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EMA Labelling and Packaging

EMA Labelling and Packaging Regulations

  Introduction   The European Medicines Agency (EMA) is a decentralised agency of the European Union (EU) in charge of scientific evaluation, regulation, and quality control of medicines in the EU.  Before approving medicinal products for distribution in the 27 EU member states along with Norway, Lichtenstein, and Iceland, the EMA makes sure that they meet safety, efficiency, and quality standards.  In relation to the labelling and packaging of medicinal products, there are certain requirements to be met before the EMA can finish its
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EU Marketing Authorisat

EU Marketing Authorization Procedures

European Medicines Agency  The European Medicines Agency (EMA) is responsible for the scientific evaluation of centralized marketing authorization applications (MAA’s). A marketing authorization (MA) is the authorization of a medicine to be sold in one, several, or all the European Union’s member states, depending on the type of application that has been submitted and to which agency. A key difference between the EMA and other regulatory bodies such as the US Food and Drug Administration (FDA) is
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EU Marketing Authorization Procedures

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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EU Marketing Authorization Procedures

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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