About HALMED

Fees

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) and 7 March 2022 (memorandum class: 023-03/22-01/72; Reg. No: 534-03-2-1/1-22-02).

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:

  1. the withdrawal of a submitted request before the application validity assessment will not be charged
  2. the withdrawal of a submitted request after the application validity assessment will be charged 40% of the total price
  3. the withdrawal of a submitted request after the medicinal product quality assessment will be charged 30% of the total price
  4. 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/HRK PRICE/EUR
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 200.000,00 HRK 26.544,56 €
2. For one strength and pharmaceutical form - generic medicinal product 150.000,00 HRK 19.908,42 €
3. For one strength and pharmaceutical form - medicinal product with well-established medicinal use 185.000,00 HRK 24.553,72 €
4. For one strength and pharmaceutical form - hybrid, biosimilar medicinal product 185.000,00 HRK 24.553,72 €
5. For one strength and pharmaceutical form - with the consent to use the dossier of a reference medicinal product 75.000,00 HRK 9.954,21 €
6. For one strength and pharmaceutical form - new combination of known active substances 185.000,00 HRK 24.553,72 €
7. Request for a duplicate (submitted at the same time - for all strengths and pharmaceutical forms) 75.000,00 HRK 9.954,21 €
8. For an additional pharmaceutical form (at the same time) 100.000,00 HRK 13.272,28 €
9. For an additional pharmaceutical form (subsequently) 120.000,00 HRK 15.926,74 €
10. For an additional strength (at the same time ) 75.000,00 HRK 9.954,21 €
11. For an additional strength (subsequently) 85.000,00 HRK 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 30.000,00 HRK 3.981,68 €
2. For one strength and pharmaceutical form - generic medicinal product 30.000,00 HRK 3.981,68 €
3. For one strength and pharmaceutical form - medicinal product with well-established medicinal use 30.000,00 HRK 3.981,68 €
4. For one strength and pharmaceutical form - hybrid, biosimilar medicinal product 30.000,00 HRK 3.981,68 €
5. For one strength and pharmaceutical form - with the consent to use the dossier of a reference medicinal product 30.000,00 HRK 3.981,68 €
6. For one strength and pharmaceutical form - new combination of known active substances 30.000,00 HRK 3.981,68 €
7. Request for a duplicate (submitted at the same time - for all strengths and pharmaceutical forms) 30.000,00 HRK 3.981,68 €
8. For an additional pharmaceutical form (submitted at the same time) 24.000,00 HRK 3.185,35 €
9. For an additional pharmaceutical form (submitted subsequently) 30.000,00 HRK 3.981,68 €
10. For an additional strength (submitted at the same time) 14.000,00 HRK 1.858,12 €
11. For an additional strength (submitted subsequently) 16.000,00 HRK 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 120.000,00 HRK 15.926,74 €
2. For one strength and pharmaceutical form - generic medicinal product 90.000,00 HRK 11.945,05 €
3. For one strength and pharmaceutical form - medicinal product with well-established medicinal use 110.000,00 HRK 14.599,51 €
4. For one strength and pharmaceutical form - hybrid, biosimilar medicinal product 110.000,00 HRK 14.599,51 €
5. For one strength and pharmaceutical form - with the consent to use the dossier of a reference medicinal product 45.000,00 HRK 5.972,53 €
6. For one strength and pharmaceutical form - new combination of known active substances 110.000,00 HRK 14.599,51 €
7. Request for a duplicate (submitted at the same time - for all strengths and pharmaceutical forms) 45.000,00 HRK 5.972,53 €
8. For an additional pharmaceutical form (submitted at the same time) 60.000,00 HRK 7.963,37 €
9. For an additional pharmaceutical form (submitted subsequently) 72.000,00 HRK 9.556,04 €
10. For an additional strength (submitted at the same time) 45.000,00 HRK 5.972,53 €
11. For an additional strength (submitted subsequently) 50.000,00 HRK 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 30.000,00 HRK 3.981,68 €
2. For one strength and pharmaceutical form - generic medicinal product 30.000,00 HRK 3.981,68 €
3. For one strength and pharmaceutical form - medicinal product with well-established medicinal use 30.000,00 HRK 3.981,68 €
4. For one strength and pharmaceutical form - hybrid, biosimilar medicinal product 30.000,00 HRK 3.981,68 €
5. For one strength and pharmaceutical form - with the consent to use the dossier of a reference medicinal product 30.000,00 HRK 3.981,68 €
6. For one strength and pharmaceutical form - new combination of known active substances 30.000,00 HRK 3.981,68 €
7. Request for a duplicate (submitted at the same time - for all strengths and pharmaceutical forms) 30.000,00 HRK 3.981,68 €
