Fees
- Marketing a medicinal product
- Renewal of the marketing authorization for a medicinal product
- Variations to a marketing authorization for a medicinal product, withdrawal of an authorization and issuing reports on the medicinal product dossier
- 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
Agency's fees are listed below.
All prices are expressed in HRK and 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.
Minister of Health approved the Agency's price list on 28 December 2012 (with memorandum class: 530-01/12-11/23; Reg. No. 534-07-1-4/1-12/02), as well as the amendments to the price list on 2 August 2013 (with memorandum class: 530-09/13-02/02; Reg. No. 534-07-1-4/5-13/12), 8 January 2014 (with memorandum class: 400-01/13-01/53; Reg. No. 534-07-1-4/5-14/02), 28 September 2017 (with memorandum class: 501-01/17-02/24; Reg. No.: 534-03-4-1/1-17-02), 19 April 2019 (with memorandum class: 530-01/19-11/03; Reg. No.: 534-03-4-1/6-19-02), 14 August 2019 (with memorandum class: 530-09/19-13/23; Reg. No: 534-03-4-1/6-19-02), 7 March 2022 (with memorandum class: 023-03/22-01/72; Reg. No: 534-03-2-1/1-22-02) and 17 May 2023 (with memorandum class: 530-07/23-10/02; Reg. No: 534-03-2/1-23-02).
Ministry of Health approved the costs of Agency's supervision of the repositories system on 6 October 2021 (with memorandum class: 023-03/20-01/657; Reg. No.: 534-03-2-2/4-21-02), applicable from 1 November 2021.
Ministry of Health determined on 7 March 2022 (with memorandum class: 530-07/22-10/02, Reg. No: 534-03-2-1/1-22-01) the Price list for authorisation of applications for conducting clinical trials of medicinal products and their substantial modifications in line 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.
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.
Conversion rate: 1 EUR = 7,53450 HRK
1. Marketing a medicinal product
Apply to national procedures
| No | SERVICE | PRICE/EUR | PRICE/HRK |
|---|---|---|---|
| 1.1. | Granting/refusal of a marketing authorization for a medicinal product | ||
| 1. | For one strength and pharmaceutical form | 3.981,68 € | 30.000,00 HRK |
| 2. | For an additional pharmaceutical form (submitted at the same time) | 3.185,35 € | 24.000,00 HRK |
| 3. | For an additional pharmaceutical form (submitted subsequently) | 3.981,68 € | 30.000,00 HRK |
| 4. | For an additional strength (submitted at the same time) | 1.858,12 € | 14.000,00 HRK |
| 5. | For an additional strength (submitted subsequently) | 2.123,56 € | 16.000,00 HRK |
| 6. | Issuing of a Plasma Master File (PMF) certificate | 2.654,46 € | 20.000,00 HRK |
| 7. | Issuing of an additional Plasma Master File (PMF) certificate | 796,34 € | 6.000,00 HRK |
The withdrawal of a submitted application will be charged for the applications received before the accession of Croatia to the EU according to the following scale of charges:
- the withdrawal of a submitted request before the application validity assessment will not be charged
- the withdrawal of a submitted request after the application validity assessment will be charged 40% of the total price
- the withdrawal of a submitted request after the medicinal product quality assessment will be charged 30% of the total price
- the withdrawal of a submitted request after the medicinal product efficacy/safety assessment will be charged 30% of the total price
Apply to MRP / DCP procedures
| No | SERVICE | PRICE/EUR | PRICE/HRK |
|---|---|---|---|
| 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 € | 200.000,00 HRK |
| 2. | For one strength and pharmaceutical form - generic medicinal product | 19.908,42 € | 150.000,00 HRK |
| 3. | For one strength and pharmaceutical form - medicinal product with well-established medicinal use | 24.553,72 € | 185.000,00 HRK |
| 4. | For one strength and pharmaceutical form - hybrid, biosimilar medicinal product | 24.553,72 € | 185.000,00 HRK |
| 5. | For one strength and pharmaceutical form - with the consent to use the dossier of a reference medicinal product | 9.954,21 € | 75.000,00 HRK |
| 6. | For one strength and pharmaceutical form - new combination of known active substances | 24.553,72 € | 185.000,00 HRK |
| 7. | Request for a duplicate (submitted at the same time - for all strengths and pharmaceutical forms) | 9.954,21 € | 75.000,00 HRK |
| 8. | For an additional pharmaceutical form (at the same time) | 13.272,28 € | 100.000,00 HRK |
| 9. | For an additional pharmaceutical form (subsequently) | 15.926,74 € | 120.000,00 HRK |
| 10. | For an additional strength (at the same time ) | 9.954,21 € | 75.000,00 HRK |
| 11. | For an additional strength (subsequently) | 11.281,44 € | 85.000,00 HRK |
| 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 € | 30.000,00 HRK |
| 2. | For one strength and pharmaceutical form - generic medicinal product | 3.981,68 € | 30.000,00 HRK |
| 3. | For one strength and pharmaceutical form - medicinal product with well-established medicinal use | 3.981,68 € | 30.000,00 HRK |
