Ordinance on reporting of information on doctors, dentists and pharmacists associated with pharmaceutical companies, etc.
Under section 43 (a) and section 104 (1) (8). 1 of law No. 1180 of 12. December 2005 on medicinal products, as amended by Act No. 1557 by 20. December 2006 and law No. 534 by 17. June 2008, fixed:
§ 1. The holder of a permit after the Danish Medicines Act § 7 (marketing authorisation) or § 39, paragraph 1, (business permit) must give the Danish Medicines Agency notice of physicians, dentists and pharmacists who are affiliated with the company, see. the Danish Medicines Act section 43 (a), paragraph 1.
(2). The obligation under paragraph 1 includes doctors and dentists who prescribe or supply medicinal products, and pharmacists, who negotiates the drugs as part of patient care in Denmark.
(3). Notwithstanding paragraph 1, a mapping need not be reported, if
1) doctor, dentist or pharmacist only has delivered a simple performance, as a lecture, etc., of negligible within a calendar year, and the fees are proportionate to the delivered performance, or
2) doctor, dentist or pharmacist has not received payment for the service, and there is no long term close connection, such as a Board of Directors in the company.
§ 2. The notification provided for in paragraph 1 must include this information:
1) Report the name and registration No.
2) Physician, dentist or pharmacist's name, address and social security number.
3) period for the Association.
(2). The Danish Medicines Agency may require additional information from the reporter on the individual relationship, including on the nature and scope as well as about the size of the fee, the doctor, dentist or pharmacist has received.
§ 3. Reporting must be done digitally once a year not later than 31 December. January via a reporting form, which the Danish Medicines Agency makes available over the Internet. The notification must include all doctors, dentists and pharmacists, which has been associated with the company within the previous calendar year, in accordance with article 3. However, section 1, paragraphs 2 and 3.
(2). The company shall at the same time as the notification to the Danish Medicines Agency inform the individual physician, dentist or pharmacist about the content of the reporting to the Danish Medicines Agency.
§ 4. With fine punished anyone who violates section 2 or section 3.
(2). That can be imposed on companies, etc. (legal persons) criminal liability in accordance with the provisions of the criminal code 5. Chapter.
§ 5. The notice shall enter into force on the 1. August 2008.
The Ministry of health and prevention, the 15. July 2008 Jakob Axel Nielsen/Paul Schüder