Usually, it is only after having joined the EU that those countries of the
European continent that aim at full membership in the EU enjoy all
advantages of the European Single Market. In order to remove trade
barriers for these membership applicants, the EU has negotiated the PECA
agreements with these countries. The acronym stands for Protocol to the European agreement on Conformity
assessment and Acceptance of industrial products. These
agreements are valid until the state in question has joined the EU and
cease to be in force when it has become a full member.
With a PECA regarding the import and export
of medicinal products, a batch certification scheme is established that is
of benefit both to the exporter in the third country and to the importer
in the EU member state: The GMP Certificate accompanying a medicinal
product batch confirms that it has been manufactured in compliance with
the GMP principles and enables the receiver to omit any further analysis.
In the main, the duties of the importer are limited to maintaining the GMP
Certificate of the batches and to showing it if required on the occasion
of an inspection. In addition to this, the importer has to keep a
Certificate register in which it is confirmed that each batch has been
delivered with the corresponding GMP Certificate. These are the duties of
the Qualified Person, whose range of tasks is described in detail in Annex
16 to the GMP Guideline ("Certification by a Qualified Person and Batch
Release").
Further regulations laid down in the PECAs
concern the Rapid Alert System triggered off in case of quality
deficiencies, the exchange of inspection reports and other official
information intended to harmonise the quality requirements and the 'common
understanding'.
The GMP Certificate itself is available as
Annex B to the Guidance Document "Implications of the Operational phase of the GMP annexes
to the ... (PECA) with European Union associated countries" in
the form of a template.
The latest PECAs concerning GMP entered into
force with two countries not too long ago: with Hungary on
medicinal products for human use (01/12/2001) and with the Czech
Republic on medicinal products for human and/or veterinary use
(01/01/2002).
One has to distinguish between PECAs
and MRAs (Mutual Recognition
Agreements). Within the framework of an MRA, the equivalence of the
authorities' requirements and inspection systems of two different
countries is evaluated. Strictly speaking, MRAs are no harmonisation
tools. Within the framework of PECAs, the partner states accept the same
standards; MRAs on the other hand make it possible for the states to have
different standards, provided that they are mutually recognised. In the
end, however, MRAs do support the process of harmonisation because they
help to build mutual confidence in the long term.
The Guidance Document with the
certificate template issued by the EU Commission can be downloaded here.
The Agreement has a great influence on
the import and export of medicinal products - just like the new Annex 16
and other current MRAs (e.g. EU - Switzerland). These regulations are of
basic importance especially for manufacturing and testing in third
countries (or for third countries).
Writer:
Dr Gerhard Becker
CONCEPT HEIDELBERG
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