8. For an additional pharmaceutical form (submitted at the same time) 24.000,00 HRK 3.185,35 €
9. For an additional pharmaceutical form (submitted subsequently) 30.000,00 HRK 3.981,68 €
10. For an additional strength (submitted at the same time) 14.000,00 HRK 1.858,12 €
11. For an additional strength (submitted subsequently) 16.000,00 HRK 2.123,56 €
1.2.3. Repeat use procedure
1. For one strength and pharmaceutical form 30.000,00 HRK 3.981,68 €
2. For an additional pharmaceutical form (submitted at the same time) 24.000,00 HRK 3.185,35 €
3. For an additional pharmaceutical form (submitted subsequently) 30.000,00 HRK 3.981,68 €
4. For an additional strength (submitted at the same time) 14.000,00 HRK 1.858,12 €
5. For an additional strength (submitted subsequently) 16.000,00 HRK 2.123,56 €
6. Request for a duplicate for all strengths and pharmaceutical forms (submitted at the same time) 24.000,00 HRK 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 150.000,00 HRK 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) 15.000,00 HRK 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) 15.000,00 HRK 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) 1.500,00 HRK 199,08 €
5. Allergen for epidermal tests 75.000,00 HRK 9.954,21 €
6. For an additional concentration, strength or pharmaceutical form of an allergen for epidermal tests (request submitted at the same time) 7.500,00 HRK 995,42 €
7. For each additional allergen for epidermal tests (request submitted at the same time) 7.500,00 HRK 995,42 €
8. For an additional concentration, strength or pharmaceutical form of an additional allergen for epidermal tests (request submitted at the same time) 750,00 HRK 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 30.000,00 HRK 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) 3.000,00 HRK 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) 3.000,00 HRK 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) 300,00 HRK 39,82 €
5. Allergen for epidermal tests 15.000,00 HRK 1.990,84 €
6. For an additional concentration, strength or pharmaceutical form of an allergen for epidermal tests (request submitted at the same time) 15.000,00 HRK 1.990,84 €
7. For each additional allergen for epidermal tests (request submitted at the same time) 1.500,00 HRK 199,08 €
8. For an additional concentration, strength or pharmaceutical form of an additional allergen for epidermal tests (request submitted at the same time) 150,00 HRK 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) 11.000,00 HRK 1.459,95 €
2. For one strength and pharmaceutical form - (when there is no EU monograph) 18.000,00 HRK 2.389,01 €
3. For an additional pharmaceutical form of a traditional herbal medicinal product (submitted at the same time) 9.000,00 HRK 1.194,51 €
4. For an additional pharmaceutical form based on an EU monograph (submitted subsequently) 11.000,00 HRK 1.459,95 €
5. For an additional pharmaceutical form when there is no EU monograph (submitted subsequently) 18.000,00 HRK 2.389,01 €
6. For an additional strength of a traditional herbal medicinal product (submitted at the same time) 7.000,00 HRK 929,06 €
7. For an additional strength of a traditional herbal medicinal product (submitted subsequently) 8.000,00 HRK 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 40.000,00 HRK 5.308,91 €
2. For an additional pharmaceutical form of a traditional herbal medicinal product (submitted at the same time) 32.000,00 HRK 4.247,13 €
3. For an additional pharmaceutical form of a traditional herbal medicinal product (submitted subsequently) 40.000,00 HRK 5.308,91 €
4. For an additional strength of a traditional herbal medicinal product (submitted at the same time) 19.000,00 HRK 2.521,73 €
5. For an additional strength of a traditional herbal medicinal product (submitted subsequently) 21.000,00 HRK 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 18.000,00 HRK 2.389,01 €
2. For an additional pharmaceutical form of a traditional herbal medicinal product (submitted at the same time) 9.000,00 HRK 1.194,51 €
3. For an additional pharmaceutical form of a traditional herbal medicinal product (submitted subsequently) 18.000,00 HRK 2.389,01 €
4. For an additional strength of a traditional herbal medicinal product (submitted at the same time) 7.000,00 HRK 929,06 €
5. For an additional strength of a traditional herbal medicinal product (submitted subsequently) 8.000,00 HRK 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 20.000,00 HRK 2.654,46 €
2. For each pharmaceutical form of a multi-component homeopathic medicinal product 25.000,00 HRK 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 4.000,00 HRK 530,89 €
2. For each pharmaceutical form of a multi-component homeopathic medicinal product 7.500,00 HRK 995,42 €

