Fees
- Marketing a medicinal product
- Renewal of the marketing authorization for a medicinal product
- Variation to marketing authorisation for medicinal product
- Manufacturing and inspection
- Medicinal product marketing
- Quality control of medicinal products
- Annual fees
- Medical devices
- Training and provision of expert advice from the Agency's scope of work and Croatian Pharmacopoeia
- Clinical trials
- Pharmacovigilance
- Veterinary medicinal products (VMP)
- Provision of a scientific opinion on a substance which has action ancillary to that of a medical device
The HALMED's price list, effective from 9 March 2024, is available below. Amendments to the HALMED's price list in the field of medicines and medical products, which entered into force on 1 July 2024, have been implemented in the said HALMED's price list.
All prices are expressed in EUR, VAT not included.
Important note: For the purpose of payment for the services under 1. Marketing a medicinal product, 2. Renewal of the marketing authorization for a medicinal product, 3. Variations to a marketing authorization for a medicinal product, withdrawal, revocation of an authorization and issuing reports on the medicinal product dossier, 4. Manufacturing and inspection, 5. Medicinal product marketing, 8. Medical devices, 10. Clinical trials and certain services under 11. Pharmacovigilance, the applicants are required to use the software application Web ponude, which is available here. The software application allows the applicants to create proforma invoices for the procedures they want to initiate, pursuant to which the payments are carried out.
The Minister of Health approved the Amendments to the HALMED’s price list in the field of medicines and medical products on 17 May 2024 (by letter, CLASS: 530-09/24-04/04, REF. NO.: 534-03-2-2/1-24-04).
The Minister of Health approved the HALMED’s price list on 29 February 2024 (by letter, CLASS: 530-09/24-04/04, REF. NO.: 534-03-2-2/1-24-02).
Minister of Agriculture determined the prices of services related to veterinary medicinal products on 17 September 2019 (with memorandum class: 322-05/19-01/13; Reg. No. 525-13/0785-19-2).
Ministry of Agriculture approved the costs of Agency's laboratory testing services related to quality control of veterinary medicinal products on 11 May 2020 (with memorandum class: UP/I-322-01/19-01/52; Reg. No. 525-13/0785-20-10).
Prices of services related to veterinary medicinal products are listed under 12. Veterinary medicinal products (VMP). For the purpose of payment for the services under the said group the applicants are also required to use the software application Web ponude, which is available here. The software application allows the applicants to create proforma invoices for the procedures they want to initiate, pursuant to which the payments are carried out.
1. Marketing Authorisation Procedures (*)
Applies to national procedures
| No. | Service | Price |
|---|---|---|
| 1.1. | Granting / refusal of marketing authorisation for medicinal and homeopathic medicinal products / registration of traditional herbal medicinal product | |
| 1.1.1 | Granting / refusal of marketing authorisation for medicinal and homeopathic medicinal products | |
| 1. | New active substance - one strength and pharmaceutical form | 9.700,00 € |
| 2. | Known active substance - one strength and pharmaceutical form | 8.900,00 € |
| 3. | New combination of known active substances - one strength and pharmaceutical form | 8.900,00 € |
| 4. | Well-established medicinal use - one strength and pharmaceutical form | 8.300,00 € |
| 5. | Generic medicinal product - one strength and pharmaceutical form | 7.800,00 € |
| 6. | Hybrid medicinal product - one strength and pharmaceutical form | 8.100,00 € |
| 7. | Biosimilar medicinal product - one strength and pharmaceutical form | 8.100,00 € |
| 8. | For each additional pharmaceutical form or strength submitted simultaneously | 3.900,00 € |
| 9. | Informed consent application - one strength and pharmaceutical form | 3.500,00 € |
| 10. | For each additional pharmaceutical form or strength submitted simultaneously with the informed consent application | 500,00 € |
| 11. | Certification of Plasma Master File (PMF) | 2.700,00 € |
| 12. | Re-certification of Plasma Master File (PMF) | 800,00 € |
| 1.1.2. | Registration / refusal of registration of traditional herbal medicinal product | |
| 1. | Traditional herbal medicinal product (supported by an EU monograph) - one strength and pharmaceutical form | 2.750,00 € |
| 2. | Traditional herbal medicinal product (with no EU monograph) - one strength and pharmaceutical form | 4.600,00 € |
| 3. | For an additional pharmaceutical form or strength submitted simultaneously | 1.375,00 € |
| 1.1.3. | Registrationl / refusal of registration of homeopathic medicinal product | |
| 1. | Single-component homeopathic medicinal product, each pharmaceutical form | 750,00 € |
| 2. | Multi-component homeopathic medicinal product, each pharmaceutical form | 2.250,00 € |
| 1.1.4 | Transfer and withdrawal of marketing authorisation | |
| 1. | Transfer of marketing authorisation, for each marketing authorisation | 405,00 € |
| 2. | Withdrawal of marketing authorisation requested by the applicant; withdrawal in case the medicinal product has not been placed on the market within three years of the authorisation being granted - for each marketing authorisation | 270,00 € |
