The revised Ordinance on Fees for Therapeutic Products became effective in Switzerland on 1st January 2013. Swissmedic has now published detailed information regarding the submission of Plasma Master Files under the new regulation.
Even though Switzerland is no member of the EU, the Guideline on plasma-derived medicinal products of the European Medicines Agency (EMA) also applies to medicinal products in Switzerland which contain proteins from human plasma as API, excipient or raw material in the manufacturing steps.
The documentation regarding the origin and the control of the collected human plasma as starting material needed for the manufacture of medicinal products can be submitted as Plasma Master File (PMF). The PMF is an independent documentation which may be used at the same time for different preparations. There may be several PMFs for one preparation. The documentation regarding the origin and the control of the plasma must comply with the requirements of EMA's Guideline on scientific data requirements for a plasma master file (PMF).
Switzerland and, accordingly, Swissmedic are not affiliated to the certification procedure of the EMA with regard to the control of PMFs but their contents and scientific requirements are based on the relevant EMA Guidelines.
Further details can be found in the edition 11/2012 of the Swissmedic Journal.
Note: A new international conference on "Blood, Blood Products and Plasma - Quality and Safety" will take place in Vienna, Austria, on 9 and 10 April 2013.