Ordinance On The Fees For Medicines, Etc.

Original Language Title: Bekendtgørelse om gebyrer for lægemidler m.v.

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Overview (table of contents)



Annex 1



Annex to the Ordinance on the fees for medicines, etc.


The full text of the Ordinance on the fees for medicines, etc.

Under section 103, paragraph 1, and section 103 (a) of law No. 1180 of 12. December 2005 on medicinal products, as amended by Act No. 1557 by 20. December 2006 and law No. 534 by 17. June 2008, fixed: § 1. The Health Agency applying for authorisation for a medicinal product (marketing authorisation), is the holder of the marketing authorisation for a medicinal product or parallel distributes a drug must pay the fee to the Board of health for: 1) application for the granting of a marketing authorisation.

2) application for extension of a marketing authorisation.

3) application for approval of additional dosage forms and strengths.

4) application for amendment of a marketing authorisation with a view to the expansion of indications, including a new species for medicinal products for animals.

5) application for approval of a drug that is identical to an already approved drug, with the permission of the holder of the existing permit (parallel discovery).

6) application for the issue of a marketing authorisation for parallel imports.

7) application for other than those in (i); 4 changes to a marketing authorisation (variations).

8) continuous product monitoring and control.

9) Tasks resulting from the fact that a marketing authorisation issued by the National Board of health is used as the basis for the granting of a marketing authorisation in other EU/EEA countries (mutual recognition).

10) Review of parallel distribution on the basis of a community marketing authorisation.

(2). The provisions of paragraph 1, nr. 1-9, and sections 10-12 shall apply mutatis mutandis to the applicant the Board of health for registration of homeopathic medicinal products and traditional herbal medicinal products and the holder of a registration of these medicines.

§ 2. The applicant for approval of a pharmaceutical company, or who is the holder of such authorization, shall pay the fee to the Board of health for: 1) application for a permit for the manufacture/importation of medicines in one geographic location.

2) application for permission for other forms of handling of medicines in one geographic location.

3) Continuous business checks (annual fee).

§ 3. The applicant for a permit for the manufacture/importation of intermediate products, or who is the holder of such a licence, must pay the fee to the Board of health for: 1) application for a permit for the manufacture/importation of intermediate products in one geographic location.

2) application for permission for other forms of handling of intermediate products in one geographic location.

3) Continuous business checks (annual fee).

§ 4. The, requesting to be registered as a facilitator of drugs, or who are already registered, must pay the fee to the Board of health for: 1) application for registration as a facilitator of medicines in one geographic location.

2) Ongoing corporate control (annual fee).

§ 5. The, requesting to be registered as a manufacturer, importer or distributor of active substances, or has been previously registered, must pay the fee to the Board of health for: 1) application for registration as an importer or distributor, manufacture of active substances in one geographic location.

2) Ongoing corporate control (annual fee).

§ 6. The applicant for the approval and control of a company that carries out toxicological and pharmacological (non-clinical) trials in order to evaluate the safety of medicinal products, shall pay the fee to the Board of health.

§ 7. The holder of the marketing authorisation for a pharmacy reserved for medicinal product shall pay a fee to the Board of health for: 1) notification of new or changed the price on a gasket.

2) withdrawal of a pack size, when the withdrawal is done at the request of the holder of the marketing authorisation.

§ 8. The holder of the marketing authorisation for a medicinal product which is exempted from the pharmacy-reservations, must pay a fee to the Board of health for: 1) notification of new or modified package size.

2) withdrawal of a pack size, when the withdrawal is done at the request of the holder of the marketing authorisation.

§ 9. The pharmacist must pay an annual fee to the National Board of health to cover the cost of the National Board of Health's notification of pharmacies of consumer prices etc. of pharmacy-only medicines.

(2). Anyone who signs up for a subscription to medicine prices for companies, must pay an annual fee.

§ 10. The size of the fees set out in annex 1 of the basic regulation. However, section 17.

