Ordinance on corporate disclosure of diacetylmorphin to treatment centers for drug addicts
Pursuant to section 29, paragraph 3, article 60, paragraph 4, section 84 (4) and section 104 (3) 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, lays down the following:
The scope of the
§ 1. This notice includes the companies in accordance with § 7 paragraph 1 of the Executive order on euphoriant substances have received the Danish Medicines Agency's permission to negotiate and provide diacetylmorphin for the health law § 142 referred to municipal, regional and private treatment centers for drug addicts.
Conditions for corporate disclosure of diacetylmorphin to treatment centers
§ 2. The company may only negotiate and extradite diacetylmorphin, if there is a written order form from a doctor who is certified by the National Board of health to prescribe diacetylmorphin for the treatment of substance abuse.
(2). The company shall keep the order slip at the address in 2 years.
(3). The company shall only process the order slip once.
Requirements for order form
§ 3. The company shall only process an order form, if it is equipped with the date, the doctor's signature, printed or stamped information on physician's name, social security. Nr. and authorization ID, as well as phone number, SKS-code etc. and address on the treatment site.
(2). The company shall only process the order slip if it contains information about the name of the medicinal product, pharmaceutical form, strength (if the medicinal product is available in several strengths) and quantity. Strength and quantity must be given unique (with both numbers as letters) and in such a way that changes cannot be made.
(3). Are there diacetylmorphin not issued a marketing authorisation by the Danish Medicines Agency or a community marketing authorisation or diacetylmorphin not marketed in Denmark, the company must ensure that there is a compassionate, see. the Danish Medicines Act section 29, paragraph 1.
Documentation for expedition
§ 4. The company must ensure that workflows and routines allows it for at least 3 months after the expedition of the order slip can be cleared up, who have participated in the expedition.
§ 5. The company must provide the medicinal product with the company name and date for the expedition.
§ 6. The company may only provide diacetylmorphin to in paragraph 1 referred to treatment centers.
Reporting of information about circulation
§ 7. The company shall, in accordance with the rules laid down in the Ordinance on reporting of information on turnover, etc. of pharmaceuticals, etc. months submit information in machine-readable form able to the Danish Medicines Agency about circulation, etc. of diacetylmorphin.
§ 8. The Danish Medicines Agency may in exceptional cases and under conditions to be determined in each individual case derogate from the provisions of this Ordinance or put more stringent requirements.
§ 9. With fine punished anyone who violates sections 2-7.
(2). That can be imposed on companies, etc. (legal persons) criminal liability in accordance with the provisions of the criminal code 5. Chapter.
Entry into force of the
§ 10. The notice shall enter into force on the 15. May 2009.
The Danish Medicines Agency, the 11. May 2009 Jytte Lyngvig/Anne-Marie Vang place