Law on the amendment of the law on medicinal products and tissue slots 1)

(Monitors for pharmacovigilance)

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. December 2006, section 1 of law no. 534 of 17. June 2008, section 1 of law no. 464 of 18. May 2011 and section 46 of the law. 593 of 14. June 2011, 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. April 2001 establishing a Community code of veterinary medicinal products, the Official Journal of the European Communities, 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. April 2001 establishing a Community code of medicinal products for human use, the Official Journal of the European Communities, no. In 311, page 67, as amended in particular by Directive 2010 /84/EU of 15. December 2010, EU Official Journal, nr. L 348, page 74, 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. § 9 ITREAS :

" § 9. The Board of Health may attach conditions to the marketing authorization in the context of its issue.

Paragraph 2. In the case of special circumstances, the Management Board may also establish conditions for a marketing authorisation following its issue.

Paragraph 3. The Minister for Health and Prevention shall lay down rules on the health management assessment of conditions as set out in accordance with paragraph 1. 1. "

3. I § 15 pasted as paragraph 2 :

" Stop. 2. The Board of Health may amend, suspend or revoke a marketing authorisation for a medicinal product for human beings,

1) the medicinal product is not produced in accordance with the description of the manufacturing method, as shown in the application for marketing authorization and subsequent amendments thereto ; or

2) the marketing authorization holder does not carry out checks in accordance with the control methods laid down in the application for the marketing authorization and subsequent amendments thereto. ` ;

4. § 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 when rapid action is considered necessary as a result of the evaluation of information from pharmacovigilance, if :

1) The Board of Health is considering suspending or revoking a marketing authorisation for a medicinal product for human beings ;

2) The Board of Health is considering banning the provision of a medicinal product for human beings ;

3) The Board of Health is considering rejecting the renewal of a marketing authorisation for a medicinal product for human beings ;

4) The health management of the marketing authorization holder of a medicinal product for human rights shall be informed that the safety of the medicinal product has stopped the marketing of the medicinal product or has taken steps to renunciate himself ; the marketing authorization or intends to do so ; or

5) The Board of Health considers it necessary to have a new countersign, a reduction in the recommended dose or a reduction in the indications of a medicinal product for human beings.

Paragraph 2. 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 assessment of the medicinal product after a special European Union emergency procedure shall be treated.

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

Paragraph 4. If the Board of Health, with an immediate effect, is to suspend a marketing authorisation for a medicinal product for human health, cf. Section 14, paragraph 14. 1, as a result of the evaluation of information from pharmacovigilance, the Management Board shall inform the European Medicines Agency, the European Commission and the pharmaceutical authorities at the latest the European Medicines Agency, the European Commission and the pharmaceutical authorities in the other EU/EEA countries. `

5. The following section 17 is inserted :

" § 17 a. The Board of Health shall inform the European Medicines Agency if the Management Board initis a case of suspension or withdrawal of a marketing authorisation for a medicinal product for human beings.

Paragraph 2. The Board of Health shall inform the European Medicines Agency, the pharmaceutical authorities of the other EU/EEA countries and the marketing authorization holder if any new or modified risks or alterations in the relationship between benefits and risks are shown ; Medium.

§ 17 b. The Board of Health shall inform the European Medicines Agency if the Management Board initials a case of suspension or withdrawal of a marketing authorisation to a medicinal product for animals.

Paragraph 2. If the Board of Health, with an immediate effect, shall suspend a marketing authorisation to a medicinal product for animals to protect human and animal 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 Medicinal Products Agency, the Commission and the pharmaceutical authorities in the other EU/EEA countries.

6. I § 21 pasted as paragraph 2 :

" Stop. 2. The holder of a marketing authorisation for a medicinal product for human beings must update the information in the product's product summary, package leaflet and labelling with the current knowledge, including conclusions of assessments and recommendations published on ; The web portal of the European Medicines Agency on Medicinal Products. '

7. § 25, paragraph. 1, ITREAS :

' The holder of a marketing authorisation for a medicinal product shall immediately inform the Board of Health of any material new information relating to the relationship between the benefits and risks of the medicinal product which are not of the form to be informed of the steering system in accordance with the procedure for : approval of changes to marketing authorisations or in the form of periodic security updates ; If information is concerned with a medicinal product for human beings, the information must also be carried out to the European Medicines Agency. `

8. § 27, paragraph. 2 and 3, ITREAS :

" Stop. 2. The Board of Health may extend the marketing authorization if the relationship between benefits and risks remains favourable. A marketing authorization which has been extended has a limited period of validity, cf. however, paragraph 1 3 and section 14-16.

