Law Amending The Law On Drugs, The Law On Pharmacy Business And The Danish Tissue Act (Strengthened Efforts Against Illegal Drugs, Etc.)

Original Language Title: Lov om ændring af lov om lægemidler, lov om apoteksvirksomhed og vævsloven(Styrket indsats mod ulovlige lægemidler m.v.)

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Read the untranslated law here: https://www.retsinformation.dk/Forms/R0710.aspx?id=117486

Law amending the law on drugs, the law on pharmacy business and the Danish tissue Act 1)

(Strengthened efforts against illegal drugs, etc.)

WE, MARGRETHE the SECOND, by the grace of God Queen of Denmark, do indeed:

The Danish Parliament has adopted and we know Our consent confirmed the following law:

§ 1

In Act No. 1180 of 12. December 2005 on medicinal products, as amended by section 81 of the Act No. 538 of 8. June 2006 and article 1 of law No. 1557 by 20. December 2006, shall be amended as follows:

1. In the footnote to the title of the Act shall be deleted no later than ', and ' after ' (the official journal of the European Union 2004 nr. L 136, p. 34) ' reads ' and the latest by European Parliament and Council Regulation (EC) No 1782/2003. 1394/2007 of 13. November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 1782/2003. 726/2004 (Official Journal 2007 nr. L 324, p. 121) '.

2. Under section 4 is inserted:

» section 4 (a). Notwithstanding section 3, paragraph 1, and section 4, paragraph 2, the provisions of the Act do not apply to advanced therapy medicinal products which are manufactured in a hospital in Denmark specifically tailored to an individual patient after individual order of a doctor. '

3. In section 30, 1. paragraph, shall be replaced by ' Denmark's Food Research ' to: ' Veterinary Institute at the Technical University of Denmark '.

4. Under section 43 shall be inserted before the heading ' controls and inspections ' means ' section 43 (a). The holder of a permit under section 7 or § 39, paragraph 1, shall give the Danish Medicines Agency notice of physicians, dentists and pharmacists who are affiliated with the company.

(2). The Minister for health and prevention sets out rules on the obligation, including rules requiring that notice must be given by electronic means.

Counterfeit medicines

section 43 (b). There may not be the manufacture, import, export, storage, distribution, or dispensing of counterfeit medicines.

(2). The holder of a permit pursuant to section 7 and section 39, paragraph 1, shall immediately report the findings in the company of counterfeit medicines to the Danish Medicines Agency. For holders of a permit pursuant to section 7 and the holders of a permit for the manufacture of medicinal products applies to the reporting obligation also finds outside of their company as they gain knowledge of.

section 43 (c). The Danish Medicines Agency suspected discovery of a counterfeit drug to disclose all information about the discovery of a counterfeit drug to the holder of the marketing authorisation for the medicinal product specific, named, as the counterfeit drug is identical to. '

5. section 44 (1), (2). paragraph, shall be repealed, and replaced by: ' the Danish Medicines Agency also verifies that the medicines, a company with permission under section 39 (1), dealer or extradite, is covered by a marketing authorisation, without prejudice. § 7, or authorization in accordance with sections 29, 31 or 32. The Danish Medicines Agency also verifies compliance with section 40 (a), paragraph 3, and section 43 (b). '

6. In article 44, paragraph 2, 3. paragraph shall be added after ' information ': ' and materials '.

7. After section 45 shall be inserted before the heading "prohibition of distribution and dispensing ': ' paragraph 45 (a). The Minister for health and prevention can, after negotiation with the concerned minister lay down rules to the effect that representatives of authorities, under the purview of the relevant portfolio Ministers, on behalf of the Danish Medicines Agency may carry out controls in order to ensure the legal distribution of drugs. '

8. Under section 46 shall be inserted before the heading ' ban on the manufacture and import ': ' paragraph 46 (a). The Danish Medicines Agency may require the distribution and dispensing of a medicinal product which is not covered by a marketing authorisation, without prejudice. § 7, or other permissions for sale or dispensing of medicinal products referred to in article 6. §§ 29-32, brought to an end, and may order that it be withdrawn from the market. '

9. section 49 shall be replaced by the following: ' § 49. Health-care professionals and other personnel, including ambulance drivers who are established or employed in another EU/EEA country and requested assistance to accidents and disasters in this country by virtue of bilateral agreements with neighbouring countries or in pursuance of a Nordic health contingency agreement, can, to a limited extent, bring in drugs from the home country to use for the pre-hospital. Such medications may be taken, notwithstanding the fact that each drug is not covered by a marketing authorisation in Denmark, when the medicinal product is authorised in the country where health person, etc. has established or engaged. '

10. section 77, paragraph 2 is replaced by the following: ' (2). The Minister for health and prevention may lay down rules on notification pursuant to paragraph 1, including any minimum threshold for changes of Pharmacy indkøbspriser for medicinal products for human use, and form requirements for review, including that review must be done electronically. '

11. section 78, paragraph 4 is replaced by the following: ' (4). The Minister for health and prevention may lay down detailed rules for notification to the Danish Medicines Agency under paragraphs 1-3, including a minimum threshold for changes of apo teks into the purchase prices for medicines, and the requirements for notification, including the notification shall be effected by electronic means. '

12. In section 103, paragraph 1, no. 6, shall be inserted after ' approval of «:» and charge control '.

13. In article 104, paragraph 1, no. 1, the words ' 7.0 ' and ' § § 39, paragraph 1 or 2 ' and after ' § 43.0 ' reads ' section 43 (a), paragraph 1, and section 43 (b) (2) '.