(2). The applicant for or holder of a marketing authorisation for a medicinal product must pay health's expenses for travel and accommodation, if the processing of the application or the control of the drug, raw material or intermediate products requires that the Health Agency inspects an activity in a non-EU/EEA country (third country).

(3). The costs of travel and stay is calculated in accordance with the rules laid down in the Ministry of finance circular on mission agreement.

§ 11. The fee for an application for marketing authorization for a medicinal product shall be increased by DKK 6860 if the drug will be manufactured at a company outside the EU/EEA area, and this in accordance with the applicable EU rules is the responsibility of the health protection agency to control the company. Paid up to a maximum of one strength in each pharmaceutical form. Item number 30369.

(2). The fee for the application for the amendment of the marketing authorisation for a medicinal product shall be increased by DKK 6860 if the manufacturing site of the medicinal product will be changed to a company outside the EU/EEA area, and this in accordance with the applicable EU rules is the responsibility of the health protection agency to control the company. Paid up to a maximum of one strength in each pharmaceutical form. Item number 30369.

(3). The annual fee shall be increased by DKK 6860 for medicinal products which are manufactured outside the EU/EEA area, and where it is in accordance with the applicable EU rules is the responsibility of the health protection agency to control the company. Paid up to a maximum of one strength in each pharmaceutical form. Item number 30368.

§ 12. If a drug is approved, see. section 1, paragraph 1, no. 1, 3 and 5, or if there will be granted a marketing authorisation for parallel imports, see. section 1, paragraph 1, no. 6, within the first 9 months of the year, a full fee must be paid in accordance with section 1, paragraph 1, no. 8, for the year in question. If the drug will be approved within the last 3 months of the year, must not be paid any fee pursuant to section 1, paragraph 1, no. 8, for the year in question.

(2). Regardless of when in the year the authorisation of a medicinal product shall cease to be paid full fee according to section 1, paragraph 1, no. without prejudice to article 8. section 10, paragraph 3, of that year.

§ 13. The who at one time a candidate for Board of Health's approval of the same change for several forms and strengths within the same marketing authorisation, without prejudice. section 1, paragraph 1, no. 7, paying a full fee for the first variation and a reduced fee for each of the other variations, if the application results in a maximum of one academic assessment.

§ 14. The applicant for a permit for the manufacture of medicinal products must pay only that portion of the application fee for a permit for the manufacture of medicinal products, which exceed the application fee for permission to the wholesale distribution, if the applicant already has permission for the wholesale distribution of medicinal products.

(2). The applicant for a permit to sell OTC medicines or HV-labelled products must either pay the application fee or annual fee if the applicant already has permission for the wholesale distribution of medicinal products.

(3). The applicant for a permit for the manufacture of medicinal products must pay only that portion of the application fee for a permit for the manufacture of medicinal products, which exceed the application fee for retail authorisation if the applicant already has permission for retail sale of medicines.

§ 15. If a company will be approved after the Danish Medicines Act § 39, paragraph 1, during the first 9 months of the year, it must pay the full fee under section 2, nr. 3, for the year in question. If the company will be approved during the last three months of the year, it should not pay the fee pursuant to section 2, nr. 3, for the year in question.

(2). If a company will be approved after the Danish Medicines Act § 39, paragraph 2, during the first 9 months of the year, it must pay full fee pursuant to section 3, nr. 3, for the year in question. If the company will be approved during the last three months of the year shall not pay the fee pursuant to section 3, nr. 3, for the year in question.

(3). If a company is allowed after the Danish Medicines Act, section 85, paragraph 1, during the first 9 months of the year, it must pay the full fee under section 5 of that year. If the company gets permission during the last 3 months of the year, it should not pay the fee pursuant to section 5 of that year.

(4). A company that will be registered after the Danish Medicines Act section 41 (c) as an intermediary must not pay the annual fee and application fee in the same year.

