Changes to SPCs & Labels
Changes to Summary of Product Characteristics (SPC) and their impact:
From time to time changes are made to the SPC, labels and leaflets of products. These changes may be initiated by the company or may be required by the VMD. For example, changes can be made because the company wishes to add new indications. Another example could be where new data, such as residues data, have been generated which indicate that a withdrawal period needs to be changed. In these circumstances, the company applies for approval of a variation and provides appropriatesupporting data. Once the variation is approved the company is usually expected to implement the change within 6 months. On occasions where the change is required for safety reasons a shortened time period may be specified. Any new batch of product released by the Qualified Person of the company from the specified date has to detail the new safety statements.
Companies may be required to write to wholesalers and suppliers informing them of the change or where there is a serious safety concern, may even be required to recall stock that has already been released and is on the market.
Four commonly asked questions are:
Q. If a withdrawal period is extended when should the longer withdrawal period be observed?
A. Where residues surveillance has established there is a problem and a longer withdrawal period is considered important to protect consumer health, the VMD is likely to specify that the Marketing Authorisation Holder contacts wholesalers and suppliers informing them of the change. In these circumstances it is important for farmers to follow the longer withdrawal period immediately to avoid the detection of residues above the maximum residue limit in their produce, and VMD may require the MA holder to take steps to ensure farmers are so informed.
Where a withdrawal period has been extended following the precautionary principle e.g. based on new residue depletion data for the same or a similar product or based on the reanalysis of existing data and there is no evidence from current residue surveillance programmes of a problem, it is unlikely that residues will be present or detected in produce above the MRL. In these circumstances, and as long as the farmer has not been advised to follow a longer withdrawal period by the Veterinary Surgeon or a Suitably Qualified Person (SQP), the farmer should use the withdrawal specified on the pack of product which was the source of the administered dose.
Occasionally, extended withdrawal periods may only be applicable to new batches of product, for example following a change in the formulation. The VMD and Marketing Authorisation Holder will announce where this is the case. If in doubt they can be contacted to check if this situation applies.
To check the current approved withdrawal periods for a product please refer to the Summary of Product Characteristics which can be found on the product information database (which is the definitive source of authorised product information).
Q. If a withdrawal period is shortened when should the shorter withdrawal period be observed?
Farmers may use the reduced withdrawal period as soon as the announcement is made, except in exceptional circumstances where the announcement clearly specifies that the shorter withdrawal period only applies to newly manufactured batches of product.
Q. When the withdrawal period is shortened, what can the company do to communicate this to farmers and prescribers?
It is acceptable for the company to advertise the change in withdrawal period and to distribute the new SPC with the reduced withdrawal period to prescribers and farmers to avoid an unnecessarily long withdrawal period.
Q. When the distribution category of a product changes, at what point may the product be distributed according to the new route?
Product may only be distributed according to the distribution category which appears on the packaging of the relevant batch. It is important to adhere to this to avoid any potential confusion at wholesalers, distributors or retailers. Product may therefore only be distributed according to the new route when that change is indicated by the new distribution category appearing on the label.