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HPRA Guide to Combining Multiple Presentations of a Parenteral Product in One Product Authorisation

News Category: Regulatory news

Date: 30/03/2015

 The HPRA wishes to announce changes to its previous policy in relation to combining multiple presentations of parenteral products in one Product Authorisation (PA). The revised policy is outlined in the new HPRA Guide to Combining Multiple Presentations of a Parenteral Product in One Product Authorisation.
 
The main change introduced in this guide is that it will no longer be an absolute requirement for different presentations of a parenteral product to be presented in the same type of container that is made from the same materials to be listed on a single PA. This will mean that it will be possible for different container types (e.g. ampoules and vials) to be listed on the same PA provided that all other criteria outlined in the guide are met. Similarly it will be possible for bags manufactured using different types of plastic to be listed on the same PA if all other requirements are met.
 
The new guide will apply immediately for all new applications and variations to add additional presentations of a parenteral product. The guide also provides information for MAHs on how to proceed if they wish to apply to merge existing PAs for authorised medicinal products where the new criteria for merging such PAs are met.


All HPRA guides and forms can be found under Publication and forms section of our website (www.hpra.ie/homepage/about-us/publications-forms)

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