Aesgp_Publications
Country_ProfilesOTC_IngredientWMSI_Publications

The tables referenced from this page provide information on the legal classification status of over 200 active ingredients widely used in self-care around the world.

All tables were verified by the respective countries in January 2011. This type of check is carried out regularly, and this is reflected in the date mentioned at the top of the list. Individual changes in classification status are sometimes introduced into the tables in between these updates without changing the date at the top.

  • For the Ingredient Table of Europe-1 countries (Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Netherlands, Portugal, Spain, Sweden and UK) click here.
  • For the Ingredient Table of Europe-2 countries (Bulgaria, Croatia, Czech Republic, Hungary, Lithuania, Norway, Poland, Slovak Republic, Slovenia and Switzerland) click here.
  • For the Ingredient Table of selected countries worldwide (Argentina, Australia, Canada, Chile, China, Japan, Korea, Mexico, New Zealand, Philippines, Singapore and USA), click here.

The classification of ingredients by use or action follows the Anatomical Therapeutic Chemical (ATC) classification system established by the World Health Organization (WHO).  This divides medicinal products into different groups according to the organ or system on which they act and their chemical, pharmacological and therapeutic properties. It should not be interpreted as a recommendation from AESGP or WSMI. 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. 

The acronym "OTC" in the tables means that at least one dosage or form of the ingredient has "non-prescription status" 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 switch of the ingredient to non-prescription status is indicated by a "year" (e.g. 1996). "Year" therefore equals "OTC".

Wherever possible, footnotes provide some 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 AESGP and updated on an ad hoc basis. However, because of the rapidly changing situation, some information may be outdated. Users are therefore invited to check with the national competent authority for official statements. If you discover any errors or find that updating is required, please notify AESGP (info@aesgp.be).

AESGP and WSMI are convinced that these tables will facilitate comparison of the legal status of the more than 200 ingredients in the EU and many countries around the world, thus permitting all interested parties (consumers, regulatory authorities, health professionals and industry) to see clearly the extent to which the ingredients are being safely used in responsible self-medication.

AESGP and WSMI cannot be held responsible for the use made of the information in the tables.

 
7 Avenue de Tervuren, B-1040 Brussels, Belgium | Tel: +32 (0)2 735 51 30 | Fax: +32 (0)2 735 52 22 | info@aesgp.be