WRITTEN QUESTION No. 3785/98 by Anita POLLACK Licensing of herb and mineral products for human consumption
Date: 1998-12-11
Institutions: European Parliament, POLLACK
Subjects: European Medicines Agency, biotechnology, crop production, food consumption, human nutrition, innovation, market approval, marketing, medicinal product, mineral compound

C 289/88

Official Journal of the European Communities

EN

11.10.1999

(1999/C 289/116)

WRITTEN QUESTION E-3785/98

by Anita Pollack (PSE) to the Commission

(11 December 1998)

Subject: Licensing of herb and mineral products for human consumption

Is the Commission aware that some herb and mineral products, which are legally approved for sale in six EU
countries as a food product, are facing serious obstacles in securing approval from the European Medicines
Agency for the marketing of these products in the UK?

Answer given by Mr Bangemann on behalf of the Commission

(28 January 1999)

Council Regulation (EEC) 2309/93 of 22 July 1993 laying down Community procedures for the authorization
and supervision of medicinal products for human and veterinary use and establishing a European agency for
the evaluation of medicinal products (1) established a new system for granting Community marketing
authorizations for medicinal products in the Community. Community marketing authorizations are adopted
by the Commission, following an opinion of the European agency for the evaluation of medicinal products
(EMEA). Article 3 of Regulation (EEC) 2309/93 defines the scope of application of the central authorization
procedure. For medicinal products in part A of the Annex (certain biotech-products) the centralised procedure
is obligatory. For medicinal products in part B of the Annex (other biotech- and innovative products) the
applicant may choose between the centralised and the national application procedure.

The Commission is not aware of the specific problems raised by the Honourable Member. The Commission is
not aware that any application for a central marketing authorization for an herb and mineral product has been
lodged at the EMEA so far.

(1) OJ L 214, 24.8.1993.

(1999/C 289/117)

WRITTEN QUESTION E-3788/98

by Anita Pollack (PSE) to the Commission

(11 December 1998)

Subject: HIV/AIDS

Given that a recent UNAID report suggests that, every minute, 11 people are being newly infected with HIV/
AIDS, has the Commission any plans to reassess its development policies in an attempt to deal with the
problems this raises?

Answer given by Mr Pinheiro on behalf of the Commission

(2 February 1999)

The Community has been supporting acquired immune deficiency syndrome (AIDS) policies and programmes
in developing countries since 1987 and was aware of the deteriorating situation regarding the spread of AIDS
in these countries prior to the United Nations (UN)AIDS report. The Community approach to the problems
posed by AIDS in developing countries was debated in the Parliament and the Council in 1997. The outcome
of these discussions was a re-evaluated policy which focuses on the socio-economic causes and consequences
of AIDS and targets prevention policies.

In addition, the Community has developed systems to ensure that human immuno deficiency syndrome (HIV)/
AIDS assessment is included in all relevant development programmes and projects. In July 1998 the
Commission approved a communication to the Parliament and the Council (1) about increased solidarity to
confront AIDS in developing countries. Moreover, several activity reports concerning the Community efforts