| 1.1.5. | Other services | |
| 1. | Issuance of an assessment report on the medicinal product outside the marketing authorisation procedure | 2.700,00 € |
Applies to DCP/MRP
| No. | Service | Price |
|---|---|---|
| 1.2. | Granting / refusal of marketing authorisation for medicinal product and homeopathic medicinal product / registration of traditional herbal medicinal product | |
| 1.2.1. | DCP Granting / refusal of marketing authorisation for medicinal product and homeopathic medicinal product |
|
| 1.2.1.1. | Croatia as a Reference Member State (RMS) | |
| 1. | New active substance - one strength and pharmaceutical forme substance | 31.000,00 € |
| 2. | Known active substance - one strength and pharmaceutical form | 27.500,00 € |
| 3. | New combination of known active substances - one strength and pharmaceutical form | 27.500,00 € |
| 4. | Well-established medicinal use - one strength and pharmaceutical form | 26.500,00 € |
| 5. | Generic medicinal product - one strength and pharmaceutical form- | 21.900,00 € |
| 6. | Hybrid medicinal product - one strength and pharmaceutical form | 25.900,00 € |
| 7. | Biosimilar medicinal product - one strength and pharmaceutical form | 25.900,00 € |
| 8. | For each additional pharmaceutical form or strength submitted simultaneously | 10.950,00 € |
| 9. | Informed consent application - one strength and pharmaceutical form | 9.500,00 € |
| 10. | For each additional pharmaceutical form or strength submitted simultaneously with the informed consent application | 1.600,00 € |
| 11. | For a duplicate application submitted simultaneously - for all strengths and pharmaceutical forms | 10.950,00 € |
| 1.2.1.2. | Croatia as Concerned Member State (CMS) | |
| 1. | For one strength and pharmaceutical form | 4.350,00 € |
| 2. | For each additional pharmaceutical form or strength submitted simultaneously | 2.175,00 € |
| 1.2.2. | MRP Granting / refusal of marketing authorisation for medicinal product / homeopathic medicinal product | |
| 1.2.2.1. | Croatia as a Reference Member State (RMS) | |
| 1. | New active substance - one strength and pharmaceutical form | 27.500,00 € |
| 2. | Known active substance - one strength and pharmaceutical form- | 23.500,00 € |
| 3. | New combination of known active substances - one strength and pharmaceutical form | 23.500,00 € |
| 4. | Well-established medicinal use - one strength and pharmaceutical form | 19.500,00 € |
| 5. | Generic medicinal product - one strength and pharmaceutical form | 15.500,00 € |
| 6. | Hybrid medicinal product - one strength and pharmaceutical form- | 16.500,00 € |
| 7. | Biosimilar medicinal product - one strength and pharmaceutical form | 16.500,00 € |
| 8. | For each additional pharmaceutical form or strength submitted simultaneously | 7.500,00 € |
| 9. | Informed consent application - one strength and pharmaceutical form | 6.000,00 € |
| 10. | For each additional pharmaceutical form or strength submitted simultaneously with the informed consent application | 950,00 € |
| 11. | For a duplicate application submitted simultaneously - for all strengths and pharmaceutical forms | 6.000,00 € |
| 1.2.2.2. | Croatia as Concerned Member State (CMS) | |
| 1. | For one strength and pharmaceutical form | 4.350,00 € |
| 2. | For each additional pharmaceutical form or strength submitted simultaneously | 2.175,00 € |
| 1.2.3. | Repeat use procedure (RUP) | |
| 1.2.3.1. | Croatia as Reference Member State (RMS) | |
| 1. | For one strength and pharmaceutical form | 5.350,00 € |
| 2. | For each additional pharmaceutical form or strength submitted simultaneously | 2.675,00 € |
| 1.2.3.2. | Croatia as Concerned Member State (CMS) | |
| 1. | For one strength and pharmaceutical form | 4.350,00 € |
| 2. | For each additional pharmaceutical form or strength submitted simultaneously | 2.175,00 € |
| 1.2.4. | Registration / refusal of registration of traditional herbal medicinal product | |
| 1.2.4.1. | DCP / MRP - Croatia as Reference Member State (RMS) | |
| 1. | Traditional herbal medicinal product (supported by an EU monograph) - one strength and pharmaceutical form | 11.400,00 € |
| 2. | Traditional herbal medicinal product (with no EU monograph) - one strength and pharmaceutical form | 15.960,00 € |
| 3. | For each additional pharmaceutical form or strength submitted simultaneously | 6.200,00 € |
| 1.2.4.2 | DCP / MRP - Croatia as Concerned Member State (CMS) | |
| 1. | Traditional herbal medicinal product - one strength and pharmaceutical form | 2.400,00 € |
| 2. | For each additional pharmaceutical form or strength submitted simultaneously | 1.200,00 € |
| 1.2.5. | Registration / refusal of registration of homeopathic medicinal product | |
| 1.2.5.1. | DCP / MRP - Croatia as Reference Member State (RMS) | |
| 1. | Single-component homeopathic medicinal product, each pharmaceutical form | 8.200,00 € |
| 2. | Multi-component homeopathic medicinal product, each pharmaceutical form | 10.200,00 € |
| 1.2.5.2. | DCP / MRP - Croatia as Concerned Member State (CMS) | |
| 1. | Single-component homeopathic medicinal product, each pharmaceutical form | 600,00 € |
| 2. | Multi-component homeopathic medicinal product, each pharmaceutical form | 2.250,00 € |
The withdrawal of a submitted application for marketing authorization for a medicinal product will be charged in full regardless of the time of withdrawal.
