GMP News No. 210
2 July 2002
The PECA Agreements on GMP
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).