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/HRK PRICE/EUR
2.1. Renewal/refusal of a renewal of a marketing authorization for a medicinal product (no variations)
1. For one strength and pharmaceutical form 20.000,00 HRK 2.654,46 €
2. For an additional pharmaceutical form 16.000,00 HRK 2.123,56 €
3. For an additional strength 9.000,00 HRK 1.194,51 €

Apply to MRP / DCP procedures

NO SERVICE PRICE/HRK PRICE/EUR
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 40.000,00 HRK 5.308,91 €
2. For an additional pharmaceutical form 32.000,00 HRK 4.247,13 €
3. For an additional strength 18.000,00 HRK 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 20.000,00 HRK 2.654,46 €
2. For an additional pharmaceutical form 16.000,00 HRK 2.123,56 €
3. For an additional strength 9.000,00 HRK 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 40.000,00 HRK 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) 4.000,00 HRK 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) 4.000,00 HRK 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) 400,00 HRK 53,09 €
5. Allergen for epidermal tests 20.000,00 HRK 2.654,46 €
6. For an additional concentration, strength or pharmaceutical form of an allergen for epidermal tests (request submitted at the same time) 2.000,00 HRK 265,45 €
7. For each additional allergen for epidermal tests (request submitted at the same time) 2.000,00 HRK 265,45 €
8. For an additional concentration, strength or pharmaceutical form of an additional allergen for epidermal tests (request submitted at the same time) 200,00 HRK 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 20.000,00 HRK 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) 2.000,00 HRK 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) 2.000,00 HRK 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) 200,00 HRK 26,54 €
5. Allergen for epidermal tests 10.000,00 HRK 1.327,23 €
6. For an additional concentration, strength or pharmaceutical form of an allergen for epidermal tests (request submitted at the same time) 1.000,00 HRK 132,72 €
7. For each additional allergen for epidermal tests (request submitted at the same time) 1.000,00 HRK 132,72 €
8. For an additional concentration, strength or pharmaceutical form of an additional allergen for epidermal tests (request submitted at the same time) 100,00 HRK 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 9.000,00 HRK 1.194,51 €
2. For each additional pharmaceutical form / strength 3.000,00 HRK 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 7.500,00 HRK 995,42 €
2. For each additional pharmaceutical form / strength 2.000,00 HRK 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 7.000,00 HRK 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 3.000,00 HRK 398,17 €

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/HRK PRICE/EUR
3.1. Variations to a marketing authorization for a medicinal product
Minor variation (IA and IB)
1. IA 2.500,00 HRK 331,81 €
2. IB 3.500,00 HRK 464,53 €
3. Authorization for introduction of, or change to, a summary of pharmacovigilance system for every additional authorization in grouping of variations 500,00 HRK 66,36 €
Major variation (II)
4. simple 3.500,00 HRK 464,53 €
5. complex 6.000,00 HRK 796,34 €
6. very complex 10.000,00 HRK 1.327,23 €
7. Authorization for the same variation in an additional strength or pharmaceutical form (charged for both minor and major variations) 500,00 HRK 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) 1.000,00 HRK 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 1.000,00 HRK 132,72 €
2. Transfer of a marketing authorization for a medicinal product 3.000,00 HRK 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 2.000,00 HRK 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 20.000,00 HRK 2.654,46 €