(5). A company that will be registered after the Danish Medicines Act, section 50 (a) manufacture, importer or distributor shall not pay the annual fee and application fee in the same year.
§ 16. If a company is authorized to sell OTC medicines outside pharmacies, seeking permission to negotiate products covered by the Ordinance concerning the negotiation of certain iron and vitamin preparations, as well as certain antiparasitic drugs to animals outside pharmacies (HV-branded products) is paid only the difference between the fee for application for authorisation of the marketing of HV-labelled products and the fee for application for permission to sell OTC medicines outside pharmacies.

§ 17. Companies covered by the Executive order on the sale of OTC medicines outside pharmacies and the Ordinance concerning the negotiation of certain iron and vitamin preparations, as well as certain antiparasitic drugs to animals outside pharmacies do not have to pay the fee in accordance with section 2, nr. 3, the year in which the National Board of health shall issue the authorisation under medicines Act § 39, paragraph 1. Establishments covered by § 15, however, must pay the annual fee for the sale of OTC medicines outside pharmacies in that year.

§ 18. Companies that have permission to sell drugs for food animals after notice of distribution of medicines to animals outside the pharmacy, pay the fee pursuant to section 2, nr. 3, in the form of a management fee, which constitutes 0.065% of the Distributor's revenue of medicines for animals.

(2). The undertakings referred to in paragraph 1 shall pay in addition, the National Board of health a management fee of 0.77% of the turnover of drugs for food animals with a view to the financing of initiatives for strengthening food safety and animal welfare.

§ 19. A company that at the end of the startup is in possession of a business permit, pay the full annual fee for the year in question.

§ 20. The National Board of health may, in very special cases, wholly or in part exempt from payment of the fee. Item No. 30371 fee exemption for partially exempted is products. This annual fee is us $ 4448.

§ 21. The National Board of health shall notify the procedure for payment of fees pursuant to this order. The fee shall be paid to the health protection agency not later than 1 month after order.

§ 22. The notice shall enter into force on the 1. January 2013.

(2). At the same time repealed Executive Order No. 1348 by 14. December 2011 on the fees for medicines, etc.

The Ministry of health and prevention, 20. December 2012 Astrid Krag/Kirstine f. Hindsberger



Annex 1 Annex to the Ordinance on the fees for medicines, etc.







 

 

 

 

 

 

 







Procedure









Group









Case types









Delineation









Item No.









Application for









Fee exemption











MT









Extension









Item No.





Item No.







30307





30308







National procedure





All excluding. herbal, vitamin and mineral products, traditional herbal medicines and homeopathic products





New application





New applications





30301





79420





16.8891)





8.896







National procedure





New application





Bibliographic applications and fixed combination medicinal products





30303





79420





16.8891)





8.896







National procedure





New application





Synonym preparations (generic application, hybrid application and biological medicinal products similar to already approved drugs)





30302





74049





16.8891)





8.896







National procedure





New application





Parallel recording





30304





22687





16889





8896







National procedure





New application





Application rejected or withdrawn by applicant under validation





30306





13137



 

 





National procedure





Extension





New indication or animal species





30309





16889



 

 





National procedure





Extension





Additional pharmaceutical form





30310





16889



 



8896







National procedure





Extension





Additional strength





30311





15642



 



8896







National procedure





Parallel imports





First import country





30312





16889



 



8896







National procedure





Parallel imports





First import country





30314



 



15.6421)



 
National procedure





Parallel imports





2.-4. importing country





30313





15766



 

 





National procedure





Variation





Type IA and type IB





30315





1702



 

 





National procedure





Variation





Administrative type IA and type IB





30316





784



 

 





National procedure





Variation





Reduced regardless of type





30317





426



 

 





National procedure





Variation





Type II standard





30318





1702



 

 





National procedure





Variation





Type II complex





30319





1702



 

 





National procedure





Periodic safety update





Periodic safety update





40101





6.5651)



 

 





National Procedure



 



Variation





Refusal due to invalidity of B grouping comprehensive 4 variations or more





30415





5203



 

 



 



















Procedure









Group









Case types









Delineation









Item No.









Application for









Fee exemption











MT









Extension









Item No.





Item No.