| 4. | For one strength and pharmaceutical form - hybrid, biosimilar medicinal product | 3.981,68 € | 30.000,00 HRK |
| 5. | For one strength and pharmaceutical form - with the consent to use the dossier of a reference medicinal product | 3.981,68 € | 30.000,00 HRK |
| 6. | For one strength and pharmaceutical form - new combination of known active substances | 3.981,68 € | 30.000,00 HRK |
| 7. | Request for a duplicate (submitted at the same time - for all strengths and pharmaceutical forms) | 3.981,68 € | 30.000,00 HRK |
| 8. | For an additional pharmaceutical form (submitted at the same time) | 3.185,35 € | 24.000,00 HRK |
| 9. | For an additional pharmaceutical form (submitted subsequently) | 3.981,68 € | 30.000,00 HRK |
| 10. | For an additional strength (submitted at the same time) | 1.858,12 € | 14.000,00 HRK |
| 11. | For an additional strength (submitted subsequently) | 2.123,56 € | 16.000,00 HRK |
| 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 € | 120.000,00 HRK |
| 2. | For one strength and pharmaceutical form - generic medicinal product | 11.945,05 € | 90.000,00 HRK |
| 3. | For one strength and pharmaceutical form - medicinal product with well-established medicinal use | 14.599,51 € | 110.000,00 HRK |
| 4. | For one strength and pharmaceutical form - hybrid, biosimilar medicinal product | 14.599,51 € | 110.000,00 HRK |
| 5. | For one strength and pharmaceutical form - with the consent to use the dossier of a reference medicinal product | 5.972,53 € | 45.000,00 HRK |
| 6. | For one strength and pharmaceutical form - new combination of known active substances | 14.599,51 € | 110.000,00 HRK |
| 7. | Request for a duplicate (submitted at the same time - for all strengths and pharmaceutical forms) | 5.972,53 € | 45.000,00 HRK |
| 8. | For an additional pharmaceutical form (submitted at the same time) | 7.963,37 € | 60.000,00 HRK |
| 9. | For an additional pharmaceutical form (submitted subsequently) | 9.556,04 € | 72.000,00 HRK |
| 10. | For an additional strength (submitted at the same time) | 5.972,53 € | 45.000,00 HRK |
| 11. | For an additional strength (submitted subsequently) | 6.636,14 € | 50.000,00 HRK |
| 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 € | 30.000,00 HRK |
| 2. | For one strength and pharmaceutical form - generic medicinal product | 3.981,68 € | 30.000,00 HRK |
| 3. | For one strength and pharmaceutical form - medicinal product with well-established medicinal use | 3.981,68 € | 30.000,00 HRK |
| 4. | For one strength and pharmaceutical form - hybrid, biosimilar medicinal product | 3.981,68 € | 30.000,00 HRK |
| 5. | For one strength and pharmaceutical form - with the consent to use the dossier of a reference medicinal product | 3.981,68 € | 30.000,00 HRK |
| 6. | For one strength and pharmaceutical form - new combination of known active substances | 3.981,68 € | 30.000,00 HRK |
| 7. | Request for a duplicate (submitted at the same time - for all strengths and pharmaceutical forms) | 3.981,68 € | 30.000,00 HRK |
| 8. | For an additional pharmaceutical form (submitted at the same time) | 3.185,35 € | 24.000,00 HRK |
| 9. | For an additional pharmaceutical form (submitted subsequently) | 3.981,68 € | 30.000,00 HRK |
| 10. | For an additional strength (submitted at the same time) | 1.858,12 € | 14.000,00 HRK |
| 11. | For an additional strength (submitted subsequently) | 2.123,56 € | 16.000,00 HRK |
| 1.2.3. | Repeat use procedure | ||
| 1. | For one strength and pharmaceutical form | 3.981,68 € | 30.000,00 HRK |
| 2. | For an additional pharmaceutical form (submitted at the same time) | 3.185,35 € | 24.000,00 HRK |
| 3. | For an additional pharmaceutical form (submitted subsequently) | 3.981,68 € | 30.000,00 HRK |
| 4. | For an additional strength (submitted at the same time) | 1.858,12 € | 14.000,00 HRK |
| 5. | For an additional strength (submitted subsequently) | 2.123,56 € | 16.000,00 HRK |
| 6. | Request for a duplicate for all strengths and pharmaceutical forms (submitted at the same time) | 3.185,35 € | 24.000,00 HRK |
| 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 € | 150.000,00 HRK |
| 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 € | 15.000,00 HRK |
| 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 € | 15.000,00 HRK |
| 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 € | 1.500,00 HRK |
| 5. | Allergen for epidermal tests | 9.954,21 € | 75.000,00 HRK |
| 6. | For an additional concentration, strength or pharmaceutical form of an allergen for epidermal tests (request submitted at the same time) | 995,42 € | 7.500,00 HRK |
| 7. | For each additional allergen for epidermal tests (request submitted at the same time) | 995,42 € | 7.500,00 HRK |
| 8. | For an additional concentration, strength or pharmaceutical form of an additional allergen for epidermal tests (request submitted at the same time) | 99,54 € | 750,00 HRK |
| 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 € | 30.000,00 HRK |
| 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 € | 3.000,00 HRK |
| 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 € | 3.000,00 HRK |
