About HALMED

Fees

The HALMED's price list, effective from 9 March 2024, is available below.

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 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 a medicinal product

Apply to national procedures

No. Service Price
1.1. Granting/refusal of a marketing authorization for a medicinal product
1. For one strength and pharmaceutical form 3.981,68 €
2. For an additional pharmaceutical form (submitted at the same time) 3.185,35 €
3. For an additional pharmaceutical form (submitted subsequently) 3.981,68 €
4. For an additional strength (submitted at the same time) 1.858,12 €
5. For an additional strength (submitted subsequently) 2.123,56 €
6. Issuing of a Plasma Master File (PMF) certificate 2.654,46 €
7. Issuing of an additional Plasma Master File (PMF) certificate 796,34 €

Apply to MRP / DCP procedures

No. Service Price
1.2. Granting/refusal of a marketing authorization for a medicinal product/homeopathic medicinal product and registration
1.2.1. Granting/refusal of a marketing authorization for a medicinal product/homeopathic medicinal product in a Decentralised Procedure (DCP)
1.2.1.1. When Croatia acts as a Reference Member State (RMS)
1. For one strength and pharmaceutical form - requests pursuant to article 8(3) of the Directive 2001/83/EC 26.544,56 €
2. For one strength and pharmaceutical form - generic medicinal product 19.908,42 €
3. For one strength and pharmaceutical form - medicinal product with well-established medicinal use 24.553,72 €
4. For one strength and pharmaceutical form - hybrid, biosimilar medicinal product 24.553,72 €
5. For one strength and pharmaceutical form - with the consent to use the dossier of a reference medicinal product 9.954,21 €
6. For one strength and pharmaceutical form - new combination of known active substances 24.553,72 €
7. Request for a duplicate (submitted at the same time - for all strengths and pharmaceutical forms) 9.954,21 €
8. For an additional pharmaceutical form (at the same time) 13.272,28 €
9. For an additional pharmaceutical form (subsequently) 15.926,74 €
10. For an additional strength (at the same time ) 9.954,21 €
11. For an additional strength (subsequently) 11.281,44 €
1.2.1.2. When Croatia is a Concerned Member State (CMS)
1. For one strength and pharmaceutical form - requests pursuant to article 8(3) of the Directive 2001/83/EC 3.981,68 €
2. For one strength and pharmaceutical form - generic medicinal product 3.981,68 €
3. For one strength and pharmaceutical form - medicinal product with well-established medicinal use 3.981,68 €
4. For one strength and pharmaceutical form - hybrid, biosimilar medicinal product 3.981,68 €
5. For one strength and pharmaceutical form - with the consent to use the dossier of a reference medicinal product 3.981,68 €
6. For one strength and pharmaceutical form - new combination of known active substances 3.981,68 €
7. Request for a duplicate (submitted at the same time - for all strengths and pharmaceutical forms) 3.981,68 €
8. For an additional pharmaceutical form (submitted at the same time) 3.185,35 €
9. For an additional pharmaceutical form (submitted subsequently) 3.981,68 €
10. For an additional strength (submitted at the same time) 1.858,12 €
11. For an additional strength (submitted subsequently) 2.123,56 €
1.2.2. Granting/refusal of a marketing authorization for a medicinal product/homeopathic medicinal product in the Mutual Recognition Procedure (MRP)
1.2.2.1. When Croatia acts as a Reference Member State (RMS)
1. For one strength and pharmaceutical form - requests pursuant to article 8(3) of the Directive 2001/83/EC 15.926,74 €
2. For one strength and pharmaceutical form - generic medicinal product 11.945,05 €
3. For one strength and pharmaceutical form - medicinal product with well-established medicinal use 14.599,51 €