30322





30323







National procedure





Herbal remedies and strong vitamin and mineral preparations





New application





Bibliographic applications





30320





13570





1836





4304





 





National procedure





New application





Parallel recording





30321





12364





1836





4304







National procedure





New application





Application rejected or withdrawn by applicant under validation





30413





2239



 

 





National procedure





Extension





New indication or animal species





30324





3939



 

 





National procedure





Extension





Additional pharmaceutical form





30325





1826



 



4304







National procedure





Extension





Additional strength





30326





1826



 



4304







National procedure





Variation





Type IA and type IB





30327





1577



 

 





National procedure





Variation





Administrative type IA and type IB





30328





784



 

 





National procedure





Variation





Reduced regardless of type
30329





435



 

 





National procedure





Variation





Type II standard





30330





1702



 

 





National procedure





Variation





Type II complex





30331





1702



 

 















 







Procedure









Group









Case types









Delineation









Item No.









Application for









Fee exemption











MT









Extension











Item No.









Item No.









30411





30323







National procedure





Traditional herbal medicinal products





New application





New application





30409





7803





1836





4304







National procedure





New application





Parallel recording





30410





6570





1836





4304







National procedure





Extension





New indication, strength or pharmaceutical form





30418





1826



 



4304







National procedure





Variation





Type IA and type IB





30419





1577



 

 





National procedure





Variation





Administrative type IA and type IB





30420





784



 

 





National procedure





Variation





Reduced regardless of type





30421





435



 

 





National procedure





Variation





Type II standard





30422





1702



 

 





National procedure





Variation





Type II complex





30423





1702



 

 















 







Procedure









Group









Case types









Delineation









Item No.









Application for









Fee exemption











MT









Extension











Item No.









Item No.









30334





30335







National procedure





Homeopathic medicinal products registration





New application





First pharmaceutical form and strength





30332





2319





1006





938







National procedure





New application





Parallel recording





30333





517





1006



 





National procedure
Extension





Additional dosage forms and strengths





30336





517



 



938

















 







Procedure









Group









Case types









Delineation









Item No.









Application for









Fee exemption











MT









Extension











Item No.









Item No.









30343





30308







Mutual recognition, MRP, ShipCountry





All excluding. traditional herbal medicines and homeopathic products





New application





New applications





30337





67721





16.8892) 10) 8.8963) mutual recognition, MRP, ShipCountry





New application





Bibliographic applications and fixed combination medicinal products





30339





67721





16.8892) 10) 8.8963) mutual recognition, MRP, ShipCountry





New application





Synonym product (generic application, hybrid application and biological medicinal products similar to already approved drugs)





30338





67721





16.8892) 10) 8.8963) mutual recognition, MRP, ShipCountry





New application





Parallel recording





30340





16797





16.8892) 10) 8.8963) mutual recognition, MRP, ShipCountry





New application





Application rejected or withdrawn by applicant under validation





30342





13137



 

 





Mutual recognition, MRP, ShipCountry





Extension





New indication or new species





30345





16889



 

 





Mutual recognition, MRP, ShipCountry





Extension





Additional pharmaceutical form





30346





15519



 



8.8963) mutual recognition, MRP, ShipCountry





Extension





Additional strength





30347





15519



 



8.8963) mutual recognition, MRP, ShipCountry





Variation





Type IA and type IB





30348





1258



 

 





Mutual recognition, MRP, ShipCountry





Variation





Administrative type IA and type IB





30349





784



 

 





Mutual recognition, MRP, ShipCountry





Variation





Reduced regardless of type





30350





426



 

 





Mutual recognition, MRP, ShipCountry





Variation





Type II standard





30351





1702



 

 





Mutual recognition, MRP, ShipCountry





Variation





Type II complex





30352





1702



 

 





Mutual recognition, MRP, ShipCountry





Veterinary SPC harmonisation





Fee for transfer of MT under national procedure for MRP after execution of the relevant variations





30416





22574



 
 















 

 

 

 

 

 

 







Procedure









Group









Case types









Delineation









Item No.









Application for









Fee exemption











MT









Extension











Item No.









