Articles

Articles

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
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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
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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
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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
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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
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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
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