About HALMED

Fees

In effect as of 14 January 2014.

Applies to all services the Agency performs and invoices from the date of entering of the price list into force, regardless of the date of application submission.

All prices are in HRK, 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 supervision, 5. Medicinal product marketing and 8. Medical devices, 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.













1. Marketing a medicinal product

Apply to national procedures

No SERVICE PRICE
1.1. Granting/refusal of a marketing authorization for a medicinal product
1. For one strength and pharmaceutical form 30.000,00
2. For an additional pharmaceutical form (submitted at the same time) 24.000,00
3. For an additional pharmaceutical form (submitted subsequently) 30.000,00
4. For an additional strength (submitted at the same time) 14.000,00
5. For an additional strength (submitted subsequently) 16.000,00
6. For an additional type of inner packaging (container) of the same pharmaceutical form and strength (at the same time and subsequently) 11.000,00
7. Issuing of a Plasma Master File (PMF) certificate 20.000,00
8. Issuing of an additional Plasma Master File (PMF) certificate 6.000,00

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
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
2. For one strength and pharmaceutical form - generic medicinal product 150.000,00
3. For one strength and pharmaceutical form - medicinal product with well-established medicinal use 185.000,00
4. For one strength and pharmaceutical form - hybrid, biosimilar medicinal product 185.000,00
5. For one strength and pharmaceutical form - with the consent to use the dossier of a reference medicinal product 75.000,00
6. For one strength and pharmaceutical form - new combination of known active substances 185.000,00
7. Request for a duplicate (submitted at the same time - for all strengths and pharmaceutical forms) 75.000,00
8. For an additional pharmaceutical form (at the same time) 100.000,00
9. For an additional pharmaceutical form (subsequently) 120.000,00
10. For an additional strength (at the same time ) 75.000,00
11. For an additional strength (subsequently) 85.000,00
12. For an additional type of inner packaging (container) of the same pharmaceutical form and strength (at the same time and subsequently) 11.000,00
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
2. For one strength and pharmaceutical form - generic medicinal product 30.000,00
3. For one strength and pharmaceutical form - medicinal product with well-established medicinal use 30.000,00
4. For one strength and pharmaceutical form - hybrid, biosimilar medicinal product 30.000,00
5. For one strength and pharmaceutical form - with the consent to use the dossier of a reference medicinal product 30.000,00
6. For one strength and pharmaceutical form - new combination of known active substances 30.000,00
7. Request for a duplicate (submitted at the same time - for all strengths and pharmaceutical forms) 30.000,00
8. For an additional pharmaceutical form (submitted at the same time) 24.000,00
9. For an additional pharmaceutical form (submitted subsequently) 30.000,00
10. For an additional strength (submitted at the same time) 14.000,00
11. For an additional strength (submitted subsequently) 16.000,00
12. For an additional type of inner packaging (container) of the same pharmaceutical form and strength (at the same time and subsequently) 11.000,00
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
2. For one strength and pharmaceutical form - generic medicinal product 90.000,00
3. For one strength and pharmaceutical form - medicinal product with well-established medicinal use 110.000,00
4. For one strength and pharmaceutical form - hybrid, biosimilar medicinal product 110.000,00
5. For one strength and pharmaceutical form - with the consent to use the dossier of a reference medicinal product 45.000,00
6. For one strength and pharmaceutical form - new combination of known active substances 110.000,00
7. Request for a duplicate (submitted at the same time - for all strengths and pharmaceutical forms) 45.000,00
8. For an additional pharmaceutical form (submitted at the same time) 60.000,00
9. For an additional pharmaceutical form (submitted subsequently) 72.000,00
10. For an additional strength (submitted at the same time) 45.000,00
11. For an additional strength (submitted subsequently) 50.000,00
12. For an additional type of inner packaging (container) of the same pharmaceutical form and strength (at the same time and subsequently) 11.000,00
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
2. For one strength and pharmaceutical form - generic medicinal product 30.000,00
3. For one strength and pharmaceutical form - medicinal product with well-established medicinal use 30.000,00
4. For one strength and pharmaceutical form - hybrid, biosimilar medicinal product 30.000,00
5. For one strength and pharmaceutical form - with the consent to use the dossier of a reference medicinal product 30.000,00
6. For one strength and pharmaceutical form - new combination of known active substances 30.000,00
7. Request for a duplicate (submitted at the same time - for all strengths and pharmaceutical forms) 30.000,00
8. For an additional pharmaceutical form (submitted at the same time) 24.000,00
