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On 1 June 2002, the MRA (Mutual Recognition Agreement) between the EU and
Switzerland came into force. Chapter 15 of Annex 1 to this agreement
regulates batch release and certification within the framework of import
and export. Its content is interpreted in the "Explanatory
Notes," a comment on chapter 15 of Annex 1 drawn up jointly by the EU
Commission and the Swiss authorities. This document is divided into 4
parts:
- Part I: Finished Products
- Part II: Bulk and Intermediate Products
- Part III: Specific Issues
- Part IV: Official Batch Release for Vaccines and Blood Products
You can find the "Explanatory Notes" published by EMEA at:
http://www.emea.eu.int/htms/technical/mra/mra.htm
Since an MRA assumes in general equivalence of the respective GMP
inspection systems of the two states involved, a batch of medicinal
product can be imported/exported from one country into the other without
the need for a second complete batch test by the consignee. However, this
regulation, which is meant to avoid double work, requires the following
conditions:
- The manufacturer/exporter and the consignee/importer each employ a qualified person (Q.P.); in Switzerland, this person
is called "responsible person."
- The Q.P. of the manufacturer/exporter has to certify the
batch.
- The Q.P. of the consignee/importer is given this batch
certificate and administers it (entry in a batch register).
- There must not be more than one "official importer" for an
entire batch.
The last condition points to the special responsibility of the Q.P. In
case parts of a single batch are delivered to different importing sites at different
times, communication between the Q.P. of the
"official importer" and the individual sites has to go
off smoothly. This is an important task of the Q.P. as he trusts in the
supplier's certificate and confirms with his signature the GMP-conform
manufacture of each part of the batch. In principle, the Q.P. can do this
without ever having seen the batch physically. However, this batch has to
exist physically before it can be released.
The requirements on the content of a batch certificate have been
published by EMEA in the form of an internationally harmonised document
and can also be found at http://www.emea.eu.int/htms/technical/mra/mra.htm.
As, in the case of globally acting companies, several countries - also
outside the economic sphere of the EU - are involved, this may give rise
to complex situations. In a "Questions and Answers" document,
EMEA tries to give answers to the most important questions regarding the
EU-Swiss MRA. You will find this document at http://www.emea.eu.int/pdfs/technical/mra/ch/008402en.pdf.
It also deals with contract manufacture and with the manufacture
of investigational medicinal products.
According to the Explanatory Notes, Part II, the described procedure
should also be followed for bulk products, intermediate products,
partially packed products and active pharmaceutical ingredients as well as
for investigational medicinal products.
Author:
Dr Gerhard Becker
CONCEPT HEIDELBERG
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- The MRA between Europe and Switzerland - 