4. For one strength and pharmaceutical form - hybrid, biosimilar medicinal product 14.599,51 €
5. For one strength and pharmaceutical form - with the consent to use the dossier of a reference medicinal product 5.972,53 €
6. For one strength and pharmaceutical form - new combination of known active substances 14.599,51 €
7. Request for a duplicate (submitted at the same time - for all strengths and pharmaceutical forms) 5.972,53 €
8. For an additional pharmaceutical form (submitted at the same time) 7.963,37 €
9. For an additional pharmaceutical form (submitted subsequently) 9.556,04 €
10. For an additional strength (submitted at the same time) 5.972,53 €
11. For an additional strength (submitted subsequently) 6.636,14 €
1.2.2.2. When Croatia is a Concerned Member State (CMS)
1. For one strength and pharmaceutical form - requests pursuant to article 8(3) of the Directive 2001/83/EC 3.981,68 €
2. For one strength and pharmaceutical form - generic medicinal product 3.981,68 €
3. For one strength and pharmaceutical form - medicinal product with well-established medicinal use 3.981,68 €
4. For one strength and pharmaceutical form - hybrid, biosimilar medicinal product 3.981,68 €
5. For one strength and pharmaceutical form - with the consent to use the dossier of a reference medicinal product 3.981,68 €
6. For one strength and pharmaceutical form - new combination of known active substances 3.981,68 €
7. Request for a duplicate (submitted at the same time - for all strengths and pharmaceutical forms) 3.981,68 €
8. For an additional pharmaceutical form (submitted at the same time) 3.185,35 €
9. For an additional pharmaceutical form (submitted subsequently) 3.981,68 €
10. For an additional strength (submitted at the same time) 1.858,12 €
11. For an additional strength (submitted subsequently) 2.123,56 €
1.2.3. Repeat use procedure
1. For one strength and pharmaceutical form 3.981,68 €
2. For an additional pharmaceutical form (submitted at the same time) 3.185,35 €
3. For an additional pharmaceutical form (submitted subsequently) 3.981,68 €
4. For an additional strength (submitted at the same time) 1.858,12 €
5. For an additional strength (submitted subsequently) 2.123,56 €
6. Request for a duplicate for all strengths and pharmaceutical forms (submitted at the same time) 3.185,35 €
1.2.5. Granting/refusal of a marketing authorization for allergens
1.2.5.1. In a Mutual Recognition or Decentralization procedure when Croatia acts as a Reference Member State (RMS)
1. Allergen for treatment and an allergen for testing 19.908,42 €
2. For an additional concentration, strength or pharmaceutical form of an allergen for treatment and an allergen for testing (request submitted at the same time) 1.990,84 €
3. For each additional allergen for treatment and an allergen for testing from the same biologically uniform group (request submitted at the same time) 1.990,84 €
4. For an additional concentration, strength or pharmaceutical form of additional allergen for treatment and an allergen for testing (request submitted at the same time) 199,08 €
5. Allergen for epidermal tests 9.954,21 €
6. For an additional concentration, strength or pharmaceutical form of an allergen for epidermal tests (request submitted at the same time) 995,42 €
7. For each additional allergen for epidermal tests (request submitted at the same time) 995,42 €
8. For an additional concentration, strength or pharmaceutical form of an additional allergen for epidermal tests (request submitted at the same time) 99,54 €
1.2.5.2. In a Mutual Recognition or Decentralization procedure when Croatia is a Concerned Member State and in a national procedure
1. Allergen for treatment and an allergen for testing 3.981,68 €
