A batch-specific variation is a variation application to request agreement for a single or small number of batches of product to be released outside of the usual conditions of the marketing authorisation. Every year we receive more than 200 batch …
A variation allows the applicant to apply for changes to a marketing authorisation. Changes are classed either as minor changes which include Type 1A or Type 1B variations, or as a major change classed as a Type II.
The Product Information Quality Unit (PIQU) team often gets asked for help during a Type 1B variation procedure. This ranges from providing advice on missing documents to explaining why the proposed changes are not acceptable first time around.