Ordinance on the proliferation of pharmaceutical stocks in supply emergencies and in cases of accidents and disasters, including acts of war
Under section 76 and section 104 (2) and (3) of the law on medicinal products, see. Act No. 1180 of 12. December 2005, lays down:
§ 1. The provisions of this Ordinance apply in supply emergencies and in case of accidents and disasters, including acts of war. The provisions apply in advance of any conflicting provisions laid down pursuant to other legislation.
(2). If one of the situations referred to in paragraph 1 arises, the undertakings covered by article 3, paragraph 1, and 2, via the Danish Medicines Agency receive notice from the Minister of health and prevention.
(3). The Ordinance shall apply to stocks of medicinal products.
§ 2. The National Board of health shall undertake the overall coordination of medical preparedness, if any of the operations in section 1 concerning situations occurring.
§ 3. Importers of medicinal and pharmaceutical wholesalers to reduce their stockpiles of drugs to a minimum through the distribution of medicines through the usual distribution channels.
(2). Manufacturers of medicinal products must carry distribution along the usual distribution channels, reduce their stocks of the individual medicinal product with what corresponding to 45 days of normal use of the medicinal product concerned.
(3). The reduction of stocks in accordance with paragraph 1 and 2, shall be made by a proportional distribution to the usual buyers on the basis of the number of packages delivered in the quarter preceding the date of receipt of the notification of any of the operations in section 1, paragraph 1, referred situations occurring.
(4). Medicinal products that are distributed in accordance with paragraphs 1 and 2, delivered at the current trading conditions in the industry, however, as payment for the received goods first due 60 days from the end of the month in which the item is received.
§ 4. In special cases, the health protection agency decide that a company needs to diversify his stock in a different way than that stipulated in § 3, or that the company should not spread its inventory. The National Board of Health's decision must be approved in advance by the Minister for health and prevention. The National Board of health shall notify the decision to the Danish Medicines Agency then, issuing an injunction to the undertaking concerned in accordance with the National Board of Health's decision.
§ 5. A hospital pharmacy may, in the situations referred to in article 1 provide medicines for hospital pharmacies, as well as to other pharmacies.
(2). A pharmacy may, in the situations referred to in article 1 provide medicines to other pharmacies, as well as for hospital pharmacies.
§ 6. With fine punished anyone who violates § 3 as well as those who fails to comply with an injunction issued by the Danish Medicines Agency under 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.
§ 7. The notice shall enter into force on the 1. October 2008.
(2). Executive Order No. 113 of 24. February 1999 is repealed.
The Ministry of health and prevention, 16. September 2008 Jakob Axel Nielsen/Paul Schüder