Ensuring EU GMP compliance
TO resolve the issues if your Manufacturing site of your API , Finished product or batch release site is located in the UK , PharmaConsult can provide the solution to meeting the following regulations
- Active Pharmaceutical Ingredients; Directive 2001/83/EC and Directive 2001/82/EC state that manufacturing authorisation holders are obliged to use, as starting materials, only active substances that have been manufactured in accordance with the detailed guidelines on GMP for starting materials. In addition, pursuant to Article 46b(2) of Directive 2001/83/EC, active substances for medicinal products for human use shall only be imported in the Union (EEA) if, inter alia, the active substances are accompanied by a written confirmation from the competent authority of the exporting third country which, as regards the plant manufacturing the exported active substance, confirms that the standards of good manufacturing practice and control of the plant are equivalent to those in the Union (EEA).
- Finished Goods ;The competent authorities of the Union (EEA) shall ensure that the import of medicinal products into their territory is subject to an authorisation in accordance with Article 40(3) of Directive 2001/83/EC and Article 44(3) Of Directive 2001/82/EC. The authorisation is granted when a number of conditions, as defined in Articles 41 and 42 of Directive 2001/83/EC and Articles 45 and 46 of Directive 2001/82/EC, are fulfilled (e.g. availability of a qualified person within the Union (EEA), GMP inspection)
- Batch Release; In accordance with Article 51(1) of Directive 2001/83/EC and Article 55(1) of Directive 2001/82/EC, the qualified person of the manufacturing and importation authorisation holder is responsible to certify that each batch of medicinal product intended to be placed on the EEA market was manufactured in accordance with EU GMP requirements and the marketing authorisation. The batch release site has to be located in the Union (EEA).
In all of the above cases PharmaConsult can assist in generating a legal entity in Europe from which we can provide a Qualified Person for releasing imported /manufactured API’s and Finished products which will meet all the EU regulations