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GMP News No. 151
8 December 2001
NewVersion of Compilation of Community Procedures on Inspections and Exchangeof Information
The European Commission recently published a new version of compilation ofCommunity procedures on inspections and exchange of information ('RevisedCompilation of Community Procedures on Administrative Collaboration andHarmonisation on Inspections', May 2001).
This compilation updates and replacesdocument III/5698/94-EN 'Compilation of Community procedures onadministrative collaboration and harmonisation of inspection', worked outby the Working Party on control of Medicines and Inspections in 1994. Theupdated version has 86 pages and includes different guidelines that giveguidance for inspectors, e.g. on rapid alerts and procedures related toGMP-inspections. This compilation also lays down a Community format forthe GMP Inspection Report and for the manufacturers authorisation and laysdown the content of batch certificates for drug or medicinal products thatare exported to countries under the scope of a MRA (Mutual RecognitionAgreement). Furthermore, the document gives guidance on exchange ofinformation between expectorates, and procedures related topre-authorisation inspections and to the preparation of reports on GMPinspections requested by either the CPMP or CVMP in connection withapplications for marketing authorisations and with products authorisedunder the Centralised System.
Some of the guidelines have already beenpublished and entered into force some years ago, e.g. the guideline'Conduct of Inspections of Pharmaceutical Manufacturers' (1996) or theguideline 'Training of Inspectors' (1996).
Other guidelines are quite new, e.g. theguideline regarding the content of the fabricator's/manufacturer's batchcertificate for drug/medicinal products exported to countries under thescope of a Mutual Recognition Agreement' (January 2001)
According to this guideline there will beinternationally harmonised requirements for the content of the batchcertificate of a drug/medicinal product. The importer of the batch is toreceive and maintain the batch certificate issued by thefabricator/manufacturer. Besides general information about the name of theproduct, the importing country, the marketing authorisation number, etc.,results of analysis have to be documented and a certification statementhas to be given. The documentation of the analytical results shouldinclude the authorised specifications, all results obtained and refer tothe methods used. The batch certificate has to be signed and dated by theperson responsible for releasing the batch for sale or supply and export.This batch certificate is essential to exempt the importer fromre-control.
Another newer guideline as part of thiscompilation describes the procedure for co-ordinating foreign andCommunity pre-authorisation inspections during the assessment ofapplications (January 2001). The legal basis for pre-authorisationinspections of manufacturers of medicinal products in connection with thegranting of a marketing authorisation by the Community is laid down inArticle 8.2 of the Council Regulation (EEC) No 2309/93 that lays downCommunity procedures for the authorization and supervision of medicinalproducts for human and veterinary use and establishing a European Agencyfor the Evaluation of Medicinal Products. The EMEA has a coordinating rolefor theses inspections, but the responsibility for carrying them out restswith the Supervisory Authority which is defined by legislation as the'Competent Authority of the Member States' in which the product is eithermanufactured or imported, controlled and released for the sale within theEuropean Economic Area.
The guidelines gives detailed informationabout pre-submission notification by the applicant for a marketingauthorisation, designation of an inspection team and preparation for theinspection, contacts with the applicant and the manufacturer(s) to beinspected, inspection and transmission of the report and check on theimporter and submission of the final report to the Rapporteur and theEMEA. The procedure described in this guideline ('Procedure forCo-ordinating foreign and Community pre-authorisation inspections duringthe assessment of applications') is included in The Rules GoverningMedicinal Products in the European Community, The Notice to Applicants,Volume 2A, Procedures formarketing authorisations.
For more details about each of theguidelines, the complete compilation can be downloaded from theEC-homepage (see 'News'of 15/10/01).