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L.S. 458.46 Regolamenti dwar Drittijiet li Tiġbor l-Awtorità dwar il-Mediċini

MEDICINES AUTHORITY (FEES) [ S.L.458.46 1 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

  2. The title of these regulations is the Medicines Authority (Fees) Regulations.
  3. 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 Citation. Interpretation. Amended by: L.N. 228 of 2012; L.N. 444 of 2012; L.N. 254 of
  4. 2 [ S.L.458.46 MEDICINES AUTHORITY (FEES) 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; Cap.
  5. "partial manufacturing" has the same meaning as "assembly" in the Medicines Act; S.L. 458.35 "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 MEDICINES AUTHORITY (FEES) [ S.L.458.46 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; S.L.458.44 "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: (
  1. a)the application relates to the results of clinical trials or other data (including pharmacological and toxicological tests as well as extensive S.L.458.34 3 4 [ S.L.458.46 MEDICINES AUTHORITY (FEES) evidence from post marketing experience or publications) that need to be newly assessed; (
  2. b)the application is supported by substantial amounts of data, that have not previously been assessed; (
  3. c)the application relates to changes in indications for use in a therapeutic area for which the product was not previously indicated for use; (
  4. 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; (
  5. 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; (
  6. f)the application relates to an increase in the maximum dose; (
  7. g)the application relates to a new dosage regimen; (
  8. h)the application relates to a change in the method of sale or supply of an active ingredient from prescription only to pharmacy sale; (
  9. i)the application relates to a change in the conditions of prescribing; (
  10. j)the application relates to the removal of a contra-indication; (
  11. k)the application relates to an increased duration of treatment; (
  12. l)the application relates to a change in the route of administration of the same dosage form; (
  13. 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; (
  14. n)the application relates to a new method of sterilisation of the product; (
  15. o)the application relates to a new container materials for a sterile product; (
  16. 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; (
  17. 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 reevaluation of the safety or efficacy of the product, such as - MEDICINES AUTHORITY (FEES) [ S.L.458.46 5 (
  18. 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); (
  19. 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; (
  20. iv)a change which requires an in-vivo bioavailability study to be carried out; (
  21. v)a change which results in a change to the therapeutic characteristics of the product; (
  22. 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; (
  23. 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; (
  24. 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; (
  25. u)the application relates to the introduction of a novel method of analysis; (
  26. 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. 3.
(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. Cap. 458. Payment of fees. Substituted by: L.N. 228 of 2012. Amended by: L.N. 305 of 2014; L.N. 254 of 2025. 6 [ S.L.458.46 MEDICINES AUTHORITY (FEES)
(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. Products on derogation list.
  1. 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. MEDICINES AUTHORITY (FEES) SCHEDULE 1 (regulation 3) [ S.L.458.46 Substituted by: L.N. 427 of 2007; Amended by: L.N. 228 of 2012; L.N. 444 of 2012; L.N. 305 of
  2. Substituted by: L.N. 254 of
  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 7 Fee € 250 € 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 [ S.L.458.46 8 MEDICINES AUTHORITY (FEES) 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 Application withdrawn during validation 90% of relevant fee 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 Mutual Recognition Procedure/Decentralised Procedure (Malta Concerned Member State) 450 Annual fee (for each form and strength) (All Authorisations) † 275 Transfer of Marketing Authorisation Holder (change in legal entity) 150 450 † 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 Variations: Administrative Technical Renewal Type of Application € 10,000 115 500 800 MEDICINES AUTHORITY (FEES) [ S.L.458.46 Authorisation in accordance with regulation 4
(2)of the Medicines (Marketing Authorisation) Regulations (S.L. 456.34) 9 € New application 1,000 Annual fee† 500 † Activities covered include pharmacovigilance and notifications of variations Homeopathic Product New Product (single stock) New Product (for two
(2)or more stocks) Variations: Administrative Technical Renewal 40 100 100 Parallel importation licence (per strength/form/source country)) € New parallel import licence application/renewal# of Parallel Import Licence † Annual fee # † € 250 500 1,000 500 Renewal application shall be submitted 6 months before the expiration of the licence (every 5 years) Activities covered include pharmacovigilance and notifications of variation 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) Amendments to include a new investigational medicinal product dossier 410 880 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 medicinal 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 – 2nd & subsequent phases Non Commercial/Academic Clinical Trials € 3,170 7,950 2,000 4,780 500 300 Applications without Investigational Medicinal Product Dossier or with simplified Investigational Medicinal Product Dossier or a low intervention trial € 10 [ S.L.458.46 MEDICINES AUTHORITY (FEES) 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 2,155 6,750 1,500 4,595 500 300 Substantial Modifications (Part one only) - with the addition of a new Investigational Medicinal Product Dossier (IMPD) Mono National MT - Reporting Member State MT - Concerned Member State Non Commercial/Academic Clinical Trials € 1,230 1,450 1,175 100 Substantial Modifications – other Mono National MT - Reporting Member State MT - Concerned Member State Non Commercial/Academic Clinical Trials € 760 1,060 300 100 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 MEDICINES AUTHORITY (FEES) [ S.L.458.46 11 *The processing fee is not refundable if the application is withdrawn or rejected. SCHEDULE 2 (regulation 3) Substituted by: L.N. 427 of 2007; 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) Fee € Type I Type IA 115 Batch specific exemption request 115 Type IB 350 Type II Type II Simple 1000 Type II Complex * Where an application is not accompanied by an acceptable EU approval 4,000 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 150 € 2,300 800
