Feb 143 min read

A Short Guide to Product Licence Codes

A brief explanation of the product codes you may come across.

#1: The Background

As always the best way to understand something is to dive into how it came about in the first place.

To put it briefly, every single product that has a marketing authorisation (MA) within the UK will have a code to relate to the marketing authorisation holder. They have become quite varied within the last few years as we left the EU. A few teething problems have left some of us feeling very nervous when presented with a Product Licence number that is out of the normal PL 00000/000 layout.

The PL code is also known as the Marketing Authorisation number due to its ties to the marketing authorisation company. As an example, for a company with a Manufacturing & Import Authorisation (MIA) number as 12344 and their first product has been approved for manufacturing, 001, the PL code will be PL12344/001. Subsequent MA's will follow sequence 002, 003 etc.

The introduction of the PLGB code brought restrictions to where the product is licenced, and in turn a new area of concern for wholesalers. We should all appreciate the hard work put in by manufacturers to update all the necessary documentation, helping wholesalers as we navigate the post brexit landscape providing us with an understanding and tools to correctly identify products for the UK market.

As you may know though, we still have a sticking point, Northern Ireland... As many know already, NI provides unique challenge being under a confusing and complex set of regulations, all set in place to ensure not only healthy trade but peace. The 'for now' fix is the introduction of the PLNI product code. All the same previous rules apply to these codes, such as, the Marketing Authorisation numbering system.

#2: Restrictions

For those of us that deal with companies outside of Great Britain, the varying PL codes have introduced a new risk when purchasing and supplying products. The key issue is the limited products permitted to be sold to customers in Northern Ireland. Products with a 'GB' at the end of a PL code cannot be sent across to Northern Ireland as they are not licenced in this area.

Where products must now be split into either GB codes or NI codes, it cuased great concern that there will be a sudden shortage of medicines in the smaller NI market. BUT, the MHRA had already come up with a plan....

#3: NIMAR

The Northern Ireland MHRA Authorised Route was introduced to cushion the blow to Northern Irelands supply chain. As a majority of their products were sourced from manufacturers within Great Britain. Under this route, products that are not licenced in NI but are in GB can be supplied under this exemption.

#4: Your solutions

Whilst working with a plethora of clients with all sorts of business models, Modus Consultancy devised solutions for all problems in all their shapes. Our priority is always to maintain Patient safety and Product integrity, but also to make things easier for you. Mitigating the risk of bringing the wrong products in or sending the wrong products out comes in at all stages of your QMS. You could make it part of your purchasing procedure to only accept stock that is okay for the market in Northern Ireland. You could implement a Goods in Check or a booking-in location to isolate higher risk products. Or, when supplying a NI based company, ensure all goods out checks involve additional checks to ensure the product code is correct, some additional training could go a long way!

The future

With Brexit still not settled, we anxiously await the next legislation that will impact supply chains. Considering the recent announcements from the government around 'new' deals, we expect half of what we have just spoken about will be rendered useless or out of date!