9. For an additional pharmaceutical form (submitted subsequently) 30.000,00
10. For an additional strength (submitted at the same time) 14.000,00
11. For an additional strength (submitted subsequently) 16.000,00
12. For an additional type of inner packaging (container) of the same pharmaceutical form and strength (at the same time and subsequently) 11.000,00
1.2.3. Repeat use procedure
1. For one strength and pharmaceutical form 30.000,00
2. For an additional pharmaceutical form (submitted at the same time) 24.000,00
3. For an additional pharmaceutical form (submitted subsequently) 30.000,00
4. For an additional strength (submitted at the same time) 14.000,00
5. For an additional strength (submitted subsequently) 16.000,00
6. For an additional type of inner packaging (container) of the same pharmaceutical form and strength (at the same time and subsequently) 11.000,00
7. Request for a duplicate for all strengths and pharmaceutical forms (submitted at the same time) 24.000,00
1.2.4. Administrative repeat use procedure based on nCADREAC
1. For one strength and pharmaceutical form 10.000,00
2. Authorization for an additional strength or pharmaceutical form 2.500,00
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
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
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
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
5. Allergen for epidermal tests 75.000,00
6. For an additional concentration, strength or pharmaceutical form of an allergen for epidermal tests (request submitted at the same time) 7.500,00
7. For each additional allergen for epidermal tests (request submitted at the same time) 7.500,00
8. For an additional concentration, strength or pharmaceutical form of an additional allergen for epidermal tests (request submitted at the same time) 750,00
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
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
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
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
5. Allergen for epidermal tests 15.000,00
6. For an additional concentration, strength or pharmaceutical form of an allergen for epidermal tests (request submitted at the same time) 15.000,00
7. For each additional allergen for epidermal tests (request submitted at the same time) 1.500,00
8. For an additional concentration, strength or pharmaceutical form of an additional allergen for epidermal tests (request submitted at the same time) 150,00
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
2. For one strength and pharmaceutical form - (when there is no EU monograph) 18.000,00
3. For an additional pharmaceutical form of a traditional herbal medicinal product (submitted at the same time) 9.000,00
4. For an additional pharmaceutical form based on an EU monograph (submitted subsequently) 11.000,00
5. For an additional pharmaceutical form when there is no EU monograph (submitted subsequently) 18.000,00
6. For an additional strength of a traditional herbal medicinal product (submitted at the same time) 7.000,00
7. For an additional strength of a traditional herbal medicinal product (submitted subsequently) 8.000,00
8. For an additional type of inner packaging (container) of the same pharmaceutical form and strength of a traditional herbal medicinal product (at the same time and subsequently) 5.000,00
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
2. For an additional pharmaceutical form of a traditional herbal medicinal product (submitted at the same time) 32.000,00
3. For an additional pharmaceutical form of a traditional herbal medicinal product (submitted subsequently) 40.000,00
4. For an additional strength of a traditional herbal medicinal product (submitted at the same time) 19.000,00
5. For an additional strength of a traditional herbal medicinal product (submitted subsequently) 21.000,00
6. For an additional type of inner packaging (container) of the same pharmaceutical form and strength of a traditional herbal medicinal product (at the same time and subsequently) 11.000,00
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
2. For an additional pharmaceutical form of a traditional herbal medicinal product (submitted at the same time) 9.000,00
3. For an additional pharmaceutical form of a traditional herbal medicinal product (submitted subsequently) 18.000,00
4. For an additional strength of a traditional herbal medicinal product (submitted at the same time) 7.000,00
5. For an additional strength of a traditional herbal medicinal product (submitted subsequently) 8.000,00
6. For an additional type of inner packaging (container) of the same pharmaceutical form and strength of a traditional herbal medicinal product (at the same time and subsequently) 5.000,00
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
2. For each pharmaceutical form of a multi-component homeopathic medicinal product 25.000,00
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
2. For each pharmaceutical form of a multi-component homeopathic medicinal product 7.500,00

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
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
2. For an additional pharmaceutical form 16.000,00
3. For an additional strength 9.000,00
4. For an additional type of inner packaging (container) of the same pharmaceutical form and strength 7.500,00

