ALL libraries (COBIB.SI union bibliographic/catalogue database)
  • Enlarging the internal market; the role of decentralization and institutionalization in the case of pharmaceuticals
    Prange, Heiko, 1968-
    Using pharmaceutical regulation as a case study, this article examines how theEuropean Commission is attempting to keep candidate-countries' demands for derogations from the acquis communautaire to a ... minimum without deviating from the principle that future members have to accept all EU rules concerning the internal market. I argue that the dual strategy of institutionalizing and decentralizing the process of regulatory adaptation is leading to a 'smoother'enlargement process compared to the 'old' enlargement model of pure bilateral negotiations between the Commission and the candidate. By establishing this new mode of enlargement, in which an independent agency (in this case the European Agency for the Evaluation of Medicinal Products 3 the EMEA) is the core actor and the Pan-European Regulatory Forum provides the main arena of negotiation, the European Commission has shown flexibility with regard to the method by which it prepares candidates for implementing the acquis. A strategy of 'mutual understanding', 'learning' and 'network building' is likely to facilitate the more efficient adoption of EU regulations in a complex and highly standardized sector such as pharmaceuticals. Given that we expect future enlargements to be even more sophisticated, any solutions supporting efficiency and conflict resolution in the pre-accession phase are worth considering
    Source: Journal of international relations and development. - ISSN 1408-6980 (Vol. 7, no. 1, April 2004, str. 73-93)
    Type of material - article, component part
    Publish date - 2004
    Language - english
    COBISS.SI-ID - 23139677

    Link(s):

    http://www.palgrave-journals.com/jird/journal/v7/n1/abs/1800003a.html

Shelf entry