| 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 € | 300,00 HRK |
| 5. | Allergen for epidermal tests | 1.990,84 € | 15.000,00 HRK |
| 6. | For an additional concentration, strength or pharmaceutical form of an allergen for epidermal tests (request submitted at the same time) | 1.990,84 € | 15.000,00 HRK |
| 7. | For each additional allergen for epidermal tests (request submitted at the same time) | 199,08 € | 1.500,00 HRK |
| 8. | For an additional concentration, strength or pharmaceutical form of an additional allergen for epidermal tests (request submitted at the same time) | 19,91 € | 150,00 HRK |
| 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 € | 11.000,00 HRK |
| 2. | For one strength and pharmaceutical form - (when there is no EU monograph) | 2.389,01 € | 18.000,00 HRK |
| 3. | For an additional pharmaceutical form of a traditional herbal medicinal product (submitted at the same time) | 1.194,51 € | 9.000,00 HRK |
| 4. | For an additional pharmaceutical form based on an EU monograph (submitted subsequently) | 1.459,95 € | 11.000,00 HRK |
| 5. | For an additional pharmaceutical form when there is no EU monograph (submitted subsequently) | 2.389,01 € | 18.000,00 HRK |
| 6. | For an additional strength of a traditional herbal medicinal product (submitted at the same time) | 929,06 € | 7.000,00 HRK |
| 7. | For an additional strength of a traditional herbal medicinal product (submitted subsequently) | 1.061,78 € | 8.000,00 HRK |
| 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 € | 40.000,00 HRK |
| 2. | For an additional pharmaceutical form of a traditional herbal medicinal product (submitted at the same time) | 4.247,13 € | 32.000,00 HRK |
| 3. | For an additional pharmaceutical form of a traditional herbal medicinal product (submitted subsequently) | 5.308,91 € | 40.000,00 HRK |
| 4. | For an additional strength of a traditional herbal medicinal product (submitted at the same time) | 2.521,73 € | 19.000,00 HRK |
| 5. | For an additional strength of a traditional herbal medicinal product (submitted subsequently) | 2.787,18 € | 21.000,00 HRK |
| 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 € | 18.000,00 HRK |
| 2. | For an additional pharmaceutical form of a traditional herbal medicinal product (submitted at the same time) | 1.194,51 € | 9.000,00 HRK |
| 3. | For an additional pharmaceutical form of a traditional herbal medicinal product (submitted subsequently) | 2.389,01 € | 18.000,00 HRK |
| 4. | For an additional strength of a traditional herbal medicinal product (submitted at the same time) | 929,06 € | 7.000,00 HRK |
| 5. | For an additional strength of a traditional herbal medicinal product (submitted subsequently) | 1.061,78 € | 8.000,00 HRK |
| 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 € | 20.000,00 HRK |
| 2. | For each pharmaceutical form of a multi-component homeopathic medicinal product | 3.318,07 € | 25.000,00 HRK |
| 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 € | 4.000,00 HRK |
| 2. | For each pharmaceutical form of a multi-component homeopathic medicinal product | 995,42 € | 7.500,00 HRK |
For applications submitted from 1 July 2013, 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 a medicinal product
Apply to national procedures
| NO | SERVICE | PRICE/EUR | PRICE/HRK |
|---|---|---|---|
| 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 € | 20.000,00 HRK |
| 2. | For an additional pharmaceutical form | 2.123,56 € | 16.000,00 HRK |
| 3. | For an additional strength | 1.194,51 € | 9.000,00 HRK |
Apply to MRP / DCP procedures
| NO | SERVICE | PRICE/EUR | PRICE/HRK |
|---|---|---|---|
| 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 € | 40.000,00 HRK |
| 2. | For an additional pharmaceutical form | 4.247,13 € | 32.000,00 HRK |
| 3. | For an additional strength | 2.389,01 € | 18.000,00 HRK |
| 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 € | 20.000,00 HRK |
| 2. | For an additional pharmaceutical form | 2.123,56 € | 16.000,00 HRK |
| 3. | For an additional strength | 1.194,51 € | 9.000,00 HRK |
| 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 € | 40.000,00 HRK |
| 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 € | 4.000,00 HRK |
| 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 € | 4.000,00 HRK |
| 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 € | 400,00 HRK |
| 5. | Allergen for epidermal tests | 2.654,46 € | 20.000,00 HRK |
| 6. | For an additional concentration, strength or pharmaceutical form of an allergen for epidermal tests (request submitted at the same time) | 265,45 € | 2.000,00 HRK |
| 7. | For each additional allergen for epidermal tests (request submitted at the same time) | 265,45 € | 2.000,00 HRK |
| 8. | For an additional concentration, strength or pharmaceutical form of an additional allergen for epidermal tests (request submitted at the same time) | 26,54 € | 200,00 HRK |
| 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 € | 20.000,00 HRK |
| 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 € | 2.000,00 HRK |
