20 March 2012

CSC: EMA Guidance Gives the Industry Much-Needed Clarification - By Andrew Marr

After a period of waiting, the industry at last has some clearer information on the EVMPD with the release of new guidance from the EMA.

To start with, the agency confirmed that the structured substance information (SSI) would not be required for the 2nd July start date. At some point the data will need to be provided by somebody, and the agency will discuss that with industry after 2nd July and plan some form of roadmap for the provision of SSI data.

The next major change concerns labelling, with the EMA noting that the Summary of Product Characteristics (SmPC) is all that is required for labelling. The agency has done away with the requirement for the package insert, the labelling, and the Annex II for Centralised Procedure (CP).

There are also some options for the language SmPC is provided in. For CP it’s only the English, as expected. For the Mutual Recognition Procedure (MRP) and Decentralised Procedure (DCP) the preference is for the national language or languages, where relevant, but the EMA will accept the English common agreed text. For those companies choosing this approach, it does mean far fewer documents (and thus fewer resources), though it makes the EMA’s validation more difficult because regulators will have to check databases for information not included in the English common version. For National Procedure products, companies will be required to use the national language (or languages) for product information.

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CSC: EMA Guidance Gives the Industry Much-Needed Clarification - By Andrew Marr

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