What is meant by Regulatory Compliance?
Biocair deal 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.
What are the difficulties of ensuring regulatory compliance?
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.
Who sets these regulations?
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.
What are the consequences of non-compliance?
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 offer regulatory advice as part of our standard shipping service. Specific regulatory advice can also be provided as a separate service.
What's the worst that could happen?
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.
Can you give an example of the areas that would be regulated when considering the transport of pharmaceutical, biotechnological and medical research material?
An example of some of the types of regulation / standards applicable locally, nationally and internationally would be:
- dangerous goods
- agricultural (plant and animal health)
- human health
- controlled drugs
- export control
- customs / trade compliance
- endangered species
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.
I am planning a study containing animal products, do I need to contact Biocair?
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.
Are materials controlled for export out of the UK or other countries?
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.
Do Biocair have a licence to move "controlled drugs"?
Biocair are 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.
What is a "consignor's certificate"?
A document required for road transport of radioactive materials within the UK. Biocair can provide one of these for you.
What is MSDS?
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.
Do I need to consider licenses if my shipment is being exported to an EU country?
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.
I need to move the entire contents of my lab, including machinery, where do I start?
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.
My antibodies have been produced using commercially available cell lines; do they still require import licences?
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.
What licenses are required for shipments?
As with any aspect of regulatory compliance, the license requirements will depend upon the following criteria:
- Nature of the material
- Country of origin
- Final use
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.
How do I apply for a license?
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.
How does regulatory compliance affect the transit time of a consignment?
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.
What information is required to ensure that a consignment is shipped in a compliant manner?
In brief, the following information should always be supplied to ensure that the applicable regulations can be provided:
- Nature of the material
- Country of origin
- Final use
- An MSDS/ details of any associated hazards
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.
What is CITES?
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.
Why are there three appendices to the CITES agreement?
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.
Is the movement of CITES material restricted within the UK?
No. No licences are required.