| 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 € | 2.000,00 HRK |
| 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 € | 200,00 HRK |
| 5. | Allergen for epidermal tests | 1.327,23 € | 10.000,00 HRK |
| 6. | For an additional concentration, strength or pharmaceutical form of an allergen for epidermal tests (request submitted at the same time) | 132,72 € | 1.000,00 HRK |
| 7. | For each additional allergen for epidermal tests (request submitted at the same time) | 132,72 € | 1.000,00 HRK |
| 8. | For an additional concentration, strength or pharmaceutical form of an additional allergen for epidermal tests (request submitted at the same time) | 13,27 € | 100,00 HRK |
| 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 € | 9.000,00 HRK |
| 2. | For each additional pharmaceutical form / strength | 398,17 € | 3.000,00 HRK |
| 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 € | 7.500,00 HRK |
| 2. | For each additional pharmaceutical form / strength | 265,45 € | 2.000,00 HRK |
| 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 € | 7.000,00 HRK |
| 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 € | 3.000,00 HRK |
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/EUR | PRICE/HRK |
|---|---|---|---|
| 3.1. | Variations to a marketing authorization for a medicinal product | ||
| Minor variation (IA and IB) | |||
| 1. | IA | 331,81 € | 2.500,00 HRK |
| 2. | IB | 464,53 € | 3.500,00 HRK |
| 3. | Authorization for introduction of, or change to, a summary of pharmacovigilance system for every additional authorization in grouping of variations | 66,36 € | 500,00 HRK |
| Major variation (II) | |||
| 4. | simple | 464,53 € | 3.500,00 HRK |
| 5. | complex | 796,34 € | 6.000,00 HRK |
| 6. | very complex | 1.327,23 € | 10.000,00 HRK |
| 7. | Authorization for the same variation in an additional strength or pharmaceutical form (charged for both minor and major variations) | 66,36 € | 500,00 HRK |
| 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 € | 1.000,00 HRK |
| 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 € | 1.000,00 HRK |
| 2. | Transfer of a marketing authorization for a medicinal product | 398,17 € | 3.000,00 HRK |
| 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 € | 2.000,00 HRK |
| 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 € | 20.000,00 HRK |
Apply to MRP / DCP procedures
| NO | SERVICE | PRICE/EUR | PRICE/HRK |
|---|---|---|---|
| 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 € | 5.000,00 HRK |
| 2. | IB | 929,06 € | 7.000,00 HRK |
| 3. | Authorization for the same variation in an additional strength or pharmaceutical form | 265,45 € | 2.000,00 HRK |
| 4. | Authorization for introduction of, or change to, a summary of pharmacovigilance system for every additional authorization in grouping of variations | 66,36 € | 500,00 HRK |
| 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 € | 1.000,00 HRK |
| 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 € | 9.000,00 HRK |
| 2. | Complex | 1.592,67 € | 12.000,00 HRK |
| 3. | Very complex | 2.654,46 € | 20.000,00 HRK |
| 4. | Authorization for the same variation in an additional strength or pharmaceutical form (charged for both minor and major variations) | 265,45 € | 2.000,00 HRK |
| 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 € | 1.000,00 HRK |
| 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 € | 2.500,00 HRK |
| 2. | IB | 464,53 € | 3.500,00 HRK |
| 3. | Authorization for the same variation in an additional strength or pharmaceutical form | 66,36 € | 500,00 HRK |
| 4. | Authorization for introduction of, or change to, a summary of pharmacovigilance system for every additional authorization in grouping of variations | 66,36 € | 500,00 HRK |
| 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 | 1132,72 € | 1.000,00 HRK |
| 3.5.4. | Major variation (II) in a Mutual Recognition or Decentralization procedure when Croatia is a Concerned Member State | ||
| 1. | Simple | 464,53 € | 3.500,00 HRK |
| 2. | Complex | 796,34 € | 6.000,00 HRK |
| 3. | Very complex | 1.327,23 € | 10.000,00 HRK |
| 4. | Authorization for the same variations in an additional strength or pharmaceutical form (charged for both minor and major variations) | 66,36 € | 500,00 HRK |
| 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 € | 1.000,00 HRK |
| 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 € | 3.000,00 HRK |
| 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 € | 1.000,00 HRK |
| 3. | Transfer of a marketing authorization for a medicinal product (per decision) | 398,17 € | 3.000,00 HRK |
| 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 € | 2.000,00 HRK |
The price of a decision on the revocation, renewal, transfer or variation of authorization is identical to the price of granting/renewal/transfer/variation of authorization. For variations to registered homeopathic medicinal products and registered traditional herbal medicinal products, only 60% of the price is charged.
