Notice On Reporting Of Adverse Reactions To Medicinal Products, Etc.

Original Language Title: Bekendtgørelse om indberetning af bivirkninger ved lægemidler m.m.

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Table of Contents

Publication of the reporting of adverse reactions to medicinal products, etc. 1)

In accordance with section 55 and section 104 (4), Two, in Law No 1180 of 12. In December 2005 on medicinal products, as amended by law no. 534 of 17. June 2008 shall be determined :

Scope, definitions, etc.

§ 1. This notice shall include :

1) medicinal products approved for the marketing authorisation of the Medicinal Products Agency, cf. the section 7 of the medicinal product, or the European Commission,

2) registered homeopathic medicinal products and traditional herbal medicinal products, cf. The medical officer, 34, no. 3,

3) medicinal products used as a result of a special release permit, cf. Article 29 (4) of the medicinal product. 1,

4) medicinal products which are, in exceptional circumstances, sold or handed out by the State Serum Institute or the DTU Veterinary Institute, cf. the section 30 of the medicinal product, and

5) Magistrelle medicinal products.

§ 2. The declaration shall not include suspected adverse reactions occurring during a clinical trial authorised by the Medicinal Products Agency pursuant to Article 88 (2) of the Medicinal Code. 1.

§ 3. In the case of adverse reaction, a harmful and unintended reaction is meant by a medicinal product which enters into such doses normally used for humans or animals for the purpose of preventing, diagnosing or treating disease or alterating, rebuild, correcting or influencing a physiological function.

Paragraph 2. Exposure reaction means a harmful and unintended reaction, which enters into humans after contact with a medicinal product to animals.

Paragraph 3. For a serious adverse reaction caused by a medicinal product for human beings a side effect which is lethal, life-threatening requires hospitalisation or prolongation of intemperate hospitalisation, or which result in continuous or significant ; invalidity or incapacity, or which is a congenitional anomaly or birth injury.

Paragraph 4. In a serious adverse reaction caused by a medicinal product for animals, a side effect which is lethal, life-threatening or imposes significant invalidity, production reduction or incapacity for incapacity, is a congenital anomaly or a birth injury ; results in persistent or long-term symptoms in the treated animal.

Paragraph 5. An unexpected adverse reaction means a side effect of a medicinal product whose nature, severity or result has not been mentioned in the product summary.

Paragraph 6. The placing on the market of the placing on the market shall mean a pharmaco-epidemiological enquiry or a clinical trial carried out in accordance with the conditions of marketing authorization and are carried out in order to : identify and examine or quantify a security risk in connection with an approved medicinal product.

Paragraph 7. In the case of misuse of medicinal products, lasting or sporadic, intentionally excessive use of medicinal products for human beings is being accompanied by harmful physical or psychological effects.

Paragraph 8. In the case of non-use, the use of a medicinal product for animals which is not in conformity with the product summary, including misuse and serious abuse of the medicinal product, shall be the use of the medicinal product.

Duty to report adverse reactions to medicinal products

§ 4. Doctors, dentists and veterinarians are to report all suspected adverse reactions and suspected exposure reactions, they shall be presumed to be presumed by humans or animals they have in treatment.

Paragraph 2. For medicinal products covered by Section 1, no. (3), (4) and (5), the obligation to notify shall apply in paragraph 1 1 throughout the period during which the medicinal product is sold or handed out.

Paragraph 3. For medicinal products covered by Section 1, no. Paragraph 1 and 2, except for generic medicinal products, shall be subject to the obligation to notify the person concerned in paragraph 1 1 only in the first two years of actual marketing of the medicinal product have been started. The person concerned shall include all serious or unexpected side effects and exposure reactions to the person concerned in respect of human or animal treatment as they are in processing. However, the Medicinal Board may, in exceptional circumstances, decide that these medicinal products must be subject to the obligation to notify the person concerned in paragraph 1. 1 for a longer period.

Paragraph 4. For generic medicinal products covered by § 1, nr. Paragraph 1 shall apply only to serious or unexpected side effects and exposure reactions to the person concerned in respect of human or animal treatment as they are in processing. This reporting obligation shall apply from actual marketing of the medicinal product. However, in exceptional cases, the medicinal product may decide that a generic medicinal product must be subject to the obligation to notify the person concerned in paragraph 1. 1, if applicable, during a period of time.

Paragraph 5. All serious adverse reactions shall be reported to the Medicinal Products Agency within 15 days of the fact that the doctor, the dentist or the veterinarian has received an amortation of this.

§ 5. Doctors, dentists and veterinarians shall supply records, autopsy declarations and other similar documentation for the management of the type-impact report by the medical examiner and other such documents.

Access to the transmission of adverse reactions to medicinal products

§ 6. Other health professionals than those mentioned in Section 4, patients, relatives and animal owners can report all side effects and exposure reactions to medicinal products for which they are rematinated.

Reporting of the impact data

§ 7. A report must include at least the following information :

1) identification of the suspected medicinal product or active substance,

2) a description of the presumed adverse reaction or exposure response,

3) one or more information on the patient concerned : the date of birth, CPR number, gender, age or initials, cf. however, paragraph 1 2, and

4) identification of the alert.

Paragraph 2. A report from a doctor or dentist should, as far as possible, include information on the patient ' s CPR number.

Paragraph 3. Notification may be made on a table to be obtained in the place of the Medicinal Management Board, by contacting the Medicinal Products Agency or a pharmacy.

Paragraph 4. The governing board may lay down rules on the formulations of the reports referred to in sections 4 and 7.

§ 8. An updated inventory of medicinal products, where doctors, dentists and veterinarians must report all suspected side effects and exposure reactions shall be published on the place of the medicinal product in the medical board, cf. however, paragraph 1 2. The encoding can also be obtained by contacting the Medicinal Board of Direction.

Paragraph 2. From the list referred to in paragraph 1. Paragraph 1 shall be excluded from the medicinal products covered by Section 4 (4). 2.

Punishment

§ 9. With fine punishment, the person who violates Section 4 is punished.

Paragraph 2. Companies can be imposed on companies, etc. (legal persons) punishable by the rules of the penal code 5. Chapter.

Paragraph 3. The rules laid down in accordance with this notice may be punished for the penalties for infringements of the provisions laid down in the regulations.

Entry into force

§ 10. The announcement shall enter into force on 1. September, 2009.

Paragraph 2. Publication no. 1237 of 12. In December 2005 on the reporting of adverse reactions to medicinal products, etc. are hereby repealed.

The Ministry of Health and Prevention, the 171. August 2009Jakob Axel Nielsen / Dorthe Eberhardt Søndergaard
Official notes

1) The commotion contains provisions implementing Directive 2001 /83/EC of the European Parliament and of the Council of Directive 2001 /82/EC of 6. November 2001 establishing a Community code of medicinal products for human and veterinary medicinal products, as last amended by Directive 2008 /29/EC amending Directive 2001 /83/EC on the establishment of a Community code for human use, medicinal products (EU-Official L81, 20. March 2008, s. EUR 51-52) and Directive 2009 /9/EC amending Directive 2001 /82/EC on the establishment of a Community code of veterinary medicinal products (EU Official Journal L44, 14. Feb, 2009, s. 10-61.