About HALMED

Fees

The HALMED's price list, effective from 9 March 2024, is available below. Amendments to the HALMED's price list in the field of medicinal products and medical devices, which entered into force on 1 July 2024, have been implemented in the said HALMED's price list.

The amended HALMED's price list will be applied to all services in the field of medicinal products and medical devices that HALMED performs and invoices after the effective date of these amendments, i.e. 1 July 2024, regardless of the date of submission of the request.

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 9.950,00 €
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 7.750,00 €
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.

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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 €

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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

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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 €

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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

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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

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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.

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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 / large 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 €

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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. Scientific advice before procedure within the competence of HALMED
1. Simple scientific advice 1.500,00 €
2. Complex scientific advice 2.100,00 €
3. Very complex scientific advice 3.800,00 €
4. Excessively complex scientific 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 €

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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

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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

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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 €

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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 €

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