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.