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3. 4.

98 EN Official Journal of the European Communities C 102/5

Supplementary joint answer


to Written Questions E-1534/97, E-1540/97 and E-1544/97
given by Mr Bangemann on behalf of the Commission
(26 September 1997)

Veterinary medicinal products are authorised in the Community either according to Council Directive
81/851/EEC on the approximation of the laws of the Member States relating to veterinary medicinal products (1)
(decentralised procedure) or since 1 January 1995 according to Council Regulation (EEC) No 2309/93 laying
down Community procedures for the authorisation and supervision of medicinal products for human and
veterinary use and establishing a European agency for the evaluation of medicinal products (2) (centralised
procedure).

In both cases the safety assessment is carried out in accordance with the requirements of Council Directive
81/852/EEC on the approximation of the laws of Member States relating to analytical, pharmatoxicological and
clinical standards and protocols in respect of the testing of veterinary medicinal products (3). Part 3 of the Annex
to this Directive contains detailed requirements on the performance and documentation of tests and evaluations
for the applicant. For example ‘a thorough discussion of any risks for persons preparing the medicinal product or
administering it to animals followed by proposals for appropriate measures to reduce such risks’ and the
assessment of ‘the potential harmful effects which the use of the product may cause to the environment’ is
required.

The scientific evaluation is performed by the scientific committee for veterinary medicinal products (CVMP) at
the European agency for medicinal products (EMEA) in London in case of the centralised procedure or by the
national authorities in case of the decentralised procedure. The CVMP will only get involved in the decentralised
procedure if arbitration is necessary for mutual recognition.

The provisions of Council Directives 81/851/EEC and 81/852/EEC had to be applied progressively to products
authorised before the notification of these Directives. In Germany the authority for this task is the Bundesinstitut
für gesundheitlichen Verbraucherschutz und Veterinärmedizin (Federal institute for consumer health protection
and veterinary medicine). The Commission normally assumes that Member States fulfil their obligations under
Community law.

Tiguvon for cats and dogs was authorised firstly in Germany in 1983 by the Federal office for health
(Bundesgesundheitsamt) after Council Directives 81/851/EEC and 81/852/EEC came into force. Therefore it had
to be evaluated in accordance with the requirements of these Directives before a marketing authorisation was
granted.

Interaction with other cholinase inhibitors, phenothiazin derivates (e.g. neuroleptics) or muscle relaxation agents
(e.g. succinyldicholin) may give power to side effects of Fenthion in mammals. The package insert contains
consequent warnings.

(1) OJ L 317, 6.11.1981, as amended by Council Directives 90/676/EEC OJ L 373, 31.12.1990 and 93/40/EEC OJ L 214, 24.8.1993.
(2) OJ L 214, 24.08.1993.
(3) OJ L 317, 6.11.1981.

(98/C 102/07) WRITTEN QUESTION E-1773/97


by Werner Langen (PPE) to the Commission
(27 May 1997)

Subject: EU funds channelled to Rhineland-Pfalz since 1994

Via which projects and from which funds and in what amounts have Community funds been channelled to
Rhineland-Pfalz:
1. To promote employment and combat long-term unemployment?
(a) from the European Regional Development Fund?
(b) from the European Social Fund?
(c) from the EAGGF and other EU resources?