CRED SMPC 2024

23/09/2024

EU SmPC legislation – brief history

Directive 65/65 EEC

CHAPTER II: Authorisation to place medicinal products on the market

Article 4a states:

The summary of the product characteristics referred to in point 9 of the second paragraph of Article 4 shall contain the following information …

The Organisation for Professionals in Regulatory Affairs

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QRD – established June 1996

● Practical advice on how to draw up the SmPC is provided to the applicant in the form of templates developed by the Quality Review of Documents (QRD) group, for centralised, decentralised and mutual recognition procedures. ● Composition:

– EMA (chair & secretariat) – MSs (1 Human + 1 Vet) – European Commission – NO + IS (as observers) – Translation Centre

The Organisation for Professionals in Regulatory Affairs

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