Notice on reporting of adverse reactions to medicines, etc. 1)
Under section 55 and section 104 (2) of law No. 1180 of 12. December 2005 on medicinal products, as amended by Act No. 534 by 17. June 2008, fixed:
Scope, definitions, etc.
§ 1. This order includes
1) medicinal products which have been authorised by an authorisation from the Danish Medicines Agency, see. the Danish Medicines Act § 7, or the European Commission,
2) registered homeopathic medicinal products and traditional herbal medicinal products, see. the Danish Medicines Act section 34, no. 3,
3) drugs used as a result of a compassionate, see. section 29 of the Danish Medicines Act (1)
4) drugs that, in exceptional cases, sold or dispensed by the Danish State Serum Institute or of DTU Veterinary institution, without prejudice. section 30 of the Danish Medicines Act, and
5) extemporaneous medicaments.
§ 2. The notice does not include suspected adverse reactions that occur during a clinical trial, as the Danish Medicines Agency has authorised pursuant to section 88 of the Danish Medicines Act, paragraph 1.
§ 3. By an adverse reaction is a harmful and unintended reaction induced by a drug, which occurs at doses normally used in man or animals in order to prevent, diagnose or treat disease or modify, rebuild, correcting or modifying physiological functions.
(2). At an exposure response means a reaction which is noxious and unintended and which occurs in humans after contact with a medicinal product to the animals.
(3). By a serious adverse reaction induced by a drug for humans means an adverse reaction which results in death, is life-threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or is a congenital anomaly/birth defect.
(4). By a serious adverse reaction induced by a drug to animals means an adverse reaction which results in death, is life-threatening or result in significant disability, production reduction or incapacity, is a congenital anomaly/birth defect, or which results in permanent or prolonged signs in the animals treated.
(5). By an unexpected adverse reaction is an adverse reaction induced by a drug, the nature, severity or outcome of which is not mentioned in the summary of product characteristics.
(6). By post-authorisation safety study for marketing purposes a pharmacoepidemiological study or a clinical trial carried out in accordance with the terms of the marketing authorisation, conducted with the aim of identifying and investigating, or quantifying a safety hazard relating to an authorised medicinal product.
(7). By abuse of medicinal products shall mean persistent or sporadic, intentional excessive use of medicinal products for human use, which is accompanied by harmful physical or psychological Effets.
(8). Do not label use means the use of a medicinal product to the animals, which are not in accordance with the summary of product characteristics, including the misuse and serious abuse of the drug.
The obligation for reporting of adverse reactions in medicines
§ 4. Doctors, dentists and veterinarians to the Danish Medicines Agency should report all suspected adverse reactions, they get exposure and supposed presumption in humans or animals, they have in treatment.
(2). For medicinal products covered by paragraph 1, nr. 3, 4 and 5 shall be subject to the reporting obligation referred to in paragraph 1 in the whole of the period of time during which the drug is sold or dispensed.
(3). For medicinal products covered by paragraph 1, nr. 1 and 2, except for generic medicinal products shall be subject to the notification requirement in paragraph 1 only in the first 2 years from the date of actual marketing of the medicinal product has begun. Then include the reporting obligation to all serious or unexpected adverse reactions and reactions, the exposure in question gets the presumption in humans or animals, as they are in treatment. However, in special cases, the Danish Medicines Agency may decide that these drugs must be covered by the reporting obligation referred to in paragraph 1 for a long period of time.
(4). For generic medicinal products covered by paragraph 1, nr. 1, applies to the reporting obligation only for serious or unexpected adverse reactions and reactions, the exposure in question gets the presumption in humans or animals, as they are in treatment. This reporting obligation shall be valid from the actual marketing of the medicinal product has begun. However, in special cases, the Danish Medicines Agency may decide that a generic drug must be covered by the reporting obligation referred to in paragraph 1, possibly for a limited period of time.
(5). All serious adverse events must be reported to the Danish Medicines Agency within 15 days after the doctor, dentist or veterinarian has gotten a presumption to that effect.
§ 5. Doctors, dentists and veterinarians shall, at the request of the Danish Medicines Agency disclose information from medical records, autopsy reports and other similar documentation for use of the Agency's treatment of adverse reaction reports.
Access to the reporting of adverse reactions in medicines
§ 6. Other health-care professionals than those referred to in section 4 shall, patients, caregivers and animal owners may at the Danish Medicines Agency report any adverse reactions to medicinal products, and the exposure they get presumption.
Reporting of adverse reaction data
§ 7. A notification shall contain at least the following information:
1) identification of the suspect medicinal product or active substance,
2) a description of the suspected adverse reaction or exposure response
3) one or more information about the affected patient: date of birth, social security number, gender, age or initials, see. However, paragraph 2, and
4) identification of the reporter.
(2). A report from a doctor or dentist must, as far as possible, include information about the patient's social security number.
(3). Reporting can be made on a form that can be downloaded on the website of the Danish Medicines Agency, by contacting the Danish Medicines Agency or at a pharmacy.
(4). The Danish Medicines Agency may determine rules on the formulation of the reports referred to in sections 4 and 7.
§ 8. An updated list of medicines, which doctors, dentists and veterinarians must report all suspected adverse reactions, and exposure will be published on the website of the Danish Medicines Agency, see. However, paragraph 2. The list can also be obtained from the Danish Medicines Agency.
(2). From the list in paragraph 1 are exempt medicinal products subject to section 4, paragraph 2.
§ 9. With fine punished anyone who violates section 4.
(2). That can be imposed on companies, etc. (legal persons) criminal liability in accordance with the provisions of the criminal code 5. Chapter.
(3). In regulations issued under this Ordinance, may be fixed penalty of fines for violation of the provisions of the legislation.
Entry into force of the
§ 10. The notice shall enter into force on the 1. September 2009.
(2). Executive Order No. 1237 of 12. December 2005 on the reporting of adverse reactions to medicines, etc. shall be repealed.
The Ministry of health and prevention, 17. August 2009 Jakob Axel Nielsen/Dorthe Eberhardt S Official notes 1) Ordinance contains provisions transposing a European Parliament and Council Directive 2001/83/EC and Directive 2001/82/EC of 6 May 2003. November 2001 establishing a Community code relating to medicinal products for human or veterinary use, as most recently amended by Directive 2008/29/EC amending Directive 2001/83/EC on the Community code relating to medicinal products for human use (Official Journal L81, March 20, 2008, p. 51-52), and directive 2009/9/EC amending Directive 2001/82/EC on the Community code relating to veterinary medicinal products (Official Journal L44 , 14. February 2009, p. 10-61).