What are AMPP codes and NHRN Numbers?

What is an AMPP code?

Actual Medicinal Product Pack (AMPP) codes uniquely identify a packaged product.  An AMPP is the packaged product which is supplied for direct patient use. For a medicine, the AMPP description consists of:
Actual Medicinal Product (AMP) name + Supplier + Quantity + Quantity unit of measure
e.g., Amoxil 500mg capsules, GlaxoSmithKline, 21 capsules

AMPP codes are generated by the NHS Business Services Authority (NHSBSA).

The AMPP code is also known as the Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT) code.  It comprises a string of numbers (usually 16 or 17 digits) unique to the product and pack.  The AMPP identifier will never be re-used and given to another product or concept.

AMPP codes are used to identify a particular product pack in the supply chain, on electronic purchasing and record systems, when it is prescribed and appears on the patient record and when it is reimbursed.

What is an NHRN Number?

The National Health Reimbursement Number (NHRN) is a field in the Product Master Data of a product that is uploaded to the European Medicines Verification System (EMVS) for distribution to the National Medicines Verification System (NMVS) in a specific country.  For Northern Ireland the AMPP is the identifier to be loaded as the NHRN number of a product.

UKNI NMVS Requirements for AMPP/NHRN

The NHRN is not currently a required field when uploading products to the UKNI NMVS (correct at time of writing 26-Apr-2022).

Note: Version 6.0 of the Master Data Guide, EMVO-0122, approved on 02-Dec-2021 states that for the "UK (the AMPP may be required. OBPs should consult national guidance)" in the Guidance for entering National Code appendix. MAH’s/OBP’s should contact the MHRA for clarification.

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Is aggregation permitted, in particular for use of downstream wholesalers?

The Delegated Regulation allows for aggregation but does not stipulate the need for pack aggregation. The EMVS / NMVS system does not support aggregation.

Is it possible for Software Suppliers to register their clients without an agreement for the FMD service?

It is not recommended. It is necessary for the person registering to accept the terms and conditions of the EULA, which could not be justified without an agreement in place.

List of IT Software Suppliers

For those organisations who do not have an IT software provider, or who seek to find companies providing solutions, SecurMed has published the following list of providers.

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.

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.