2. Renewal of the marketing authorization for medicinal product (*)
Applies to national procedures
| No. | Service | Price |
|---|---|---|
| 2.1. | Renewal / refusal of renewal of marketing authorisation for medicinal product / homeopathic medicinal product | |
| 1. | For one strength and pharmaceutical form | 2.655,00 € |
| 2. | For each additional pharmaceutical form or strength | 1.327,00 € |
| 2.2. | Renewal / refusal of renewal of registration of traditional herbal medicinal product | |
| 1. | For one strength and pharmaceutical form | 995,00 € |
| 2. | For each additional pharmaceutical form or strength | 265,00 € |
Applies to MRP / DCP procedures
| No. | Service | Price |
|---|---|---|
| 2.3. | Renewal / refusal of renewal of marketing authorisation for medicinal product / homeopathic medicinal product | |
| 2.3.1. | DCP / MRP - Croatia as Reference Member State (RMS) | |
| 1. | For one strength and pharmaceutical form | 5.955.00 € |
| 2. | For each additional pharmaceutical form or strength | 2.975,00 € |
| 2.3.2. | DCP / MRP - Croatia as Concerned Member State (CMS) | |
| 1. | For one strength and pharmaceutical form | 2.655,00 € |
| 2. | For each additional pharmaceutical form or strength | 1.327,00 € |
| 2.4. | Renewal / refusal of renewal of registration of traditional herbal medicinal product | |
| 2.4.1. | DCP / MRP - Croatia as Reference Member State (RMS) | |
| 1. | For one strength and pharmaceutical form | 1.195,00 € |
| 2. | For an additional pharmaceutical form or an additional strenght | 400,00 € |
| 2.4.2. | DCP / MRP - Croatia as CMS | |
| 1. | For one strength and pharmaceutical form | 995,00 € |
| 2. | For each additional pharmaceutical form or strengt | 265,00 € |
3. Variation to marketing authorisation for medicinal product (*) (**)
Applies to national procedures
| No. | Service | Price |
|---|---|---|
| 3.1. | Variations to marketing authorisation for medicinal / homeopathic medicinal product | |
| 3.1.1. | Minor variation | |
| 1. | Type IA | 350,00 € |
| 2. | Type IB | 550,00 € |
| 3. | Variations to a summary of the pharmacovigilance system (PSMF) for each additional marketing authorisation within the grouped variation | 95,00 € |
| 4. | Approval of the same variation for additional strength or pharmaceutical form, submitted simultaneously | 95,00 € |
| 3.1.2. | Major variation | |
| 1. | Type II - simple | 750,00 € |
| 2. | Type II - complex | 1.500,00 € |
| 3. | Type II - very complex | 3.000,00 € |
| 4. | Approval of the same variation for additional strength or pharmaceutical form, submitted simultaneously | 95,00 € |
| 3.1.3. | Other variations | |
| 1. | Change in the labelling and/or package leaflet, including a mock-up change of the inner and outer packaging, which is not related to changes in the summary of product characteristics | 135,00 € |
Applies to MRP/DC
| Rb. | Service | Price |
|---|---|---|
| 3.2. | Variations to a marketing authorisation for medicinal / homeopathic medicinal products | |
| 3.2.1. | DCP / MRP - Croatia as RMS | |
| 3.2.1.1 | Minor variation | |
| 1. | Type IA | 750,00 € |
| 2. | Type IB | 1.250,00 € |
| 3. | Approval of the same variation for additional strength or pharmaceutical form, submitted simultaneously | 280,00 € |
| 4. | Variations to a summary of the pharmacovigilance system (PSMF) for each additional marketing authorisation within the grouped variation | 95,00 € |
| 3.2.1.2. | Major variation | |
| 1. | Type II - simple | 1.450,00 € |
| 2. | Type II - complex | 2.600,00 € |
| 3. | Type II - very complex | 3.850,00 € |
| 4. | Approval of the same variation for an additional strength or pharmaceutical form submitted simultaneously | 280,00 € |
| 3.2.2. | DCP / MRP - Croatia as CMS | |
| 3.2.2.1. | Minor variation | |
| 1. | Type IA | 350,00 € |
| 2. | Type IB | 550,00 € |
| 3. | Approval of the same variation for additional strength or pharmaceutical form, submitted simultaneously | 95,00 € |
| 4. | Variations to a summary of the pharmacovigilance system (PSMF) for each additional marketing authorisation within the grouped variation | 95,00 € |
| 3.2.2.2. | Major variation | |
| 1. | Type II | 950,00 € |
| 2. | Approval of the same variation for additional strength or pharmaceutical form, submitted simultaneously | 95,00 € |
| 3.2.3. | Other variations, DCP / MRP - Croatia as RMS or CMS | |