Paragraph 3. The Board of Health may decide that the marketing authorization may be extended only for a period of five years if the relationship between the benefits and risks of the medicinal product is attributable to it, including as a result of the evaluation of information from pharmacovigilance. ` ;

9. I § 27 pasted as paragraph 4 and 5 :

" Stop. 4. An application for the extension of a marketing authorisation to a medicinal product for human beings must be submitted to the Health Care Board of the marketing authorization holder no later than nine months before the expiry of the authorisation.

Paragraph 5. An application for the extension of a marketing authorisation to a medicinal product for animals shall be submitted to the Health Care Board of the marketing authorization holder no later than six months before the expiry of the authorisation. ` ;

10. § 34, no. 5, ITREAS :

" 5) The health management processing of cases of marketing authorisations and information to the European Medicines Agency on the conditions laid down in the case of the management of the management board. `

11. I § 44 pasted as paragraph 5 :

" Stop. 5. The control tasks of the health management service shall be carried out in cooperation with the European Medicines Agency. The Board of Health shall exchange information to the Agency on planned and completed inspections. ` ;

12. I § 46 inserted after paragraph 1. 2 as new paragraph :

" Stop. 3. In exceptional circumstances, in a transitional period, the Board of Health may authorize the extradition of a medicinal product after 29 to patients in treatment with the medicinal product concerned, even though the medicinal product is subject to a prohibition or an injunction in accordance with paragraph 1. 1. "

Paragraph 3 becomes paragraph 3. 4.

13. § 53 ITREAS :

" § 53. The holder of a marketing authorisation for a medicinal product shall :

1) use a pharmacovigilance system to monitor the safety of the medicinal product, assess the possibility of risk inimmation and, if necessary, take appropriate measures,

2) conduct a detailed description of the pharmacovigilance system and, on request, make a copy of the description available to the Health Services, cf. however, paragraph 1 2,

3) keep records of suspected adverse reactions,

4) make the records available to the Board of Health,

5) report information on suspected adverse reactions to the Health Services or the European Medicines Agency,

6) prepare and submit periodic security updates to the Health Services ; and

7) have a court of experts in the field of pharmacovigilance residing in the European Union.

Paragraph 2. Paragraph 1, no. Two, do not apply to medicines for animals.

Paragraph 3. In the case of pharmacovigilance, the Board of Health may require the marketing authorization holder to designate a medicinal product to designate a contact person in Denmark for the person referred to in paragraph 1. 1, no. Seven, referred to experts.

Paragraph 4. The minister of health and prevention shall lay down rules on the rules laid down in paragraph 1. 1 Obligations of the marketing authorization holder, including concerning the reporting of suspected adverse reactions, in Denmark or a country outside the EU and the EEA, and the professional knowledge, business area and contact of the person concerned ; experts in the field of pharmacovigilance.

Paragraph 5. The Board of Health shall check that the requirements of paragraph 1 are Paragraph 1 and the rules laid down in accordance with paragraph 1 shall apply. Four is respected. In addition, the Board of Health controls compliance with the requirements for pharmacovigilance in EU legislation laying down Community procedures for the authorisation and surveillance of medicinal products for human and veterinary medicinal products, etc.

Paragraph 6. The representatives of the Board of Health shall have the right and without a court order of access to undertakings with a view to implementing it in paragraph 1. 5 mentioned checks. The Board of Health may invite undertakings to supply all information, including written material, necessary for the control establishment.

Paragraph 7. The Board of Health shall inform the European Medicines Agency, the European Commission, the pharmaceutical authorities of the other EU/EEA countries and the marketing authorization holder, if the management board comes to conclude that the holder of the holder of the authorization is concluded ; the marketing authorization does not follow the pharmacovigilance system specified in the description of the system, cf. paragraph 1, no. TWO. "

14. § 54 ITREAS :

" § 54. The holder of a marketing authorisation for a medicinal product for human beings shall not without prior or, at the same time, notification to the Board of Health, the European Medicines Agency and the Commission to publish information on matters relating to : the security of the medicinal product based on pharmacovigilance.

