National Health Registration Number (AMPP) – Mandatory for the UK
Intended Audience: Onboarding Partners and MAHs
Situation: The National Health Registration Number (NHRN) field will be enforced for upload of Product Master Data to the UK MVS from Q4 2019 via a technical change to the EU Hub. From that time, Onboarding Partners (OBP) will be required to upload the NHRN (AMPP) in the Master Data for products marketed in the UK.
Background: 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 17digits with a permitted length between 6 and 18 digits.
The information stored in the 2D data matrix bar code includes a product code as a GS1 standard 14-digit Global Trade Identification Number (GTIN). The UK does not require a NHRN or reimbursement code adding to the data in the 2D Matrix code on the pack but does allow additional information to be included, provided this has been formally assessed as part of the marketing authorisation.
The Master Data Download (G101) transaction of the UK MVS allows download of the master data for any product or group of products. Each Product Code (GTIN) is associated with a corresponding NHRN (AMPP) code. This allows cross-referencing via a look-up to the AMPP dataset (including pricing data) maintained in the dm+d directory.
Recommendations: MAHs and their respective OBPs should begin to prepare for the change.
For accurate, fast and reliable updating of licensed medicines on dm+d, many companies prefer to use the eMC ‘In Demand’ portal (owned by DataPharm).
Alternatively, you can choose to liaise with the NHSBSA MEDS Data Team by Email: firstname.lastname@example.org or telephone: +44(0)191 203 5289.
Note: There is now no constraint to obtaining AMPP codes prior to receiving marketing authorisation.
Further information can be found in the Technical Bulletin.
See also the release notes from EMVO.