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Summaries of EU Legislation

Duty-free treatment of specified pharmaceutical active ingredients

Date of last review:
14/12/2021
Author:
Publications Office of the European Union
Responsible entity(ies):
Directorate-General for Health and Food Safety
Summarised document(s):

Duty-free treatment of specified pharmaceutical active ingredients

 

SUMMARY OF:

Regulation (EU) No 1238/2010 – duty-free treatment of specified pharmaceutical active ingredients and products in finished pharmaceuticals

Regulation (EC) No 467/97 – duty-free treatment of specified ingredients and products used in finished pharmaceuticals and withdrawing this treatment for others

WHAT IS THE AIM OF THE REGULATIONS?

  • The regulations incorporate into European Union (EU) law duty-free decisions for certain pharmaceuticals and active ingredients. These were first taken in the Uruguay Round of international trade negotiations.
  • The items each have an international nonproprietary name (INN)* and new ones have been added to the lists on several occasions.
  • Regulation (EU) No 1238/2010 updates the lists after the fourth review launched in 2009.
  • Council Regulation (EC) No 467/97 updates the lists after the first review.

KEY POINTS

Regulation (EU) No 1238/2010

  • It amends Annex I (lists of pharmaceutical substances qualifying for duty-free treatment) to Regulation (EEC) No 2658/87 setting out the EU’s combined nomenclature.
  • It gives duty-free treatment from 1 January 2011 to:
    • products with a World Health Organization international non-proprietary name (Annex I);
    • the list of prefixes and suffixes which, combined with INNs, describe their salts, esters or hydrates which are also eligible for duty-free treatment (Annex II);
    • pharmaceutical intermediates used to produce and manufacture finished pharmaceuticals (Annex III).
  • It removes certain pharmaceutical intermediates from the list of those receiving duty-free treatment (Annex IV).

Regulation (EC) No 467/97

  • It gives duty-free treatment from 1 April 1997 to:
    • 231 designated pharmaceutical active ingredients with an INN, along with their salts, esters and hydrates (Annex I);
    • 234 designated products used to produce and manufacture finished pharmaceuticals (Annex II).
  • It expands the list of specified prefixes and suffixes of INNs eligible by adding 84 names to duty-free treatment (Annex III).
  • It removes 25 products – together with their salts, esters and hydrates – from duty-free treatment since their use was predominantly non-pharmaceutical (Annex IV).

FROM WHEN DO THE REGULATIONS APPLY?

  • Regulation (EU) No 1238/2010 has applied since 1 January 2011.
  • Regulation (EC) No 467/97 has applied since 14 March 1997.

BACKGROUND

  • During the Uruguay Round, the most important producers – the EU, the United States, Japan, Canada, Switzerland, Norway and China – agreed to reduce duties on pharmaceuticals to zero. The agreement covered over 6,000 products.
  • With the development of new drugs, reviews took place in 1995–1996, 1998 and 2006, adding almost 2,400 products. The fourth review added 718 new substances, bringing the total of duty-free pharmaceutical imports into the EU to 8,619.
  • For further information, see:

KEY TERMS

International nonproprietary names (INN). Also known as generic names, they identify pharmaceutical substances or active pharmaceutical ingredients. Each INN is a unique name that is globally recognised and that is classified as public property. The World Health Organization works closely with INN experts and national nomenclature committees to select a single name that is accepted worldwide for each active substance to be marketed as a pharmaceutical.

MAIN DOCUMENTS

Regulation (EU) No 1238/2010 of the European Parliament and of the Council of 15 December 2010 amending Annex I to Council Regulation (EEC) No 2658/87 as regards the provision of duty-free treatment for specified pharmaceutical active ingredients bearing an ‘international non-proprietary name’ (INN) from the World Health Organization and specified products used for the manufacture of finished pharmaceuticals (OJ L 348, 31.12.2010, pp. 36–73).

Council Regulation (EC) No 467/97 of 3 March 1997 providing for duty-free treatment for specified pharmaceutical active ingredients bearing an ‘international non-proprietary name’ (INN) from the World Health Organization and specified products used for the manufacture of finished pharmaceuticals and withdrawing duty-free treatment as pharmaceutical products from certain INNs whose predominant use is not pharmaceutical (OJ L 71, 13.3.1997, pp. 1–15).

RELATED DOCUMENTS

Council Regulation (EEC) No 2658/87 of 23 July 1987 on the tariff and statistical nomenclature and on the Common Customs Tariff (OJ L 256, 7.9.1987, pp. 1–675).

Successive amendments to Regulation (EEC) No 2658/87 have been incorporated in the original text. This consolidated version is of documentary value only.

last update 14.12.2021

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