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Law Amending The Danish Medicines Act, The Act On Medical Equipment, Pharmacy Act, Health Law And The Law On The Marketing Of Health Services (Collaboration Between Health Professionals And The Pharmaceutical And Medical Business, Strengthening Transit...

Original Language Title: Lov om ændring af lægemiddelloven, lov om medicinsk udstyr, apotekerloven, sundhedsloven og lov om markedsføring af sundhedsydelser(Samarbejde mellem sundhedspersoner og lægemiddel- og medicoindustrien, styrket transitkontrol og overvågning af lægemidler,

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Law on the amendment of the pharmaceutical bill, the law on medical equipment, the apothecary law, the law of health and the marketing of health care 1)

(Collaboration between health-care professionals and medicinal products, strengthened transit control and supervision of medicinal products, access to medical potees to complete cytostatics for family animals and for the trade in raw materials, penalties for infringement of the rules on the placing on the market of health services 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

In the pharmaceutical bill, cf. Law Order no. 506 of 20. April 2013, the following changes are made :

1. Foot notation the title shall be replaced by the following :

" 1) The law provides for the implementation of parts of Directive 2001 /82/EC of the European Parliament and of the Council of 6. November 2001 establishing a Community code of veterinary medicinal products, the EC Official Journal of 2001, no. Paragraph 311, page 1, as amended by Regulation (EC) No, by the Regulation of the European Parliament and of the Council. 596/2009 of 18. June 2009, EU-Official Journal 2009, nr. In 188, page 14, parts of Directive 2001 /83/EC of the European Parliament and of the Council of 6. November 2001 establishing a Community code of medicinal products for human use, the Official Journal of the European Communities. In 311, page 67, as amended in particular by Directive 2010 /84/EU of 15. December 2010, EU Official Journal, nr. In 348, page 74, Directive 2011 /62/EC of 8. June 2011, EU Official Journal, nr. In 174, page 74, and Directive 2012 /26/EU of 25. Oct in October 2012, EU Official Journal, nr. In 299, page 1, parts of Directive 2001 /20/EC of the European Parliament and of the Council of 4. April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the application of good clinical practice through the conduct of clinical trials of medicinal products for human use, in the Official Journal of the European Communities, no. L 121, page 34, parts of Council Directive 90 /167/EEC of 26. March 1990 laying down the conditions for the preparation, marketing and use of feed medicinal products in the Community, the Community Official Journal of 1990, In 1992, p. 42, parts of Parliament and Council Directive 2004 /9/EC of 11. February 2004 on the inspection and verification of good laboratory practice (GLP), EU Official Journal 2004, nr. L 50, page 28, and parts of Directive 2004 /10/EC of 11. February 2004 on the approximation of legislation on the application of principles of good laboratory practice and control of their use in the case of chemical substances, the EU Official Journal 2004, nr. "L 50, page 44."

2. § 17 ITREAS :

" § 17. The Board of Health shall inform the European Medicines Agency, the European Commission and the pharmaceutical authorities of the other EU /EEA countries where the management of the Agency is based on the evaluation of information from pharmacovigilance,

1) consider suspending or revoking a marketing authorisation for a medicinal product for human beings ;

2) consider prohibiting the extradition of a medicinal product to human beings ;

3) contemdissing the extension of a marketing authorisation to a medicinal product for human beings ;

4) be informed by the holder of the marketing authorization for a medicinal product to people that, because of concerns regarding safety, the product has stopped the marketing of the medicinal product or has taken steps to renunciate himself ; the marketing authorization or intends to do so.

Paragraph 2. The Board of Health shall inform the European Medicines Agency, the European Commission and the pharmaceutical authorities of the other EU-/EEA countries where the management of the Agency for the evaluation of information from pharmacovigilance considers it necessary to have a new one ; contraindications, a reduction in the recommended dose or a reduction of the indications of a medicinal product for human beings. The notification of health management shall include information on the actions taken by the Board of Health and the reasons for the measures taken.

Paragraph 3. A quick procedure for dealing with a medicinal product subject to paragraph 1 shall be subject to paragraph 1 shall be provided by the Board of Health, if the medicinal product is authorized only for negotiation or extradition here in the country. If the medicinal product is approved for negotiation or extradition in more than one EU-/EEA country, the evaluation of the medicinal product after a specific EU emergency procedure shall be treated. The EU-emergency procedure must also be initiated for a medicinal product subject to paragraph 1. 2, if the Board of Health, a Medicinal Authority in one of the other EU /EEC-/EECs or the European Commission considers an emergency procedure necessary.

