Are EMA MAs the same as UK MHRA MAs?

No.

European Marketing Authorisations (EMA) Marketing Authorisations (MAs) are issued by the EMA under the Centralised Procedure (CP) process.  Once granted, this enables the MAH to market and distribute medicines within all EU member states.  EMA CP MAs apply in Northern Ireland only from 1st January 2021.

All pre-existing UK CP MAs have been ‘grandfathered’ by MHRA into GB MAs where the medicine is supplied to GB.   Refer to MHRA for guidance.

Medicines that were issued in EU member states before EMA was formed may require two additional processes – De-Centralised Process (DCP) and Mutual Recognition (MR) – to register medicines across the EU. 

From 1st January 2021 UKNI and GB are aligned but not part of the DCP/MR processes operated by the EU.   MAHs should seek guidance from MHRA on how to these types of MA apply.

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Useful FMD Links

Please find below links to public sites which provide useful information for the implementation of the Falsified Medicines Directive. MHRA have provided guidance for the implementation and compliance of the Safety Features Regulation: Implementing the Falsified Medicines Directive: Safety Features.

Will manufacturers and wholesalers be able to see data on products I have dispensed?

No. The Delegated Regulation asserts that all parties that are connected to the repositories system, including manufacturers, wholesalers and pharmacies, have sole responsibility, ownership and access to any data that they generate.

Do MAHs interact with the UKNI national hub for downloading pack data?

No. The MAH should upload the pack data to the EU Hub, which will determine which packs need to be sent to the UKNI national hub. The EU Hub is the master system of record for MAH pack data.

Does the WDA holder need to connect to the EMVS Hub?

No. Unless the WDA holder is also an MAH or a Parallel Distributor, there is no need to connect to the EMVS Hub.

Can 'soft-wrap' (e.g. cellophane) bundle of packs be labelled with an individual label showing the UK pack labelling requirements above?

The safety features legislation sits within Article 54 of Council Directive 2001/83/EC.

How should serialisation be implemented for ‘titration’ packs, only to outer box or it should also be applied to the inner boxes too?

Serialisation should be applied to the pack which is the unit of sale and to which the labelling provisions in Article 54 of Council Directive 2001/83/EC apply.

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