Category: Articles

Emerging Biotech achieves successful European launch with support of Orphan Drug Consulting’s comprehensive approach to navigating diverse market landscape and EU regulations

As rare disease companies continue to face the challenge of entering new markets without adequate infrastructure build and knowhow, Orphan Drug Consulting experts recently supported one such company with an accelerated launch into the EU market.   Using its cross-functional team and proven approach, Orphan Drug Consulting enabled early access of the client’s treatment to […]

The Role of a Responsible Person (RP) & a Qualified Person (QP)

What is a Marketing Authorization? A marketing authorization (MA) is the authorization from the European Medicines Agency (EMA) which permits 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. What is a Qualified Person? Under […]

Rare Disease Day 2022

What is Rare Disease Day? Rare Disease Day is a patient-led globally coordinated movement on rare diseases, working towards equity in social opportunity, healthcare, and access to diagnosis and therapies for people living with a rare disease. Rare Disease Day was established by EURORDIS and 65+ national alliance patient organization partners in 2008. Rare Disease […]

Choosing the Right 3PL Service Provider in Europe

Introduction Extensive growth in the pharmaceutical industry over the last number of years has resulted in an increased demand for third-party logistics (3PL) services as companies began to outsource and adopt more virtual operations. Outsourcing to a third-party logistics provider can often save companies money and time by allowing them to avoid the ongoing investments […]

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 […]

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. […]

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 […]

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 […]

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 […]