Paragraph 2. The holder of a marketing authorisation for a medicinal product for animals shall not, without prior or at the same time, inform the Board of Health Information on the safety of the medicinal product based on pharmacovigilance.

Paragraph 3. Information referred to in paragraph 1 1 and 2 shall be presented in an objective and not misleading manner. ` ;

15. § 56 ITREAS :

" § 56. The Board of Health shall use a pharmacovigilance system to monitor the safety of the medicinal products and shall keep a register of adverse reactions. The Minister for Health and Prevention shall lay down detailed rules on the processing of the health management of the reported information and the treatment of periodic security updates.

Paragraph 2. The Board of Health may provide information on the reporting of adverse reactions to the European Medicines Agency, the European Commission, the pharmaceutical sector in the other EU/EEA countries, the patient delivery and marketing authorization holder. The Minister for Health and Prevention shall lay down detailed rules on this. ` ;

16. I § 62 (2) 1, are deleted ' subject to a Community marketing authorisation `.

17. § 72, paragraph. 1, ITREAS :

The Board of Health shall make the following information available to the public on the Health Board's website, cf. however, paragraph 1 2 :

1) The health management decisions on issue, suspension and revocation of marketing authorisations.

2) Terms and Conditions Associated to Marketing Permissions in accordance with section 9 (4). 1 and 2, and details of any deadline for fulfillment of the terms and conditions.

3) Health Services authorised product sumes for medicinal products have been approved by the Board of Health.

4) An assessment in Danish or English of the material for marketing authorisations issued by the Board of Health, in the form of a public evaluation report. For medicinal products for human marketing to human beings, a Danish or English summary of the evaluation report shall also be published.

5) Supplementary notes for medicinal products subject to a marketing authorisation in this country.

6) Summary of risk management plans and programmes for medicinal products for human beings.

7) The list of medicinal products subject to additional surveillance within the European Union, cf. Article 23 of Regulation (EC) No, The 726/2004 published by the European Medicines Agency's web portal on medicinal products.

8) Information on how health workers and patients can report suspected adverse reactions to the Health Services, including on digital reporting.

9) Rules of business, agendas and meeting minutes accompanied by the decisions taken, poll results and explanations of vote, including minority opinion, for the advice and furnace referred to in Chapter 13. ` ;

18. I § 73 pasted as paragraph 5 :

" Stop. 5. When the Health Authority, on the basis of pharmacovigilance, informs concerns about the safety of a medicinal product for people in accordance with paragraph 1. In the case of 1 or 4, the Management Board shall inform the European Medicines Agency, the European Commission and the pharmaceutical authorities of the other EU/EECE countries at least 24 hours before publication of this information. However, the time limit for notification may be deviated if the publication is required in the interests of public health protection. `

19. § 83, paragraph. 2, ITREAS :

" Stop. 2. The Board of Health may lay down detailed rules on the number of the item numbers, including that the intake of medicinal products to animals for animals must be fitted with a separate item number, that the entry into service of a given item must be reported to the Board of Health, and that : certain pharmaceutical groups shall be excluded from the requirement laid down in paragraph 1. ONE, ONE. Pct. "

20. I § 83, paragraph. THREE, ONE. pkt., inserted after ' paragraph 1 ":", 2. Pct. "

21. I § 83 pasted as paragraph FOUR :

" Stop. 4. The Board of Health may lay down requirements for notification of the alert for the Health Services, cf. paragraph 2, including that reporting must be digitally. `

22. The following section 84 is inserted :

" § 84 a. The minister for health and prevention may lay down rules on the information on medicinal products, including confidential information, Health Services, to the authority the Minister designates to draw up and publish statistics ; the circulation of medicinal products. The authority concerned may use the confidential information in connection with the production of pharmacostatistics. ` ;

23. § 88, paragraph. ONE, TWO. pkt., revoked.