Apply to MRP / DCP procedures

NO SERVICE PRICE/HRK PRICE/EUR
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 5.000,00 HRK 663,61 €
2. IB 7.000,00 HRK 929,06 €
3. Authorization for the same variation in an additional strength or pharmaceutical form 2.000,00 HRK 265,45 €
4. Authorization for introduction of, or change to, a summary of pharmacovigilance system for every additional authorization in grouping of variations 500,00 HRK 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 1.000,00 HRK 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 9.000,00 HRK 1.194,51 €
2. Complex 12.000,00 HRK 1.592,67 €
3. Very complex 20.000,00 HRK 2.654,46 €
4. Authorization for the same variation in an additional strength or pharmaceutical form (charged for both minor and major variations) 2.000,00 HRK 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 1.000,00 HRK 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 2.500,00 HRK 331,81 €
2. IB 3.500,00 HRK 464,53 €
3. Authorization for the same variation in an additional strength or pharmaceutical form 500,00 HRK 66,36 €
4. Authorization for introduction of, or change to, a summary of pharmacovigilance system for every additional authorization in grouping of variations 500,00 HRK 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 1.000,00 HRK 132,72 €
3.5.4. Major variation (II) in a Mutual Recognition or Decentralization procedure when Croatia is a Concerned Member State
1. Simple 3.500,00 HRK 464,53 €
2. Complex 6.000,00 HRK 796,34 €
3. Very complex 10.000,00 HRK 1.327,23 €
4. Authorization for the same variations in an additional strength or pharmaceutical form (charged for both minor and major variations) 500,00 HRK 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 1.000,00 HRK 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 3.000,00 HRK 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 1.000,00 HRK 132,72 €
3. Transfer of a marketing authorization for a medicinal product (per decision) 3.000,00 HRK 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 2.000,00 HRK 265,45 €

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/HRK PRICE/EUR
1. Granting/refusal of a manufacturing licence 5.000,00 HRK 663,61 €
2. Variation of a manufacturing licence 2.000,00 HRK 265,45 €
3. Revocation of a manufacturing licence 2.000,00 HRK 265,45 €
4. Good Manufacturing Practice (GMP) certificate 1.000,00 HRK 132,72 €
5. Good Manufacturing Practice (GMP) certificate, for manufacturers outside of Croatia 5.000,00 HRK 663,61 €
6. Good Manufacturing Practice inspection of manufacturers outside of Croatia (per day and per inspector) 14.000,00 HRK + travel and accommodation costs 1.858,12 € + travel and accommodation costs
7. Entry into the register of manufacturers, suppliers or importers of active substances 3.000,00 HRK 398,17 €
8. Variation to an entry into the register of manufacturers, suppliers or importers of active substances 2.000,00 HRK 265,45 €
9. Good Manufacturing Practice inspection and Good Pharmacovigilance inspection (per day and per inspector) 7.000,00 HRK 929,06 €
10. Supervision of the repositories system (per day and per inspector) 7.000,00 HRK 929,06 €
11. Granting/refusal of a licence for the wholesale distribution of medicinal products 9.000,00 HRK 1.194,51 €
12. Variation of a licence for the wholesale distribution of medicinal products - administrative enforcement 2.000,00 HRK 265,45 €
13. Variation of a licence for the wholesale distribution of medicinal products - in case of inspection 3.000,00 HRK 398,17 €
14. Revocation of a licence for the wholesale distribution of medicinal products 2.000,00 HRK 265,45 €
15. Granting/refusal of a licence for the retail sale of medicinal products (in specialised retail shops) 5.000,00 HRK 663,61 €
16. Variation of a licence for the retail sale of medicinal products (in specialised retail shops) - administrative enforcement 1.000,00 HRK 132,72 €
17. Variation of a licence for the retail sale of medicinal products (in specialised retail shops) - in case of inspection 4.000,00 HRK 530,89 €
18. Revocation of a licence for the retail sale of medicinal products (in specialised retail shops) 1.000,00 HRK 132,72 €
19. Granting/revocation of a broker licence 3.000,00 HRK 398,17 €
20. Variation of a broker licence 1.000,00 HRK 132,72 €
21. Revocation of a broker licence 1.000,00 HRK 132,72 €
22. Internet sale licence 3.000,00 HRK 398,17 €
23. Variation of an Internet sale licence 1.000,00 HRK 132,72 €
24. Revocation of an Internet sale licence 1.000,00 HRK 132,72 €

