Self-selection of OTC medicines for human use
On 1 January 2018, new rules on self-selection of OTC medicines become effective. With the change in law (act no. 1736 of 27 December 2016 amending the Danish Act on Pharmacy Practice and the Danish Medicines Act), certain OTC medicines will be available for self-selection, which means that they can be sold from shop areas and not only at the counter.
The purpose of the change in law
The purpose is to give citizens improved access to medicinal products by allowing them to assess which OTC medicines they want to buy. In this connection, the Danish Ministry of Health has asked the Danish Medicines Agency to review the range of OTC medicines and assess which medicines should not be available for self-selection in future.
Criteria for assessment of the product range
Based on the below criteria, the Danish Medicines Agency has assessed whether some OTC medicines should not be available for self-selection.
- Expected improved effect/compliance based on improved accessibility
- Unnecessary increase in consumption
The Danish Medicines Agency’s assessment was presented to the Medicinal Products Committee and was submitted for consultation to relevant stakeholders and on our website. And the medicines for human use that will not be available for self-selection have now been identified.
Decision about self-selection of medicinal products for human use
All OTC medicines in dispensing groups HA and HF may be available for self-selection at pharmacies because pharmacists can advise consumers on the use of medicines.
Certain OTC medicines in dispensing group HF will not be available for self-selection in retail outlets because consumers cannot be offered advice at the counter on the use of medicines.
Not available for self-selection
Medicinal products in dispensing groups HA18, HX and HX18 are not available for self-selection.
The following medicinal products in dispensing group HF are not available for self-selection in retail outlets
- A07DA03; Loperamide
- Imodium, Imodium Instant, Imodium Lingual, Imodium Smelt, Imolope, Lopacut, Lopedium Loperamid Bluefish tablets, freeze-dried tablets and capsules 2 mg
- A07DA53; Loperamide and combinations
- Imodium Plus, Imolopesim, Loperuma, tablets and chewable tablets 2 mg + 125 mg
- C01DA02; Glyceryl nitrate
- Nitroglycerin DAK sublingual tablets 0.25 mg and 0.5 mg
- Nitrolingual and Glytrin sublingual spray 0.4mg/dose
- D01AC01; Clotrimazole
- Canesten cream 10 mg/g (1%)
- D01AC02; Miconazole
- Brentan cream 20mg/g
- D01AC08; Ketoconazole
- Nizoral cream 2%
- Nizoral shampoo 1%
- D01AE15; Terbinafine
- Finigen, Funginix, Terbistad cream 10mg/g
- Lamisil and Lamisil Once cream, gel and cutaneous solution 10mg/g
- D01AE16; Amorolfine
- Finail and Loceryl medicated nail lacquer 5%
- G01AF02; Clotrimazole
- Canesten vaginal tablets 100mg and 500mg
- Canesten cream 10 mg/g (1%)
- Combination packs of the above
- Canvag vaginal tablets 100 mg and cream 10 mg/g (1%)
- N07CA02; Cinnarizine
- Sepan tablets 25 mg
- P01BC01; Quinine
- Kinin "Copyfarm" and Kinin DAK tablets 100 mg
- R06AE03; Cyclizine
- Gotur tablets 50 mg
- Marzine tablets 50 mg
- R06AE05; Meclozine
- Postafen tablets 25 mg
By 1 January 2018, this list will be updated and include a column specifying whether an HF medicine is available for self-selection in retail outlets. The list of authorised HF medicinal products is updated daily. However, the self-selection column is only updated once a fortnight at the same time as new medicine prices are published.
Since all medicinal products in dispensing groups HA and HF may be available for self-selection at pharmacies, there will not be a list for pharmacies.
Follow-up after two years
After a period of two years, the Danish Medicines Agency will look at the sales figures for all medicinal products available for self-selection to identify any inappropriate increases in the sale and use of certain types of medicinal products available for self-selection. In such case, the Danish Medicines Agency will assess whether the relevant medicinal product should no longer be available for self-selection.