Consultation Paper Proposals to Boost MHRA Authority Against Counterfeiters
The MHRA has published for consultation a proposal to better control the movement of medicines throughout the legitimate supply chain. Some of the provisions of the document provide for:
• An applicant for a Wholesale Dealer’s license demonstrate that he/she is a “fit and proper person” to undertake such a role, with minimum requirements to be set out in guidance
• A disclosure is made by applicants of relevant criminal records
• Enabling the MHRA to decline a Wholesale Dealer’s license if an applicant discloses a relevant criminal conviction
• Introduction of a “due diligence” obligation into the legislation, with a requirement to notify the MHRA of suspicious events
The consultation deadline for responses is March 12, 2010.
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European Medicines Agency Requests Comment on Road Map Initiative
The European Medicines Agency has published a draft paper outlining its vision for the strategic development of the Agency for five years to 2015.
Building on the previous strategy paper of 2010, this paper, called The European Medicines Agency Road Map to 2015: The Agency’s Contribution to Science, Medicines, Health, chart’s the future direction of the Agency through developments in medical science and pharmaceutical research. It also looks at the evolution of the European and international regulatory environments.
Comments should be sent using the Agency’s comments form by April 30, 2010 to roadmap@ema.europa.eu.
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European Medicines Agency Consults Toxicological/Pharmacological Experts Regarding Dedicated Facilities Policies
The European Medicines Agency is making progress in its effort to align its dedicated facilities policies with the ICH guidance, Q9, Quality Risk Management, according to a recent update.
The Agency is looking to clarify the dedicated facilities language in the existing GMP guide. Specifically, Chapters 3 (Sec. 6) and 5 (Sec. 18, 19) were singled out in a 2005 Concept Paper as lacking clarity with respect to when a medicinal product should be manufactured in dedicated, self-contained facilities.
In looking at the different aspects of the issue, an Agency drafting group has received input from toxicologists and pharmacologists. The Agency recommends companies also consult with toxicologists whenever introducing a product into a shared facility for product types covered by GMP Annexes that do not contain language on dedicated facilities. Currently, only new draft Annex 2 (biologicals), which is due out for comment later this year, and Annex 4 (veterinary products) address this issue.
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European Commission Regulation Expands Variation Application Procedure to Mutual Recognition and Centralized Procedure
An application form for variations to a marketing authorization for medicinal products will now be used in the mutual recognition and the centralized procedure in accordance with Commission Regulation (EC) No. 1234/2008.
This variations regulation aims to establish a simple, clearer and more flexible legal framework for variations to marketing authorization while ensuring a high level of protection of public and animal health.
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