FAQ - Late Stage Labelling

Q1: We have a high percentage of stock keeping units for certain products, for which we receive many low volume orders. How would Late Stage Labelling help us?

A1: The principle of Late Stage is to produce a core pack common to all participating markets. The annual volume of the core pack is the cumulative volume of the low volume stock keeping units. This allows the filling and packing line to run at more optimum output efficiencies. This can allow the core pack supply site to plan production.

Q2: Does the supply site have to also operate the Late Stage Labelling operation?

A2: No, the LSL operation can be conducted in any appropriate location relevant to the distribution of the finished packs. The Late Stage Labelling operation will need to meet the necessary GMP and regulatory requirements applying to that location. A core pack supply site may also wish to operate an LSL line in order to gain higher output efficiencies on a high speed line.

Q3: How is my artwork prepared and how is the text sent to the Pago machine?

A3: The informative text is prepared by the normal artwork processes used by the client company, and approved in the normal way. Once approved, the artwork is stored on a server and then when an order is produced the Pago machine software draws down the relevant text file from the server and commences the print job. The server can be remote from the print and apply machine. This has advantages for asset management. It also means that in the event of an approved artwork update, the very next print job will be compliant with the update.

Q4: We currently work to minimum order quantities or only supply small orders once a year. How does Late Stage Labelling help our business?

A4: It can be that the minimum order quantity volume is greater than that required by the market. This means they have to carry higher than required inventory. This can lead to stock write-offs if the stock is not cleared once the minimum remaining shelf life is reached. In some markets there may be stock value issues when they have to carry higher levels of inventory.
With infrequent deliveries there is a risk of being out of stock or replenishment having an excessively long lead time for that market to be competitive.
If the ‘old’ stock has to be dispensed with then there can be issues with lost sales value, or parallel trade as the ‘old’ stock is cleared to other countries for which that product may not meet the regulatory requirements.

Q5: Is approved by the regulatory authorities?

A5: As each product moves into an LSL format the new pack will need to meet the local regulatory requirements. This is usually done at a local level. The concept of LSL has generally met with regulatory approval. Most authorities appreciate the benefit of a local language pack produced professionally and to GMP standards. Often low volume demand is met by ‘World Trade’ packs made in a language not understood by the local market. The practice of traditional over labelling and supplying a loose leaflet is open to recall issues or counterfeiting opportunities.

Q6: Can Late Stage Labelling be applied to all dose forms and pack formats?

A6: In general, yes. There are LSL design rules which need to be applied. This may require some pack design changes.

Q7: How can the amount of informative text be managed?

A7: The amount of informative text is that which is mandated by regulatory requirements. This is often quite minimal and standard for all products.

Q8: How do I work out which products will benefit from Late Stage Labelling?

A8: There are no fixed rules, the objective is to deliver an added value benefit to the patient and the business.

Q9: I understand that Late Stage Labelling needs to be considered as a business strategy, rather than just a labelling operation, why?

A9: LSL requires certain rules. For example, the core pack needs to be common to all participating markets. This may be on a regional or area basis. Hence, the pack graphics need to be standardised, as must the brand name, active name, dose form description. Should these be different market by market then this is best managed at a corporate strategy level. An LSL pack may form part of a product pack portfolio, only to be used for certain markets or certain order volume sizes. Hence, this may need to be controlled at a central level.

Q10: I use multi-lingual label-leaflets on my packaging. How would Late Stage Labelling be an improvement?

A10: Multi-lingual packaging assumes that all participating markets accept the same text. In pharmaceutical products markets often require special instructions or indications in their patient information leaflet. Each regulatory authority can amend the leaflet wording as part of the approval process. In the case of a multi-lingual pack any updates from a single market must be approved by each participating market. Not all countries have the same approval lead times. This can create problems with which issue of label-leaflet is acceptable to each market. LSL offers more flexibility and simplicity as each LSL label and leaflet is a single market.

Q11: Batch No. and Expiry Date are printed on the Late Stage Labelling Informative Text label. How do I ensure that they are the same as the primary pack data?

A11: Only the BN and Exp legend is printed on the LSL label. The actual BN and Exp date is coded on the primary packaging.

Q12: I have a number of markets that I wish to group together to create a core pack and service their demand through a Late Stage Labelling strategy. However, these markets use different brand names and different active names. How can I use Late Stage Labelling in this case?

A12: Often markets have effectively ‘local’ products to defend their sales against imports or to compete head to head with a local competitor. Unless the participating markets are willing to accept a single brand name and active name then LSL will not work for this group of markets. This is one reason why LSL must be adopted as a business strategy to be followed by all markets. LSL offers benefits of fast order lead times, in any quantity, without the risk of stock write-offs or out-of-stock, produced from a core pack produced in volumes, hence with cost benefits not possible with market specific, low volume orders. Hence, with LSL these special markets should be able to compete even better, more profitably with LSL.