English — official text

PART I — Amendment to the Licensing Fees for Private Medical Premises Regulations

PART II — Amendments to the Medicines Authority (Fees) Regulations

SCHEDULE 1 — Product authorisation fees and other activities (regulation 3)

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 250 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Procedure 10,000 Duplicate application (different timetable from lead procedure) 15,000 90% of relevant fee Application withdrawn during validation is refunded Change from Malta Concerned Member State to Reference Member State 5,000 Zero Day procedure (per product included in procedure) 500 *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) † 900 † Activities covered include pharmacovigilance; Type of Application € OTHER ACTIVITIES Renewal application per product (where applicable) National procedure 450 Mutual Recognition Procedure/Decentralised Procedure (Malta Concerned Member State) Annual fee (for each form and strength) (All Authorisations) † 275 Transfer of Marketing Authorisation Holder (change in legal entity) 150 † 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 115 Technical 500 Renewal 800 Type of Application Authorisation in accordance with regulation 4(2) of the Medicines (Marketing € Authorisation) Regulations (S.L. 456.34) New application 1,000 Annual fee† 500 † Activities covered include pharmacovigilance and notifications of varia- tions Homeopathic Product € New Product (single stock) 250 New Product (for two (2) or more stocks) 500 Variations: Administrative 40 Technical 100 Renewal 100 Parallel importation licence (per strength/form/source country)) € New parallel import licence application/renewal# of Parallel Import Licence 1,000 Annual fee † 500 # 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 1,500 Investigational medicinal product containing a new active substance 2,000 Amendments to Clinical Trials € Notice of Amendment under the Clinical Trial Regulations (S.L. 458.43) 410 Amendments to include a new investigational medicinal product dossier 880 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 3,170 MT – Reporting Member State 7,950 MT – Concerned Member State 2,000 Supplement – where MT subsequently becomes the Reporting Member State 4,780 Reporting Member State – 2nd & subsequent phases 500 Non Commercial/Academic Clinical Trials 300 Applications without Investigational Medicinal Product Dossier or with simplified Investigational Medicinal Product Dossier or a low interven- tion trial € Mono National 2,155 MT – Reporting Member State 6,750 MT – Concerned Member State 1,500 Supplement - where MT subsequently becomes the Reporting Member State 4,595 Reporting Member State - 2nd & subsequent phases 500 Non Commercial/Academic Clinical Trials 300 Substantial Modifications (Part one only) - with the addition of a new Investiga- tional Medicinal Product Dossier (IMPD) € Mono National 1,230 MT - Reporting Member State 1,450 MT - Concerned Member State 1,175 Non Commercial/Academic Clinical Trials 100 Substantial Modifications – other € Mono National 760 MT - Reporting Member State 1,060 MT - Concerned Member State 300 Non Commercial/Academic Clinical Trials 100 Classification Committee € Classification Committee per product 50 Scientific advice/pre-submission meetings € Malta Reference Member State/Rapporteur in European procedures or for national procedures 2,300 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 550 specific product details) and 50* processing fee New application for medicinal products sourced from third countries (per 1,500 specific product details) and 50* 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) 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 — Variation fees per product (regulation 3)

SCHEDULE 2 (regulation 3) VARIATION FEES PER PRODUCT Variation Type (for national procedures* and procedures where Malta is the Fee Reference Member State in the Mutual Recognition Procedure and € Decentralised Procedure) Type I Type IA 115 Batch specific exemption request 115 Type IB 350 Type II Type II Simple 1000 Type II Complex 4,000 * 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 2,300 Assessment of Post Authorisation Safety Studies (PASS) protocol 800 (400) 1 Assessment of Post Authorisation Efficacy Studies (PAES) protocol 800 (400) 1 Assessment of PASS Results 1,000 Assessment of PAES Results 1,000 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 6,000 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 — Inspectorate fees (regulation 3)