Item No.









30354





303,084)







Mutual recognition, MRP, analogue country





All excluding. traditional herbal medicines and homeopathic products





New application





Application where the Danish Medicines Agency issued national marketing authorisation form the basis of a mutual recognition procedure. Include new applications, bibliographic applications as well as synonym preparations





30353





71.5085) 13.1376) mutual recognition, MRP, analogue country





New application





Parallel recording





30355





32.9075) 13.1376) mutual recognition, MRP, analogue country





Extension





Application where the Danish Medicines Agency issued national marketing authorisation form the basis of a mutual recognition procedure. Includes new supplemental form or strengthen





30414





32.9077) mutual recognition, MRP, analogue country





Variation

The fee covers the MRP procedures. For this specialist assessment will be charged national variation fee





Type IA and type IB





30356





1968



 

 





Mutual recognition, MRP, analogue country





Variation

The fee covers the MRP procedures. For this specialist assessment will be charged national variation fee





Type II standard





30357





7870



 

 





Mutual recognition, MRP, analogue country





Variation

The fee covers the MRP procedures. For this specialist assessment will be charged national variation fee





Type II complex





30358





13137



 

 





Mutual recognition, MRP, analogue country





Periodic safety update





Periodic safety update





40102





13.1376) mutual recognition, MRP, analogue country





Variation





Worksharing



 



The same fee as for variations, moreover,



 

 





Mutual recognition, MRP, analogue country





Veterinary SPC harmonisation





Fee for transfer of MT under national procedure for MRP after execution of the relevant variations





30417





70521



 

 















 







Procedure









Group









Case types









Delineation









Item No.









Application for









Fee exemption











MT









Extension











Item No.









Item No.









30354





30308







Decentralised procedure, ShipCountry





All excluding. traditional herbal medicines and homeopathic products





New application





New Applications





30376





160.1685)



 



8.896







Decentralised procedure, ShipCountry





New application
Bibliographic applications and fixed combination medicinal products





30378





160.1685)



 



8.896







Decentralised procedure, ShipCountry





New application





Synonym product (generic application, hybrid application and biological medicinal products similar to already approved drugs)





30377





148.7845)



 



8.896







Decentralised procedure, ShipCountry





New application





Parallel recording





30379





37.1955)



 



8.896







Decentralised procedure, ShipCountry





New application





Application rejected or withdrawn by applicant under validation





30381





13137



 

 





Decentralised procedure, ShipCountry





Extension





New indication or new species





30382





36818



 

 





Decentralised procedure, ShipCountry





Extension





New pharmaceutical form





30383





36818



 



8896







Decentralised procedure, ShipCountry





Extension





New strength





30384





34097



 



8896





















Procedure









Group









Case types









Delineation









Item No.









Application for









Fee exemption











MT









Extension











Item No.









Item No.









30402





30308







Decentralised procedure, reference country





All excluding. traditional herbal medicines and homeopathic products





New application





New applications





30392





251.8378)



 



8.896







Decentralised procedure, reference country





New application





Bibliographic applications and fixed combination medicinal products





30394





251.8378)



 



8.896







Decentralised procedure, reference country





New application





Synonym product (generic application, hybrid application and biological medicinal products similar to already approved drugs)





30393





233.7448)



 



8.896







Decentralised procedure, reference country





New application





Parallel recording





30395





72462



 



8896







Decentralised procedure, reference country





New application





Application rejected or withdrawn by applicant under validation





30397





13137



 

 





Decentralised procedure, reference country





Extension





New indication or new species





30398





56419



 

 





Decentralised procedure, reference country





Extension





New pharmaceutical form





30399





56419



 



8896







Decentralised procedure, reference country





Extension





New strength





30400





52244



 



8896





 



Variation
Worksharing



 



The same fee as for variations, moreover,



 

 





Decentralised procedure, reference country





Periodic safety update





40103





40103





13.1376)



 





1) Pr. D. sp. nr.

2) per d. SP. nr.

