(including those using Mutual Recognition or Decentralised Procedures) has now been published within Eudralex Volume 2B in pdf and Word formats by the European Commission’s Health and Consumers Directorate-General and is available for use.
As from 1 July 2013 when the Republic of Croatia joins the European Union the form can also be used for MA applications to include this new Member State which has the code HR.
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Title: On the Background, Content and Detail of Module 3 of the Common Technical Document (CTD), the ‘QUALITY MODULE’ being held on 2-3 July 2013 at the Royal Society of Chemistry, Burlington House, Piccadilly, London
Do not delay too long to book your place as numbers are limited!
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What is a medicine? What is a cosmetic, a food, a food supplement, a device? What happened to unlicensed herbal remedies? Do you have a product which you think might be considered a borderline substance, somewhere between a number of the above classes?
What is a disease?
You will find helpful information about the UK’s position on these subjects in the revised MHRA Guidance Note No. 8
The document is not a complete or definitive statement of the law and it is not intended as a substitute for legal or other professional advice but you might be surprised about what you learn.
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On the Background, Content and Detail of Module 3 of the Common Technical Document (CTD), the ‘Quality Module’
2-3 July 2013 Royal Society of Chemistry, Burlington House, Piccadilly, London W1J 0BA, UK
Much change is happening in the pharmaceutical licensing arena and the course will reflect the latest news and requirements.
Some major new developments evolving this Spring and early Summer are connected with the Falsified Medicines Directive (FMD).
There are new rules for manufacturing, importing, placing on the market, and the wholesale distribution of medicinal products in the European Union (EU). There are new rules relating to active substances and certain excipients.
Substances for pharmaceutical use and dosage forms are affected by the FMD. Many are sourced from outside the EU, adding enormously to the need to operate with GMP and GDP procedures that are fit for purpose in EU eyes!
Compliance and verification are both going to be big challenges and will add substantially to the costs that companies, who shoulder most of FMD implementation burden, have to bear.
We aim to deliver high-quality training to help you play your part in your company’s compliance work.
Here you can access our course-booking procedure.
Place numbers are limited, they really are! So don’t delay if you want to secure your booking.
We look forward to welcoming you at the course.
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March 2013 EMEA-H-19984/03 Rev 28 Patient Health Protection
This guidance document addresses many questions which marketing authorisation holders (MAHs) may have on post-authorisation procedures.
It provides an overview of the Agency’s position on issues that are typically addressed in discussions or meetings with MAHs in the post-authorisation phase of the drug product life cycle.
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March 2013 EMEA/CHMP/225411/2006
Committee for Human Medicinal Products (CHMP)
Yet more EMA Procedural advice for another target audience, intended as an overview of the EMA position on issues that are typically addressed during the course of Pre-Submission Meetings.
Filed under Uncategorized
Committee for Human Medicinal Products (CHMP) March 2013 EMA/940451/2011
This document addresses a number of questions which users of the Centralised Procedure may have with regards to similar biological medicinal products. It provides an overview of the EMA position on issues that are typically addressed during the course of Pre-Submission Meetings.
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