After the approval of the draft of the new Commission Directive amending regarding advanced therapy medicinal products, Annex I to Directive 2001/83/EC, the draft Directive was put to vote at a meeting of the Standing Committee on Medicinal Products for Human Use.
Now the Directive enters a three months examination period by the European Parliament and Council before it can be formally adopted by the Commission and becomes effective.
The text which is set out in the Annex of this Directive will replace the Part IV of Annex I to Directive 2001/83/EC. The Directive is concerned with requirements for all Advanced Therapy Medicinal Products with elaborations of the specific requirements for Gene Therapy Medicinal Products, Somatic Cell Therapy Medicinal Products, Tissue Engineered Products and Products containing Devices.
In Article 2 is stipulated: "Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by six months from entry into force at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.
When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made."
More details about the Directive you will find here.
Axel H. Schroeder
On behalf of the European Compliance Academy (ECA)