2. For an additional concentration, strength or pharmaceutical form of an allergen for treatment and an allergen for testing (request submitted at the same time) 398,17 €
3. For each additional allergen for treatment and an allergen for testing from the same biologically uniform group (request submitted at the same time) 398,17 €
4. For an additional concentration, strength or pharmaceutical form of additional allergen for treatment and an allergen for testing (request submitted at the same time) 39,82 €
5. Allergen for epidermal tests 1.990,84 €
6. For an additional concentration, strength or pharmaceutical form of an allergen for epidermal tests (request submitted at the same time) 1.990,84 €
7. For each additional allergen for epidermal tests (request submitted at the same time) 199,08 €
8. For an additional concentration, strength or pharmaceutical form of an additional allergen for epidermal tests (request submitted at the same time) 19,91 €
1.2.6. Registration/refusal of registration of a traditional herbal medicinal product
1.2.6.1. In a national procedure
1. For one strength and pharmaceutical form - traditional herbal medicinal product (based on an EU monograph) 1.459,95 €
2. For one strength and pharmaceutical form - (when there is no EU monograph) 2.389,01 €
3. For an additional pharmaceutical form of a traditional herbal medicinal product (submitted at the same time) 1.194,51 €
4. For an additional pharmaceutical form based on an EU monograph (submitted subsequently) 1.459,95 €
5. For an additional pharmaceutical form when there is no EU monograph (submitted subsequently) 2.389,01 €
6. For an additional strength of a traditional herbal medicinal product (submitted at the same time) 929,06 €
7. For an additional strength of a traditional herbal medicinal product (submitted subsequently) 1.061,78 €
1.2.6.2. In a Mutual Recognition or Decentralization procedure when Croatia acts as a Reference Member State (RMS)
1. For one strength and pharmaceutical form - traditional herbal medicinal product 5.308,91 €
2. For an additional pharmaceutical form of a traditional herbal medicinal product (submitted at the same time) 4.247,13 €
3. For an additional pharmaceutical form of a traditional herbal medicinal product (submitted subsequently) 5.308,91 €
4. For an additional strength of a traditional herbal medicinal product (submitted at the same time) 2.521,73 €
5. For an additional strength of a traditional herbal medicinal product (submitted subsequently) 2.787,18 €
1.2.6.3. In a Mutual Recognition or Decentralization procedure when Croatia is a Concerned Member State
1. For one strength and pharmaceutical form - traditional herbal medicinal product 2.389,01 €
2. For an additional pharmaceutical form of a traditional herbal medicinal product (submitted at the same time) 1.194,51 €
3. For an additional pharmaceutical form of a traditional herbal medicinal product (submitted subsequently) 2.389,01 €
4. For an additional strength of a traditional herbal medicinal product (submitted at the same time) 929,06 €
5. For an additional strength of a traditional herbal medicinal product (submitted subsequently) 1.061,78 €
1.2.7. Registration/refusal of registration of a homeopathic medicinal product
1.2.7.1. In a Mutual Recognition or Decentralization procedure when Croatia acts as a Reference Member State (RMS)
1. For each pharmaceutical form of a single-component homeopathic medicinal product 2.654,46 €
2. For each pharmaceutical form of a multi-component homeopathic medicinal product 3.318,07 €
1.2.7.2. In a Mutual Recognition or Decentralization procedure when Croatia is a Concerned Member State and in a national procedure
1. For each pharmaceutical form of a single-component homeopathic medicinal product 530,89 €
2. For each pharmaceutical form of a multi-component homeopathic medicinal product 995,42 €

