Clarification of requirements for parallel importers using 'batch pooling'

The term batch pooling is used by parallel importers when different batches of a parallel imported medicinal product (raw materials) are pooled and repackaged into one repackaging batch. For a two-year trial period, the Danish Medicines Agency has accepted batch pooling with due account being taken to several manufacturing and labelling requirements, cf. the rules on good manufacturing practice and the labelling rules. These requirements have now become established practice and are clarified below.

The requirements only apply to medicinal products parallel imported into the Danish market.

Batch numbers

It appears from the Guidelines on parallel import of medicinal products (no. 9107 of 27 February 2018) that only the parallel importer’s own batch number must appear on the outer as well as the inner packaging.

We are now changing this practice to protect the interests of patients. When ‘batch pooling’ is used, the ‘raw material batch number’ (original batch number) as well as the parallel importer’s own batch number must appear from the inner packaging, because ‘batch pooling’ involves different ‘raw material batch numbers’.

The reason for the changed practice is that when the manufacturer of the original product assesses complaints and adverse reactions, it is important that the manufacturer can be informed of or see the ‘original batch number’ if the manufacturer receives a complaints package.

It is not accepted to cover the ‘raw material batch number’ on the inner packaging with a label that must be removed to get information about the batch number of the manufacturer of the original product. The reason is that the package may be damaged when the label is removed, and in some cases the label will be removed by the patient.

For example, if the label covers the entire back of a blister, the batch number of the manufacturer of the original product can be printed on the label in the same way as the batch number allocated by the parallel importer. It must be clear which batch number is the original batch number, and which is the parallel importer’s batch number.

The batch number of the manufacturer of the original product does not have to be visible on the inner packaging if ‘batch pooling’ is not used, because there is no doubt about which original batch the medicinal product originates from. In such case, the parallel importer decides whether the batch number of the manufacturer of the original product should appear from the inner packaging or be covered on the inner packaging.

As previously, only the batch number allocated by the parallel importer must appear from the outer packaging.

Expiry

We would also like to clarify the criteria for labelling of expiry when ‘batch pooling’ is used. When ‘batch pooling’ is used, the batch expiry must be determined by the ‘raw material batch’ with the shortest expiry date. We therefore do not accept different expiry dates on the inner packaging. Similarly, we do not accept additional labelling on the outer packaging stating differences in the stated expiry dates on the inner packaging – e.g. blisters.

Only the shortest expiry date must appear from the inner packaging as well as the outer packaging. No other expiry dates must appear from the packaging material. This means that some expiry dates must be covered. Preferably, a label or ink print should be used to cover the expiry dates, but other methods can be used, provided that the covering has a professional and consistent look.

In special cases, where the inner packaging is sealed in a foil bag, we have accepted that the patient/citizen adds an additional label to the inner packaging when the seal is broken. In such cases, information about this to the patient/citizen must appear from the outer packaging. Information on the outer packaging must instruct the patient/citizen on how to add the label, so that the expiry date of the manufacturer of the original product is covered on the inner packaging.

The parallel importer is responsible for ensuring that such information is stated on the outer packaging. Consequently, it can only be accepted that another expiry date appears from the inner packaging if the parallel importer in this way has ensured that the non-effective expiry date on the inner packaging will be covered by the label that the patient/citizen will add.

Homogeneous batch

We would also like to clarify the practice for the GMP concept of ‘homogeneous batch’ in connection with ‘batch pooling’. It is a prerequisite for ‘batch pooling’ that the same variant of ‘raw materials’ is used, so that the quality and labelling of the ‘raw materials’ in one repackaging batch are identical (that is batches released to the same market or country). The ‘raw materials’ included in the repackaging can only differ in terms of batch numbers and expiry dates.

Moreover, each package of finished product can only contain inner packaging from a ‘raw material’ with the same batch number and expiry.