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:
- International nonproprietary names programme and classification of medical products (World Health Organization).

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).