14. In section 104 shall be inserted after paragraph 1 as new paragraph: "(2). Unless a higher penalty is inflicted upon the rest of the law are punishable by fine or imprisonment up to 1 year and 6 months the infringing section 7, section 39 (1) or (2) or section 43 (b) (1) or fails to comply with an injunction issued under section 46 (a). '




Paragraphs 2 and 3 shall become paragraphs 3 and 4 hereafter.



§ 2

The law on pharmacy company, see. lovbekendtgørelse nr. 657 of 28. July 1995, as amended, inter alia, by law No. 1042 by 23. December 1998 and, most recently, by section 2 of Act No. 1557 by 20. December 2006, shall be amended as follows:

1. In article 3, paragraph 2, shall be replaced by ' consent ' to: ' authorization '.

2. In article 3, paragraphs 2 and 3, the words ' section 39 (1) or 2.0 ' to: ' section 7 or section 39 (1) '.

3. In paragraph 3 shall be inserted in paragraph 4:

' (4). Permissions pursuant to paragraph 2 or 3, shall be published on the Agency's website. '

4. In article 11, paragraph 1, the following is inserted as a no. 13:

» 13) immediately reporting to the Danish Medicines Agency of finds at the pharmacy of counterfeit medicines, see. section 43 (b), of the law on medicinal products. '

5. In article 65, paragraph 1, shall be inserted after 1. paragraph: ' the Danish Medicines Agency further oversight and monitoring of the medicinal products marketed from pharmacy units, is covered by an authorisation in accordance with §§ 7, 29, 31 or 32 of the law on medicinal products and are not covered by the prohibition provided for in section 43 (b), paragraph 1, of the same law. '



§ 3

In Act No. 273 of 1. April 2006 about the quality and safety requirements for the handling of human tissues and cells (tissue Act) is amended as follows:

1. In the footnote to the title of the Act shall be added after ' (Official Journal 2004, nr. L 102, p. 48) «:» and parts of the European Parliament and Council Directive 2001/83/EC on the Community code relating to medicinal products for human use (Official Journal of the European Communities 2001 nr. L 311, p. 67), as amended most recently by the European Parliament and of the Council Regulation (EC) No 1782/2003. 1394/2007 of 13. November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 1782/2003. 726/2004 (Official Journal 2007 nr. L 324, p. 121) '.

2. In article 2, paragraph 1, the following is inserted as a 2. item:




» The law applies also for the sale and delivery of hospital-made advanced therapy medicinal products, see. Chapter 4 (a). '



3. Under section 11 is added:

» Chapter 4 (a)

Sale and delivery of hospital-made advanced therapy medicinal products

section 11 (a). Advanced therapy medicinal products which are manufactured in a hospital in Denmark specifically tailored to an individual patient after individual order of a physician, see. the Danish Medicines Act section 4 (a), shall only be sold or dispensed for use for patient treatment, when the Danish Medicines Agency has issued a compassionate to the attending physician.

(2). The Danish Medicines Agency may attach conditions to the permit and may revoke the authorization, if these conditions are not complied with or acting serious problems with the quality, safety or efficacy of the medicinal product, including serious side effects. '

4. section 13, paragraph 1 is replaced by the following: ' TES and procurement organisations shall report information about serious adverse events and serious adverse reactions in receiver that can have an influence on or associated with the quality and safety of tissues and cells, to the Danish Medicines Agency. The reporting obligation includes the events and reactions, which can be attributed to the procurement, testing, processing, storage or distribution of human tissues and cells '.



5. In article 13, paragraph 2, the words ' serious adverse events ' to: ' serious adverse reactions in donors '.

6. In article 14, paragraph 1, insert after no. 2 as a new number: ' 3) Sale or dispensing of medical manufactured advanced therapy medicinal products. '




No. 3 is then no. 4.



7. In article 17, paragraph 2, the words ' serious adverse events ' to: ' serious adverse reaction '.

8. In article 21, paragraph 1, no. 1, section 5 shall be added after ', ': ' section 11 (a) (1) '.

§ 4

The law shall enter into force on the 1. July 2008.

§ 5

The law does not apply to the Faroe Islands and Greenland Given at Christiansborg Palace, on 17 March. June 2008

MARGRETHE r./Jakob Axel Nielsen Official notes 1) Act contains provisions implementing parts of a European Parliament and Council Directive 2001/83/EC on the Community code relating to medicinal products for human use (Official Journal of the European Communities 2001 nr. L 311, p. 67), as amended most recently by the European Parliament and of the Council Regulation (EC) No 1782/2003. 1394/2007 of 13. November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 1782/2003. 726/2004 (Official Journal 2007 nr. L 324, p. 121).