Parallel distribution (human medicines) procedures

Standard operating procedure for processing of annual update notifications for parallel distribution

Adopted Reference Number: SOP/INS/2058 Legal effective date: 07/05/2015 Summary:

The purpose of this SOP is to define the procedure for processing the annual update notifications for parallel distribution in a consistent way.

English (EN) (125.23 KB - PDF)

Pubblicato per la prima volta: 08/05/2015 Ultimo aggiornamento: 08/05/2015

Work instructions for product information for parallel distributors

Adopted Reference Number: WIN/INS/2035 Legal effective date: 10/07/2013

English (EN) (217.8 KB - PDF)

Pubblicato per la prima volta: 10/07/2013 Ultimo aggiornamento: 10/07/2013

Standard operating procedure for processing of parallel distribution notifications of a change

Adopted Reference Number: SOP/INSP/2039 Legal effective date: 27/09/2012

English (EN) (107.71 KB - PDF)

Pubblicato per la prima volta: 28/09/2012 Ultimo aggiornamento: 28/09/2012

Standard operating procedure for Processing of parallel distribution initial notifications

Adopted Reference Number: SOP/INSP/2014 Legal effective date: 19/07/2012

English (EN) (110.81 KB - PDF)

Pubblicato per la prima volta: 19/07/2012 Ultimo aggiornamento: 19/07/2012

Work instructions for Regulatory check of initial notifications of parallel distribution

Adopted Reference Number: WIN/INSP/2031 Legal effective date: 19/07/2012

English (EN) (89.87 KB - PDF)

Pubblicato per la prima volta: 19/07/2012 Ultimo aggiornamento: 19/07/2012

Standard operating procedure for handling of financial procedure for parallel distribution

Adopted Reference Number: SOP/INSP/2013 Legal effective date: 11/10/2011

English (EN) (190.64 KB - PDF)

Pubblicato per la prima volta: 17/10/2011 Ultimo aggiornamento: 17/10/2011

Work instructions for publication of the monthly and annual overview of parallel distribution notices issued by the European Medicines Agency

Adopted Reference Number: WIN/H/2037 Legal effective date: 11/07/2012

English (EN) (180.84 KB - PDF)

Pubblicato per la prima volta: 20/07/2009 Ultimo aggiornamento: 11/07/2012

Work instructions for checking licences for parallel distribution

Adopted Reference Number: WIN/INSP/2038 Legal effective date: 19/07/2012

English (EN) (97.29 KB - PDF)

Pubblicato per la prima volta: 23/06/2009 Ultimo aggiornamento: 24/07/2012

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