| 1. | Change in the labelling and/or package leaflet, including a mock-up change of the inner and outer packaging, which is not related to changes in the summary of product characteristics - Croatia as RMS | 410,00 € |
| 2. | Change in the labelling and/or package leaflet, including a mock-up change of the inner and outer packaging, which is not related to changes in the summary of product characteristics - Croatia as CMS | 135,00 € |
(*) In case of withdrawal of a submitted application for marketing authorisation, renewal or variation, a full fee will be charged regardless of the withdrawal time.
(**) 60% of the fee for variations, listed in section 3 of this fee list, will be charged for variations to registered homoeopathic and traditional herbal medicinal products
4. Manufacturing and inspection
| No. | Service | Price | |
|---|---|---|---|
| 1. | Granting/refusal of a manufacturing licence | 331,81 € | |
| 2. | Variation of a manufacturing licence | 132,73 € | |
| 3. | Revocation of a manufacturing licence | 132,73 € | |
| 4. | Good Manufacturing Practice (GMP) certificate | 66,36 € | |
| 5. | Entry into the register of manufacturers, suppliers or importers of active substances | 199,09 € | |
| 6. | Deletion from the register of manufacturers, suppliers or importers of active substances | 132,73 € | |
| 7. | Variation to an entry into the register of manufacturers, suppliers or importers of active substances | 132,73 € | |
| 8. | Good Manufacturing Practice inspection and Good Pharmacovigilance inspection (per day and per inspector) | 464,53 € | |
| 9. | Material costs of Good Manufacturing Practice inspection and Good Pharmacovigilance Practice inspection (per day and per inspector) | 500,00 € | |
| 10. | Supervision of the repositories system (per day and per inspector) | 929,06 € | |
| 11. | Granting/refusal of a licence for the wholesale distribution of medicinal products | 597,26 € | |
| Variation of a licence for the wholesale distribution of medicinal products | |||
| 12. | - administrative enforcement | 132,73 € | |
| 13. | - in case of inspection | 199,09 € | |
| 14. | Revocation of a licence for the wholesale distribution of medicinal products | 132,73 € | |
| 15. | Enrolment in the record of natural or legal persons established outside the Republic of Croatia that are authorised for the wholesale distribution or brokering of medicinal products in the European Union member state and meet the requirements of the wholesale distribution or brokering of medicinal products in the country of establishment and wish to carry out the same activities on the territory of the Republic of Croatia | 500,00 € | |
| 16. | Granting/refusal of a licence for the retail sale of medicinal products (in specialised retail shops) | 331,81 € | |
| Variation of a licence for the retail sale of medicinal products (in specialised retail shops) | |||
| 17. | - administrative enforcement | 66,36 € | |
| 18. | - in case of inspection | 265,45 € | |
| 19. | Material costs of conducting inspection in specialised retail shops | 300,00 € | |
| 20. | Revocation of a licence for the retail sale of medicinal products (in specialised retail shops) | 66,36 € | |
| 21. | Granting/revocation of a broker licence | 199,09 € | |
| 22. | Variation of a broker licence | 66,36 € | |
| 23. | Revocation of a broker licence | 66,36 € | |
| 24. | Internet sale licence | 199,09 € | |
| 25. | Variation of an Internet sale licence | 66,36 € | |
| 26. | Revocation of an Internet sale licence | 66,36 € | |
| 27. | Good Manufacturing Practice (GMP) inspection of manufacturers located in third countries (per day and per inspector) | 2.500,00 € + travel and accommodation costs | |
| 28. | Issuing of Good Manufacturing Practice (GMP) certificate for manufacturers located in third countries | 1.500,00 € | |
5. Medicinal product marketing
| No. | Service | Price |
|---|---|---|
| 1. | Approval for an import of an active substance | 350,00 € |
| 2. | Approval for the exemption to the labelling and/or package leaflet obligation | 500,00 € |
| Approval for entry / import of medicinal product without marketing authorization in the following cases: | ||
| 3. | - when there is a medically justified need to protect human health | 350,00 € |
| 4. | - for research purposes | 350,00 € |
| 5. | - for pharmaceutical testing | 350,00 € |
| 6. | - for non-clinical studies | 350,00 € |
| 7. | - for clinical trials | 350,00 € |
| 8. | - in case of natural disasters or other emergencies | 350,00 € |