5. Medicinal product marketing

NO SERVICE PRICE/HRK PRICE/EUR
Approvals
1. Approval for an import of an active substance 1.000,00 HRK 132,72 €
2. Approval for the exemption to the labelling and/or package leaflet obligation 2.000,00 HRK 265,45 €
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 2.000,00 HRK 265,45 €
4. - for research purposes 2.000,00 HRK 265,45 €
5. - for pharmaceutical testing 2.000,00 HRK 265,45 €
6. - for non-clinical studies 2.000,00 HRK 265,45 €
7. - for clinical trials 2.000,00 HRK 265,45 €
8. - in case of natural disasters or other emergencies 2.000,00 HRK 265,45 €
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 1.000,00 HRK 132,72 €
10. Approval for entry/import of medicinal product with marketing authorization:
- medicinal product derived from blood or plasma
- immunological medicinal product
- radiopharmaceutical
1.000,00 HRK 132,72 €
11. Certificate of a pharmaceutical product (CPP) 1.000,00 HRK 132,72 €
12. Free Sales Certificate (FSC) 1.000,00 HRK 132,72 €
13. Providing information on the consumption of medicinal products 1.000,00 HRK 132,72 €
14. Analysis of information on the consumption of medicinal products 3.000,00 HRK 398,17 €
15. Approval for the parallel import of medicinal products 10.000,00 HRK 1.327,23 €
16. Variation of approval for the parallel import of medicinal products 2.000,00 HRK 265,45 €
17. Determination of maximal wholesale prices of prescription medicinal products 3.000,00 HRK 398,17 €
18. - for an additional strength or pharmaceutical form (submitted at the same time or submitted subsequently) 1.000,00 HRK 132,72 €
19. - for an additional packaging (submitted at the same time or submitted subsequently) 500,00 HRK 66,36 €

6. Quality control of medicinal products

NO SERVICE PRICE/HRK PRICE/EUR
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 7,00 HRK/point 0,93 eur/point
2. Quality control of a sample of a marketed medicinal product 7,00 HRK/point 0,93 eur/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 7,00 HRK/point 0,93 eur/point
4. Quality control in the procedure for granting marketing authorization, renewal or variation to a marketing authorization for a medicinal product 7,00 HRK/point 0,93 eur/point
5. Quality control at special request for food supplements and interlaboratory testing for other institutions 7,00 HRK/point 0,93 eur/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 7,00 HRK/point 0,93 eur/point
2. Regular quality control of VMP 7,00 HRK/point 0,93 eur/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/HRK PRICE/EUR
1. Registration/refusal of registration in the register of manufacturers or manufacturer representatives 5.000,00 HRK 663,61 €
2. Variation/refusal of variation of registration in the register of manufacturers or authorized manufacturer representatives 1.000,00 HRK 132,72 €
3. Registration/refusal of registration in the register of medical devices (1 to 5 devices) 6.000,00 HRK 796,34 €
4. Registration/refusal of registration in the register of medical devices (6 to 30 devices) 6.500,00 HRK 862,70 €
5. Registration/refusal of registration in the register of medical devices for over 30 medical devices 7.000,00 HRK 929,06 €
6. Variation of registration in the medical device register 2.000,00 HRK 265,45 €
7. Variation of registration in the medical device register without changing registration certificate 1.000,00 HRK 132,72 €
8. Certificate of registration of a medical device in the medical device register 1.000,00 HRK 132,72 €
9. Classification of medical devices with regard to risk class 7.000,00 HRK 929,06 €
10. Classification of a product as a medical device at the manufacturer's request 4.000,00 HRK 530,89 €
Registration/refusal of registration in the register of wholesalers
11. - in case of inspection 6.000,00 HRK 796,34 €
12. - administrative enforcement 4.000,00 HRK 530,89 €
Variation/refusal of variation of a license for the wholesale distribution of medical devices
13. - administrative enforcement 2.000,00 HRK 265,45 €
14. - in case of inspection 4.000,00 HRK 530,89 €
15. Issuing/refusal of a licence to specialised shops for the retail sale of medical devices 3.000,00 HRK 398,17 €
Variation of a licence to specialised shops for the retail sale of medical devices
16. - administrative enforcement 1.000,00 HRK 132,72 €
17. - in case of inspection 2.000,00 HRK 265,45 €
18. Registration/refusal of registration in register of medical device manufacturers - for medical devices custom made for individual users 2.000,00 HRK 265,45 €
19. Variation/refusal of variation of registration in the register of medical device manufacturers - for medical devices custom made for individual users 500,00 HRK 66,36 €

