Obtaining the necessary documentation for importing comparator products into Europe can be a complicated business. BAP Pharma, a specialist supplier of comparator products for clinical trials, explains what considerations need to be taken into account, and how problems can be overcome.
When sourcing comparator products for clinical trials, the documentation that will be provided from the manufacturer needs to be considered. For large clinical trial programmes, a central or regional sourcing model will often be used to avoid the challenges and risks associated with sourcing products in multiple local markets. Such models may require transportation of comparators across international borders and, to do this, local regulations and guidelines need to be understood and adhered to.
Countries that issue import licences will often require manufacturing site information and documents like a certificate of analysis and/or a batch release certificate for the licence application. In some instances, further information or documentation may be required - for example, secondary site of packaging and testing.
To import comparators from outside Europe for use in the EU, a company is required to have an MIA (IMP) licence, which in turn requires them to employ a named qualified person (QP) as defined in Article 13 of EC Directive 2001/20/EC, who can certify the products. The QP will require sufficient evidence to be adequately assured that the batch of product being imported has been manufactured to equivalent standards of EU good manufacturing practice.
In addition, local regulatory authorities and organisations running clinical trials may have their own documentation requirements.
It is essential therefore that the documentation which can be obtained when purchasing medicinal products is not an afterthought but a key consideration in the planning stages of comparator sourcing.
Before importing products for clinical trials, BAP Pharma ascertains the requirements for obtaining the documents its clients need and assesses the supply route on a case-by-case basis. In the following case study, a robust solution was put in place when a BSE/TSE statement (a document that certifies a product is free from bovine spongiform encephalopathy and transmissible spongiform encephalopathy) could not be obtained.
BAP Pharma was contacted to source a vaccine from the US for supply as a comparator product for a clinical trial within Europe. A source of the vaccine was confirmed through an established wholesale dealer located in the US who purchased the vaccine directly from the original manufacturer.
Dr Bashir Parkar, owner and managing director of BAP Pharma, says: "Sourcing comparator products via a short supply chain - where all parties are known - significantly reduces the risk of purchasing a falsified medicine, compared with purchasing through a broker or parallel trader."
When sourcing material from outside Europe, the BSE/TSE statement of compliance can prove difficult to obtain. In the US the BSE/TSE evaluation forms part of the new drug application submission so it is not always provided as a statement from the manufacturer. In this case, there was no certificate available. BAP Pharma's solution for overcoming this challenge was to obtain sufficient information from the manufacturer to conduct a risk assessment with BAP Pharma's QP and the sponsor QP, alongside the continuous involvement of the UK competent health authority. This was done to assess the information obtained for BSE/TSE and make a decision on whether sufficient information was available to allow for QP certification. Performing a risk assessment for this activity is atypical, but BAP Pharma worked closely with the UK competent health authority to confirm that such a risk assessment could provide a robust solution to the challenge.
This import activity also required a QP technical agreement to be in place between BAP Pharma and the sponsor organisation to define the specific roles and responsibilities for the QP certification.
Despite the process being complex, and involving the movement of the goods across international borders, BAP Pharma was able to use its expertise and network to ensure the products arrived on time and in perfect condition.