4. Manufacturing and inspection
| NO | SERVICE | PRICE/EUR | PRICE/HRK |
|---|---|---|---|
| 1. | Granting/refusal of a manufacturing licence | 663,61 € | 5.000,00 HRK |
| 2. | Variation of a manufacturing licence | 265,45 € | 2.000,00 HRK |
| 3. | Revocation of a manufacturing licence | 265,45 € | 2.000,00 HRK |
| 4. | Good Manufacturing Practice (GMP) certificate | 132,72 € | 1.000,00 HRK |
| 5. | Good Manufacturing Practice (GMP) certificate, for manufacturers outside of Croatia | 663,61 € | 5.000,00 HRK |
| 6. | Good Manufacturing Practice inspection of manufacturers outside of Croatia (per day and per inspector) | 1.858,12 € + travel and accommodation costs | 14.000,00 HRK + travel and accommodation costs |
| 7. | Entry into the register of manufacturers, suppliers or importers of active substances | 398,17 € | 3.000,00 HRK |
| 8. | Variation to an entry into the register of manufacturers, suppliers or importers of active substances | 265,45 € | 2.000,00 HRK |
| 9. | Good Manufacturing Practice inspection and Good Pharmacovigilance inspection (per day and per inspector) | 929,06 € | 7.000,00 HRK |
| 10. | Supervision of the repositories system (per day and per inspector) | 929,06 € | 7.000,00 HRK |
| 11. | Granting/refusal of a licence for the wholesale distribution of medicinal products | 1.194,51 € | 9.000,00 HRK |
| 12. | Variation of a licence for the wholesale distribution of medicinal products - administrative enforcement | 265,45 € | 2.000,00 HRK |
| 13. | Variation of a licence for the wholesale distribution of medicinal products - in case of inspection | 398,17 € | 3.000,00 HRK |
| 14. | Revocation of a licence for the wholesale distribution of medicinal products | 265,45 € | 2.000,00 HRK |
| 15. | Granting/refusal of a licence for the retail sale of medicinal products (in specialised retail shops) | 663,61 € | 5.000,00 HRK |
| 16. | Variation of a licence for the retail sale of medicinal products (in specialised retail shops) - administrative enforcement | 132,72 € | 1.000,00 HRK |
| 17. | Variation of a licence for the retail sale of medicinal products (in specialised retail shops) - in case of inspection | 530,89 € | 4.000,00 HRK |
| 18. | Revocation of a licence for the retail sale of medicinal products (in specialised retail shops) | 132,72 € | 1.000,00 HRK |
| 19. | Granting/revocation of a broker licence | 398,17 € | 3.000,00 HRK |
| 20. | Variation of a broker licence | 132,72 € | 1.000,00 HRK |
| 21. | Revocation of a broker licence | 132,72 € | 1.000,00 HRK |
| 22. | Internet sale licence | 398,17 € | 3.000,00 HRK |
| 23. | Variation of an Internet sale licence | 132,72 € | 1.000,00 HRK |
| 24. | Revocation of an Internet sale licence | 132,72 € | 1.000,00 HRK |
5. Medicinal product marketing
| NO | SERVICE | PRICE/EUR | PRICE/HRK |
|---|---|---|---|
| Approvals | |||
| 1. | Approval for an import of an active substance | 132,72 € | 1.000,00 HRK |
| 2. | Approval for the exemption to the labelling and/or package leaflet obligation | 265,45 € | 2.000,00 HRK |
| 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 | 265,45 € | 2.000,00 HRK |
| 4. | - for research purposes | 265,45 € | 2.000,00 HRK |
| 5. | - for pharmaceutical testing | 265,45 € | 2.000,00 HRK |
| 6. | - for non-clinical studies | 265,45 € | 2.000,00 HRK |
| 7. | - for clinical trials | 265,45 € | 2.000,00 HRK |
| 8. | - in case of natural disasters or other emergencies | 265,45 € | 2.000,00 HRK |
| 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 | 132,72 € | 1.000,00 HRK |
| 10. | Approval for entry/import of medicinal product with marketing authorization: - medicinal product derived from blood or plasma - immunological medicinal product - radiopharmaceutical |
132,72 € | 1.000,00 HRK |
| 11. | Certificate of a pharmaceutical product (CPP) | 132,72 € | 1.000,00 HRK |
| 12. | Free Sales Certificate (FSC) | 132,72 € | 1.000,00 HRK |
| 13. | Providing information on the consumption of medicinal products | 132,72 € | 1.000,00 HRK |
| 14. | Analysis of information on the consumption of medicinal products | 398,17 € | 3.000,00 HRK |
| 15. | Approval for the parallel import of medicinal products | 1.327,23 € | 10.000,00 HRK |
| 16. | Variation of approval for the parallel import of medicinal products | 265,45 € | 2.000,00 HRK |
| 17. | Determination of maximal wholesale prices of prescription medicinal products | 398,17 € | 3.000,00 HRK |
| 18. | - for an additional strength or pharmaceutical form (submitted at the same time or submitted subsequently) | 132,72 € | 1.000,00 HRK |
| 19. | - for an additional packaging (submitted at the same time or submitted subsequently) | 66,36 € | 500,00 HRK |
6. Quality control of medicinal products
| NO | SERVICE | PRICE/EUR | PRICE/HRK |
|---|---|---|---|
| 6.1. | Quality control of medicinal products | ||
| Quality control certificate: | |||
| 1. | Special quality control of each batch of a blood or plasma-based medicinal product or immunological medicinal product | 0,93 eur/point | 7,00 HRK/point |
| 2. | Quality control of a sample of a marketed medicinal product | 0,93 eur/point | 7,00 HRK/point |
| 3. | Emergency quality control at the request of a ministry of health care or the Agency due to adverse effects or doubts regarding the quality of a medicinal product | 0,93 eur/point | 7,00 HRK/point |
| 4. | Quality control in the procedure for granting marketing authorization, renewal or variation to a marketing authorization for a medicinal product | 0,93 eur/point | 7,00 HRK/point |
| 5. | Quality control at special request for food supplements and interlaboratory testing for other institutions | 0,93 eur/point | 7,00 HRK/point |
| 6. | For medicinal products for which the control is conducted based on the international contract, and are taken from the market of other countries | 2.500 points | 2.500 points |
| 6.2. | Quality control of veterinary medicinal products (VMP) | ||
| Final report of quality control | |||
| 1. | Exceptional quality control of VMP | 0,93 eur/point | 7,00 HRK/point |
| 2. | Regular quality control of VMP | 0,93 eur/point | 7,00 HRK/point |
Detailed list of laboratory testing fees of the Official Medicines Control Laboratory Division (OMCL) can be found here.
