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Law Amending The Law On Medicines And The Law On Medical Devices (Reinforcement Of Control Efforts, In The Case Of Illegal Drugs, Etc.) Reprinted Definitive Series

Original Language Title: Lov om ændring af lov om lægemidler og lov om medicinsk udstyr(Styrkelse af kontrolindsatsen, for så vidt angår ulovlige lægemidler m.v.) Omtryk

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Law on the amendment of the law on medicinal products and the law on medical equipment

(Strengthening of the control measures in the case of illegal medicinal products etc.)

We, by God's grace, the Queen of the Danes, do our thing.

The parliament has adopted the following law, and we know that the following law has been approved by Parliament's consent :

§ 1

Law no. 1180 of 12. In December 2005 on medicinal products, as amended by Section 81 of Law No 538 of eight. June 2006, section 1 of law no. 1557 of 20. In December 2006 and section 1 of the Law No 534 of 17. June 2008, the following changes are made :

1. I § 39, paragraph. 3, pasted as no. 5 :

" 5) Imports, export and storage of medicinal products as referred to in section 43 d. `

2. I § 39, paragraph. 4, the ' no. 1-4 " to : ONE-FIVE.

3. The following section 39 is added :

" § 39 a. The holder of a permit after paragraph 39 (5). 1, which, within the framework of its authorisation, wishes to negotiate medicinal products online for the users, shall inform the Board of Medicinal Products before or at the beginning of this debate at the beginning of this debate.

Paragraph 2. The governing board may lay down detailed rules on the content and form of the communication, including rules that the notification is to be sent electronically.

§ 39 b. It is not permitted for commercial providers of electronic communications networks or services for end users to disseminate access to an Internet domain from which, in violation of section 7, section 39, paragraph 7. Paragraph 1, or § 60 (2). 1, negotiated medicinal products for users, cf. however, paragraph 1 2.

Paragraph 2. The prohibition in paragraph 1. Paragraph 1 shall not apply where the Internet domain is owned by a service provider established in a country within the territory of the European Union or the EEA. `

4. I § 40, paragraph. 1, is inserted after no 1 :

" 2) Requirements for the requirements of no. 1 mentioned applications, including whether applications should be made electronically. ` ;

The second paragraph becomes number two. 3.

5. I § 40 inserted after paragraph 1. 3 as new paragraph :

" Stop. 4. The governing board may lay down rules for the dispatch of medicinal products to users for undertakings authorised in accordance with section 39 (5). 1, including rules concerning the special obligation of medicinal products to be carried out. `

Paragraph 4 becomes paragraph 4. 5.

6. I § 43 a, paragraph. 1, pasted as Act 2. :

" This does not apply to public hospitals. ` ;

7. I § 43 (b) (b) 1, the following medicinal product shall be inserted after ' medicinal products ` : `. However, section 43 ".

8. I § 43 b pasted as paragraph 3 :

" Stop. 3. The governing board may lay down rules on the content and requirements for the requirements referred to in paragraph 1. 2 the reports referred to, including notification of the electronic means. ` ;

9. Insert after section 43 c :

" § 43 d. The holder of a permit in accordance with section 7 may, in limited quantity, import and store medicinal products purchased in order to examine the presence of counterfeit medicines among the medicinal products covered by the authorization. ` ;

10. § 44 ITREAS :

" § 44. The governing board shall check compliance with requirements laid down in this Act and in accordance with the rules laid down in the law on content, quality and handling of medicinal products, intermediate products and commodities. The governing board shall, moreover, control compliance with § 40 a, paragraph 1. 3.

Paragraph 2. In order to carry out their control tasks in accordance with paragraph 1, 1 or in order to grant a request from another country within the European Union or the EEA, or from the European Commission or the European Medicines Agency, the representatives of the medicinal form of the Medicinal Management Board shall have the appropriate credentials and without a court order of access to :

1) Companies which are holders of a permit in section 7.

2) Companies which are holders of a permit in accordance with section 39 (4). One or two.

3) Undertakings producing raw materials used in the manufacture of medicinal products if the raw material is subject to rules laid down in Article 40 (1). 3.

Paragraph 3. Inspecting visits to undertakings referred to in paragraph 1. 2, no. Paraguation 1 and 3 may be carried out without prejudice if the Medical Agency has a reasoned request that the rules for the manufacture of medicinal products, intermediate products and raw materials are laid down in accordance with section 40 (4). 3, violation.

Paragraph 4. The governing board may, irrespective of the provision set out in paragraph 1, 2, no. 3, take inspection visits to an establishment producing raw materials used in the manufacture of medicinal products, if so requested. ` ;

11. The following section 44 is inserted :

" § 44 a. In order to carry out its control tasks in accordance with section 44 (2), 1, the FDA may charge free of charge against receipt of the receipt or require extraditing samples of medicinal products and products which are grounds for the consumption of medicinal products, including their packaging and package leaflets, intermediate products and commodities. The Management Board may also require all information and materials necessary for the control company.

Section 44 b. The governing board may give the holder of a permit in accordance with section 39 (5). 1 or 2, in order to amend the task (s), organisation, construction or operation, and establish a deadline for the implementation of the amendments to ensure compliance with the rules laid down in section 40 (1). Three, or § 40 b.

