Global-Regulation

Overview (table of contents) Annex 1

Annex 2 the full text, notice of item numbers to lægemidler1)

Under section 83 (2) and section 104 (3) of law No. 1180 of 12. December 2005 on medicinal products, as amended by Act No. 534 by 17. June 2008, fixed:

§ 1. Each pharmaceutical form, strength and package size of an authorised medicinal product must have a unique item number, see. However, section 7.

(2). A pharmaceutical packaging shall be fitted with a new item number, if the medicinal product changes its name.

(3). A pharmaceutical packaging shall be fitted with a new item number, if you make changes to a new marketing authorisation holder or if the holder of the marketing authorization changes its name.

(4). The demand for a new product number in accordance with paragraph 3 shall not apply if the new holder of the marketing authorisation is another company within the same group, and the name of the medicinal product and the name of the holder of the marketing authorisation shall remain unchanged. Change alone indication of corporate form in the name of the marketing authorisation holder, leads this change, however, no requirement for a new item number.

(5). The provisions in paragraphs 2 and 3 shall not apply to medicinal products have an item number, but have never been marketed.

§ 2. An assigned item number may only be used for one marketing authorisation number.

§ 3. A multi pack, that is to say a package that consists of two or more identical packages of an authorised medicinal product (delpakninger), which also are negotiated individually, shall be provided with a separate item number.

(2). The individual delpakninger in a multi pack must be fitted with a separate item number. If delpakningerne is included in several multi packs, they must have a separate SKU for each size multi pack.

§ 4. In a pharmaceutical packaging of a medicinal product to the animals, which consist of several inderpakninger, which itself provides the drug sufficient protection against external influences (a big packaging), inderpakningerne can be supplied with a separate item number.

(2). The provision in paragraph 1 applies only to drugs that are approved for





1) animals whose flesh or products are used for human consumption, or

2) fur animals.





§ 5. Extemporaneous medicaments shall be provided with the item number, if they are included in annex 1 or 2.

§ 6. The item number must be affixed on the pharmaceutical package in such a way that it cannot be removed.

§ 7. The item number to approved drugs obtained from the Danish Medicines Agency or an institution of the Danish Medicines Agency is empowered to take charge of the allocation of item numbers. Information about how item numbers may be obtained, can be obtained from the Danish Medicines Agency.

(2). No later than 14 days before an item number using (the Pack put on the market), this must be reported to the Danish Medicines Agency. This also applies to the item number to a share-or inderpakning. Reporting shall be on a form which can be obtained from the Danish Medicines Agency.

§ 8. The Ordinance shall not apply to medicinal products subject to





1) notice on homeopathic medicinal products,

2) notice on herbal and traditional herbal medicinal products,

3) Ordinance on radioactive medicinal products or

4) Ordinance on vitamin and mineral preparations, etc.





§ 9. The Danish Medicines Agency may, in specific cases and under the conditions laid down in each case, grant a derogation from the provisions of this Ordinance.

§ 10. With fine punished anyone who violates sections 1-6 or § 7, paragraph 2.

(2). That can be imposed on companies, etc. (legal persons) criminal liability in accordance with the provisions of the criminal code 5. Chapter.

§ 11. The notice shall enter into force on the 3. July 2009.

(2). Executive Order No. 961 of 26. October 2000 on item numbers for medicinal products shall be repealed.
The Danish Medicines Agency, the 29. June 2009 Jytte Lyngvig/Mette Aaboe H Annex 1

Extemporaneous medicinal products for human use pursuant to § 5 shall be provided with the item number









Item number





Drug substance (s)





Pharmaceutical form





Strength





Pack size







685008





Amphetamin





Solution for injection





50 mg/ml





10 amp. (a) 1 ml







685016





Amphetamin





Tablets





5 mg





10 PCs.







685024





Amphetamin





Tablets





5 mg





25 PCs.







685032





Amphetamin





Tablets





5 mg





100 PCs.







685081





Amphetamin





Miscellaneous forms



 



0-50 g/ml







685099





Amphetamin





Miscellaneous forms



 



51-75 g/ml







685107





Amphetamin





Miscellaneous forms



 



76 paragraph g/ml or more







685123





Cocaine





Eye drops





2%





10 ml







685131





Cocaine





Eye drops





4%





10 ml







685149





Chlorpromazine hydrochloride 7 mg Pethidin hydrochloride 28 mg Promethazin hydrochloride 7 mg





Solution for injection



 



2 ml







685156





Atropine sulfate 10 mg Papaverinhydrochlorid 0.5 mg Morphinhydrochlorid 40 mg





Tablets



 



