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News

Acting as a Responsible Person (import) (RPI) in the UK

Background The Medicines and Healthcare products Regulatory Agency (MHRA) recently published guidance called “Acting as a Responsible Person (import) (RPi) from 1 January 2021”. The guidance describes the role of an RPi and how to become a RPi. Also of relevance is the guidance “Sourcing medicines for the Great Britain market from an approved country for import or Northern Ireland”. The RPi is described in regulations 45AA and 45AB of the Human Medicines Regulations 2012.  
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BREXIT: Approved Country Lists Post-Transition Period

Countdown to Transition Period End Date Days Hours Minutes Seconds Introduction On 31 December 2020, the Brexit transition period will officially end which means that from 1 January 2021 changes to the current arrangements in place may occur. During the transitional period, the UK has remained a member of the European Economic Area (EEA), the single market, and the customs union. EU laws have continued to apply to the UK, and the UK has continued
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Grainne Higgins Orphan Drug Consulting

Orphan Drug Consulting Appoint Grainne Higgins as Human Resources Consultant

Dublin, Ireland, 28 September 2020 – Orphan Drug Consulting is delighted to welcome Grainne Higgins to its growing international consulting team. Grainne’s focus will be twofold within Orphan Drug Consulting, both supporting our clients with their Human Resources needs across talent/recruitment/organizational strategy & development; in addition to providing Executive and Leadership coaching to implement best practice to our new client leadership teams. Coupling Grainne’s significant experience to our existing entity establishment services adds to our
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Mike Gannon Orphan Drug Consulting Financial and Entity Planning

Orphan Drug Consulting Appoint Mike Gannon as Financial and Entity Planning Consultant

Dublin, Ireland, 25 August 2020 – Orphan Drug Consulting is delighted to welcome Mike Gannon to its growing international consulting team. Mike specializes in helping organizations grow and develop internationally as well as advising on optimum structures for finance, tax, treasury and business administration and support functions. Providing this expert advice to Orphan Drug Consulting clients addresses this growing and strategic part of our consulting business. Mike has over 25 years of financial leadership within
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Orphan Drug Consulting Open Office in Boston, MA, and Appoint Christy Webb as US-based Consultant

Dublin, Ireland, 20 July 2020 – Orphan Drug Consulting today announced the opening of office space in Boston, Massachusetts, and the further growth of its US-based consultant team with the appointment of Christy Webb as a Quality Assurance consultant. This further expansion into the US market by Orphan Drug Consulting addresses an increased demand for its expert consulting services and follows on from the recent appointment of Tanya Quinn as a Supply Chain consultant in
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Orphan Drug Consulting Appoint Tanya Quinn as US-based Consultant

Dublin, Ireland, 02 June 2020 – Orphan Drug Consulting is delighted to welcome Tanya Quinn (through her company Knowledge Base LLC) to its international consulting team. Tanya will support Orphan Drug Consulting with its growing client requirements in the US from her New York/New Jersey-Metro location. Tanya is a well-respected, experienced senior supply chain management consultant with over 7 years building her own consulting business and over 15 years in industry employed in senior supply
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