Apply to MRP / DCP procedures

NO SERVICE PRICE
2.2. Renewal/refusal of renewal of a marketing authorization for a medicinal product/homeopathic medicinal product
2.2.1. Renewal/refusal of a renewal of a marketing authorization for a medicinal product (no variations)
2.2.1.1. In a Mutual Recognition or Decentralization procedure when Croatia acts as a Reference Member State (RMS)
1. For one strength and pharmaceutical form 40.000,00
2. For an additional pharmaceutical form 32.000,00
3. For an additional strength 18.000,00
4. For an additional type of inner packaging (container) of the same pharmaceutical form and strength 15.000,00
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
2. For an additional pharmaceutical form 16.000,00
3. For an additional strength 9.000,00
4. For an additional type of inner packaging (container) of the same pharmaceutical form and strength 7.500,00
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
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
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
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
5. Allergen for epidermal tests 20.000,00
6. For an additional concentration, strength or pharmaceutical form of an allergen for epidermal tests (request submitted at the same time) 2.000,00
7. For each additional allergen for epidermal tests (request submitted at the same time) 2.000,00
8. For an additional concentration, strength or pharmaceutical form of an additional allergen for epidermal tests (request submitted at the same time) 200,00
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
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
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
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
5. Allergen for epidermal tests 10.000,00
6. For an additional concentration, strength or pharmaceutical form of an allergen for epidermal tests (request submitted at the same time) 1.000,00
7. For each additional allergen for epidermal tests (request submitted at the same time) 1.000,00
8. For an additional concentration, strength or pharmaceutical form of an additional allergen for epidermal tests (request submitted at the same time) 100,00
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
2. For each additional pharmaceutical form / strength / packaging type 3.000,00
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
2. For each additional pharmaceutical form / strength / packaging type 2.000,00
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
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

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

Apply to national procedures

NO SERVICE PRICE
3.1. Variations to a marketing authorization for a medicinal product
Minor variation (IA and IB)
1. IA 2.500,00
2. IB 3.500,00
3. Authorization for introduction of, or change to, a summary of pharmacovigilance system for every additional authorization in grouping of variations 500,00
Major variation (II)
4. simple 3.500,00
5. complex 6.000,00
6. very complex 10.000,00
7. Authorization for the same variation in an additional strength or pharmaceutical form (charged for both minor and major variations) 500,00
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
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
2. Dossier upgrade including minor variations 9.000,00
3. Dossier upgrade including major variations 15.000,00
4. Dossier upgrade for an additional pharmaceutical form of strength 2.000,00
5. Transfer of a marketing authorization for a medicinal product 3.000,00
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
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

Apply to MRP / DCP procedures

NO SERVICE PRICE
3.5. Variations to a marketing authorization for a medicinal product (including allergens) and homeopathic medicinal products
3.5.1. Minor variations (IA and IB) in a Mutual Recognition or Decentralization procedure when Croatia acts as a Reference Member State (RMS)
1. IA 5.000,00
2. IB 7.000,00
3. Authorization for the same variation in an additional strength or pharmaceutical form 2.000,00
4. Authorization for introduction of, or change to, a summary of pharmacovigilance system for every additional authorization in grouping of variations 500,00
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
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
2. complex 12.000,00
3. Very complex 20.000,00
4. Authorization for the same variation in an additional strength or pharmaceutical form (charged for both minor and major variations) 2.000,00
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
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
2. IB 3.500,00
3. Authorization for the same variation in an additional strength or pharmaceutical form 500,00
4. Authorization for introduction of, or change to, a summary of pharmacovigilance system for every additional authorization in grouping of variations 500,00
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
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
2. complex 6.000,00
3. very complex 10.000,00
4. Authorization for the same variations in an additional strength or pharmaceutical form (charged for both minor and major variations) 500,00
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
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
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
3. Transfer of a marketing authorization for a medicinal product (per decision) 3.000,00
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

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 supervision

NO SERVICE PRICE
1. Procedure for granting/refusal of a manufacturing licence 5.000,00
2. Postupak izmjene proizvodne dozvole 2.000,00
3. Procedure for the revocation of a manufacturing licence 2.000,00
4. Good Manufacturing Practice (GMP) certificate 1.000,00
5. Supervision of good manufacturing practice for manufacturers outside of Croatia 7.000,00 + travel and accommodation costs
6. Entry into the register of manufacturers, suppliers or importers of active substances 3.000,00
7. Variation to an entry into the register of manufacturers, suppliers or importers of active substances 2.000,00
8. Supervision of good manufacturing practice and supervision of pharmacovigilance (per day and per inspector) 7.000,00

