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Case Studies

Bionical Emas Regulatory Affairs: Mutual Recognition Submission Strategy

Situation

Our client has a portfolio of generic ophthalmic products with EU national licences. Keen to expand their commercial footprint in Europe, they wish to file additional Marketing Authorisations, and approached Bionical Emas to help with their Submission Strategy, MAH activities and become the single EU Regulatory Point of Contact.

Approach

  • Submission Strategy & Brexit: Considered the most appropriate EU community procedure to undertake (MRP) and supported the client’s application for Requesting MRP. Outlined a customised approach to mitigate the potential impact of Brexit, for their UK filing strategy
  • Submission documentation: Reviewing packaging, updating summary of product characteristics (SPCs) and patient information leaflets (PILs). Written a number of submission documentation, such as; clinical expert overviews and a quality overall summary. Liaising with the client’s centralised regulatory team
  • Delegation of MAH services: Our client requested a service provider who would be prepared to receive delegated services for an MAH for several members states, including the UK, reinforcing the prime request to become a single EU Regulatory Point of Contact

Outcomes

  • Provided regulatory operational expertise in several EU markets, comprehensive delegation of MAH responsibilities in UK and EU
  • Expertise and support in providing Submission documentation
  • Clear strategy which continues to provide a consultative service, on an ad-hoc basis
  • A collaborative approach in which there is a common objective… supporting our client’s commercial portfolio in Europe

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