WRITTEN QUESTION No. 156/99 by Phillip WHITEHEAD The new EMEA Procedure for Notification of Parallel Distribution of Centrally Authorised Medicinal Products
Date: 1999-02-11
Institutions: European Parliament, WHITEHEAD
Subjects: European Medicines Agency, market approval, marketing standard, medicinal product, pharmaceutical legislation, quasi-fiscal charge

3.12.1999

EN

Official Journal of the European Communities

C 348/27

(1999/C 348/031)

WRITTEN QUESTION E-0156/99

by Phillip Whitehead (PSE) to the Commission

(11 February 1999)

Subject: The new EMEA Procedure for Notification of Parallel Distribution of Centrally Authorised Medicinal

Products

In the light of the recently published Procedure for Notification of Parallel Distribution of Centrally Authorised
Medicinal Products (EMEA-H-HB-37678-1998), can the Commission please explain the basis upon which the
sum of ECU 3 000 has been calculated as the administrative fee which is to be paid with each notification per
product type? Is the Commission aware that such a level of fee is not only excessive when compared to the
scale of fees payable to national regulatory authorities for the issue of a national PL(PI) Licence but is also likely
to act as an impediment to the free movement of pharmaceutical products, as some products do not yield a
sufficient profit margin to enable the proposed annual administrative charge to be met.

(NB: In the United Kingdom, for example, an importer will currently pay the sum of £1 000 per product for
which he applies for a Licence to import and parallel distribute. The period of validity is five years, not one
year, as proposed by the EMEA. The renewal fee is £250 for a further five years).

Answer given by Mr Bangemann on behalf of the Commission

(17 March 1999)

In accordance with section D of the Commission communication on the Community marketing authorisation
procedures for medicinal products (1) the European agency for the evaluation of medicinal products (EMEA)
checks compliance with the terms of the Community marketing authorisation in case of parallel distribution of
centrally authorised products.

The € 3 000 fee levied by the EMEA for checking notifications of parallel distribution of centrally authorised
products covers all changes made during a one-year period. The level of this fee has been set on a cost recovery
basis and is fully supported by the extent and frequency of the checks required (multilingual product
information amended on average three to four times a year). The administrative charge levied by the EMEA in
case of notification of parallel distribution is substantially lower than the possible maximum level of € 5 000,
fixed by Article 8 paragraph 2 of Council Regulation (EC) 2743/98 of 14 December 1887 amending
Regulation (EC) 297/95 on fees payable to the EMEA (2). The fees levied by national authorities in case of
parallel import cover only checks in one language and generally for a single operation only.

The level of the fee levied by the EMEA for checking notifications of parallel distribution of centrally authorised
products will be reviewed at the end of 1999 taking into account the practical experience acquired in the
operation of the procedure. The Commission is not convinced that a renewal fee of € 3 000 is justified and has
therefore requested the EMEA management board not to maintain this fee.

(1) OJ C 229, 22.7.1998.
(2) OJ L 345, 19.12.1998.

(1999/C 348/032)

WRITTEN QUESTION E-0157/99

by Nikitas Kaklamanis (UPE) to the Commission

(11 February 1999)

Subject: Incorporation of Community legislation by Greece

Will the Commission say how many and which Regulations and Directives have not been incorporated into
national law in Greece?