Annex
2 to EU GMP has recently been updated. This is: “Annex 2 Manufacture of
Biological active substances and Medicinal Products for Human Use.” This came
into effect on 26th June 2018.
Annex
2 of the GMP Guide has been revised as a consequence of the adoption of the
Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal
Products pursuant to Article 5 of Regulation (EC) 1394/2007 of the European Parliament
and of the Council of 13 November 2007 on advanced therapy medicinal products and
amending Directive 2001/83/EC and Regulation (EC) No 726/2004.
Please
note Annex 2 is no longer applicable to Advanced Therapy Medicinal Products to
which applies the Commission guideline on Good Manufacturing Practice for
Advanced Therapy Medicinal Products, published in Part IV of Eudralex Volume 4
and operational as of 22 May 2018.
Posted by Dr. Tim Sandle,
Pharmaceutical Microbiology