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 a medicinal product

Apply to national procedures

No. Service Price
2.1. Renewal/refusal of a renewal of a marketing authorization for a medicinal product (no variations)
1. For one strength and pharmaceutical form 2.654,46 €
2. For an additional pharmaceutical form 2.123,56 €
3. For an additional strength 1.194,51 €

Apply to MRP / DCP procedures

No. Service Price
2.2. Renewal/refusal of renewal of a marketing authorization for a medicinal product/homeopathic medicinal product
2.2.1. Renewal/refusal of a renewal of a marketing authorization for a medicinal product (no variations)
2.2.1.1. In a Mutual Recognition or Decentralization procedure when Croatia acts as a Reference Member State (RMS)
1. For one strength and pharmaceutical form 5.308,91 €
2. For an additional pharmaceutical form 4.247,13 €
3. For an additional strength 2.389,01 €
2.2.1.2. In a Mutual Recognition or Decentralization procedure when Croatia is a Concerned Member State
1. For one strength and pharmaceutical form 2.654,46 €
2. For an additional pharmaceutical form 2.123,56 €
3. For an additional strength 1.194,51 €
2.2.2. Renewal/refusal of a renewal of a marketing authorization for an allergen (no variations)
2.2.2.1. In a Mutual Recognition or Decentralization procedure when Croatia acts as a Reference Member State (RMS)
1. Allergen for treatment and an allergen for testing 5.308,91 €
2. For an additional concentration, strength or pharmaceutical form of an allergen for treatment and an allergen for testing (request submitted at the same time) 530,89 €
3. For each additional allergen for treatment and an allergen for testing from the same biologically uniform group (request submitted at the same time) 530,89 €
4. For an additional concentration, strength or pharmaceutical form of additional allergen for treatment and an allergen for testing (request submitted at the same time) 53,09 €
5. Allergen for epidermal tests 2.654,46 €
6. For an additional concentration, strength or pharmaceutical form of an allergen for epidermal tests (request submitted at the same time) 265,45 €
7. For each additional allergen for epidermal tests (request submitted at the same time) 265,45 €
8. For an additional concentration, strength or pharmaceutical form of an additional allergen for epidermal tests (request submitted at the same time) 26,54 €
2.2.2.2. In a Mutual Recognition or Decentralization procedure when Croatia is a Concerned Member State and in a national procedure
1. Allergen for treatment and an allergen for testing 2.654,46 €
2. For an additional concentration, strength or pharmaceutical form of an allergen for treatment and an allergen for testing (request submitted at the same time) 265,45 €
3. For each additional allergen for treatment and an allergen for testing from the same biologically uniform group (request submitted at the same time) 265,45 €
4. For an additional concentration, strength or pharmaceutical form of additional allergen for treatment and an allergen for testing (request submitted at the same time) 26,54 €
5. Allergen for epidermal tests 1.327,23 €
6. For an additional concentration, strength or pharmaceutical form of an allergen for epidermal tests (request submitted at the same time) 132,72 €
7. For each additional allergen for epidermal tests (request submitted at the same time) 132,72 €
8. For an additional concentration, strength or pharmaceutical form of an additional allergen for epidermal tests (request submitted at the same time) 13,27 €
2.2.3. Renewal /refusal of renewal of registration of a traditional herbal medicinal product
2.2.3.1. In a Mutual Recognition or Decentralization procedure when Croatia acts as a Reference Member State (RMS)
1. For one strength and pharmaceutical form 1.194,51 €
2. For each additional pharmaceutical form / strength 398,17 €
2.2.3.2. In a Mutual Recognition or Decentralization procedure when Croatia is a Concerned Member State and in a national procedure
1. For one strength and pharmaceutical form 995,42 €
2. For each additional pharmaceutical form / strength 265,45 €
2.2.4. Renewal /refusal of renewal of registration of a homeopathic medicinal product
2.2.4.1. In a Mutual Recognition or Decentralization procedure when Croatia acts as a Reference Member State (RMS)
1. For each pharmaceutical form of a single or multi-component homeopathic medicinal product 929,06 €
2.2.4.2. In a Mutual Recognition or Decentralization procedure when Croatia is a Concerned Member State and in a national procedure
1. For each pharmaceutical form of a single or multi-component homeopathic medicinal product 398,17 €

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3. Variations to a marketing authorization for a medicinal product, withdrawal of an authorization and issuing reports on the medicinal product dossier

Apply to national procedures

No. Service Price
3.1. Variations to a marketing authorization for a medicinal product
Minor variation (IA and IB)
1. IA 331,81 €
2. IB 464,53 €
3. Authorization for introduction of, or change to, a summary of pharmacovigilance system for every additional authorization in grouping of variations 66,36 €
Major variation (II)
4. simple 464,53 €
5. complex 796,34 €
6. very complex 1.327,23 €
7. Authorization for the same variation in an additional strength or pharmaceutical form (charged for both minor and major variations) 66,36 €
8. Decision on variations to a decision on a marketing authorization for a medicinal product/Refusal of authorization of variations to the marketing authorization for a medicinal product (charged for both minor and major variations) 132,72 €
3.2. Other variations
1. Variation to labelling and/or package leaflet, including variation of a mock-up of inner and outer packaging, that does not require changes in the summary of product characteristics 132,72 €
2. Transfer of a marketing authorization for a medicinal product 398,17 €
3.3. Withdrawal of a marketing authorization for a medicinal product
1. Withdrawal of a marketing authorization for a medicinal product at the applicant's request, and in case the medicinal product has not been placed on the market within three years of the authorisation being granted 265,45 €
3.4. Issuing a report on the medicinal product dossier outside of a marketing authorization procedure for a medicinal product
1. Issuing a report on the medicinal product dossier outside of a marketing authorization procedure for a medicinal product 2.654,46 €

