1. Product is imported from the USA and tested and released in the UK. Baltic countries perform overlabelling and are proposing a local release. Is this acceptable?
2. Regarding temperature records for product imported from Third Countries, if there are excursions above 40oC, does the MHRA expect stability studies to be performed above 40oC?
3a. A Centrally Approved product is QP certified in the UK. Does all the stock for this product have to come into the UK before it can be sent to other EU markets?
3b. What are the expectations for the QP whereby product is QP certified in the UK but stocks are sent direct to another EU country?
5. Can product manufactured in the US be imported to the UK but tested in Switzerland?
6. What are MHRAs expectations of importation for export?
1. Product is imported from the USA and tested and released in the UK. Baltic countries perform overlabelling and are proposing a local release. Is this acceptable?
The UK QP can only certify against a marketing authorisation. If further labelling is required to meet the requirements of local markets then the certification carried out in the UK is only partial. Further certification against the local marketing authorisation would need to be done. The requirements of local legislation would need to be met.
2. Regarding temperature records for product imported from Third Countries, if there are excursions above 40oC, does the MHRA expect stability studies to be performed above 40oC?
Product should be transported under appropriate conditions and in accordance with the storage conditions described on the product label. For example, if a product is labelled as store below 25°C, it should be stored and transported to comply with this. Any excursions outside the labelled conditions which occur during shipment should be treated as a deviation with appropriate impact assessment and actions to prevent recurrence. Stability data should not be used to justify poor transportation practices. As part of assessing the impact of an excursion, prior to certification the QP should understand the stability profile of the product. In order to make this assessment it would be prudent to have data available covering the stressed conditions.
Please refer to 'Class 2 Drug Alert (Action within 48 hours): Karib Kemi Pharm Ltd - Multiple product Drug Alert - EL (09)A/23' for an example of what can go wrong.
These principles are also be applicable to the transportation of API's.
3a. A Centrally Approved product is QP certified in the UK. Does all the stock for this product have to come into the UK before it can be sent to other EU markets?
It is not necessary for all stocks to enter the UK; however measures should be in place to ensure QC testing performed in the UK is representative of the whole batch, regardless of its final destination. Product imported into other member states must go into an appropriately authorised site and the UK QP will need to receive confirmation from that site QP of the safe arrival of the batch (identity, quantity, temperature records, and physical condition) prior to certification. It is necessary to ensure that adequate sampling and retention samples are in place. This may include multiple pack outs and each would need to be individually certified. Reference Annex 16: 4.2-4.5; 6.1-6.3.
3b. What are the expectations for the QP whereby product is QP certified in the UK but stocks are sent direct to another EU country?
The QP should have all the relevant information and samples required before certifying the batch, including a copy of the relevant excerpts from the relevant EU MAA for each market. The receiving site should confirm to the QP in the UK that stock has arrived in a suitable condition before the QP certifies the batch. Also please refer to answer A3 above.
5. Can product manufactured in the US be imported to the UK but tested in Switzerland?
No, the site of testing after importation should be in the EEA and be named on the marketing authorisation.
6. What are MHRAs expectations of importation for export?
This is not currently a licensable activity under UK legislation but is being considered as part of the EU Commission recommendations to reduce counterfeiting therefore there may be future implications.