24. § 90, paragraph. 2 and 3, is hereby repealed and the following shall be inserted :

" Stop. 2. The health inspector may, during and after the implementation of a clinical trial of medicinal products, including in the course of the examination of an application for marketing authorization and following up the marketing authorization, any checks on the application of a marketing authorisation ; company, etc., performing or carried out a clinical trial. The Management Board may provide for the supply of all information, including written material, necessary for the checks.

Paragraph 3. In the light of a request from a competent authority of another EU/EEA country, on the basis of a request from a competent authority in another EU/EEA country, for the control of a clinical trial, control any activity, etc., carrying out or carried out a clinical trial of medicinal products. The Management Board may provide for the supply of all information, including written material, necessary for the checks.

Paragraph 4. As part of the control of health management in accordance with paragraph 1. 2 and 3 have the Management Board's representatives against appropriate legitimacy and without a court order of access to establishments, hospitals, practices and other places that are affected by the implementation of the study.

Paragraph 5. Dissemination and treatment of information on health conditions and other purely private and other confidential information as part of the control of the Health Management Board, cf. paragraph 2-4, happen without the consent of the subject.

Paragraph 6. In the case of medicinal products for human beings, the control of health management shall be carried out in accordance with paragraph 1. 2 and 3 that good clinical practice is complied with. The Minister for Health and Prevention shall lay down detailed rules on this control. ` ;

Paragraph 4-6 will then be referred to in paragraph 4. 7-9.

25. After § 92 a is inserted in Chapter 11 :

" Non-intervention security surveys

§ 92 b. A non-intervention safety examination of an approved medicinal product for human beings, which is a condition for a marketing authorisation, as determined by the marketing authorisation, cf. Section 9 (1). First, when the Board of Health has authorised the investigation, the second Health Services Board shall first be implemented. The Management Board shall be available when the investigation is to be carried out only in Denmark.

Paragraph 2. The Minister for Health and Prevention shall lay down detailed rules on the applications for authorisation pursuant to paragraph 1. 1 shall include, and the processing of such applications.

Paragraph 3. When a non-intervention security inquiry is permitted in accordance with paragraph 1. 1 has been initiated, the marketing authorization holder may only make significant changes to the protocol on the subject of rules laid down by the Minister for Health and Prevention.

§ 92 c. The holder of a marketing authorisation shall send a report on the results of a non-intervention safety survey to the Health Care Board. Furthermore, if a study is carried out in other EU/EEA countries, the report shall also be forwarded to the countries concerned. Transmission shall be completed within 12 months of the completion of the examination of the data submitted by the investigation, unless the Board of Health has authorized a derogation from this time limit.

Paragraph 2. The Minister for Health and Prevention shall lay down rules on the requirements for content and the submission of the measures referred to in paragraph 1. 1 mentioned reports, including separate requirements for reports from non-intervention safety tests, which are a condition for the marketing authorization.

§ 92. Non-intervention safety examinations of authorised medicinal products must not be carried out if the use of a medicinal product is thus promoted.

Paragraph 2. Remuneration to health professionals who have taken part in a non-intervention safety examination of an approved medicinal product shall be limited to compensation for the duration and expenditure of the investigation. '

26. § 96 ITREAS :

" § 96. The Board of Health may consult the Mediemedial Board on matters of :

1) Issue, alteration, suspension or revocation of marketing authorisations for medicinal products.

2) Monitoring of adverse reactions and other risks of medicinal products.

3) weighing up the benefits of a medicinal product to the risks of the medicinal product.

4) Clinical trials with medicinal products.

Paragraph 2. The Medical Board shall consist of a maximum of 15 members, two of whom shall represent the interests of patients and consumers ' interests. '

27. § 101 ITREAS :

" § 101. In the case of adverse reactions and other risks of medicinal products, the Board of Health shall consult the Council for Medicinal Products for the Health Services.

Paragraph 2. The Council for Medicinal Products shall consist of not more than 11 members. Among the members, there must be representations on health professionals, pharmaceutical companies, pharmacists and other retailers of medicinal products, patients and consumers.

Paragraph 3. The Council for Medicinal Products shall be set up by the Board of Health in accordance with public record. The Board of Health shall appoint 1 President of the Council members.

