Association Européenne des Spécialités Pharmaceutiques Grand Public │ Association of the European Self-Medication Industry



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Association Européenne des Spécialités Pharmaceutiques Grand Public │ Association of the European Self-Medication Industry | Europäischer Verband der Arzneimittel-Hersteller




Legal classification status of selected ingredients in Europe | List 1

Last updated on: 31 January 2011




Please note:


  • The grouping of ingredients by use or action follows the Anatomical Therapeutic Chemical (ATC) classification system1 established by the World Health Organization (WHO). This divides medicinal products into different groups according to the organ / system on which they act and their chemical, pharmacological and therapeutic properties. For ease of reference, ingredients are listed only in the ATC class where non-prescription use is most likely to occur. This does not exclude use of the ingredient in other organ systems / disease areas. It should not be interpreted as a recommendation from the Association of the European Self-Medication Industry (AESGP).

  • The acronym “OTC” means that at least one dosage or form of the ingredient has the legal status of “non-prescription medicinal product” in the country concerned. This is totally independent from the reimbursement or advertising status of a product containing the ingredient or combination of ingredients in question.

  • In case the information is available, the first move of the ingredient from prescription to non-prescription status is indicated by the “year” in which this “switch” took place. “Year” therefore equals “OTC”.

  • Wherever possible, footnotes provide additional information. However, the absence of a footnote does not mean that there are no particular restrictions attached to the non-prescription use of the ingredient.

  • The table is issued by the Association of the European Self-Medication Industry (AESGP). Data in this overview were checked and updated by AESGP national associations in January 2011. Changes notified are being introduced on an ad hoc basis. As some information may nevertheless be outdated, users are invited to check with the national competent authority for official statements concerning an ingredient’s legal status.

  • AESGP cannot be held responsible for the use made of the information in the table.






Legal classification status of selected ingredients in Europe | List 1
Data for other European countries (List 2) and selected countries worldwide are available in separate tables

Ingredient

Austria

Belgium

Denmark

Finland

France

Germany

Greece

Ireland

Italy

Netherl.

Portugal

Spain

Sweden

UK

A. Alimentary Track And Metabolism

A01 Stomatological preparations


Fluoride (sodium)

OTC1

OTC

Rx

OTC

OTC

19862

OTC

OTC

OTC

OTC

OTC

1995

OTC

OTC3

Hexetidine

OTC

OTC

N.R.

N.R.

OTC

OTC

OTC

OTC

OTC

OTC

OTC

19924

N.R.

OTC

Triamcinolone (oral)

Rx

N.R.

Rx

20035

Rx

20036

N.R.

Rx

OTC7

Rx

OTC

Rx

Rx

OTC8
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