SCHEDULE 3 (regulation 3) INSPECTORATE FEES Fee for type of Licence € Activity (involving an inspection in Malta or within the European Issue of new Annual Union/European Economic Area) licence and, or renewal of major initial licence2 inspection 1 GOOD MANUFACTURING PRACTICE3 Issue of licence and annual renewal Full manufacture Small (less than 15 employees 4) 4,700 1,000 Medium (15 to 75 employees4) 7,000 1,500 Large (76 to 200 employees4) 9,350 2,000 Super (more than 200 employees4) 14,000 3,000 Partial manufacturing 1,400 300 Fee per type of Licence € Activity (involving an inspection in Malta or within the European Issue of new Annual Union/European Economic Area) licence and, or renewal of major initial licence2 Inspection1 IMPORTATION, WHOLESALE DEALING Issue of licence and annual renewal Import5 950 500 Wholesale 500 250 PHARMACY Issue of pharmacy licence and inspection every year (includes In accordance all follow up and other inspections) 400 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 OTHER ACTIVITIES Initial Follow-up and inspection routine (Frequency as required and involving an inspection in Malta or inspections within the European Union) Good Clinical Practice (clinical trials) / centre / trial 1,100 250 Pharmacovigilance inspections 600 250 Activity Fee for type of Certificate/ 6,9) (involving an inspection in a third country Inspection € 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 inspector7 per day per inspector7 Partial manufacturing 15,000 5,000 and 600 per day and 600 per day per inspector7 per inspector7 OTHER ACTIVITIES Follow up and Initial routine (Frequency as required and involving an inspection in a third Inspection Inspections 6, country ) 9 Good Clinical Practice (clinical trials) / centre / trial 20,000 5,000 and and 600 per day 600 per day per per inspector7 inspector7 Pharmacovigilance inspections 20,000 5,000 and and 600 per day 600 per day per per inspector7 inspector7 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. 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 — General fees (regulation 3)

SCHEDULE 4 (regulation 3) GENERAL Activity Fee € Consultation (per man hour) 40 Issue of original copies of licences/certificates 20 Appeals 40 Appeals to Medicines Review Board* 11,650 (*Fee for appeals shall be fully refunded if appeal is successful)

SCHEDULE 5 — Fees related to Medical Devices and In Vitro Diagnostic Medical Devices (regulation 3)

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 100 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: > 150 employees1 25,000 100 – 150 employees1 18,000 50 – 99 employees1 12,000 16 – 49 employees1 5,000 5 – 15 employees1 1,250 < 5 employees1 250 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 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 2,500* based in Malta Annual Organisation Registration of Manufacturer (Non-EU) whose Authorised 2,500 Representative is based in Malta Annual Fee Change in Organisation Registration of Manufacturer (Non-EU) whose Authorised 100* 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 €50,000) 1,000 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 30,000 Notified Body Designation application – Extension of Scope 10,000 Annual Application for Notified Body Designation 20,000 Application timeframe is according to EU legislation and Guidance document timelines. Certificate of Free Sale € Certificate of Free Sale application (per DoC) 250* *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 100* DoC) Device Registration – placing a medical device on the European market application – 100* 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 1,000 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 1,000 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 750 (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 1,000 Application/notification for clinical investigation in accordance with Articles 62 and 5,000 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 1,000 EU Regulation 2017/745 of the European Parliament and Council Application/notification for performance study in accordance with EU Regulation 5,000 2017/746 of the European Parliament and Council Modification to Clinical Investigation/ Performance Study application 500 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 350* Covid-19 Tests application Annual renewal application for a designated premises for the performing of Point-of- 350* Care Covid-19 Tests Amending details for Designated Premises for the performing of Point-of-Care Covid- 175* 19 Tests application (to revise premises details within approved premises) Amending details for Designated Premises for the performing of Point-of-Care Covid- 50* 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- 200* 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- 200 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- 100* 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 500 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 500 Products in Malta Request Form for Medical Device / In Vitro Diagnostic confirmation of risk 1,000 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 1,500 Per hour, per member of the surveillance team 200 Inspection Letter for Good Practice for Manufacturer (every 3 years) 500 Inspection Letter for Good Practice for Authorised Representative (every 3 years) 500 Inspection Letter for Distributor/Importer (every 3 years) 300 Clinical investigations/performance study initial inspection 1,500 Clinical investigations/performance study follow up inspection 500 Other Activities € Search Function fee of national medical devices database 50 Scientific Advice request 2,300

SCHEDULE 6 — Fees related to Apostille of documents (regulation 3)

SCHEDULE 6 (regulation 3) Fees related to Apostille of documents Apostille Fees € Apostille handling fee (per document, excluding third-party expenses) 200