9. Training and provision of expert advice from the Agency's scope of work and Croatian Pharmacopoeia

NO SERVICE PRICE/HRK PRICE/EUR
9.1. Training
9.1.1. Half-day training
1. for health workers, university workers and students 500,00 HRK 66,36 €
2. for regulatory bodies 600,00 HRK 79,63 €
3. for authorization holders and others 1.000,00 HRK 132,72 €
9.1.2. Training per day - up to 3 days
1. for health workers, university workers and students 800,00 HRK 106,18 €
2. for regulatory bodies 950,00 HRK 126,09 €
3. for authorization holders and others 1.600,00 HRK 212,36 €
9.1.3. Each additional day of training over 3 days
1. for health workers, university workers and students 300,00 HRK 39,82 €
2. for regulatory bodies 350,00 HRK 46,45 €
3. for authorization holders and others 600,00 HRK 79,63 €
9.1.4. Training with international participation, per day - up to 2 days
1. for health workers, university workers and students 900,00 HRK 119,45 €
2. for regulatory bodies 1.050,00 HRK 139,36 €
3. for authorization holders and others 1.800,00 HRK 238,90 €
9.1.5. Each additional day of training with international participation over 3 days
1. for health workers, university workers and students 400,00 HRK 53,09 €
2. for regulatory bodies 500,00 HRK 66,36 €
3. for authorization holders and others 800,00 HRK 106,18 €
9.2. Expert advice prior to procedures from HALMED competence
1. Simple expert advice 2.000,00 HRK 265,45 €
2. Complex expert advice 5.000,00 HRK 663,61 €
3. Extremely complex expert advice 10.000,00 HRK 1.327,23 €
4. Expert advice in translation of instructions for use and labelling of medical device 500,00 HRK 66,36 €
9.3. Croatian Pharmacopoeia
1. Annual fee for online access to Pharmacopoeia 300,00 HRK 39,82 €

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/HRK PRICE/EUR
1. Assessment of a Periodic Safety Update Report 12.000,00 HRK 1.592,67 €
2. Assessment of additional risk minimisation measures 9.000,00 HRK 1.194,51 €
3. Assessment of variation of additional risk minimisation measures 6.000,00 HRK 796,34 €
4. Assessment of additional risk minimisation measures for medicinal products of different marketing authorisation holders containing the same active substance 3.500,00 HRK 464,53 €
5. Assessment of variation of additional risk minimisation measures for medicinal products of different marketing authorisation holders containing the same active substance 2.500,00 HRK 331,81 €
6. Assessment of a Development Safety Update Report 4.000,00 HRK 530,89 €
7. Procuring opinion of the Agency for medicinal products and medical devices for conducting non-interventional trial for medicinal products 10.000,00 HRK 1.327,23 €
8. Major alterations and amendments to non-interventional trial for medicinal products 4.000,00 HRK 530,89 €
9. Minor administrative alterations and amendments to non-interventional trial for medicinal products, additional research centres and head research changes 1.000,00 HRK 132,72 €
10. Safety assessment in clinical trials (sAMS)* 38.000,00 HRK 5.043,47 €
11. Safety assessment in clinical trials (sAMS) for active substance included in different sponsors' clinical trials* 11.250,00 HRK 1.493,13 €

* 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/HRK PRICE/EUR
1. Granting/refusal of a VMP manufacturing licence 5.000,00 HRK 663,61 €
2. Variation of a VMP manufacturing licence 2.000,00 HRK 265,45 €
3. Removal from the register of VMP manufacturing licence holders, at licence holder's request 1.000,00 HRK 132,72 €
4. Granting Good Manufacturing Practice (GMP) certificate for VMP, for manufacturers seated in Croatia 1.000,00 HRK 132,72 €
5. Good Manufacturing Practice inspection for VMP (per day and per inspector) 7.000,00 HRK 929,06 €
6. Granting/refusal of a licence for the wholesale distribution of VMP 2.500,00 HRK 331,81 €
7. Variation of a licence for the wholesale distribution of VMP - administrative enforcement 1.000,00 HRK 132,72 €
8. Variation of a licence for the wholesale distribution of VMP - in case of inspection 1.500,00 HRK 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 1.000,00 HRK 132,72 €
10. Good Distribution Practice inspection of the VMP wholesale (per day and per inspector) 2.000,00 HRK 265,45 €

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