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Do you want to register with us, inform us of changes, or tell us about an alert? Please select one of the four options below, or type key words into the 'What do you want to do?' search box, select the relevant category and end user type and press the search icon. If you are looking for information, please go to our How can we help? page.

I am a Manufacturer – where can I find more information?

More information is available from the British Generic Manufacturers Association (BGMA).  

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

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

Does Article 37(d) require that a National Medicine Verification Organisation (NMVO) directly alerts the relevant national competent authorities, the EMA and the Commission about a falsification? Is there is a time limit for such alerting?

The use of the term “provide for” in Article 37(d) of Commission Delegated Regulation (EU) 2016/161 means that an NMVO has to ensure that the National Competent Authorities (NCA), the EMA and the Commission are informed.

Can the initial certificate download be done via the web service?

Yes, this service is available. Useful resources:

Technical Bulletin: Certificate and Password Management Issues

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