7. Annual fees
| NO | SERVICE | PRICE/HRK | PRICE/EUR |
|---|---|---|---|
| 1. | Annual fee for a medicinal product | 4.800,00 HRK | 637,07 € |
| 2. | Annual fee for a homeopathic medicinal product/device | 500,00 HRK | 66,36 € |
| 3. | Annual fee for registration in the register of custom made medical device manufacturers | 300,00 HRK | 39,82 € |
| 4. | Annual fee for registration in the register of batch produced medical device manufacturers | 1.000,00 HRK | 132,72 € |
| 5. | Annual fee for registration in the register of medical device wholesalers | 2.000,00 HRK | 265,45 € |
| 6. | Annual fee for a licence for the wholesale distribution of medicinal products | 2.000,00 HRK | 265,45 € |
| 7. | Annual fee for a licence for the retail sale of medical devices | 500,00 HRK | 66,36 € |
| 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) | 500,00 HRK | 66,36 € |
| 9. | Annual fee for manufacture of medicinal products | 3.000,00 HRK | 398,17 € |
| 10. | Annual fee for brokering | 1.000,00 HRK | 132,72 € |
| 11. | Annual fee for entry into the register of manufacturers, suppliers or importers of active substances | 1.000,00 HRK | 132,72 € |
An annual fee is charged for each valid decision.
8. Medical devices
| NO | SERVICE | PRICE/EUR | PRICE/HRK |
|---|---|---|---|
| 1. | Registration/refusal of registration in the register of manufacturers or manufacturer representatives | 663,61 € | 5.000,00 HRK |
| 2. | Variation/refusal of variation of registration in the register of manufacturers or authorized manufacturer representatives | 132,72 € | 1.000,00 HRK |
| 3. | Registration/refusal of registration in the register of medical devices (1 to 5 devices) | 796,34 € | 6.000,00 HRK |
| 4. | Registration/refusal of registration in the register of medical devices (6 to 30 devices) | 862,70 € | 6.500,00 HRK |
| 5. | Registration/refusal of registration in the register of medical devices for over 30 medical devices | 929,06 € | 7.000,00 HRK |
| 6. | Variation of registration in the medical device register | 265,45 € | 2.000,00 HRK |
| 7. | Variation of registration in the medical device register without changing registration certificate | 132,72 € | 1.000,00 HRK |
| 8. | Certificate of registration of a medical device in the medical device register | 132,72 € | 1.000,00 HRK |
| 9. | Classification of medical devices with regard to risk class | 929,06 € | 7.000,00 HRK |
| 10. | Classification of a product as a medical device at the manufacturer's request | 530,89 € | 4.000,00 HRK |
| Registration/refusal of registration in the register of wholesalers | |||
| 11. | - in case of inspection | 796,34 € | 6.000,00 HRK |
| 12. | - administrative enforcement | 530,89 € | 4.000,00 HRK |
| Variation/refusal of variation of a license for the wholesale distribution of medical devices | |||
| 13. | - administrative enforcement | 265,45 € | 2.000,00 HRK |
| 14. | - in case of inspection | 530,89 € | 4.000,00 HRK |
| 15. | Issuing/refusal of a licence to specialised shops for the retail sale of medical devices | 398,17 € | 3.000,00 HRK |
| Variation of a licence to specialised shops for the retail sale of medical devices | |||
| 16. | - administrative enforcement | 132,72 € | 1.000,00 HRK |
| 17. | - in case of inspection | 265,45 € | 2.000,00 HRK |
| 18. | Registration/refusal of registration in register of medical device manufacturers - for medical devices custom made for individual users | 265,45 € | 2.000,00 HRK |
| 19. | Variation/refusal of variation of registration in the register of medical device manufacturers - for medical devices custom made for individual users | 66,36 € | 500,00 HRK |
9. Training and provision of expert advice from the Agency's scope of work and Croatian Pharmacopoeia
| NO | SERVICE | PRICE/EUR | PRICE/HRK |
|---|---|---|---|
| 9.1. | Training | ||
| 9.1.1. | Half-day training | ||
| 1. | for health workers, university workers and students | 66,36 € | 500,00 HRK |
| 2. | for regulatory bodies | 79,63 € | 600,00 HRK |
| 3. | for authorization holders and others | 132,72 € | 1.000,00 HRK |
| 9.1.2. | Training per day - up to 3 days | ||
| 1. | for health workers, university workers and students | 106,18 € | 800,00 HRK |
| 2. | for regulatory bodies | 126,09 € | 950,00 HRK |
| 3. | for authorization holders and others | 212,36 € | 1.600,00 HRK |
| 9.1.3. | Each additional day of training over 3 days | ||
| 1. | for health workers, university workers and students | 39,82 € | 300,00 HRK |
