Ordinance On The Fees For Medicines, Etc.

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

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Read the untranslated law here: https://www.retsinformation.dk/Forms/R0710.aspx?id=122820

Overview (table of contents) Annex 1 The full text of the Ordinance on the fees for medicines, etc.

Pursuant to sections 103 and 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 Danish Medicines 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 Danish Medicines Agency 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 (annual fee).

9) Tasks resulting from the fact that a marketing authorisation issued by the Danish Medicines Agency 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 Danish Medicines Agency 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 Danish Medicines Agency 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 Danish Medicines Agency 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 producing raw materials for medicinal products must pay the fee to the Danish Medicines Agency of control pursuant to § 44 of the Danish Medicines Act, (2) or (5).

§ 5. 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 Danish Medicines Agency.

§ 6. The holder of the marketing authorisation for a pharmacy reserved for medicinal product shall pay a fee to the Danish Medicines Agency 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.





§ 7. The holder of the marketing authorisation for a medicinal product which is exempted from the pharmacy-reservations, must pay a fee to the Danish Medicines Agency 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.





§ 8. The pharmacist must pay an annual fee to the Danish Medicines Agency to cover the costs of medicines under the direction of pharmacies of consumer prices etc. of pharmacy-only medicines.

§ 9. 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 the Danish Medicines Agency'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 Danish Medicines 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.

§ 10. The fee for an application for marketing authorization for a medicinal product shall be increased by us $ 6,489., if the medicinal product 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 Danish Medicines Agency to control the company. Paid up to a maximum of one strength in each pharmaceutical form. Item number 30368.

(2). The fee for the application for the amendment of the marketing authorisation for a medicinal product shall be increased by us $ 6,489. 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 Danish Medicines Agency to control the company. Paid up to a maximum of one strength in each pharmaceutical form. Item number 30368.

(3). The annual fee shall be increased by us $ 6,489. 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 Danish Medicines Agency to check the company paid up to a maximum of one strength in each pharmaceutical form. Item number 30368.

§ 11. 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.

§ 12. The who at once submit multiple applications for amendment of marketing authorisation, without prejudice. section 1, paragraph 1, no. 7, to one or more drugs, more pharmaceutical forms or more forces, pays the full fee for the first variation and a reduced fee for each of the other variations, if the applications only leads to one academic assessment.

(2). The who at once submit multiple applications for amendment of marketing authorisation, without prejudice. section 1, paragraph 1, no. 7, to one or more drugs, more pharmaceutical forms or more forces, and applications only deals with administrative changes, usually pays the fee for the first variation and a reduced fee for each of the other variations.

§ 13. 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.

§ 14. 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 three months of the year shall not pay the fee pursuant to section 5 of that year.


§ 15. 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.

§ 16. 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 Danish Medicines Agency issues 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.

§ 17. 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, the Danish Medicines Agency also pays a processing fee on 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.

§ 18. 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.

§ 19. The Danish Medicines Agency may in exceptional cases be wholly or partly exempt from payment of the fee. Item No. 30371 fee exemption for partially exempted is products.

§ 20. The Danish Medicines Agency notifies the procedure for payment of fees pursuant to this order. The fee shall be paid to the Danish Medicines Agency not later than 1 month after order.

§ 21. The notice shall enter into force on the 1. January 2009.

(2). Executive Order No. 1416 of 13. December 2006 of charges for medicines and manufacturers of pharmaceuticals, intermediates and raw materials are hereby repealed.

(3). Executive Order No. 1418 of 13. December 2006 on the fee for review of prices, under the direction of pharmacies of prices at the pharmacy-only medicines as well as review of pack sizes on non-pharmacy-only medicines is lifted.
The Ministry of health and prevention, the 15. December 2008 Jakob Axel Nielsen/Paul Schüder Annex 1