100 PCs.







685164





Pethidin





Drops





50 mg/ml





30 ml







685172 Methadone Potion (sugar free)





1 mg/ml





1000 ml or less







685180 Dexamfetamin





Tablets





5 mg





100 PCs.







Annex 2

Extemporaneous medicinal products for veterinary use, within the meaning of section 5 shall be provided with the item number









Item number





Drug substance (s)





Pharmaceutical form





Strength





Pack size







686051





Lignocaine Hydrochloride Adrenaline





Solution for injection





20 mg + 0.0125 mg/ml





100 ml







686112





Sulfathiazol





kutanvæske





10%





1000 ml







686115





Megestrol acetate





tablets





5 mg






100 PCs.







686117





Salicylic acid Ethylparahydroxy benzoate





kutanvæske





2% 5%





200 ml







686118





Salicylic acid Ethylparahydroxy benzoate





kutanvæske





2% 5%





300 ml







686119





SalicylsyreEthylparahydroxy benzoate





kutanvæske





2% 5%





1000 ml







686120





SalicylsyreEthylparahydroxy benzoate





kutanvæske





2% 5%





5000 ml







686121





OxichinolinLidocainBorsyre





ear drops





0.1% 1% 3%





10 ml







686125





Chloramphenicol





ear drops





10%





30 ml







686126





Calciumborogluconat





solution for injection





14 mg/ml





500 ml







686133





Potassium bromide





oral solution





65 mg/ml





500 ml







686134





Sodium citrate





resolution





3.8%





10 ml







686135





Sodium citrate





resolution





3.8%





20 ml







686136





Caffein





solution for injection





150 mg/ml





50 ml







686137





Apomorphinhydrochlorid





solution for injection





10 mg/ml





1 ml







686138





Sulfadimidinnatrium





premix





100%





100 g







686139





Lidocainhydrochlorid Norepinephrine





solution for injection





20 mg/ml5 mikg/ml





100 ml







686140





Lidocainhydrochlorid





solution for injection





20 mg/ml





100 ml







686142





Sulfamethizol





cream





2.5%





50 ml







686143





Sodium selenite





solution for injection





20 mg/ml





50 ml







686144





Thiamin hydrochloride





solution for injection





250 mg/ml





10 ml







686145





Magnesiumtrisilikat





powder, single dose container





100 g





1 PCs.







686146





HydrocortisonDimethylsulfoxidMacrogol 400Macrogol 3000Propylenglycol





ointment





1% 16.4% 8m1% 33,1% 41.4%





100 g







686147





Bismuth subsalicylate





oral suspension





35 mg/ml





100 ml







686148





Neostigmine





solution for injection





0.5 mg/ml





5 ml







686149





Atropine





solution for injection





1 mg/ml





10 ml







686150





Atropine





solution for injection





10 mg/ml





5 ml







686151





Potassium iodide





powder, single dose container





10 g





1 PCs.







686152





Meprobamate





tablets





400 mg





100 PCs.







686153





Levothyroxinnatrium





tablets





0.5 mg





100 PCs.







686154





Lobelinhydrochlorid





solution for injection





10 mg/ml





10 ml







686155





Natriumdioctylsulfosuccinat





oral solution





5%





100 g







686156





Phthalylsulfathiazol





powder, single dose container





45 g





1 PCs.







686157





Phytomenadione





solution for injection





25 mg/ml





10 ml







686158





' Sulfacombin ' SulfadiazinSulfadimidinSulfamerazinSaccharinnatriumSaccharoseCarboxymethylcelluloseslim





oral suspension





830 mg830 mg830 mg25 mg6, 3 gAd 25 ml





25 ml







686159






17-Alpha-methyltestosteron Strong alcohol





resolution





4 mg100 ml





100 ml







686161





Acetylsalicylic acid





powder, single dose container





2 g





1 PCs.







686162





Glucosamine





oral powder





100%





50 g







686163





Glucosamine





oral powder





100%





100 g







686164





Glucosamine





oral powder





100%





250 g







686165





Glucosamine





oral powder





100%





500 g







686166





Glucosamine





oral powder





100%





1000 g







686167





Zinc oxide





premix





100%





1 kg







686168





Zinc oxide





premix





100%





5 kg







686169





Zinc oxide





premix





100%





10 kg







686170





Zinc oxide





premix





100%





25 kg







Official notes 1) Notice has been notified in draft form in accordance with European Parliament and Council Directive 98/34/EC (information procedure directive) as amended by Directive 98/48/EC.