| 9. | - for emergency treatments of individual patients with a medicinal product prescribed on their own responsibility by a medical doctor or a dental medicine doctor in charge | 250,00 € |
| 10. | Approval for entry/import of medicinal product with marketing authorization: - medicinal product derived from blood or plasma - immunological medicinal product - radiopharmaceutical |
150,00 € |
| 11. | Certificate of a pharmaceutical product (CPP) | 350,00 € |
| 12. | Free Sales Certificate (FSC) | 350,00 € |
| 13. | Providing information on the consumption of medicinal products | 200,00 € |
| 14. | Analysis of information on the consumption of medicinal products | 500,00 € |
| 15. | Approval for the parallel import of medicinal products | 1.327,23 € |
| 16. | Variation of approval for the parallel import of medicinal products | 265,45 € |
| 17. | Batch-specific request related to labelling | 500,00 € |
| 18. | Re-application of a batch request where the request is identical to the original application | 200,00 € |
| 19. | Other batch-specific request | 800,00 € |
| 20. | Determination of maximal wholesale prices of prescription medicinal products | 500,00 € |
| 21. | - for an additional strength or pharmaceutical form (submitted at the same time or submitted subsequently) | 200,00 € |
| 22. | - for an additional packaging (submitted at the same time or submitted subsequently) | 100,00 € |
| 23. | Decision on an exceptional increase in the maximum permitted wholesale price of a medicinal product | 600,00 € |
| 24. | Certificate of the determination of the maximum permitted wholesale price of a medicinal product | 200,00 € |
| 25. | Annual calculation of medicinal product prices (per package)* | 35,00 € |
* applies from annual calculation of medicinal product prices for 2025
6. Quality control of medicinal products
| No. | Service | Price | |
|---|---|---|---|
| 6.1. | Quality control of medicinal products | ||
| EU / EEA OCABR certificate: | |||
| 1. | Special quality control of each batch of a blood or plasma-based medicinal product or immunological medicinal product | 0,47 € / point | |
| 2. | Administrative procedure for vaccines/blood derivatives | 500,00 € | |
| Quality control report: | |||
| 3. | Quality control of a sample of a marketed medicinal product | 0,47 € / point | |
| 4. | Emergency quality control at the request of a Ministry of Health or the Agency due to adverse effects or doubts regarding the quality of a medicinal product | 0,47 € / point | |
| 5. | Quality control in the procedure for granting marketing authorization, renewal or variation to a marketing authorization for a medicinal product | 0,47 € / point | |
| 6. | Quality control at special request - documentation assessment - laboratory quality control |
100,00 € 1,2 € / point |
|
| 7. | Quality control for international contracts - documentation assessment - laboratory quality control |
100,00 € 1,2 € / point |
|
| 8. | Labelling check | 450,00 € | |
| 6.2 | Quality control of veterinary medicinal products (VMP) | ||
| Final report of quality control | |||
| 1. | Exceptional quality control of VMP | 0,93 € / point | |
| 2. | Regular quality control of VMP | 0,93 € / point | |
7. Annual fees
| No. | Service | Price |
|---|---|---|
| 1. | Annual fee for a medicinal product | 318,54 € |
| 2. | Annual fee for a homeopathic medicinal product/device | 33,18 € |
| 3. | Annual fee for registration in the register of custom made medical device manufacturers | 19,91 € |
| 4. | Annual fee for registration in the register of batch produced medical device manufacturers | 66,36 € |
| 5. | Annual fee for registration in the register of medical device wholesalers | 132,73 € |
| 6. | Annual fee for a licence for the wholesale distribution of medicinal products | 132,73 € |
| 7. | Annual fee for a licence for the retail sale of medical devices | 33,18 € |
| 8. | Annual fee for a licence for the retail sale of medicinal products or medicinal products and medical devices (specialised stores for the retail sale) | 33,18 € |
| 9. | Annual fee for manufacture of medicinal products | 199,09 € |
| 10. | Annual fee for brokering | 66,36 € |
| 11. | Annual fee for entry into the register of manufacturers, suppliers or importers of active substances | 66,36 € |
An annual fee is charged for each valid decision, and it refers to the previous period of one year.