Paragraph 4. If the Health Board in the assessment of information from pharmacovigilance information with an immediate effect, a marketing authorisation shall be suspended for a medicinal product for human health, cf. Section 14, paragraph 14. 1, the Management Board shall inform the European Medicines Agency, the European Commission and the pharmaceutical authorities at the latest, by the European Medicines Agency, the European Commission and the pharmaceutical authorities in the other EU-/EEC/EC-countries on the suspension and justification

Paragraph 5. The Minister for Health and Prevention may lay down detailed rules on the treatment of medicinal products under paragraph 1. THREE, TWO. and 3. Pct. "

3. § 22 ITREAS :

" § 22. The holder of a marketing authorisation for a medicinal product for human beings shall inform the Board of Health, at the earliest opportunity, when the actual marketing of the medicinal product is actually placed on the market.

Paragraph 2. The holder of a marketing authorisation for a medicinal product for human health shall inform the Board of Health of a decision to suspend the placing on the market at least two months before the end of the marketing, unless available ; exceptional circumstances. The marketing authorization holder shall explain the decision, in particular, whether the decision is based on some of the reasons set out in section 14 (4). Paragraph 1 and paragraph. 2, no. One, and section 15.

Paragraph 3. The holder of a marketing authorisation for a medicinal product for animals shall inform the Health Service as soon as the marketing of the medicinal product is actually placed on the market, and when placing on the market is temporarily or permanently suspended.

Paragraph 4. Reporting to Pharmaceutical Prices, cf. section 82, and notification by the rules laid down in accordance with Article 78 shall be deemed to be subject to notification of paragraph 1. One and three. "

4. § 23 ITREAS :

" § 23. The holder of a marketing authorisation shall immediately inform the Board of Health of the measures taken with a view to

1) to suspend the placing on the market of a medicinal product ;

2) withdrawing a medicinal product from the market,

3) to request that a marketing authorisation be revoked, or

4) not apply to the extension of a marketing authorisation.

Paragraph 2. The marketing authorization holder shall be subject to notification in accordance with paragraph 1. 1 justify the decision, including in particular whether the decision is based on some of the reasons mentioned in section 14 (4). Paragraph 1 and paragraph. 2, no. One, and section 15.

Paragraph 3. The holder of a marketing authorisation for a medicinal product for human beings shall also immediately inform the European Medicines Agency if a decision is covered by paragraph 1. Paragraph 1 is based on some of the reasons mentioned in paragraph 14 (4). Paragraph 1 and paragraph. 2, no. One, and section 15. "

5. The following section 23 is inserted :

" § 23 a. The holder of a marketing authorisation for a medicinal product for human beings shall immediately inform the Board of Health and the European Medicines Agency if the holder has taken one or more of the measures referred to in section 23 (2). 1, in a country which is not a member of the European Union or with the EEA, and whose approach is based on some of the reasons mentioned in section 14 (4). Paragraph 1 and paragraph. 2, no. One, and section 15. "

6. § 26 ITREAS :

" § 26. The holder of a marketing authorisation issued by the Board of Health must, by means of a change to the product summary and the documents undergoing marketing authorization, the Commission Regulation on the treatment of the amendments to : the conditions of marketing authorisations for medicinal products for human use and veterinary medicinal products (variations application).

Paragraph 2. The holder of a marketing authorisation or a permit to parallelimport a medicinal product shall apply to the Board of Health for the approval of other changes in product summary and the documents undergoing the authorization than those which are : are referred to in the Regulation referred to in paragraph 1. 1.

Paragraph 3. In the case of changes to the Annexes to the Medical Redef Regulation, the marketing authorization holder shall, within 60 days of its publication, apply the Board of Health to make the necessary changes or ; even withdraw the marketing authorization. `

7. The following section 43 (b) pasted before the before section 44 :

" § 43 c. The one authorized in accordance with section 7 (2). Paragraph 1, or Section 39 (2). 1, in the conclusion of an agreement on the association of a doctor, a dentist or pharmacist to the establishment, inform the health workers of the section 202 (a) and 202 (202) rules of Health Law and of rules laid down in accordance with those provisions. This does not, however, apply to public hospitals.

Paragraph 2. The one authorized in accordance with section 7 (2). Paragraph 1, or Section 39 (2). 1, by submitting an undertaking to grant financial assistance to a health or other professional person for their participation in an ant activity abroad, inform the person of the rules of section 202 b and 202 c and on rules laid down in : pursuant to these provisions. This does not, however, apply to public hospitals.

