EN Official Journal of the European Union CE 78/663

(2004/C 78 E/0707)

WRITTEN QUESTION E-3874/03

by Francesco Fiori (PPE-DE) to the Commission

(16 December 2003)

Subject: Imports into the EU of uncertified active pharmaceutical ingredients

Imports from outside the EU (mostly from India, China and other emerging Asian nations) of active ingredients which have not received inspection certificates from any European authority are threatening to cause lasting damage to Italy's producers of active ingredients for the pharmaceutical industry. The products concerned enter the EU accompanied only by paper documentation (the Certificate of Suitability or COS) stating that they conform to the contents of the European Pharmacopeia. This is not a sufficient health guarantee. Italy's producers of active ingredients for the global pharmaceutical industry enjoy a reputation for excellence, thanks to the quality and reliability of their products, which are guaranteed by following Good Manufacturing Practices (GMP) in line with the European guidelines (‘GMP Guide for Active Pharmaceutical Ingredients’), and to the fact that the products have been inspected either by the American Food and Drug Administration or by the Italian health ministry.

Given the above, what action will the Commission take with a view to protecting the health of the European public from imports of active ingredients for the pharmaceutical industry produced by companies from the above-named countries?

Does the Commission not consider that the Community's principles imply the need for harmonised rules placing all producers under the same conditions of competitiveness and reliability in the Community context, with safeguards against international competition based on product quality, especially in the case of products relating to human health?

Does the Commission not consider it necessary to propose and implement at European level a Community regulation to deal with this entire problem and ensure, through inspections of imports, suitable guarantees and standards of precautionary protection for substances and pharmaceuticals consumed within the Union?

Answer given by Mr Liikanen on behalf of the Commission

(5 February 2004)

Present Union pharmaceutical legislation does not foresee any obligation for Active Pharmaceutical Ingredients (APIs) to be produced according to Good Manufacturing Practice (GMP) standards. Therefore, being aware of this situation, the Commission adopted on 26 November 2001 new legislative proposals (1) that introduce the requirement for pharmaceutical manufacturers to only use active substances which have been manufactured according to GMP requirements for medicinal products. After agreement has been reached, following the second reading in the Parliament on 17 December 2003, the Commission is now anticipating the final adoption of the new legislation in early 2004. Bearing in mind the 18 month implementation period of the new legislation, the provisions for APIs could be applicable from the end of 2005.

Nevertheless, the current situation in the Union already makes it possible that GMP inspections of API manufacturers may voluntarily be carried out by the competent authorities of Member States whenever these authorities find reasons for concern. In those cases, Union inspectors may conduct inspections against the requirements of Annex 18 (‘Good Manufacturing Practice for Active Pharmaceutical Ingredients’) to the Union Guide to Good Manufacturing Practice, which already covers internationally agreed GMP standards for APIs. This guideline will become mandatory as soon as the new legislation enters into force.

(1) Proposals for Directives of the European Parliament and of the Council amending Directive 2001/83/EC on the Community code relating to medicinal products for human use and amending Directive 2001/82/EC on the Community code relating to veterinary medicinal products.