Yesterday the amendments on the Directive EC 2001/83/EC to combat counterfeit medicines (The Pharma Package) have been discussed in the European Parliament. Today, the EU Parliament adopted the amendments with an overwheling majority of votes.
The proposed amendments, which will have to be transferred into national law within two years include
- introduction of safety features (serial numbers and/or tamper-evident seals)
- more stringent rules for importation of APIs
- better controls of the supply chain (traders and wholesalers)
- Rules for the internet sale of medicines
- Harmonisation of GMP inspections
The wording in the official text which was under discussion yesterday may need further interpretation - see also our GMP News from 2. February 2011. More information on how the requirements will have to be implemented (e.g. the safety features) are expected to be published by delegated acts. Working groups already started to work on papers with a higher detail level. A possible problem is the timeframe for implementing requirements from the delegated acts which does not match the time schedule for implementing the directive into national law.
The New Directive on Falified Medicine will have a major impact on everyone involved in manufacturing and quality assurance of medicinal products, APIs and Excipients. The ECA plans to cover this important development at future conferences. The 4th European GMP Conference will take this important issue into account and will add a key note presentation on the consequences of the new Directive. Please find the programme at www.gmp-conference.org.
For further information please also see the final draft from 17 December 2010 (which is nearly identical to the final document).
Also, join todays press conference with the raporteur of the Directive, MEP Marisa Matias, scheduled from 14.30h - 15.00h. If you are further interested in learning more about the debate in the Parliament please view this video. Please select falsified medicinal products in the list of subjects (box on the right hand side) after you opened the website.
Dr Robert Eicher
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)