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Apr 14

European regulatory requirements during COVID-19

The European Commission (EC) and European Medicines Agency (EMA) have produced guidance for marketing authorisation holders, regarding the topic of potential changes to regulatory requirements during the COVID-19 pandemic.

In summary of their guidance, the topics addressed include marketing authorisation procedures and timelines; manufacturing; distribution and quality, with the aim being to ensure the maintained standards in quality, safety and efficacy throughout the European pharmaceutical industry.

When regarding the marketing authorisation for a product intended for trade within the EU, is has been communicated that the Coordination Group for Mutual recognition and Decentralised procedures – Human (CMDh) will promote a zero-day recognition/repeat use procedure for new member states. Furthermore, under current Directives, the guidance also alludes to MAH’s being potentially enabled to authorise the use of a medicinal product already authorised in a different member state, in addition to the possibility for compassionate use or distribution of an unauthorised medicinal product to occur in scenarios where no appropriate national marketing authorisation exists.

Moreover, when addressing the timescales involved with the marketing authorisation, the guidance states that companies unable to meet the requirements associated with renewing their product’s existing marketing authorisation may seek to postpone this deadline, beyond the current 5-year validation period, by notifying the appropriate authority with their reasoning; in accordance with the currently required timescale of 9 months prior to the marketing authorisation’s expiration.

In conjunction, for circumstances where new products are prevented from coming to market and where existing products have ceased to trade, as direct results of the COVID-19 pandemic, the guidance states that MAH’s may request an exemption to the 3-year ‘sunset clause’ – via their product’s appropriate authority.

Furthermore, to ensure that the impact of COVID-19 on the pharmaceutical industry does not become exceedingly detrimental for the manufacturing and distribution of medicinal products, the EC and EMA have stated that the MAH’s of crucial products will be allowed to propose and implement an exceptional change management process (ECMP), which will be required when addressing the topics of seeking alternative suppliers; sourcing new manufacturing sites and making any necessary changes in a product’s quality control.

With further regards to quality control, the guidance also states that existing flexibilities within current Directives should be fully utilised where possible and, with reference to deviations in packaging and labelling information and amendments to quality control schemes, these will need to be communicated to all appropriate authorities.

Following all propositions outlined within their guidance, the EC and EMA have specified that, where any and all changes are made regarding the aforementioned solutions, these process deviations must be communicated to all relevant international and national authorities – outlining ‘CONCERNS COVID-19’ as the subject.

Moreover, it has also been stated that MAH’s with queries regarding specific products not mentioned within this guidance are to contact the EMA or, where appropriate, their national competent authority at the earliest concern.

With regards to further communications, the EC and EMA have notified that this document will remain valid until further updates are provided.

PharSafer will continue to monitor this situation and await any further upcoming regulatory information and communicate these updates as and when we receive them.

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