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EC-Swiss, Explanatory Notes to Chapter 15 (Medicinal Products GMP inspection and batch certification) of Annex 1 of the EU-Swiss MRA October 2002


EG Kommission

Document Type:
Explanatory Notes
On 21 June 1999, the EC and Switzerland signed an Agreement on Mutual Recognition in relation to Conformity Assessment (MRA). The MRA includes a Chapter (Chapter 15 of Annex 1) on Medicinal Products GMP Inspection and Batch Certification. In order to ensure a proper and uniform implementation and application of this Chapter, and to allow industry to make the necessary arrangements, the European Commission and the Swiss Authorities have established these Explanatory Notes, which shall be read in conjunction with the MRA. These Notes represent the Commission’s and the Swiss Authorities’common interpretation of Chapter 15, taking into account the legislative, regulatory and administrative provisions existing in June 2002 and are without prejudice to further changes. They are applicable from the date of entry into force (1st of June 2002) of the MRA.

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