Laws and regulations
As we have seen, congenital atransferrinemia is a disease treated with apotransferrin, which is currently not regarded as "medicine in investigation".
Nevertheless, it is possible to have apotransferrin produced if one gets special permits from the Health Authorities, and some rules and procedures are followed in the production process.
In the European Union there exist rules governing medicinal products. They comprise pharmaceutical legislation, quality guidelines , good manufacturing practices and pharmacovigilance.
In Spain, if you take a look at the rules mentioned above, they are applied in the national legislation by the Royal Decree 223/2004 , the Circular 15/2001 about clinical assays and the same rules governing medicinal products
According Spanish Laws it is possible to get import and production permits for special cases such as the compassionate use treatments (Law of the Medicine Products among others). Liabilities about medicine import and suitability are regulated under Spanish Law and seeking the patient benefit (Legal opinion )
Therefore, it is easy and feasible to get apotransferrin production permits in the frame of a compassionate use treatment, specially when they are related to a single patient and when apotransferrin import permits have been authorised.