What is an AMPP code and how can I identify it?

The National Health Registration Number (NHRN) is a required field for UK Product Master Data uploads but, in order to allow OBPs and MAHs time to source the relevant the AMPP codes from the dm+d, SecurMed has determined this will NOT be enforced with this release of the EU-Hub. Subject to agreement with EMVO, AMPP codes will be technically enforced in a forthcoming release of the EU-Hub.

The Actual Medicinal Product Pack (AMPP) code has been defined as the NHRN for the UK. AMPP codes (mapping to GTIN product codes) are generated by the NHS dm+d database and consist of numbers typically 16 or 17 digits with a permitted length between 6 and 18 digits.

Further details are provided in the Technical Bulletin:

Technical Bulletin: AMPP Codes

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No. Please contact GS1 directly.

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.

Where can I find a copy of the Delegated Regulation?

You can find the Delegated Regulation here.

Which medicines are in scope of FMD?

For details of the scope of the regulation please check: FMD Delegated Regulation 2016_161

Where stakeholders are unclear on the legislation, for example whether types of medicine are in/out of scope, please contact DHSC/MHRA at fmd. safetyfeatures@mhra. gov. uk.

My company has not yet submitted to the MHRA White List of products exempt from FMD charges. Can products still be added to the White List?

Yes. Article 46 of the Delegated Regulation (DR) notifies the commission of additional medicinal products that are at risk or not at risk of falsification. All submissions must be made by the MHRA. Please contact the MHRA for information on how to submit.