8. Medical devices
| No. | Service | Price |
|---|---|---|
| 1. | Registration/refusal of registration in the register of manufacturers or manufacturer representatives | 700,00 € |
| 2. | Variation/refusal of variation of registration in the register of manufacturers or authorized manufacturer representatives | 200,00 € |
| 3. | Registration/refusal of registration in the register of medical devices (1 to 5 devices) | 800,00 € |
| 4. | Registration/refusal of registration in the register of medical devices (6 to 30 devices) | 900,00 € |
| 5. | Registration/refusal of registration in the register of medical devices for over 30 medical devices | 1.000,00 € |
| 6. | Variation of registration in the medical device register | 300,00 € |
| 7. | Variation of registration in the medical device register without changing registration certificate | 200,00 € |
| 8. | Certificate of registration of a medical device in the medical device register | 150,00 € |
| 9. | Classification of medical devices with regard to risk class | 1.000,00 € + additional costs if an external expert is included |
| 10. | Classification of a product as a medical device at the manufacturer's request | 1.000,00 € + additional costs if an external expert is included |
| 11. | Registration/refusal of registration in register of medical device manufacturers - for medical devices custom made for individual users | 300,00 € |
| 12. | Variation/refusal of variation of registration in the register of medical device manufacturers - for medical devices custom made for individual users | 100,00 € |
| 13. | Issuing of SRN number - micro enterprises | 300,00 € |
| 14. | Issuing of SRN number - small enterprises | 600,00 € |
| 15. | Issuing of SRN number - medium sized enterprises | 800,00 € |
| 16. | Free sale certificate issued for one country (1-5 medical devices) | 150,00 € |
| 17. | Free sale certificate issued for one country (6-20 medical devices) | 200,00 € |
| 18. | Free sale certificate issued for one country (more than 20 medical devices) | 250,00 € |
| 19. | Register for distributors - micro enterprises | 400,00 € |
| 20. | Register for distributors - small enterprises | 550,00 € |
| 21. | Register for distributors - medium sized enterprises | 700,00 € |
| 22. | Variation of registration in the register of distributors - micro enterprises | 200,00 € |
| 23. | Variation of registration in the register of distributors - small enterprises | 280,00 € |
| 24. | Variation of registration in the register of distributors - medium sized enterprises | 350,00 € |
| 25. | Annual fee for the register of distributors - micro enterprises | 140,00 € |
| 26. | Annual fee for the register of distributors - small enterprises | 200,00 € |
| 27. | Annual fee for the register of distributors - medium sized enterprises | 240,00 € |
| 28. | Derogation from the conformity assessment procedures according to MDR Article 59., IVDR Article 54. | 600,00 € |
| 29. | Issuing of statement regarding incident reports for specific manufacturer for the period of one year | 150,00 € |
| 30. | Issuing confirmation letter for notification of placing a medical device on the Croatian market | 100,00 € |
| 31. | Issuing confirmation letter for variation of notification of placing a medical device on the Croatian market | 70,00 € |
| 32. | Dispute settlement between the manufacturer and the notified body concerned, arising from the application of Annex VIII | 1.000,00 € |
| 33. | Verification of medical device conformity (1-5 medical devices) on request | 200,00 € |
| 34. | Verification of medical device conformity (6-20 medical devices) on request | 300,00 € |
| 35. | Verification of medical device conformity (more than 20 medical devices) on request | 400,00 € |
9. Training and provision of expert advice from the Agency's scope of work and Croatian Pharmacopoeia
| No. | Service | Price |
|---|---|---|
| 9.1. | Training | |
| 9.1.1. | Half-day training | |
| 1. | for health workers, university workers and students | 90,00 € |
| 2. | for regulatory bodies | 110,00 € |
| 3. | for authorization holders and others | 200,00 € |
| 9.1.2. | Training per day - up to 3 days | |
| 1. | for health workers, university workers and students | 150,00 € |
| 2. | for regulatory bodies | 180,00 € |
| 3. | for authorization holders and others | 300,00 € |
| 9.1.3. | Each additional day of training over 3 days | |
| 1. | for health workers, university workers and students | 60,00 € |
| 2. | for regulatory bodies | 70,00 € |