Paragraph 3. The Minister for Health and Prevention shall lay down detailed rules on the obligation to provide information in accordance with paragraph 1. 1 and 2, including the publication of information on the form of such information. `

8. After Section 45 is inserted in Chapter 3 :

" § 45 a. The representatives of the Board of Health shall, at all times, be given appropriate credentials without a court order of access to all locations where there are medicinal products introduced in this country for the purpose of exporting to a country outside the EU/EEA, for the purpose of : to carry out checks to prevent counterfeit medicines from being put into circulation.

Paragraph 2. The Board of Health may impound medicinal products introduced in this country with a view to exports to a country outside the EU/EEA to prevent counterfeit medicines from being put into circulation.

Paragraph 3. Poscation carried out pursuant to paragraph 1. 2 shall be carried out in accordance with Chapter 74 of the Court of Justice of the Law of the Law on seizure.

Paragraph 4. To carry out its task of control in accordance with paragraph 1. 1, the Board of Health shall be free of charge against receipt of the payment or call for extraditing samples of medicinal products and products which are grounds for forging falsified medicinal products. ` ;

9. I § 66, paragraph. 2, the following shall be inserted after ' radiograf ` : ', social and health assistant '.

10. After paragraph 71 c is inserted in Chapter 7 :

" § 71 d. The association of patients and relatives whose purpose is to protect the interests of patients ' groups must publish what economic benefits they have received from pharmaceutical companies.

Paragraph 2. The Minister for Health and Prevention shall lay down detailed rules for publication in accordance with paragraph 1. 1. "

11. I § 104, paragraph 1. 1, no. 4, shall be inserted after ' Section 22, paragraph 1. 1, "2 or 3," and after "section 23," is inserted : "§ 23 a,".

12. I § 104, paragraph 1. 1, no. 4, is inserted after ' § 43 b (b), ONE, ONE. pkt., ` : ". 43 c (s). 1 or 2, and in accordance with paragraph 70 b (b), 6, ' shall be inserted : ' 71 d (1) (d) 1, "

§ 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, section 2 of Law No law no. 464 of 18. May 2011 and Law No 359 of 9. April 2013, the following changes are made :

1. Section 2 (2). 2, revoked.

2. After Section 2 is inserted :

" § 2 a. A manufacturer and an owner of a special business established in Denmark and market or reseller medical equipment at risk-class II (II) (II (II) or (III) or active, implant medical equipment in this country must give the Board of Health, notification of its business. A representative established in Denmark for a manufacturer of or an owner of a special store with medical devices at risk-load II (a, II (II) or III or active, implant medical equipment must also notify the Health Services Board of its notification ; Company.

Paragraph 2. The Minister for Health and Prevention may lay down rules on the obligation to be subject to notification under paragraph 1. 1.

Paragraph 3. The Minister for Health and Prevention may lay down the requirements for submission of notification in accordance with paragraph 1. 1, including submission of the submission of a digital digital file.

§ 2 b. Media companies established in Denmark must notify the Health Services Board of doctors, dentists, nurses and pharmacists who are associated with the company. The notification requirement applies to manufacturers who market medical equipment at risk-load II (a, II (II (II) or III, medical devices for in-vitro diagnostics or active, implant medical equipment, representatives of manufacturers of this type of product as well as importers and distributors of this type of products established in Denmark.

Paragraph 2. Special business with medical equipment established in Denmark shall notify the Board of Health of the doctors assigned to the company. The notification obligation applies to owners of special business owners who are distributing medical devices at risk-load II (a, II (II (II) or III, medical devices for in vitro diagnostics or active, implant medical equipment, and owners of owners of special business operations with this type of product established in Denmark.

Paragraph 3. The minister of health and prevention shall lay down rules on the obligation to be subject to notification under paragraph 1. One and two.

Paragraph 4. The Minister for Health and Prevention may lay down the requirements for submission of notification in accordance with paragraph 1. 1 and 2, including notification of the digital information.

§ 2 c. Companies covered by section 2 b (s). 1, in the conclusion of an agreement on the association of a doctor, dentist, nurse or pharmacist to the establishment, inform the health workers of the section 202 (a) and 202 (202) rules of health law and laying down rules laid down in accordance with those provisions.

Paragraph 2. Special business covered by Section 2 b (s). 2, in the conclusion of an agreement on the association of a doctor to the undertaking, the doctor shall inform the doctor of the rules laid down in section 202 (a) and 202 (202 (c) and the rules laid down in accordance with those provisions.

