Principles and Practice of Pharmaceutical Medicine

transmit and make publicly available assessment
reports, Summary of product characteristics
(SmPC), product labeling and package informa-
tion leaflets for medicines subject to community
procedures;

coordinate verification of compliance with good
manufacturing, good laboratory, and good clin-
ical practices guidelines (GMP, GLP and GCP,
respectively).

The EMEA comprises (Figure 34.1)

a Management Board that approves the Agen-
cy’s work program and approves the budget;

an Executive Director, legal representative of the
Agency and responsible for the overall working
of the Agency;

a Secretariat that provides technical, scientific
and administrative support to the scientific com-
mittees;

the Scientific Committees, responsible for the

scientific opinions delivered by the Agency:

• Committee for Human Medicinal Products
  (CHMP; formerly CPMP)


• Committee for Veterinary Medicinal Products
  (CVMP)


• Committee for Orphan Medicinal Products
  (COMP)


• Committee on Herbal Medicinal Products
  (HCMP)

Standing working parties andad hocexpert groups

support these committees. Some 3500 European

experts have been listed and will support on request

the scientific work of the Committees. The list is

published on the EMEA web site.

In addition, there can be pilot project teams. For

example, one such team is currently testing

whether Therapeutic Advisory Groups (TAGs)

Executive Director

Integrated quality

management / audit

Pre-authorization

evaluation of

medicines for

human use

Scienbtific advice and

orphan drugs

Regulatory affairs and

orgnizational support

Veterinary marketing

authorization procedures

Document management

and publishing

Meeting management

and conferences

Inspections Project management

Information technology

Accounting

Infrastructure services

Personal and budget

Safety of veterinary

medicines

Pharmacovigilance and

post-authorization safety

and efficacy of medicines

Quality of madicines

Safety and efficacy

of medicines

Post-authorization

evaluation of

medicines for

human use

Veterinary

medicines

and inspections

Communications

and networking

Administration

Executive support

Figure 34.1 The organizational structure of the EMEA

34.5 THE EUROPEAN MEDICINES EVALUATION AGENCY 447