(400)1 800
(400)1 1,000 1,000 6,000 12 [ S.L.458.46 MEDICINES AUTHORITY (FEES) 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 Authority. SCHEDULE 3 (regulation 3) Substituted by: L.N. 427 of 2007; L.N. 254 of
  1. INSPECTORATE FEES Activity (involving an inspection in Malta or within the European Union/European Economic Area) GOOD MANUFACTURING PRACTICE3 Issue of licence and annual renewal Full manufacture Small (less than 15 employees 4) Medium (15 to 75 employees4) Large (76 to 200 employees4) Super (more than 200 employees4) Partial manufacturing Activity (involving an inspection in Malta or within the European Union/European Economic Area) IMPORTATION, WHOLESALE DEALING Issue of licence and annual renewal Import5 Wholesale PHARMACY Issue of pharmacy licence and inspection every year (includes all follow up and other inspections) Variation to pharmacy licence Administrative variation Non-administrative variation including an inspection Fee for type of Licence € Issue of new Annual licence and, or renewal of major initial licence2 inspection1 4,700 7,000 9,350 14,000 1,400 1,000 1,500 2,000 3,000 300 Fee per type of Licence € Issue of new Annual licence and, or renewal of major initial licence2 Inspection 1 950 500 400 500 250 In accordance with the Licensing Fees for Private Medical Premises Regulations (S.L. 458.26) 80* 150* [ S.L.458.46 MEDICINES AUTHORITY (FEES) 13 *Fast-track service is offered at double the original fee OTHER ACTIVITIES (Frequency as required and involving an inspection in Malta or within the European Union) Good Clinical Practice (clinical trials) / centre / trial Pharmacovigilance inspections Activity 6,9 (involving an inspection in a third country ) GOOD MANUFACTURING PRACTICE Issue of licence and annual renewal Full manufacture Partial manufacturing Initial inspection Follow-up and routine inspections 1,100 600 250 250 Fee for type of Certificate/ Inspection € Issue of new Annual certificate and, renewal of or major initial certificate2 inspection1 25,000 and 600 7,500 and 600 per day per per day per inspector7 inspector7 15,000 5,000 and 600 per day and 600 per day per inspector7 per inspector7 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 inspector7 inspector7 Pharmacovigilance inspections 20,000 5,000 and and 600 per day 600 per day per inspector7 per inspector7 ADMINISTRATIVE ACTIVITIES Variations (not requiring an inspection) Issue of Certificate of a Pharmaceutical Product Issue of Certificate of a Pharmaceutical Product (fasttrack)8 Issue of Good Manufacturing Practice Certificates (not requiring an inspection) Supervision of destruction of pharmaceutical waste Fee € 80 100 150 80 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. 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. 3 14 [ S.L.458.46 MEDICINES AUTHORITY (FEES) 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 (regulation 3) Substituted by: L.N. 427 of 2007; L.N. 254 of
  2. GENERAL Activity Fee € 40 20 40 11,650 Consultation (per man hour) Issue of original copies of licences/certificates Appeals Appeals to Medicines Review Board* (*Fee for appeals shall be fully refunded if appeal is successful) Added by: L.N. 254 of
  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. MEDICINES AUTHORITY (FEES) [ S.L.458.46 15 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 € 500* 500* 100* 100 15* 100* 100* 100* 50* *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: > 150 employees1 100 – 150 employees1 50 – 99 employees1 16 – 49 employees1 5 – 15 employees1 < 5 employees1 Change in Organisation Registration application for Manufacturer € 2,500* 25,000 18,000 12,000 5,000 1,250 250 100* *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 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 € 2,500* 2,500 100* € 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 € 16 [ S.L.458.46 MEDICINES AUTHORITY (FEES) Notified Body Designation application – Initial Setup of Notified Body Notified Body Designation application – Extension of Scope Annual Application for Notified Body Designation 30,000 10,000 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 DoC) 100* Device Registration – placing a medical device on the European market application – Amending Registration of Medical Device (Revised) Withdrawal incurs no charge 100* *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) € 1,000 1,000 750 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 € 1,000 5,000 1,000 5,000 500 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-ofCare Covid-19 Tests application € 350* MEDICINES AUTHORITY (FEES) [ S.L.458.46 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-ofCare Covid-19 Tests application (to revise premises details within approved premises) Amending details for Designated Premises for the performing of Point-ofCare 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 17 350* 175* 50* 200* 200 100* *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 Products in Malta Request Form for Medical Device / In Vitro Diagnostic confirmation of risk classification € 500 1,000 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 18 [ S.L.458.46 MEDICINES AUTHORITY (FEES) Clinical investigations/performance study follow up inspection 500 Other Activities € Search Function fee of national medical devices database 50 Scientific Advice request 2,300 Added by: L.N. 254 of 2025. SCHEDULE 6 (regulation 3) Fees related to Apostille of documents Apostille Fees € Apostille handling fee (per document, excluding third-party expenses) 200

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