Paragraph 3. In the case of an undertaking to grant financial support to a health or other professional person to participate in an activity abroad, the media must inform the person of the rules of section 202 b and 202 c and, if any, rules laid down in accordance with these provisions.

Paragraph 4. The Minister for Health and Prevention shall lay down rules on the obligation to provide information under paragraph 1. 1-3, including the publication of information on the management of the management board.

§ 2 d. The Minister for Health and Prevention may lay down rules on the advertising of medical equipment, economic benefits or any other approach that can contribute to the promotion of sales and the supply of medical equipment.

Paragraph 2. The Minister for Health and Prevention may lay down rules that the Board of Health at the request of undertakings shall give an opinion on its views on the legality of proposed advertising measures.

§ 2 e. The associations of patients and relatives whose purpose is to serve patients ' interests must publish what economic benefits they have received from media companies.

Paragraph 2. The Minister for Health and Prevention shall lay down detailed rules for publication in accordance with paragraph 1. 1. "

3. Section 6 (2). 1, ITREAS :

" The penalty shall be punished by the penalty which violates Article 1 (c). Paragraph 1, or Section 2 (a), 1 or fail to comply with the post-1 (2) (d) of the health board. THREE, TWO. pkt., section 5 or § 5 a, unless higher penalty is inflicted on other legislation. In addition, the person who denies the representatives of the Board of Health shall be punished in accordance with section 1 (1) (1). THREE, ONE. Pct. "

4. Section 6 (2). 1, ITREAS :

" The penalty shall be punished by the penalty which violates Article 1 (c). Paragraph 1, section 2 (a), 1, section 2 (b) (b). 1 or 2, section 2 (c), 1, 2 or 3, or § 2 e (3). 1 or fail to comply with the post-1 (2) (d) of the health board. THREE, TWO. pkt., section 5 or § 5 a, unless higher penalty is inflicted on other legislation. In addition, the person who denies the representatives of the Board of Health shall be punished in accordance with section 1 (1) (1). THREE, ONE. Pct. "

§ 3

In the apothecary, see. Law Order no. 855 of 4. In August 2008, as amended in particular by Section 1 of Act 1. A hundred of 10. Feb, 2009, bill. 465 of 18. May 2011 and section 2 of the law. 1259 of 18. December 2012 and no later than Section 2 of Law No 63 of 29. January 2013, the following changes are made :

1. Section 3, paragraph 3. 2-4, revoked.

2. I Section 13 (1). TWO, TWO. pkt., " § 56 (2) The fifth shall be : section 56 (5). 7 ".

3. I Section 22 (2). 1, no. 3, in section 15, paragraph 1 shall be amended. 4, no. 1 and 2 ` shall be : ' 15, paragraph 1. 5, no. One and two.

4. Section 22 (2). 1, no. 4, ITREAS :

" 4) where the holder of section 6 of the law on health care professionals and on health professional activities applicable to the practice of pharmacist activities, or Article 79 of the bourgeo penal code, loses the right to run the pharmacy and '.

5. I § 56, paragraph. 3, pasted as Act 2. :

' The same shall apply to cytostatics for individual family animals. ` ;

6. I § 56 pasted as paragraph 8 :

" Stop. 8. A medical corpsman may be able to use the medicinal products produced in accordance with paragraph 1. 1, sell the quantities of active substances, formulants and packaging to other nursing pods. ` ;

7. § 61 revoked.

§ 4

In the health code, cf. Law Order no. 913 of 13. July 2010, as last amended by law no. 344 of 7. April 2014, the following changes are made :

1. The following Chapter 61 is inserted :

" Chapter 61 a

Industrial cooperation

§ 202 A. Doctors, dentists and pharmacists must not, without the authorisation of the Board of Health, operate or be linked to a pharmaceutical company authorized by Article 7 (7) of the medicinal product. Paragraph 1, or Section 39 (2). 1, unless the association is subject to the notification requirement in accordance with paragraph 1. 3. This does not apply to public health hospitals.

Paragraph 2. Doctors, dentists, nurses and pharmacists must not, without the permission of the Board of Health, operate or be linked to a media company covered by the Act on medical equipment, section 2 b (3). 1, unless the association is subject to the notification requirement in accordance with paragraph 1. 3.

Paragraph 3. Healthcare workers are covered by paragraph 1. 1 and 2 may be associated with a medicinal product or media services following prior notification to the Board of Health, the association of which consists of :

1) tasks of teaching or research ; or

2) possession of shares or other securities to a value of not more than DKK 200. at each establishment at the time of acquisition.