Apply to MRP / DCP procedures

No. Service Price
3.5. Variations to a marketing authorization for a medicinal product (including allergens) and homeopathic medicinal products
3.5.1. Minor variations (IA and IB) in a Mutual Recognition or Decentralization procedure when Croatia acts as a Reference Member State (RMS)
1. IA 663,61 €
2. IB 929,06 €
3. Authorization for the same variation in an additional strength or pharmaceutical form 265,45 €
4. Authorization for introduction of, or change to, a summary of pharmacovigilance system for every additional authorization in grouping of variations 66,36 €
5. Decision on variations to a decision on a marketing authorization for a medicinal product/Refusal of authorization of variations to the marketing authorization for a medicinal product 132,72 €
3.5.2. Major variations (II) in a Mutual Recognition or Decentralization procedure when Croatia acts as a Reference Member State (RMS)
1. Simple 1.194,51 €
2. Complex 1.592,67 €
3. Very complex 2.654,46 €
4. Authorization for the same variation in an additional strength or pharmaceutical form (charged for both minor and major variations) 265,45 €
5. Decision on variations to a decision on a marketing authorization for a medicinal product/Refusal of authorization of variations to the marketing authorization for a medicinal product 132,72 €
3.5.3. Minor variations (IA and IB) in a Mutual Recognition or Decentralization procedure when Croatia is a Concerned Member State
1. IA 331,81 €
2. IB 464,53 €
3. Authorization for the same variation in an additional strength or pharmaceutical form 66,36 €
4. Authorization for introduction of, or change to, a summary of pharmacovigilance system for every additional authorization in grouping of variations 66,36 €
5. Decision on variations to a decision on a marketing authorization for a medicinal product/Refusal of authorization of variations to the marketing authorization for a medicinal product 132,72 €
3.5.4. Major variation (II) in a Mutual Recognition or Decentralization procedure when Croatia is a Concerned Member State
1. Simple 464,53 €
2. Complex 796,34 €
3. Very complex 1.327,23 €
4. Authorization for the same variations in an additional strength or pharmaceutical form (charged for both minor and major variations) 66,36 €
5. Decision on variations to a decision on a marketing authorization for a medicinal product/Refusal of authorization of variations to the marketing authorization for a medicinal product 132,72 €
3.5.5. Other variations in a Mutual Recognition or Decentralization procedure when Croatia acts as a Reference Member State (RMS) of when it is a Concerned Member State
1. Variation to labelling and/or package leaflet, including variation of a mock-up of inner and outer packaging, that does not require changes in the summary of product characteristics when Croatia acts as a Reference Member State 398,17 €
2. Variation to labelling and/or package leaflet, including variation of a mock-up of inner and outer packaging, that does not require changes in the summary of product characteristics when Croatia is a Concerned Member State 132,72 €
3. Transfer of a marketing authorization for a medicinal product (per decision) 398,17 €
3.5.6. Withdrawal of a marketing authorization for a medicinal product in a Mutual Recognition or Decentralization procedure when Croatia acts as a Reference Member State (RMS) or when it is a Concerned Member State
1. Withdrawal of a marketing authorization for a medicinal product at the applicant's request, and in case the medicinal product has not been placed on the market within three years of the authorisation being granted 265,45 €

For variations to registered homeopathic medicinal products and registered traditional herbal medicinal products, 60% of the price is charged.

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4. Manufacturing and inspection

