European Directive on Transitional Qualified Persons for Herbal Medicines
The draft Directive on Traditional Herbal Medicinal Products (THMPD) widens the scope of existing EC legislation to bring certain herbal medicines under Directive
2001/83/EC1 (http://pharmacos.eudra.org/F2/eudralex/vol-1/home.htm). Specifically Article 16(g)1 of the THMPD applies Articles 49-52, of Directive 2001/83/EC to the activities of manufacture and importation (from a third country) to certain herbal medicines. Any company that manufactures and/or imports, or intends to manufacture
and/or import certain herbal medicines will require either a manufacturers licence or wholesale dealers import licence respectively, authorising such activities, that names
a Qualified Person (QP)
A QP has a personal responsibility for ensuring that the required tests and controls are carried out and must sign or certify, for each batch, that the appropriate tests have been carried out and that it complies with the relevant marketing authorisation, product licence or herbal registration and has been manufactured in accordance with Good
Manufacturing Practice. The QP must ensure that the register or record is regularly maintained and that entries are made as soon as practicable after each batch has been
manufactured and before the batch is released for sale.
If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com
Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.
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