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Have a look at some of the most frequently asked questions relating to compliance, including:
Biocair deals with regulations that govern the transport, import and export of materials associated with the pharmaceutical, biotechnology and medical research communities, so when we refer to Regulatory Compliance we mean that we work to and abide by those regulations, as well as industry, client and our own internal standards.
The difficulty in ensuring regulatory compliance lies in the sheer volume of regulation. There are local, national and international regulations; regulations that govern the transport of material; regulations that govern the export of material; regulations that govern the import of material, and all of these regulations are subject to constant change.
Each country’s government body will produce its own set of regulations. Hence each countries import and export regulations will be different. One material could be imported under several different government bodies, for instance a clinical trial drug containing animal products would not only be legistlated by “animal health” departments but also “drug development” deparments.
The main consequences of non-compliance depend upon which regulations have been breached. The consequences can range from delay to a consignment, which is particularly significant for temperature sensitive items, to destruction of samples, large fines and prosecution. It is therefore imperative that you are sure which regulations need to be observed with any consignment.
Biocair Note: Biocair offers regulatory advice as part of our standard shipping service. Specific regulatory advice can also be provided as a separate service.
For temperature sensitive shipments a delay in customs could result in degredation if they have not been correctly packed. In more serious cases if the appropriate documentation cannot be provided your shipment could be impounded and destroyed. If your company is found to be knowingly exporting/importing illegal shipments it could be prosecuted, the prosecution could lead to large fines or possibly even imprisonment.
An example of some of the types of regulation / standards applicable locally, nationally and internationally would be:
Regulations change for different countries, even different ports into the country. These import reglations can change monthly. For instance if a country has had an outbreak of “ foot and mouth” disease they will find it difficult to export products containing bovine material (even FCS or BSA) to countries where there is a thriving beef trade. It is always wise to check with the specialist courier first.
We can advise you regarding different permits required. A change to the constituents of a nutrient broth could negate the need for a permit, it’s always wise to check first.
Yes some goods may require an export licence, such as CITES material, some pesticides and materials that are controlled under anti-terrorism and warfare laws. Biocair can advise you on export requirements.
Biocair is a courier company, as such we do not require a licence to move controlled drugs. The shipper/consignee must apply for the licences to move the materials. Biocair will need to see a copy of this licence before the shipment can commence, as there may be certain conditions that concern transport.
A document required for road transport of radioactive materials within the UK. Biocair can provide one of these for you.
An MSDS is a Material Safety Data Sheet. It is a form with data regarding the properties of a particular substance. It is intended to provide workers and emergency personnel with procedures for handling or working with that substance in a safe manner, and includes information such as physical data, toxicity, health effects, first aid, reactivity, storage, disposal, protective equipment, and spill-handling procedures.
Why are you asking for an MSDS?
Biocair will need to classify your material for transport. Often the information for classification or the classification itself can be found on the MSDS. If the shipment is hazardous, we will require a copy of the MSDS to pass to our Emergency Responders.
Many EU countries have their own import requirements which sit alongside EU regulations. Some materials will require licences wherever they are sent. It is always wise to check with Biocair.
Laboratory moves are extremely complicated as they often involve multiple hazards (including hidden ones), multiple temperature requirements, varying packaging requirements and licencing needs. Biocair have years of experience in laboratory moves, we can help you through this minefield.
It is likely that they will, depending on where they are going, nutrient media used and type of cell line. Biocair can guide you through the process of licence application.
As with any aspect of regulatory compliance, the license requirements will depend upon the following criteria:
Each of these aspects will affect which regulatory agencies are concerned with the consignment and consequently what licenses and/or documents will be required.
Biocair Note: Biocair offer specific regulatory advice dependant upon these details.
The application process for licenses will vary depending upon the country of origin and destination. Some regulatory agencies offer electronic submissions services, whereas others require hardcopy applications.
Biocair Note: Biocair can offer advice as to the application process dependant upon the spcific licenses required.
The specific regulations associated with a consignment could lead to an increase in transit time in some cases. Some countries have extremely rigorous controls associated with the regulatory and customs clearance process, and as such, clearance can sometimes take slightly longer.
Biocair Note: Biocair will provide full information as to expected transit times if this is affected by any aspect of regulatory compliance.
In brief, the following information should always be supplied to ensure that the applicable regulations can be provided:
Further required details will depend upon these factors.
Biocair Note: Biocair will use the provided information to identify the appropriate regulations prior to shipping. Specific information will be requested in compliance with the regulations.
CITES stands for the Convention on International Trade in Endangered Species (Flora and Fauna) and is an international agreement between governments controlling the transport of materials taken from rare animals and plants.
Appendix I lists animals which are extremely rare, while Appendix II lists animals which are rare but not as endangered as those on Appendix I. Appendix III contains species that are protected in at least one country, which has asked other CITES Parties for assistance in controlling the trade. Changes to Appendix III follow a distinct procedure from changes to Appendices I and II, as each Party is entitled to make unilateral amendments to it.
No. No licences are required.