Many countries are applying increasingly stringent conditions to the importation of biological materials. These countries typically require an import permit to accompany the goods, certifying that the items comply with the local regulations. This permit has to be obtained from the national authorities by the importing organisation. NIBSC is using its best efforts through the World Health Organization (WHO) to obtain a dispensation for standards and related products to assist importation but a global resolution cannot be expected soon.
Where appropriate we recommend that you request the permit using phrases such as:
We also recommend that you avoid using phrases such as:
Please do not refer to the product number in the licence application as we may on occasion have to supply an alternative or replacement product.
Where you are unable to obtain an import licence which matches the product description provided, we cannot provide any different information. You will have to negotiate with your national authorities.
For the USA, staff at the port of entry may request that our reagents are classified under the FDA National Drug Code system. The FDA has confirmed that this system only applies to prescription drugs and insulin products for commercial distribution. Therefore these regulations do not apply to NIBSC products. This problem has reduced in recent years but to be safe NIBSC recommend that US customers obtain a statement of exemption from their local FDA office to accompany any import permit.
If you cannot obtain a suitable licence, then we do not recommend shipping the product as it is likely to be detained at the port of entry and destroyed or returned.