| 3. | for authorization holders and others | 110,00 € |
| 9.1.4. | Training with international participation, per day - up to 2 days | |
| 1. | for health workers, university workers and students | 170,00 € |
| 2. | for regulatory bodies | 200,00 € |
| 3. | for authorization holders and others | 350,00 € |
| 9.1.5. | Each additional day of training with international participation over 3 days | |
| 1. | for health workers, university workers and students | 80,00 € |
| 2. | for regulatory bodies | 90,00 € |
| 3. | for authorization holders and others | 150,00 € |
| 9.2. | Expert advice prior to procedures from HALMED competence | |
| 1. | Simple expert advice | 1.500,00 € |
| 2. | Complex expert advice | 2.100,00 € |
| 3. | Extremely complex expert advice | 3.800,00 € |
| 4. | The most complex expert advice | 5.200,00 € |
| 5. | Expert advice for translation of the instructions for use and labeling of a medical device up to 650 words | 66,36 € |
| 6. | Expert advice for translation of the instructions for use and labeling of a medical device up to 1200 words | 200,00 € |
| 7. | Expert advice for translation of the instructions for use and labeling of a medical device for more than 1200 words | 300,00 € |
| 9.3. | Croatian Pharmacopoeia | |
| 1. | Annual fee for online access to Pharmacopoeia | 39,82 € |
10. Clinical trials
| No. | Service | Price | |
|---|---|---|---|
| 1. | Procuring a Central Ethics Committee opinion regarding a clinical trial* | 1.659,04 € | |
| 2. | Procuring a Central Ethics Committee opinion regarding bioequivalence study* | 995,42 € | |
| 3. | Procuring a Central Ethics Committee opinion regarding conducting non-interventional trial for medical devices* | 663,62 € | |
| 4. | Procuring a Central Ethics Committee opinion regarding conducting non-interventional trial for medicinal products* | 132,73 € | |
| 5. | Procuring a Central Ethics Committee opinion regarding academic research* | 265,45 € | |
| 6. | Major alterations and amendments to clinical trials* | 265,45 € | |
| 7. | Minor administrative alterations and amendments, additional research centres and head researcher changes* | 66,36 € | |
| 8. | Initial applications** | ||
| 8.1. | Clinical trial of unauthorised medicinal product** | ||
| 1. | Mono-national trial - Part I | 995,42 € | |
| 2. | Mono-national trial - Part II | 530,89 € | |
| 3. | Mono-national trial - Part I+II | 1.526,31 € | |
| 4. | Multinational trial - Croatia RMS - Part I | 2.654,46 € | |
| 5. | Multinational trial - Croatia RMS - Part II | 530,89 € | |
| 6. | Multinational trial - Croatia RMS - Part I+II | 3.185,35 € | |
| 7. | Multinational trial - Croatia MSC - Part I | 663,62 € | |
| 8. | Multinational trial - Croatia MSC - Part II | 530,89 € | |
| 9. | Multinational trial - Croatia MSC - Part I+II | 1.194,51 € | |
| 10. | Additional MSC application for Croatia - Part I+II | 1.327,23 € | |
| 11. | Non-commercial clinical trials | Free of charge | |
| 8.2. | Clinical trial of authorised medicinal product** | ||
| 1. | Mono-national trial - Part I | 663,62 € | |
| 2. | Mono-national trial - Part II | 331,81 € | |
| 3. | Mono-national trial - Part I+II | 995,42 € | |
| 4. | Multinational trial - Croatia RMS - Part I | 2.322,65 € | |
| 5. | Multinational trial - Croatia RMS - Part II | 331,81 € | |
| 6. | Multinational trial - Croatia RMS - Part I+II | 2.654,46 € | |
| 7. | Multinational trial - Croatia MSC - Part I | 331,81 € | |
| 8. | Multinational trial - Croatia MSC - Part II | 331,81 € | |
| 9. | Multinational trial - Croatia MSC - Part I+II | 663,62 € | |
| 10. | Additional MSC application for Croatia - Part I+II | 796,34 € | |
| 11. | Non-commercial clinical trials | Free of charge | |
| 9. | Applications for the authorisation of a substantial modification** | ||
| 9.1. | Clinical trial of unauthorised medicinal product** | ||
| 1. | Mono-national trial - Part I | 265,45 € | |
| 2. | Mono-national trial - Part II | 132,73 € | |
| 3. | Mono-national trial - Part I+II | 398,17 € | |
| 4. | Multinational trial - Croatia RMS - Part I | 398,17 € | |
| 5. | Multinational trial - Croatia RMS - Part II | 132,73 € | |
| 6. | Multinational trial - Croatia RMS - Part I+II | 530,89 € | |
| 7. | Multinational trial - Croatia MSC - Part I | 199,09 € | |
| 8. | Multinational trial - Croatia MSC - Part II | 132,73 € | |
| 9. | Multinational trial - Croatia MSC - Part I+II | 331,81 € | |
| 10. | Non-commercial clinical trials | Free of charge | |
| 9.2. | Clinical trial of authorised medicinal product** | ||