No. Service Price until 30.6.2024. Price from 1.7.2024.
1. Granting/refusal of a manufacturing licence 663,61 € 331,81 €
2. Variation of a manufacturing licence 265,45 € 132,73 €
3. Revocation of a manufacturing licence 265,45 € 132,73 €
4. Good Manufacturing Practice (GMP) certificate 132,72 € 66,36 €
5. Entry into the register of manufacturers, suppliers or importers of active substances 398,17 € 199,09 €
6. Deletion from the register of manufacturers, suppliers or importers of active substances 132,73 € 132,73 €
7. Variation to an entry into the register of manufacturers, suppliers or importers of active substances 265,45 € 132,73 €
8. Good Manufacturing Practice inspection and Good Pharmacovigilance inspection (per day and per inspector) 929,06 € 464,53 €
9. Material costs of Good Manufacturing Practice inspection and Good Pharmacovigilance Practice inspection (per inspector) 0,00 € 500,00 €
10. Supervision of the repositories system (per day and per inspector) 929,06 € 929,06 €
11. Granting/refusal of a licence for the wholesale distribution of medicinal products 1.194,51 € 597,26 €
Variation of a licence for the wholesale distribution of medicinal products
12. - administrative enforcement 265,45 € 132,73 €
13. - in case of inspection 398,17 € 199,09 €
14. Revocation of a licence for the wholesale distribution of medicinal products 265,45 € 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 € 500,00 €
16. Granting/refusal of a licence for the retail sale of medicinal products (in specialised retail shops) 663,61 € 331,81 €
Variation of a licence for the retail sale of medicinal products (in specialised retail shops)
17. - administrative enforcement 132,72 € 66,36 €
18. - in case of inspection 530,89 € 265,45 €
19. Material costs of conducting inspection in specialised retail shops 0,00 € 300,00 €
20. Revocation of a licence for the retail sale of medicinal products (in specialised retail shops) 132,72 € 66,36 €
21. Granting/revocation of a broker licence 398,17 € 199,09 €
22. Variation of a broker licence 132,72 € 66,36 €
23. Revocation of a broker licence 132,72 € 66,36 €
24. Internet sale licence 398,17 € 199,09 €
25. Variation of an Internet sale licence 132,72 € 66,36 €
26. Revocation of an Internet sale licence 132,72 € 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 2.500,00 € + travel and accommodation costs
28. Issuing of Good Manufacturing Practice (GMP) certificate for manufacturers located in third countries 1.500,00 € 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 until 30.6.2024. Price from 1.7.2024.
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 0,93 € / point 0,47 €
2. Administrative procedure for vaccines/blood derivatives 500,00 € 500,00 €
Quality control report:
3. Quality control of a sample of a marketed medicinal product 0,93 € / point 0,47 €
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 0,93 € / point 0,47 €
5. Quality control in the procedure for granting marketing authorization, renewal or variation to a marketing authorization for a medicinal product 0,93 € / point 0,47 €
6. Quality control at special request
- documentation assessment
- laboratory quality control
100,00 €
1,2 € / point
100,00 €
1,2 € / point
7. Quality control for international contracts
- documentation assessment
- laboratory quality control
100,00 €
1,2 € / point
100,00 €
1,2 € / point
8. Labelling check 450,00 € 450,00 €

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7. Annual fees

No. Service Price until 30.6.2024. Price from 1.7.2024.
1. Annual fee for a medicinal product 637,07 € 318,54 €
2. Annual fee for a homeopathic medicinal product/device 66,36 € 33,18 €
3. Annual fee for registration in the register of custom made medical device manufacturers 39,82 € 19,91 €
4. Annual fee for registration in the register of batch produced medical device manufacturers 132,72 € 66,36 €
5. Annual fee for registration in the register of medical device wholesalers 265,45 € 132,73 €
6. Annual fee for a licence for the wholesale distribution of medicinal products 265,45 € 132,73 €
7. Annual fee for a licence for the retail sale of medical devices 66,36 € 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) 66,36 € 33,18 €
9. Annual fee for manufacture of medicinal products 398,17 € 199,09 €
10. Annual fee for brokering 132,72 € 66,36 €
11. Annual fee for entry into the register of manufacturers, suppliers or importers of active substances 132,72 € 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 until 30.6.2024. Price from 1.7.2024.
1. Registration/refusal of registration in the register of manufacturers or manufacturer representatives 663,61 € 700,00 €
2. Variation/refusal of variation of registration in the register of manufacturers or authorized manufacturer representatives 132,72 € 200,00 €
3. Registration/refusal of registration in the register of medical devices (1 to 5 devices) 796,34 € 800,00 €
4. Registration/refusal of registration in the register of medical devices (6 to 30 devices) 862,70 € 900,00 €
5. Registration/refusal of registration in the register of medical devices for over 30 medical devices 929,06 € 1.000,00 €
6. Variation of registration in the medical device register 265,45 € 300,00 €
7. Variation of registration in the medical device register without changing registration certificate 132,72 € 200,00 €
8. Certificate of registration of a medical device in the medical device register 132,72 € 150,00 €
9. Classification of medical devices with regard to risk class 929,06 € 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 530,89 € 1.000,00 € + additional costs if an external expert is included
Registration/refusal of registration in the register of wholesalers
11. - in case of inspection 796,34 € 0,00 €
12. - administrative enforcement 530,89 € 0,00 €
Variation/refusal of variation of a license for the wholesale distribution of medical devices
13. - administrative enforcement 265,45 € 0,00 €
14. - in case of inspection 530,89 € 0,00 €
15. Issuing/refusal of a licence to specialised shops for the retail sale of medical devices 398,17 € 0,00 €
Variation of a licence to specialised shops for the retail sale of medical devices
16. - administrative enforcement 132,72 € 0,00 €
17. - in case of inspection 265,45 € 0,00 €
18. Registration/refusal of registration in register of medical device manufacturers - for medical devices custom made for individual users 265,45 € 300,00 €
19. Variation/refusal of variation of registration in the register of medical device manufacturers - for medical devices custom made for individual users 66,36 € 100,00 €


