Distributor / Importer (renewable annually) Change in Organisation Registration Application details Initial Application for Notification of device per manufacturer Annual Notification per device (renewable annually per group) Amending Notification of Medical Device Initial Application for Medical Device Registered Person (MDRP) Annual Registration of Medical Device Registered Person (MDRP) (renewable annually) Amending Medical Device Registered Person (MDRP) details

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

Manufacturer based in Malta Initial Application for Organisation Registration application of Manufacturer Annual Organisation Registration for Manufacturer: 1 > 150 employees 1 100 – 150 employees 1 50 – 99 employees 16 – 49 employees1 1 5 – 15 employees 1 < 5 employees 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 pany to inform the Regulatory Authority of any changes in the number of its

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 Designation application Initial Setup of Notified Body 30,000 – Designation application – Extension of Scope 10,000 Application for Notified Body Designation 20,000 . timeframe is according to EU legislation and Guidance document timelines Free Sale €

Free Sale application (per DoC) 250*

service is offered at double the original fee

Registration in the European Market €

Registration – placing a medical device on the European market 100* (per DoC) Registration – placing a medical device on the European market 100* Amending Registration of Medical Device (Revised) incurs no charge service is offered at double the original fee

€ application in terms of Article 59 of Regulation (EU) 2017/745 European Parliament and Council and Article 54 of Regulation (EU) 1,000 the European Parliament and Council application in terms of Article 97 of Regulation (EU) 2017/745 European Parliament and Council and Article 92 of Regulation (EU) 1,000 the European Parliament and Council Derogation (Regulation (EU) 2017/745 on medical devices) Article 59 (Regulation (EU) 2017/746 on in vitro diagnostic medical Article 54, and MDR (Regulation (EU) 2017/745 on medical 750 Article 97 and IVDR (Regulation (EU) 2017/746 on in vitro medical devices) Article 92 (Renewal)

the processing of an application is within a 90 working day timeframe from date submission of the application and supporting documentation.

Investigation/ Performance Study € Pre-Submission Meeting Request application 1,000 Application/notification for clinical investigation in accordance with Articles of EU Regulation 2017/745 of the European Parliament and 5,000

Application/notification for clinical investigation in accordance with Article 1,000 Regulation 2017/745 of the European Parliament and Council Application/notification for performance study in accordance with EU 5,000 2017/746 of the European Parliament and Council to Clinical Investigation/ Performance Study application 500

timeframe is according to EU legislation and Guidance document timelines.

related to Point-of-Care Covid-19 Testing € Application for a designated premises for the performing of Point-of- 350* 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 / Diagnostic confirmation of risk In Vitro classification Timeline for the processing of an application is within a 90 working day timeframe of submission of the application and supporting documentation

Audit / Inspection fees - If the activity is of 8 hours, that is a whole the ‘per day’ fee is applicable. Otherwise, ‘per hour’ fee applies. The fees the unannounced or ‘for-cause’ local reviews, addressing a particular issue compliance; which may include but are not limited, to inspections intended 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 investigations/performance study follow up inspection 500

Activities €

Function fee of national medical devices database 50

Advice request 2,300

SCHEDULE 6

(regulation 3)

Fees related to Apostille of documents

€

handling fee (per document, excluding third-party expenses) 200