The following guideline can be ordered through the address listed in the "Source/Publisher"-category. In cases in which you can order through the Internet we have established a hyperlink.

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

Origin/Publisher:

EG Kommission

Document Type:
Explanatory Notes
Content:
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.

Go back

GMP Conferences by Topics

Cookies help us in providing our services. By using our services, you agree that we use cookies. Further information

OK