| 1. | Mono-national trial - Part I | 132,73 € | |
| 2. | Mono-national trial - Part II | 66,36 € | |
| 3. | Mono-national trial - Part I+II | 199,09 € | |
| 4. | Multinational trial - Croatia RMS - Part I | 265,45 € | |
| 5. | Multinational trial - Croatia RMS - Part II | 66,36 € | |
| 6. | Multinational trial - Croatia RMS - Part I+II | 331,81 € | |
| 7. | Multinational trial - Croatia MSC - Part I | 66,36 € | |
| 8. | Multinational trial - Croatia MSC - Part II | 66,36 € | |
| 9. | Multinational trial - Croatia MSC - Part I+II | 132,73 € | |
| 10. | Non-commercial clinical trials | Free of charge | |
* Services apply to requests submitted in accordance with the Directive 2001/20/EZ and Medicinal Products Act (Official Gazette No. 76/13., 90/14., 100/18.) until the end of transition period (31 January 2025)
** Services apply to requests submitted in accordance with the 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
11. Pharmacovigilance
| No. | Service | Price | |
|---|---|---|---|
| 1. | Assessment of a Periodic Safety Update Report | 796,34 € | |
| 2. | Assessment of additional risk minimisation measures | 597,26 € | |
| 3. | Assessment of variation of additional risk minimisation measures | 398,17 € | |
| 4. | Assessment of additional risk minimisation measures for medicinal products of different marketing authorisation holders containing the same active substance | 232,27 € | |
| 5. | Assessment of variation of additional risk minimisation measures for medicinal products of different marketing authorisation holders containing the same active substance | 165,19 € | |
| 6. | Assessment of a Development Safety Update Report | 265,45 € | |
| 7. | Procuring opinion of the Agency for medicinal products and medical devices for conducting non-interventional trial for medicinal products | 1.500,00 € | |
| 8. | Major alterations and amendments to non-interventional trial for medicinal products | 740,00 € | |
| 9. | Minor administrative alterations and amendments to non-interventional trial for medicinal products, additional research centres and head research changes | 320,00 € | |
| 10. | Safety assessment in clinical trials (sAMS)* | 5.043,47 € | |
| 11. | Safety assessment in clinical trials (sAMS) for active substance included in different sponsors' clinical trials* | 1.493,13 € | |
| Assessment of measures regarding the safe and effective use of the medicinal product needed to be taken in the interest of medicinal product safety | |||
| 12. | - simple | 330,00 € | |
| 13. | - complex | 510,00 € | |
| 14. | - very complex | 900,00 € | |
| 15. | Assessment of other procedures related to the safe use of medicinal products | 400,00 € | |
* Services apply to requests submitted in accordance with the Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16th April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC
12. Veterinary Medicinal Products (VMP)
| No. | Service | Price |
|---|---|---|
| 1. | Granting/refusal of a VMP manufacturing licence | 663,61 € |
| 2. | Variation of a VMP manufacturing licence | 265,45 € |
| 3. | Removal from the register of VMP manufacturing licence holders, at licence holder's request | 132,72 € |
| 4. | Granting Good Manufacturing Practice (GMP) certificate for VMP, for manufacturers seated in Croatia | 132,72 € |
| 5. | Good Manufacturing Practice inspection for VMP (per day and per inspector) | 929,06 € |
| 6. | Granting/refusal of a licence for the wholesale distribution of VMP | 331,81 € |
| 7. | Variation of a licence for the wholesale distribution of VMP - administrative enforcement | 132,72 € |
| 8. | Variation of a licence for the wholesale distribution of VMP - in case of inspection | 199,08 € |
| 9. | Removal of the VMP wholesaler from HALMED's register of the wholesale distribution of VMP licence holder, at licence holder's request | 132,72 € |
| 10. | Good Distribution Practice inspection of the VMP wholesale (per day and per inspector) | 265,45 € |
13. Provision of a scientific opinion on a substance which has action ancillary to that of a medical device
| No. | Service | Price |
|---|---|---|
| 1. | Provision of a scientific opinion on a substance which has action ancillary to that of a medical device - a new substance and a known substance in a new use | 26.700,00 € |
| 2. | Provision of a scientific opinion on a substance which has action ancillary to that of a medical device - a known substance in a known use | 20.000,00 € |
| 3. | Variation type II | 2.700,00 € |
| 4. | Variation type I | 950,00 € |
