WRITTEN QUESTION No. 1773/97 by Werner LANGEN to the Commission. EU funds channelled to Rhineland-Pfalz since 1994 (SUPPLEMENTARY ANSWER)
Date: 1997-05-27
Institutions: European Parliament, LANGEN
Subjects: EAGGF, European Regional Development Fund, European Social Fund, Germany, Rhineland-Palatinate, action programme, aid system, employment policy, fund (EU), unemployment

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 (cid:145)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(cid:146)  and  the
assessment  of  (cid:145)the  potential  harmful  effects  which  the  use  of  the  product  may  cause  to  the  environment(cid:146)  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
fu¤r gesundheitlichen Verbraucherschutz und Veterina¤rmedizin (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?