§ 44 c. The medicinal product may be subject to the seizure of medicinal products and products which are grounds for shipodgeable medicinal products to be traded to users in contravention of Clause 7, section 39, paragraph 1. Paragraph 1, or § 60 (2). 1. The governing board may also impound medicinal products and products which are grounds for the consumption of medicinal products which, contrary to the rules on the importation of private individuals, are to be imported from countries that are not a member ; by the EU or the EEA.

Paragraph 2. Poscation carried out pursuant to paragraph 1. 1 shall be carried out in accordance with Chapter 74 of the Court of Justice Chapter 74 of the Court of Justice. ` ;

12. § 45 a ITREAS :

" § 45 a. Whereas, in the course of negotiations with the minister concerned, the minister may lay down rules that representatives of authorities belonging to the relevant ministers are able to carry out checks on behalf of the Medicinal Board and to carry out their activities ; powers of section 44 (a) and (44 c) of this law. ONE, ONE. pkton shall be placed on the medical board for the purpose of ensuring the lawful distribution of medicinal products. ` ;

13. After Section 54 is inserted :

" § 54 a. The governing board may require the marketing authorization holder to publish to a medicinal product publishes or to a specific group of health professionals or hospitals emitting information on the medicinal product which serves patient safety ; purpose, including information about suspected side effects.

Paragraph 2. The governing board may make demands on the form and content of the management referred to in paragraph 1. 1 mentioned information. The governing board may also lay down a deadline for the publication or dispatch of the information. ` ;

14. The following section 56 is inserted :

" § 56 a. The Minister for Domestic and Health may lay down rules on requirements for reporting and periodic safety updates drawn up by holders of marketing authorisations after this chapter, including that it should be done electronically. ` ;

15. I § 66, paragraph. 2, the following shall be inserted after ' Pharmackonom ` : ', midwife, bio-analyst, clinical, clinical, radiograph '.

16. I § 72 pasted as paragraph 3 :

" Stop. 3. The governing board shall also inform the public where special health matters are, by the way, to make it necessary. In this respect, the governing board may, whatever the case may be, 2 publish the name of the legal or physical person who has committed an offence. ` ;

17. After § 92 is inserted in Chapter 11 :

" Requirements

§ 92 a. The Minister for Domestic and Health may lay down rules concerning the requirements for applications and information provided for in this Chapter, including that the application or notification shall be made electronically. ` ;

18. I § 93 pasted as paragraph 5 :

" Stop. 5. The governing board may lay down rules concerning the requirements for notification and applications pursuant to paragraph 1. 1 and 3, including notification or application shall be made by electronic means. ` ;

19. After paragraph 103 a is inserted :

" Chapter 14 a

Appeal access

§ 103 b. The Minister for Domestic Affairs and the Internal Affairs Minister may lay down rules on complaints against the decisions of the Medicinal Management Board, including rules on complaints. `

20. I § 104, paragraph 1. 1, no. 1, is inserted after "section 26," : " § 39 a, paragraph. One, and section 43 (a) (1). 1 ` shall be replaced by : ". 43 a, paragraph. ONE, ONE. Pkton, ".

21. I § 104, paragraph 1. 1, no. 4, in the words ' section 44 (4), TWO, TWO, FOUR. pkt., "to : section 44 a, section 44 b,", and after " § 53 (3). Paragraph 1 or paragraph 1. FIVE, TWO. pkt. ` shall be inserted : § 54 a, ".

22. I § 104, paragraph 1. 1, no. 5, in the words ' section 44 (4), TWO, ONE. pkt., " to : section 44 (4). TWO, "

23. I § 104 a, paragraph. 1, pasted as Act 2. :

Furthermore, the Ministry of Interior and the Health Minister may lay down rules that the claims of the confiscation of medicinal products seized pursuant to section 44 c may be adopted in the same way without legal proceedings. `

§ 2

Law no. 1046 of 17. In December 2002 on medical equipment, as amended by Section 109 of Law No 1180 of 12. In December 2005, the following changes are made :

1. I § 1 pasted as paragraph 3 :

" Stop. 3. The governing board may lay down rules governing the requirements for applications, notifications and notifications to be submitted to the Administrative Board by rules issued in accordance with paragraph 1. 1 and 2, including the application, notification or notification of electronic means. ` ;

§ 3

The law shall enter into force on 1. July, 2011.

§ 4

Entities providing medicinal products for sale online and which, before the entry into force of this law, have obtained a permit in accordance with section 39, paragraph 1. 1, in the case of medicinal products for the use of medicinal products for the use of medicinal products, no later than two months after the entry into force of the law, notify the Medicinal Board in accordance with section 39 a of the provisions of section 1 of this Act. 3, if the company continues to wish to negotiate medicinal products online.

§ 5

The law does not apply to the Faroe Islands and Greenland.

Givet at the Christiansborg Castle, the 18s. May 2011

Under Our Royal Hand and Segl

MARGRETHE R.

/ Bertel Haarder

Retryksnote
  • 24-08-2011 :
  • The law has been reprinted, since the text "Under Our Royal Hand and Segl" prior to the name of the Regent or Regent, due to an error in the technical production of the formula, was omitted. The failure therefore does not apply to the law.