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The globalisation of the manufacture of human and veterinary medicinal products has brought both benefits and a wide range of challenges. This paper is concerned with challenges related to the maintenance of appropriate transit conditions during transport as products move through all stages of the manufacturing and wholesale distribution system from active substance through the wholesale distribution system to ensure that patients and animals receive safe and efficacious medicinal products. The current guidance (CPMP/QWP/609/96/Rev2) was written in 1996 and revised in 2003, during this time significant changes continued to occur in the globalisation of manufacture with a consequent increase in the complexity and vulnerability in the supply chain.

There is a lack of clear guidance on the regulatory expectations for ensuring that medicinal products and APIs are not damaged during transportation. In order that products are fit for their intended purpose, including the ability to tolerate the range of expected storage conditions during use by patients or use in animals, simple and risk-based guidance is required for the transport. Such guidance needs to cover cold chain and non-cold chain products and all of the different stages of manufacture, importation and distribution.

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Organisations and/or individuals that commented on the draft Reflection Paper as released for
public consultation on 6 November 2008 until March 15th, 2009.
Organisations and/or individuals
1 Association of the European Self-Medication Industry (AESGP)
2 Kooperation Phytopharmaka, Germany
3 Association of Natural Medicine in Europe (ANME e.V.)
4 German Pharmaceutical Industry Association (BPI)

Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my 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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Sign up for the most value add free newsource you can get for free. We spend a huge amount of time and effort monitoring the main drug / device regulators websites for changes in the regulatory environment, and capture between 20 and 40 new regulattions, rules and initiatives each month, and summarise them in a fantastic FREE monthly Regulatory and Market Round Up. You can Un-Subscribe at any time and we don not share your details with anybody. You can’t afford to miss out on this service. Just fill in the form below.

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“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”