Paragraph 4. Doctors can drive or be associated with a special business covered by law on medical equipment § 2 b (s). 2, following prior notification to the Board of Health.

Paragraph 5. The Minister for Health and Prevention shall lay down rules on the conditions for obtaining an authorization pursuant to paragraph 1. One or two.

Paragraph 6. The Ministry of Health and Prevention may lay down rules on the information to accompany applications and requirements for applications and notifications pursuant to paragraph 1. 1-4, including application and review to be digitally.

202 b. Health professionals and certain professionals from the purchasing and sales links of medicinal products and medical equipment must make notification to the Board of Health when they receive financial support from a medicinal product or media coon for participation in Fagretenant activities abroad.

Paragraph 2. The Minister for Health and Prevention shall lay down rules concerning the trade in medicinal products and pharmaceuticals for medicinal products and medical devices to be covered by paragraph 1. 1.

Paragraph 3. The Minister for Health and Prevention may lay down requirements for notification under paragraph 1. 1, including notification, must be done digitally.

§ 202 c. The Board of Health shall publish on its website all authorisations and notifications in accordance with section 202 (a) and 202 b.

Paragraph 2. The Minister for Health and Prevention shall lay down rules on content and form of publication in accordance with paragraph 1. 1, including the details of the information to be published and how long they shall be published.

§ 202 d. The Board of Health may check that the requirements of section 202 (a) (i) are checked. One-four, respected. In addition, the Board of Health may verify compliance with requirements laid down in accordance with section 202 (a) (1). 6.

Paragraph 2. The Board of Health may provide health care professionals to supply all information, including written material necessary for the control establishment in accordance with paragraph 1. 1. "

2. I § 272 the following shall be inserted after ' after ' : ' § 202 (a) (1). 1-4, section 202 b, paragraph 1. One, or ".

§ 5

Law no. 326 of 6. May 2003 on the marketing of health services, as amended by law no. 360 of 9. April 2013, the following change is made :

1. Section 5 (5). 1, ITREAS :

" Intireation of section 2, paragraph. 1-3, 5 and 6, and section 3, paragraph 3. 2 and 3, and failure to comply with an injunction in accordance with section 4 (4). 5 and 6 shall be punished by fine. `

§ 6

Paragraph 1. The law shall enter into force on 1. June 2014, cf. however, paragraph 1 2.

Paragraph 2. § 1, no. 7, 9, 10 and 12, section 2, nr. 1, sections 2 b-2 e in the law on medical equipment, as drawn up by this law's section 2, no. 2, section 2, no. 4, section 3, no. Number one, section 4, number. 1 and 2, enter into force on 1. November 2014.

Paragraph 3. A manufacturer of medical equipment and an owner of a special business which distributor medical equipment, or their representatives established in Denmark on 1. June 2014 shall notify the Board of Health of the information set out pursuant to section 2 (a) (1). Two, in medical equipment, no later than 1. October 2014.

Paragraph 4. The doctors, dentists, nurses, or apothecaries, there's that one. November 2014 has an association with a medicinal product or media company or special business covered by the health insurance section 202 (a) (2) (a). 1 4, as drawn up by the section 4 of this law. 1, may after notification to the Board of Health at the latest by 1. April 2015 continue to be such a link.

Paragraph 5. The health or other professional persons who before 1. November 2014 has concluded an agreement with a medicinal product-or media-company on financial support for participation in an offshore activity that takes place after that date, which is covered by the section 202 b (1) of the Health Code. 1, as drawn up by the section 4 of this law. 1 shall not later than 1. In April 2015, notification of this to the Board of Health.

§ 7

Paragraph 1. The law does not apply to the Faroe Islands and Greenland, cf. however, paragraph 1 2.

Paragraph 2. sections 4 and 5 may, by means of a royal contraption, be fully or partially set in force for the Faeroe Islands, with the changes that the ferotable conditions are attributable.

Givet at Christiansborg Castle, 26. May 2014

Under Our Royal Hand and Segl

MARGRETHE R.

/ Nick Hood up

Official notes

1) The law provides for the implementation of parts of the Directive 2011 /62/EC of the European Parliament and of the Council of 8. June 2011 amending Directive 2001 /83/EC on the establishment of a Community code on medicinal products for human use in the prevention of falsified medicinal products into the legal supply chain, 2011 EU Official Journal. In 174, page 74, and parts of Directive 2012 /26/EU of the European Parliament and of the Council of 25. October 2012 amending Directive 2001 /83/EC in relation to pharmacovigilance, 2012 EU Official Journal. L-299, page one.