Last week’s round-up, 16-20 March 2020

By Stephanie Allampalli, Tessa Fiorini-Cohen and Marthese Mifsud


Brexit-related guidance for companies

20 March 2020

The EMA’s Brexit-related guidance for companies has been updated, with the publication of updated ‘EMA notice to stakeholders’ and ‘EMA practical guidance’. The two documents explain the intricate preparations companies need to make to prepare for the end of the transition period on 31 December 2020 (unless extended), as well as the legal situation thereafter.

The applicable rules in Northern Ireland (NI) after the end of the transition period are particularly interesting. In some ways, NI will be regarded as an EU Member State. A medicinal product placed on the market in NI must be compliant with EU law and it will still be possible to obtain marketing authorisations in NI following EU procedures, e.g. NI can be included in a DCP as a CMS, but cannot act as RMS.

Clinical pharmacology and pharmacokinetics: Q&A

18 March 2020

The European Medicines Agency (EMA) has released two new questions and answers (3.10 and 4.11) related to clinical pharmacology and pharmacokinetics, concerning the following products:

  • Lozenges: The EMA has released advice on the extent of active pharmaceutical ingredient that should be released from lozenges in a comparative local in vivo bioavailability study, in order to be able to conclude comparable local exposure.
  • Orally inhaled products containing beclomethasone dipropionate: The EMA has released its recommendation on the most sensitive analyte (parent compound or main metabolite beclomethasone-17-monopropionate) for assessing lung deposition, and the required studies (with and/or without charcoal block) for establishing therapeutic equivalence by means of pharmacokinetic data for these products.

Impact of Covid-19 outbreak on the EDQM Certificate of Suitability (CEP) procedure

17 March 2020

The EDQM has released some information on the impact of the coronavirus pandemic on CEP related procedures.

The Directorate will be contacting CEP holders in high risk zones, who may have difficulties in delivering CEPs, in order to confirm whether delivery is possible or to propose alternative solutions. CEP holders and active substance manufacturers should inform the EDQM as soon as possible if any deadlines for submitting responses to deficiency letters, inspections and risk assessments related to nitrosamines, cannot be met. Companies should also inform their customers in advance of any changes and revisions that will be made.

The EDQM will be postponing inspections of API manufacturers and the companies concerned will be informed. Further information will be released by the EDQM in due course.

EMA COVID-19 updates

16 March 2020

The EMA is collating all its coronavirus disease (COVID-19) related updates on a dedicated page.

Among recent updates are that the EMA is providing full fee waivers for scientific advice for potential vaccines and treatments for COVID-19. Additionally, the authority is taking measures to monitor the potential impact of the outbreak on human and veterinary medicine supply chains in the EU.

The authority is asking pharmaceutical industry associations, companies and manufacturers in the EU to carry out risk assessments and to inform regulators about the resilience of supply chains. It has also started a review of manufacturing information on centrally authorised human and veterinary medicines to identify those most at risk:


Image: Novel Coronavirus SARS-CoV-2,   CC BY 2.0

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