No. Service Price
1. Issuing of SRN number - micro enterprises 300,00 €
2. Issuing of SRN number - small enterprises 600,00 €
3. Issuing of SRN number - medium sized enterprises 800,00 €
4. Free sale certificate issued for one country (1-5 medical devices) 150,00 €
5. Free sale certificate issued for one country (6-20 medical devices) 200,00 €
6. Free sale certificate issued for one country (more than 20 medical devices) 250,00 €
7. Register for distributors - micro enterprises 400,00 €
8. Register for distributors - small enterprises 550,00 €
9. Register for distributors - medium sized enterprises 700,00 €
10. Variation of registration in the register of distributors - micro enterprises 200,00 €
11. Variation of registration in the register of distributors - small enterprises 280,00 €
12. Variation of registration in the register of distributors - medium sized enterprises 350,00 €
13. Annual fee for the register of distributors - micro enterprises 140,00 €
14. Annual fee for the register of distributors - small enterprises 200,00 €
15. Annual fee for the register of distributors - medium sized enterprises 240,00 €
16. Derogation from the conformity assessment procedures according to MDR Article 59., IVDR Article 54. 600,00 €
17. Issuing of statement regarding incident reports for specific manufacturer for the period of one year 150,00 €
18. Issuing confirmation letter for notification of placing a medical device on the Croatian market 100,00 €
19. Issuing confirmation letter for variation of notification of placing a medical device on the Croatian market 70,00 €
20. Dispute settlement between the manufacturer and the notified body concerned, arising from the application of Annex VIII 1.000,00 €
21. Verification of medical device conformity (1-5 medical devices) on request 200,00 €
22. Verification of medical device conformity (6-20 medical devices) on request 300,00 €
23. 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. 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 €