| 2. | for regulatory bodies | 46,45 € | 350,00 HRK |
| 3. | for authorization holders and others | 79,63 € | 600,00 HRK |
| 9.1.4. | Training with international participation, per day - up to 2 days | ||
| 1. | for health workers, university workers and students | 119,45 € | 900,00 HRK |
| 2. | for regulatory bodies | 139,36 € | 1.050,00 HRK |
| 3. | for authorization holders and others | 238,90 € | 1.800,00 HRK |
| 9.1.5. | Each additional day of training with international participation over 3 days | ||
| 1. | for health workers, university workers and students | 53,09 € | 400,00 HRK |
| 2. | for regulatory bodies | 66,36 € | 500,00 HRK |
| 3. | for authorization holders and others | 106,18 € | 800,00 HRK |
| 9.2. | Expert advice prior to procedures from HALMED competence | ||
| 1. | Simple expert advice | 265,45 € | 2.000,00 HRK |
| 2. | Complex expert advice | 663,61 € | 5.000,00 HRK |
| 3. | Extremely complex expert advice | 1.327,23 € | 10.000,00 HRK |
| 4. | Expert advice in translation of instructions for use and labelling of medical device | 66,36 € | 500,00 HRK |
| 9.3. | Croatian Pharmacopoeia | ||
| 1. | Annual fee for online access to Pharmacopoeia | 39,82 € | 300,00 HRK |
10. Clinical trials
| NO | SERVICE | PRICE/HRK | PRICE/EUR |
|---|---|---|---|
| 1. | Procuring a Central Ethics Committee opinion regarding a clinical trial* | 25.000,00 HRK | 3.318,07 € |
| 2. | Procuring a Central Ethics Committee opinion regarding bioequivalence study* | 15.000,00 HRK | 1.990,84 € |
| 3. | Procuring a Central Ethics Committee opinion regarding conducting non-interventional trial for medical devices* | 10.000,00 HRK | 1.327,23 € |
| 4. | Procuring a Central Ethics Committee opinion regarding conducting non-interventional trial for medicinal products* | 2.000,00 HRK | 265,45 € |
| 5. | Procuring a Central Ethics Committee opinion regarding academic research* | 4.000,00 HRK | 530,89 € |
| 6. | Major alterations and amendments to clinical trials* | 4.000,00 HRK | 530,89 € |
| 7. | Minor administrative alterations and amendments, additional research centres and head researcher changes* | 1.000,00 HRK | 132,72 € |
| 8. | Initial applications** | ||
| 8.1. | Clinical trial of unauthorised medicinal product** | ||
| 1. | Mono-national trial - Part I | 15.000,00 HRK | 1.990,84 € |
| 2. | Mono-national trial - Part II | 8.000,00 HRK | 1.061,78 € |
| 3. | Mono-national trial - Part I+II | 23.000,00 HRK | 3.052,62 € |
| 4. | Multinational trial - Croatia RMS - Part I | 40.000,00 HRK | 5.308,91 € |
| 5. | Multinational trial - Croatia RMS - Part II | 8.000,00 HRK | 1.061,78 € |
| 6. | Multinational trial - Croatia RMS - Part I+II | 48.000,00 HRK | 6.370,69 € |
| 7. | Multinational trial - Croatia MSC - Part I | 10.000,00 HRK | 1.327,23 € |
| 8. | Multinational trial - Croatia MSC - Part II | 8.000,00 HRK | 1.061,78 € |
| 9. | Multinational trial - Croatia MSC - Part I+II | 18.000,00 HRK | 2.389,01 € |
| 10. | Additional MSC application for Croatia - Part I+II | 20.000,00 HRK | 2.654,46 € |
| 11. | Non-commercial clinical trials | Free of charge | Free of charge |
| 8.2. | Clinical trial of authorised medicinal product** | ||
| 1. | Mono-national trial - Part I | 10.000,00 HRK | 1.327,23 € |
| 2. | Mono-national trial - Part II | 5.000,00 HRK | 663,61 € |
| 3. | Mono-national trial - Part I+II | 15.000,00 HRK | 1.990,84 € |
| 4. | Multinational trial - Croatia RMS - Part I | 35.000,00 HRK | 4.645,30 € |
| 5. | Multinational trial - Croatia RMS - Part II | 5.000,00 HRK | 663,61 € |
| 6. | Multinational trial - Croatia RMS - Part I+II | 40.000,00 HRK | 5.308,91 € |
| 7. | Multinational trial - Croatia MSC - Part I | 5.000,00 HRK | 663,61 € |
| 8. | Multinational trial - Croatia MSC - Part II | 5.000,00 HRK | 663,61 € |
| 9. | Multinational trial - Croatia MSC - Part I+II | 10.000,00 HRK | 1.327,23 € |
| 10. | Additional MSC application for Croatia - Part I+II | 12.000,00 HRK | 1.592,67 € |
| 11. | Non-commercial clinical trials | Free of charge | 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 | 4.000,00 HRK | 530,89 € |
| 2. | Mono-national trial - Part II | 2.000,00 HRK | 265,45 € |
| 3. | Mono-national trial - Part I+II | 6.000,00 HRK | 796,34 € |
| 4. | Multinational trial - Croatia RMS - Part I | 6.000,00 HRK | 796,34 € |
| 5. | Multinational trial - Croatia RMS - Part II | 2.000,00 HRK | 265,45 € |