Paragraph 4. The Board of Health shall lay down rules for the Council of the Medicinal Products Council. `

28. After paragraph 103 a is inserted :

" Chapter 14 a

Kundstatement

§ 103 b. The minister for health and prevention may lay down rules that standards for the quality and manufacture, control and storage of medicinal products referred to by the Health Services granted by the Board of Health in accordance with this law, shall not be established ; shall be introduced in the law of law.

Paragraph 2. The Ministry of Health and Prevention may lay down rules on how the Board of Health should give information on the content of the rules issued by the Management Board, cf. paragraph 1.

Paragraph 3. The Ministry of Health and Prevention may lay down rules that prescribe regulations and technical specifications which are not introduced in the law, cf. paragraph 1 shall apply even if they are not available in Danish. ` ;

29. I § 104, paragraph 1. 1, no. 1, is inserted after ' § 92 (1) ONE, ONE. pkt. ` : " § 92 b, paragraph. 1 and 3, Section 92 c (3). 1, $92 d, "

30. I § 104, paragraph 1. 1, no. 3, in the words ' section 90 (4), Five, "to :" § 90, paragraph. 8, ".

31. I § 104, paragraph 1. 1, no. 4, the following section shall be inserted after ' Section 53. Paragraph 1 shall be : ' : 3 ".

32. I § 104, paragraph 1. 1, no. 4, in the words ' section 90 (4), TWO, ONE. pkt., and paragraph. Five, "to :" § 90, paragraph. TWO, TWO. pkt., paragraph THREE, TWO. pkt., and paragraph. 8, ".

33. I § 104, paragraph 1. 1, no. 5, in the words ' section 90 (4), TWO, TWO. pkt., "to :" § 90, paragraph. FOUR, "

§ 2

Law no. 273 of 1. April 2006 on the requirements for quality and safety in the handling of human tissues and cells (tissue slots) as amended by section 3 of Act 3. 534 of 17. June 2008, the following changes are made :

1. The following section 20 is inserted :

" Chapter 10 A

Kundstatement

§ 20 a. The minister for health and prevention may lay down rules that standards for human tissues and cells quality and for the manufacture, control and storage of those referred to in rules issued by the Board of Health in accordance with this law, shall be introduced in the law of law.

Paragraph 2. The Ministry of Health and Prevention may lay down rules on how the Board of Health should give information on the content of the rules issued by the Management Board, cf. paragraph 1.

Paragraph 3. The Ministry of Health and Prevention may lay down rules that prescribe regulations and technical specifications which are not introduced in the law, cf. paragraph 1 shall apply even if they are not available in Danish. ` ;

§ 3

Paragraph 1. The law shall enter into force on the 21st. July 2012.

Paragraph 2. The Ministry of Health and Prevention shall take over by the entry into force of the law, all assets and liabilities for the Registration Board and shall enter into all the rights and obligations of all the Board. The Minister for Health and Prevention is appointed to the President and the members of the Registration Board and are responsible for the conduct of the activity of the Board.

Paragraph 3. The Board of Health shall take over by the law into force of the law, all assets and liabilities for the Assistance Council and shall enter into all the Council's rights and obligations. The Management Board shall refuse the President and the members of the Efficiation Council and conduct the conduct of the Council's activities.

§ 4

The deadline for submitting an application for the extension of a marketing authorisation to the Health Services pursuant to section 27 (3). 4, in the law on medicinal products, such as paragraph 1 of this law. 9 shall apply to marketing authorisations which expire after the 21. April 2013. For marketing authorisations, which expire on 21. In April 2013 or earlier, applications for renewal of the authorisation shall be submitted no later than six months before the expiry of the authorisation.

§ 5

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

1) The law provides for the implementation of parts of Directive 2001 /83/EC of the European Parliament and of the Council of 6. April 2001 establishing a Community code of medicinal products for human use, the Official Journal of the European Communities, no. In 311, page 67, as amended in particular by Directive 2010 /84/EU of 15. December 2010, EU Official Journal, nr. L 348, page 74, and parts of Directive 2001 /82/EC of the European Parliament and of the Council of 6. April 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 adapting to Council Decision 1999 /468/EC of certain acts subject to the procedure laid down in Article 251 of the Treaty in the context of the regulatory procedure with scrutiny, EU Official Journal 2009, nr. In 188, page 14.