3) For this procedure is paid annual fees, as this is not already a marketing authorisation issued in Denmark.

4 the annual fee will be charged For this procedure) for the marketing authorisation issued in accordance with the national procedure.

5) For all pharmaceutical forms, strengths and indications subject to the proceeding. One fee per procedure.

6) per d. SP. nr.

7) per pharmaceutical form, strength, and indication (one fee per procedure).

8) For all pharmaceutical forms, strengths and indications subject to the proceeding. A fee per procedure.

9) per d. SP. nr.

10) application for renewal or variation of a drug approved by DCP should be classified as a MRP application























 

 

 

 







Procedure









Case types









Item No.









Application for









Fee exemption









Centralised procedure





Review of the parallel distribution of pharmaceuticals with a community marketing authorisation





30360







MT









Extension









6577



 

 



















Enterprises







 

 

 

 

 

 







Company









Case types









Delineation









Item No.









Application-





fee









Fee exemption









Enterprises





Handling of medicinal products and intermediate products





Fremstillling/

imports





50115





16329



 





Enterprises





Handling of medicinal products and intermediate products

According to section 13, paragraph 1 + 3





Fremstillling/

imports





50109





12936



 





Enterprises





Handling of medicinal products and intermediate products

According to section 13, paragraph 3





Fremstillling/

imports





50110





13426



 





Enterprises





Handling of medicinal products and intermediate products





Fremstillling/

imports





50112



 



16672







Enterprises





The manufacture of active substances for use in pharmaceuticals





Manufacture





50150





33649



 





Enterprises





The manufacture of active substances for use in pharmaceuticals





Manufacture





50151



 



33649







Enterprises





Handling of medicinal products and intermediate products





Wholesale distribution





50116





3980



 





Enterprises





Handling of medicinal products and intermediate products





Wholesale distribution





50111



 



3999







Enterprises





Importation and distribution of active substances for use in pharmaceuticals





Import/wholesale distribution





50152





11787



 





Enterprises





Importation and distribution of active substances for use in pharmaceuticals





Import/wholesale distribution





50153



 



11787







Enterprises





Dissemination of medicinal products





Dissemination





50154





9732
 





Enterprises





Dissemination of medicinal products





Dissemination





50155



 



9732







Enterprises





Negotiation of HV-branded products





Retail





50114





3427



 





Enterprises





Negotiation of HV-branded products





Retail





50136



 



3446







Enterprises





Negotiation of HV-branded products, while OTC medicines





Retail





50124





3980



 





Enterprises





Negotiation of HV-branded products, while OTC medicines (reduced fee by existing permission for over-the-counter medicines)





Retail





50119





495



 





Enterprises





Negotiation of HV-branded products, while OTC medicines





Retail





50135



 



3999







Enterprises





Distribution of medicines to animals outside the Pharmacy





Retail





50133





21110



 





Enterprises





Sale of OTC medicines outside pharmacies





Retail





50122





3489



 





Enterprises





Sale of OTC medicines outside pharmacies





Retail





50123



 



3489







Enterprises





Distribution of medicinal products for the treatment of nuisance by smoking cessation products





Retail





50129





310



 





Enterprises





Distribution of medicinal products for the treatment of nuisance by smoking cessation products





Retail





50130



 



310







Enterprises





Medical gases, gases for medical use





Retail





50131





3484



 





Enterprises





Medical gases, gases for medical use





Retail





50132



 



3510







Enterprises





Modification of OTC outlets to place of business after the Danish Medicines Act § 39, paragraph 1





Retail





50134





1763



 





Enterprises





GLP





All companies





50117





15899



 





Enterprises





GLP





All companies





50118



 



16245







Commodity producers





Control of raw material manufacturers





In countries outside the EU/EEA





50138





69772



 















 







Prices







 

 

 



 





Item number









Fee









Notification of new or changed the price on a gasket





60101





156







Withdrawal of a pack size





60101





156







Fee exemption, under the direction of pharmacies of consumer prices





60105





1452







Subscription for medicine prices for companies





60114





1452 ex. VAT