EMA Labelling and Packaging Regulations

EMA Labelling and Packaging

  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 […]

EU Marketing Authorization Procedures

EU Marketing Authorisat

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. […]

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

EU Marketing Authorization Procedures

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 […]

BREXIT: Approved Country Lists Post-Transition Period

EU Marketing Authorization Procedures

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 […]

Orphan Drug Consulting Appoint Grainne Higgins as Human Resources Consultant

Grainne Higgins Orphan Drug Consulting

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 […]

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

Mike Gannon Orphan Drug Consulting Financial and Entity Planning

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 […]

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 […]

EU Regulatory Flexibility During COVID-19 Pandemic

In these uncertain times it can be challenging to comply with regulatory requirements while maintaining supply demands, but there has been advice published by the authorities to help. This guidance has outlined regulatory flexibility that can be applied to help pharmaceutical companies cope with the consequences of the pandemic, while ensuring a high level of […]

EU-GMP Guideline of Annex 21 ‘Importation of Medicinal Products’

On 20th March 2020 the EU-GMP Guideline of Annex 21 ‘Importation of Medicinal Products’ was published as a draft.  In addition to the guidance outlined in the main chapters and annexes, it was a thought that there was a need to publish a specific guideline on importation of medicinal products under a dedicated annex of […]