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

Date of Change

30 June 2020

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.

Situation

With the R1.6 release of the EU-Hub deployed in December 2019, the upload of a value to the NHRN field was configured to technically enforce this for 4 countries; Austria, Germany, Portugal & Spain.

The National Health Registration Number (NHRN) is a required field for UK Product Master Data uploads. For the present SecurMed has decided NOT to enforce NHRN upload.

A determination will be made at an appropriate time in the future and subject to agreement with EMVO, the change would be deployed with a future release of the EU-Hub.

Further details are provided in the Technical Bulletin:

Technical Bulletin: AMPP Codes

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EU Exit and UK MVS

The United Kingdom formally departed from the European Union on 31st January 2020, entering into a Transition Period lasting until 31st December 2020.

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Should we contact SecurMed to infiliate to GS1?

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.