Berlin: (hib/PK) The federal government defends the handling of therapy allergens against criticism from the Union faction. The demand that non-approved therapy allergens or those in the process of being re-approved should be withdrawn from the market before the end of the transition period provided for in the Therapy Allergen Ordinance (TAV) due to a lack of effectiveness is not justified, the answer says (20/7056) of the Federal Government on a small inquiry (20/6620) of the CDU/CSU parliamentary group.
If there are justified doubts about the approval of individual TAV preparations or if study data are not submitted by the set deadline, the Paul Ehrlich Institute (PEI) has the option of refusing to extend the deadline or refuse to release further batches. The PEI makes use of these options in such cases. Irrespective of this, as with other medicinal products, unauthorized individual formulations could be prescribed and used.