References in periodicals archive ?
Food and Drug Administration and has filed in Europe in August 2008, using the decentralised authorisation procedure.
The market authorisation procedure for the ORALAIR(R) Grasses allergen tablet by the P.
The next key date is June 1, 2009, when the second pillar of REACH, its special authorisation procedure saying how chemical substances deemed particularly hazardous can or cannot be used comes into force.
Meanwhile, the court has declared an illegal restriction of trade France's insistence on a prior authorisation procedure for imported homeopathic medicines lawfully sold in other EU member states.
Another key date is June 1, 2009, when the second pillar of REACH, its special authorisation procedure saying how chemical substances deemed particularly hazardous can or cannot be used comes into force.
THE EUROPEAN Parliament today (Wednesday 10-7) voted for more openness within a proposed common European Union (EU) authorisation procedure for food additives enzymes and flavourings: "any decisions and the reasons behind them must be made public", said MEPs.
Orphan drug designation provides protocol assistance from the EMA during the product development phase, specific scientific advice and direct access to the centralised authorisation procedure.
A single authorisation procedure for clinical trials will be introduced that will be performed electronically via a new EU portal.