5. Medicinal product marketing

NO SERVICE PRICE
1. Procedure for granting/refusal of licence for the wholesale distribution of medicinal products 9.000,00
Procedure for the variation of a licence for the wholesale distribution of medicinal products
2. - administrative enforcement 2.000,00
3. - in the case of inspection 3.000,00
4. Procedure for the revocation of a licence for the wholesale distribution of medicinal products 2.000,00
Approvals
5. Approval for an import of an active substance 1.000,00
6. Approval for the exemption to the labelling and/or package leaflet obligation 2.000,00
Approval for entry/import of medicinal product without marketing authorization in the following cases:
7. - when there is a medically justified need to protect human health 2.000,00
8. - for research purposes 2.000,00
9. - for pharmaceutical testing 2.000,00
10. - for non-clinical studies 2.000,00
11. - in case of natural disasters or other emergencies 2.000,00
12. - 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
13. Approval for entry/import of medicinal product without marketing authorization:
- medicinal product derived from blood or plasma
- immunological medicinal product
- radiopharmaceutical
1.000,00
14. Procedure for granting / refusal of a licence for the retail sale of medicinal products (in specialised retail shops) 5.000,00
Procedure for the variation of a licence for the retail sale of medicinal products (in specialised retail shops)
15. - the administrative enforcement of changes 2.000,00
16. - in the case of inspection 4.000,00
17. Procedure for the revocation of a licence for the retail sale of medicinal products (in specialised retail shops) 1.000,00
18. Certificate of a pharmaceutical product (CPP) 1.000,00
19. Free Sales Certificate (FSC) 1.000,00
20. Giving information on the consumption of medicinal products 1.000,00
21. Analysis of information on the consumption of medicinal products 3.000,00
22. Approval for the parallel import of medicinal products 10.000,00
23. Variation of approval for the parallel import of medicinal products 2.000,00
24. Procedure for granting/revocation of agency licence 3.000,00
25. Procedure for the variation of agency licence 1.000,00
26. Procedure for revocation of agency licence 1.000,00
27. Internet sale licence 3.000,00
28. Procedure for the variation of an Internet sale licence 1.000,00
29. Procedure for revocation of an Internet sale licence 1.000,00

6. Quality control of medicinal products

NO SERVICE PRICE
Quality control certificate:
1. - Special quality control of each batch of a blood or plasma-based medicinal product or immunological medicinal product 1.500,00 + 9,00 HRK/point
2. Quality control of a sample of a marketed medicinal product 1.500,00 + 9,00 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 1.500,00 + 9,00 HRK/point
4. Quality control in the procedure for granting marketing authorization, renewal or variation to a marketing authorization for a medicinal product 9,00 HRK/point
5. Quality control at special request for food supplements and interlaboratory testing for other institutions 9,00 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

Detailed list of laboratory testing fees of the Official Medicines Control Laboratory Division (OMCL) can be found here.

7. Annual fees

NO SERVICE PRICE
1. Annual fee for a medicinal product 3.000,00
2. Annual fee for a homeopathic medicinal product/device 500
3. Annual fee for a register of medical device manufacturers 300
4. Annual fee for a licence for the wholesale distribution of medical devices 2.000,00
5. Annual fee for a licence for the wholesale distribution of medicinal products 2.000,00
6. Annual fee for a licence for the retail sale of medical devices 500
7. 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
8. Annual pharmacovigilance fee 2.300,00
9. Annual fee for manufacture of medicinal products 3.000,00
10. Annual fee for brokering 1.000,00
11. Annual fee for entry into the register of manufacturers, suppliers or importers of active substances 1.000,00

An annual fee is charged for each valid decision.

