Appendix 1

Annex to the notification of fees for medicinal products and so on.

Publication of fees for medicinal products and so on

In accordance with section 103 (1). 1, and section 103 a of Law No 1180 of 12. In December 2005 on medicinal products, as amended by law no. 1557 of 20. December 2006 and Law No 534 of 17. June 2008 shall be determined :

§ 1. The holder of the Board of Health for the approval of a medicinal product (marketing authorisation) is the holder of the marketing authorization for a medicinal product or parallel distributes a medicinal product, to pay the FDA to :

1) Application for the marketing authorisation issue.

2) Application for an extension of a marketing authorisation.

3) Application for the approval of additional pharmaceutical forms and forces.

4) Application for amendment of a marketing authorisation for the purpose of widening the indication of the area of origin, including a new animal species for medicinal products for animals.

5) Application for approval of a medicinal product which is identical to an already approved medicinal product, authorised by the holder of the existing authorisation (parallel registration).

6) Application for marketing authorisation for parallelior imports.

7) Application for someone other than those in number two. 4 mentioned changes in a marketing authorisation (variations).

8) Continuous product monitoring and control.

9) Tasks arising from the marketing authorisation issued by the Health Services as the basis for marketing authorisation in other EU-/EEC-countries (mutual recognition) shall be used.

10) Notification of parallel distribution on the basis of a Community marketing authorisation.

Paragraph 2. The provisions of paragraph 1. 1, no. 1 9, and § 10 12 apply to the applicant for the applicant for the Board of Health for the registration of traditional herbal medicinal products and homeopathic medicinal products and the holder of a registration of these medicinal products.

§ 2. The applicant for the approval of a pharmaceutical company or holder of such approval shall have to pay the FDA for :

1) Applications for the manufacture / import of medicinal products at one geographical location.

2) Application for authorisation for other types of handling of medicinal products at one geographical location.

3) Ongoing company control (annual tax).

§ 3. The holder of the authorization for the production / import of intermediate products or holders of such authorisation shall pay a fee to the Health Board for :

1) Applications for the production / import of intermediate products at one geographical location.

2) Applications for permits for other forms of handling of intermediate products at one geographical location.

3) Ongoing company control (annual tax).

§ 4. The applicant to be registered for medicinal products, or which has already been registered, shall pay a fee to the Health Board for :

1) Request for the registration of medicinal products at one geographical location.

2) Ongoing company control (annual tax).

§ 5. The applicant to be registered as a manufacturer, importer or distributor of active substances, or in the past, has been registered, shall pay a fee to the Health Board for :

1) Request for registration, such as the manufacturing, importer or distributor of active substances at one geographical location.

2) Ongoing company control (annual tax).

§ 6. The applicant for the approval and control of an undertaking making toxicological and pharmacological (non-clinical) tests in order to assess the safety of medicinal products shall be subject to the payment of the Board of Health at the cost of the health inspector.

§ 7. The holder of the marketing authorization to a medicinal product for the medicinal product shall pay a fee to the Health Board for :

1) Rectification of new or changed price on a packaging.

2) Withdrawal of a package size when the withdrawal occurs on the marketing authorization holder.

§ 8. The holder of the marketing authorization to a medicinal product exempted from apothecary reservations shall pay a fee to the Health Board for :

1) Notification of new or changed package size.

2) Withdrawal of a package size when the withdrawal occurs on the marketing authorization holder.

§ 9. The apothecary shall pay an annual fee to the Health Services to cover the costs of the health management notification by the pharmacies of consumer prices etc on pharmacist-reserved medicinal products.

Paragraph 2. The addition of a subscription to the price of medical fees for the trade should be paid an annual fee.

§ 10. The size of the fees is specified in Appendix 1, cf. however, Section 17.

Paragraph 2. The applicant for or holder of a marketing authorisation for a medicinal product shall pay the cost of the Health Board on a voyage and residence if the treatment of the application or control of the medicinal product, intermediate products or commodities necessitates, that the Board of Health inspects a company in a non-EU-/EEA country (non-member country).

Paragraph 3. Costs of travel and accommodation shall be made in accordance with the rules of the Ministry of Finance concerning the mission's mission.

§ 11. The fee for marketing authorization for a medicinal product shall be increased by 6.860 if the medicinal product is manufactured on a company outside the EU/EEA territory, and the relevant Community rules shall be responsible for verifying the control of the medicinal product on a company outside the EU/EEA territory. the company. However, a maximum of one strength shall be paid in each medicinal product. Item number 30369.

Paragraph 2. The fee for the application for a change to the marketing authorization for a medicinal product shall be increased by 6.860 if the manufacturing site of the medicinal product is changed to a company outside the EU/EEA territory, and the relevant Community rules shall be the responsibility of the Board of Health and Food Safety, to check the company. However, a maximum of one strength shall be paid in each medicinal product. Item number 30369.

Paragraph 3. The annual charge shall be increased by 6.860 kr. in the case of medicinal products manufactured outside the EU/EEA territory, and where the relevant Community rules apply to the Health Authority to check the company. However, a maximum of one strength shall be paid in each medicinal product. Item number 30368.