| 6. | Multinational trial - Croatia RMS - Part I+II | 8.000,00 HRK | 1.061,78 € |
| 7. | Multinational trial - Croatia MSC - Part I | 3.000,00 HRK | 398,17 € |
| 8. | Multinational trial - Croatia MSC - Part II | 2.000,00 HRK | 265,45 € |
| 9. | Multinational trial - Croatia MSC - Part I+II | 5.000,00 HRK | 663,61 € |
| 10. | Non-commercial clinical trials | Free of charge | Free of charge |
| 9.2. | Clinical trial of authorised medicinal product** | ||
| 1. | Mono-national trial - Part I | 2.000,00 HRK | 265,45 € |
| 2. | Mono-national trial - Part II | 1.000,00 HRK | 132,72 € |
| 3. | Mono-national trial - Part I+II | 3.000,00 HRK | 398,17 € |
| 4. | Multinational trial - Croatia RMS - Part I | 4.000,00 HRK | 530,89 € |
| 5. | Multinational trial - Croatia RMS - Part II | 1.000,00 HRK | 132,72 € |
| 6. | Multinational trial - Croatia RMS - Part I+II | 5.000,00 HRK | 663,61 € |
| 7. | Multinational trial - Croatia MSC - Part I | 1.000,00 HRK | 132,72 € |
| 8. | Multinational trial - Croatia MSC - Part II | 1.000,00 HRK | 132,72 € |
| 9. | Multinational trial - Croatia MSC - Part I+II | 2.000,00 HRK | 265,45 € |
| 10. | Non-commercial clinical trials | Free of charge | 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 16th April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC
11. Pharmacovigilance
| NO | SERVICE | PRICE/EUR | PRICE/HRK |
|---|---|---|---|
| 1. | Assessment of a Periodic Safety Update Report | 1.592,67 € | 12.000,00 HRK |
| 2. | Assessment of additional risk minimisation measures | 1.194,51 € | 9.000,00 HRK |
| 3. | Assessment of variation of additional risk minimisation measures | 796,34 € | 6.000,00 HRK |
| 4. | Assessment of additional risk minimisation measures for medicinal products of different marketing authorisation holders containing the same active substance | 464,53 € | 3.500,00 HRK |
| 5. | Assessment of variation of additional risk minimisation measures for medicinal products of different marketing authorisation holders containing the same active substance | 331,81 € | 2.500,00 HRK |
| 6. | Assessment of a Development Safety Update Report | 530,89 € | 4.000,00 HRK |
| 7. | Procuring opinion of the Agency for medicinal products and medical devices for conducting non-interventional trial for medicinal products | 1.327,23 € | 10.000,00 HRK |
| 8. | Major alterations and amendments to non-interventional trial for medicinal products | 530,89 € | 4.000,00 HRK |
| 9. | Minor administrative alterations and amendments to non-interventional trial for medicinal products, additional research centres and head research changes | 132,72 € | 1.000,00 HRK |
| 10. | Safety assessment in clinical trials (sAMS)* | 5.043,47 € | 38.000,00 HRK |
| 11. | Safety assessment in clinical trials (sAMS) for active substance included in different sponsors' clinical trials* | 1.493,13 € | 11.250,00 HRK |
* 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/EUR | PRICE/HRK |
|---|---|---|---|
| 1. | Granting/refusal of a VMP manufacturing licence | 663,61 € | 5.000,00 HRK |
| 2. | Variation of a VMP manufacturing licence | 265,45 € | 2.000,00 HRK |
| 3. | Removal from the register of VMP manufacturing licence holders, at licence holder's request | 132,72 € | 1.000,00 HRK |
| 4. | Granting Good Manufacturing Practice (GMP) certificate for VMP, for manufacturers seated in Croatia | 132,72 € | 1.000,00 HRK |
| 5. | Good Manufacturing Practice inspection for VMP (per day and per inspector) | 929,06 € | 7.000,00 HRK |
| 6. | Granting/refusal of a licence for the wholesale distribution of VMP | 331,81 € | 2.500,00 HRK |
| 7. | Variation of a licence for the wholesale distribution of VMP - administrative enforcement | 132,72 € | 1.000,00 HRK |
| 8. | Variation of a licence for the wholesale distribution of VMP - in case of inspection | 199,08 € | 1.500,00 HRK |
| 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 € | 1.000,00 HRK |
| 10. | Good Distribution Practice inspection of the VMP wholesale (per day and per inspector) | 265,45 € | 2.000,00 HRK |
13. Provision of a scientific opinion on a substance which has action ancillary to that of a medical device
| NO | SERVICE | PRICE/EUR | PRICE/HRK |
|---|---|---|---|
| 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 € | 201.171,15 HRK |
| 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 € | 150.690,00 HRK |
| 3. | Variation type II | 2.700,00 € | 20.343,15 HRK |
| 4. | Variation type I | 950,00 € | 7.157,78 HRK |