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10. Clinical trials

No. Service Price until 30.6.2024. Price from 1.7.2024.
1. Procuring a Central Ethics Committee opinion regarding a clinical trial* 3.318,07 € 1.659,04 €
2. Procuring a Central Ethics Committee opinion regarding bioequivalence study* 1.990,84 € 995,42 €
3. Procuring a Central Ethics Committee opinion regarding conducting non-interventional trial for medical devices* 1.327,23 € 663,62 €
4. Procuring a Central Ethics Committee opinion regarding conducting non-interventional trial for medicinal products* 265,45 € 132,73 €
5. Procuring a Central Ethics Committee opinion regarding academic research* 530,89 € 265,45 €
6. Major alterations and amendments to clinical trials* 530,89 € 265,45 €
7. Minor administrative alterations and amendments, additional research centres and head researcher changes* 132,72 € 66,36 €
8. Initial applications**
8.1. Clinical trial of unauthorised medicinal product**
1. Mono-national trial - Part I 1.990,84 € 995,42 €
2. Mono-national trial - Part II 1.061,78 € 530,89 €
3. Mono-national trial - Part I+II 3.052,62 € 1.526,31 €
4. Multinational trial - Croatia RMS - Part I 5.308,91 € 2.654,46 €
5. Multinational trial - Croatia RMS - Part II 1.061,78 € 530,89 €
6. Multinational trial - Croatia RMS - Part I+II 6.370,69 € 3.185,35 €
7. Multinational trial - Croatia MSC - Part I 1.327,23 € 663,62 €
8. Multinational trial - Croatia MSC - Part II 1.061,78 € 530,89 €
9. Multinational trial - Croatia MSC - Part I+II 2.389,01 € 1.194,51 €
10. Additional MSC application for Croatia - Part I+II 2.654,46 € 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 1.327,23 € 663,62 €
2. Mono-national trial - Part II 663,61 € 331,81 €
3. Mono-national trial - Part I+II 1.990,84 € 995,42 €
4. Multinational trial - Croatia RMS - Part I 4.645,30 € 2.322,65 €
5. Multinational trial - Croatia RMS - Part II 663,61 € 331,81 €
6. Multinational trial - Croatia RMS - Part I+II 5.308,91 € 2.654,46 €
7. Multinational trial - Croatia MSC - Part I 663,61 € 331,81 €
8. Multinational trial - Croatia MSC - Part II 663,61 € 331,81 €
9. Multinational trial - Croatia MSC - Part I+II 1.327,23 € 663,62 €
10. Additional MSC application for Croatia - Part I+II 1.592,67 € 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 530,89 € 265,45 €
2. Mono-national trial - Part II 265,45 € 132,73 €
3. Mono-national trial - Part I+II 796,34 € 398,17 €
4. Multinational trial - Croatia RMS - Part I 796,34 € 398,17 €
5. Multinational trial - Croatia RMS - Part II 265,45 € 132,73 €
6. Multinational trial - Croatia RMS - Part I+II 1.061,78 € 530,89 €
7. Multinational trial - Croatia MSC - Part I 398,17 € 199,09 €
8. Multinational trial - Croatia MSC - Part II 265,45 € 132,73 €
9. Multinational trial - Croatia MSC - Part I+II 663,61 € 331,81 €
10. Non-commercial clinical trials Free of charge -
9.2. Clinical trial of authorised medicinal product**
1. Mono-national trial - Part I 265,45 € 132,73 €
2. Mono-national trial - Part II 132,72 € 66,36 €
3. Mono-national trial - Part I+II 398,17 € 199,09 €
4. Multinational trial - Croatia RMS - Part I 530,89 € 265,45 €
5. Multinational trial - Croatia RMS - Part II 132,72 € 66,36 €
6. Multinational trial - Croatia RMS - Part I+II 663,61 € 331,81 €
7. Multinational trial - Croatia MSC - Part I 132,72 € 66,36 €
8. Multinational trial - Croatia MSC - Part II 132,72 € 66,36 €
9. Multinational trial - Croatia MSC - Part I+II 265,45 € 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 until 30.6.2024. Price from 1.7.2024.
1. Assessment of a Periodic Safety Update Report 1.592,67 € 796,34 €
2. Assessment of additional risk minimisation measures 1.194,51 € 597,26 €
3. Assessment of variation of additional risk minimisation measures 796,34 € 398,17 €
4. Assessment of additional risk minimisation measures for medicinal products of different marketing authorisation holders containing the same active substance 464,53 € 232,27 €
5. Assessment of variation of additional risk minimisation measures for medicinal products of different marketing authorisation holders containing the same active substance 331,81 € 165,19 €
6. Assessment of a Development Safety Update Report 530,89 € 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 € 1.500,00 €
8. Major alterations and amendments to non-interventional trial for medicinal products 740,00 € 740,00 €
9. Minor administrative alterations and amendments to non-interventional trial for medicinal products, additional research centres and head research changes 320,00 € 320,00 €
10. Safety assessment in clinical trials (sAMS)* 5.043,47 € 5.043,47 €
11. Safety assessment in clinical trials (sAMS) for active substance included in different sponsors' clinical trials* 1.493,13 € 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 € 330,00 €
13. - complex 510,00 € 510,00 €
14. - very complex 900,00 € 900,00 €
15. Assessment of other procedures related to the safe use of medicinal products 400,00 € 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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