§ 12. If a medicinal product is approved, cf. Section 1 (1). 1, no. 1, 3 and 5, or if marketing authorization is issued to paralleliimports, cf. Section 1 (1). 1, no. 6, before the first nine months of the year, shall be paid full in accordance with section 1 (2). 1, no. 8, for the year in question. If the medicinal product is approved in the last three months of the year, no charge shall be paid after paragraph 1 (1). 1, no. 8, for the year in question.

Paragraph 2. By way of derogation from the date of approval of a medicinal product, a full fee shall be paid in accordance with section 1 (1). 1, no. 8, cf. ~ 10 (1)) Three, for the year in question.

§ 13. The applicant for the approval of the Health Management Board for the same change for several forms and forces in the same marketing authorisation, cf. Section 1 (1). 1, no. 7, pay full fee for the first variation and reduced the fee for each of the other variations if the application is a maximum of one professional assessment.

§ 14. The applicant for the authorization for the manufacture of medicinal products shall pay only that part of the application fee for the manufacture of medicinal products exceeding the application fee for a licence for wholessnegotiation, if the applicant is already in advance ; are authorised for the wholessals negotiation of medicinal products.

Paragraph 2. The applicant for the authorisation of the processing of small-time medicinal products or HV products shall not be required to pay for the application fees or the annual charge if the applicant is already authorized for the wholes-use of medicinal products.

Paragraph 3. The applicant for the authorization for the manufacture of medicinal products shall pay only that part of the application fee for the manufacture of medicinal products exceeding the application fee for authorisation for retailer, if the applicant is already in question ; are subject to authorisation for the detailed discussion of medicinal products.

§ 15. If a company is approved in accordance with the provisions of Article 39 of the medicinal product, 1, during the first nine months of the year, the payment shall be fully charged in accordance with section 2 (2). Three, for the year in question. If the undertaking is approved during the last three months of the year, it shall not be subject to payment in accordance with section 2 (2). Three, for the year in question.

Paragraph 2. If a company is approved in accordance with the provisions of Article 39 of the medicinal product, In the first nine months of the year, the payment shall be fully charged in accordance with section 3. Three, for the year in question. If the undertaking is approved during the last three months of this year, it shall not be subject to payment in accordance with section 3 (2). Three, for the year in question.

Paragraph 3. If a company is authorised under Article 85 (3) of the medicinal product, 1, during the first nine months of the year, it shall pay a full fee after paragraph 5 for the year in question. If the undertaking is granted authorisation during the last three months of the year, it shall not be subject to payment after section 5 of the year in question.

Paragraph 4. A company registered under Article 41 c of the medicinal product shall not be charged for the payment of the annual fee and the application fee in the same year.

Paragraph 5. A company registered after the 50 a manufacturer, the importer or distributor of the medicinal product, shall not be subject to the payment of the annual fee and the application fee in the same year.

§ 16. If an undertaking authorised to negotiate hand-purchase medicinal products outside the pharmacy is to be sought to negotiate products covered by the announcement of certain irons and vitamin preparations and certain anti-parasitic medicinal products, in the case of animals outside of pharmacy (where products are labelled), the difference between the fee for an application for authorisation for the negotiation of HV-labelled products and the application for authorisation to negotiate the trade in hand-purchase medicinal products outside the pharmacy shall be subject to the difference between the fee for authorisation to be negotiated by the HV.

§ 17. Entities covered by the announcement of the negotiation of small-pharmacy hand-over pharmacies and the announcement of the negotiation of certain irons and vitamin preparations and certain anti-parasitic medicinal products for animals outside the pharmacy should not be charged ; in section 2, no. 3, the year when the Board of Health shall issue the authorization in accordance with Article 39 (3) of the medicinal product. 1. Companies covered by section 15, shall, however, pay the annual charge for the negotiation of buyers outside of pharmacy in the year in question.

§ 18. Entities authorised to negotiate medicinal products for production animals after notification of the marketing of medicinal products to production animals out of the pharmacy, the fee shall be paid in accordance with section 2 (2). 3, in the form of an administrative fee, which amounts to 0,065%. by the distributor ' s circulation of medicinal products for production animals.

Paragraph 2. The people in paragraph 3. In addition, 1 above, the Board of Health shall pay an administrative fee of 0,77%. of the reproduction of medicinal products for production animals for the purpose of financing initiatives to strengthen food safety and animal welfare.

§ 19. A company that, at the beginning of the year, is in possession of a company permit, pays the full annual charge for the year in question.

20. The Board of Health may, in exceptional cases, be wholly or partially exempt from the payment of the fee. Item number 30371 is the year fee for partially exempted products. This year-end fee is 4,448 kr.

§ 21. The Board of Health shall notify the procedure for the payment of fees pursuant to this notice. The fees payable to the Board of Health shall be paid no later than one month after comment;.

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

Paragraph 2. At the same time, notice No 1348 of 14. December 2011 on fees for medicinal products and so on

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Appendix 1

Annex to the notification of fees for medicinal products and so on.