Post-authorisation procedures

HumanVeterinaryCorporateGovernance

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Standard operation procedure for handling of requests from a national competent authority to the CMDh for a recommendation on the classification of an unforeseen variation under Article 5 of Commission Regulation (EC) No...

Adopted Reference Number: SOP/H/3375 Legal effective date:

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Standard operating procedure for provision of scientific recommendation on classification of advanced-therapy medicinal products

Adopted Reference Number: SOP/H/3309 Legal effective date:

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Work instructions for handling of paediatric Article 45 work-sharing procedures by the Co-ordination Group for Mutual Recognition and Decentralised Procedure – Human (CMDh) secretariat

Adopted Reference Number: WIN/H/3374 Legal effective date:

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Work instructions for handling of paediatric Article 46 work-sharing procedures by the Co-ordination Group for Mutual Recognition and Decentralised Procedure – Human (CMDh) secretariat

Adopted Reference Number: WIN/H/3376 Legal effective date:

English (EN) (231.23 KB - PDF)

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Standard Operating Procedure for marketing status reporting and sunset clause monitoring (Human Medicine)

Adopted Reference Number: SOP/H/3128 Legal effective date:

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Veterinary

Work instructions for handling of renewals for centrally authorised veterinary medicinal products

Adopted Reference Number: WIN/V/4030 Legal effective date: Summary:

Handling of renewals for centrally authorised veterinary medicinal products

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Standard operating procedure on annual re-assessment of centrally authorised veterinary medicinal products under exceptional circumstances

Adopted Reference Number: SOP/V/4006 Legal effective date: Summary:

The purpose of this SOP is to provide the project managers and assistants in the Veterinary Medicines

sector with guidance on the procedure to be followed for dealing with annual reassessments for

centrally authorised medicinal products for veterinary use authorised under exceptional circumstances.

English (EN) (155.1 KB - PDF)

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Standard operating procedure for processing of type II variations for medicinal products for veterinary use

Adopted Reference Number: SOP/V/4004 Legal effective date:

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Standard operating procedure for type IA variations (single and grouped) to centralised marketing authorisations (medicines for veterinary use)

Adopted Reference Number: SOP/V/4010 Legal effective date:

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Standard operating procedure for type IB variations to centralised marketing authorisations (medicines for veterinary use)

Adopted Reference Number: SOP/V/4011 Legal effective date:

English (EN) (181.93 KB - PDF)

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Work instructions for marketing status and sunset clause monitoring for centrally authorised veterinary medicinal products

Adopted Reference Number: WIN/V/4125 Summary:

New WIN following revision of IQM structure and simplification of procedure.

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