8. Medical devices

NO SERVICE PRICE
1. Procedure for registration/ refusal of registration in the register of manufacturers or manufacturer representatives 7.000,00
2. Procedure for variation/refusal of variation of registration in the register of manufacturers or authorized manufacturer representatives 1.000,00
3. Procedure for a removal from the register of manufacturers or authorized manufacturer representatives 1.000,00
4. Procedure for registration/ refusal of registration in the register of medical devices (1 to 5 devices) 6.000,00
5. Procedure for registration/ refusal of registration in the register of medical devices (6 to 30 devices) 6.500,00
6. Procedure for registration/ refusal of registration in the register of medical devices for over 30 medical devices 7.000,00
7. Procedure for the removal of a medical device from the register 1.000,00
8. Procedure for the variation of registration in the medical device register 2.000,00
9. Procedure for the variation of registration in the medical device register without changing registration certificate 1.000,00
10. Certificate of registration of a medical device in the medical device register 1.000,00
11. Classification of medical devices with regard to risk class 7.000,00
12. Classification of a product as a medical device at the manufacturer's request 4.000,00
Procedure for registration/refusal of registration in the register of wholesalers
13. - in the case of inspection 6.000,00
14. - the administrative enforcement of changes 4.000,00
Procedure for variation/refusal of variation of license for the wholesale distribution of medical devices
15. - the administrative enforcement of changes 2.000,00
16. - in the case of inspection 4.000,00
17. Procedure for a removal from the register of manufacturers, at the request of licence holder 2.000,00
18. Procedure for revoking a licence for the retail sale of medical devices in specialised retail shops, at the request of licence holder 1.000,00
19. Procedure for issuing/ refusal of a licence to specialised shops for the retail sale of medical devices 3.000,00
Procedure for the variation of licence to specialised shops for the retail sale of medical devices
20. - the administrative enforcement of changes 1.000,00
21. - in the case of inspection 2.000,00
22. Procedure for registration/ refusal of registration in register of medical device manufacturers - for medical devices custom made for individual users 2.000,00
23. Procedure for variation/ refusal of variation of registration in the register of medical device manufacturers - for medical devices custom made for individual users 500,00
24. Procedure for a removal from the register of medical device manufacturers - for medical devices custom made for individual users 500,00

9. Training and provision of expert advice from the scope of Agency activities and Croatian Pharmacopoeia

NO SERVICE PRICE
9.1. Training
9.1.1. Half-day training
1. for health workers, university workers and students 500,00
2. for regulatory bodies 600,00
3. for authorization holders and others 1.000,00
9.1.2. Training per day - up to 3 days
1. for health workers, university workers and students 800,00
2. for regulatory bodies 950,00
3. for authorization holders and others 1.600,00
9.1.3. Each additional day of training over 3 days
1. for health workers, university workers and students 300,00
2. for regulatory bodies 350,00
3. for authorization holders and others 600,00
9.1.4. Training with international participation, per day - up to 2 days
1. for health workers, university workers and students 900,00
2. for regulatory bodies 1.050,00
3. for authorization holders and others 1.800,00
9.1.5. Each additional day of training with international participation over 3 days
1. for health workers, university workers and students 400,00
2. for regulatory bodies 500,00
3. for authorization holders and others 800,00
9.2. Expert advice prior to procedures from HALMED competence
1. Simple expert advice 2.000,00
2. Complex expert advice 5.000,00
3. Extremely complex expert advice 10.000,00
9.3. Croatian Pharmacopoeia
1. Annual fee for online access to Pharmacopoeia 930,00

10. Register of clinical trials and central ethics committee

NO SERVICE PRICE
1. The cost of procuring a central ethics committee opinion regarding a clinical trial 25.000,00
2. The cost of procuring a central ethics committee opinion regarding bioequivalence study 15.000,00
3. The cost of procuring a central ethics committee opinion regarding conducting non-interventional trial for medical devices 10.000,00
4. The cost of procuring a central ethics committee opinion regarding conducting non-interventional trial for medicinal products 2.000,00
5. The cost of procuring a central ethics committee opinion regarding academic research 4.000,00
6. Major alterations and amendments to clinical trials 4.000,00
7. Minor administrative alterations and amendments, additional research centres and head researcher changes 1.000,00

11. Pharmacovigilance

NO SERVICE PRICE
1. Assessment of a Periodic Safety Update Report 12.000,00
2. Assessment of risk minimisation measures 9.000,00
3. Assessment of a Risk Management Plan 10.000,00
4. Assessment of a Development Safety Update Report 4.000,00
5. The cost of administrative processing in clinical trials 1.000,00
6. The cost of administrative processing for a Periodic Safety Update Report 1.000,00
7. The cost of procuring opinion of the Agency for medicinal products and medical devices for conducting non-interventional trial for medicinal products 10.000,00
8. Major alterations and amendments to non-interventional trial for medicinal products 4.000,00
9. Minor administrative alterations and amendments to non-interventional trial for medicinal products, additional research centres and head research changes 1.000,00

The 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) and 8 January 2014 (with memorandum class: 400-01/13-01/53; Reg. No. 534-07-1-4/5-14/02).

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